a publication by medical technology investment digest · 2007. 9. 18. · | medical technology...

PROGRESS REPORTS

REGIONAL REPORT: ST. LOUIS, MO

UROLOGY FOCUS

In developing its life sciences sector, St. Louis is looking back to its strong economic roots for guidance.

Acorn Cardiovascular, ATS Medical, Chembio, CNS Response, Endocare, HemCon, ISTO Technologies, Minrad, NovaDel, PercSys, PhotoMedex, Small Bone Innovations, SyntheMed

ORTHOPEDICS UPDATE EVENTS

The List: 110 Urology Companies to Watch

Industry Trends

StereotaxisKereosSynergeticsGridlogix

Profi les Interviews

Profi les Interviews

ISTO TechnologiesTranS1ClearantJuvent

Profi les

St. Louis, MO

Regional Report

UROLOGYCOMPANIESTO WATCH 110

page 38

Medical TechnologyInvestment DigestQuarterly Digest of the Medical Technology Companies Shaping the Future Fall 2007

AdvaMed 2007

SPECIAL ISSUE

A publication by

Feature

PROFILES & INTERVIEWS

38

EnvisioneeringSRS MedicalPercSysIkonisysColby Pharmaceuticals

Acorn CardiovascularSymphony MedicalTimothy Sullivan, Mystic PharmaceuticalsRobert Hickey, SyntheMed

Robert Calcaterra, Nidus CenterDaryl Tegtmeier, Lincoln FinancialFrank Stokes, Innovate St. Louis

Craig Davenport, Endocare

3327

37

5663

6

20

323130

34

444342

4548

51

545352

55

171513

19

49

46 Cathy Naughton, MD, Center for Sexual Health

AdvaMed 2007Schedule of Events

page 20

www.onemedplace.com | Medical Technology Investment Digest 3

For subscription information, visit www.medtechdigest.com

OneMedPlace219 E. 83rd St., New York, NY 10028

(212) 734-1008

President Brett Johnson

Vice President of Development Cynthia Haines, MD

Director of DevelopmentAmy Thomas, MD

Vice President of SponsorshipsLaurie Gatch

Chief Information Officer Chris Scrivo

Director of Technology Maegan Dolan

Finance Director Wayne Thompson

Volume 3 / Fall 2007

Medical Technology Investment Digest

NOTE: Companies appearing in Medical Technology Investment Digest are existing or prospective members of OneMedPlace, an organization funded principally by membership fees. While it makes every effort to perform fact checks, OneMedPlace does not guarantee the accuracy of statements made by its member companies.

Medical Technology Investment Digest is published quarterly by OneMedPlace, a

communications firm that facilitates the flow of information about emerging healthcare and life sciences companies to investors, strategic partners and customers throughout the world.

Editor-in-Chief Sara Calabro

Executive Editor Brett Johnson

Art Director I-Ying Yvonne LiaoAssociate Editor

Douglas CressResearch Manager

Prakash PotodiaResearch Associate

Charlotte ReardonSenior Analyst M. Anand Chary

Copyright © 2007 OneMedPlace. All rights reserved

Editorial Advisory BoardRhett Drugge, MDEve Leeman, MD

Kerry Sulkowicz, MD

Gregory Bailey, MDJohn de Csepel, MDJoseph DiTrolio, MD

Sara CalabroEditor-in-ChiefOneMedPlace

Look forward to seeing you there,

Editor’s Letter

ver the past three months, the OneMedPlace community has grown exponentially. Reflecting that, this fall issue of Medical Technology Investment Digest includes nearly 200 emerging medical technology

companies from a variety of clinical areas and regions. One particular region -- St. Louis, MO -- is explored at length, in our first

regional report (see page 20). Shortly after initiating coverage of the Midwest region in our summer issue, St. Louis emerged as a likely place to concentrate our efforts, to find and provide exposure for the city’s many promising, undiscov-ered medical technology firms. Inside you’ll find a feature article on the region’s economic development, interviews with local executives, profiles of med tech com-panies, and a list of close to 50 additional firms located in and around St. Louis.

Look to forthcoming issues for regional foci on other cities -- we’re currently looking at Cleveland, OH, and cities in the Southern California region.

Clinically, we take a close look at urology. We’ve identified 110 companies working in the space (page 38), including five for which we’ve done full-page pro-files. Also included is an interview with one of St. Louis’ two – yes, two! – female urologists, Dr. Cathy Naughton, who spoke with us about her soon-to-open Center for Sexual Health.

And as a follow-up to last issue’s extensive coverage of orthopedics, we’ve in-cluded a sector update, along with full profiles of four ortho companies.

We’re excited to welcome aboard our newest member companies: Symphony Medical (pg. 15), Stereotaxis (page 30), Kereos (page 31), Synergetics (page 33), Gridlogix (page 34), Envisioneering (page 42), SRS Medical (page 43), PercSys (page 44), Ikonysis (page 45), Colby Pharmaceuticals (page 48), ISTO Technologies (page 52), TranS1 (page 53), Clearant (page 54) and Juvent (page 55).

All of these companies – plus the nearly 200 additional emerging fi rms that are mentioned throughout this issue – will enjoy considerable exposure. Copies are being distributed at AdvaMed 2007, a fi rst-year conference that will attract 800 senior-level executives representing 500 med tech companies from 30 states and 16 countries. The event was created, in part, to improve partnering and networking op-portunities for small-company members of AdvaMed (see story on page 56).

OneMedPlace, as a main media sponsor of AdvaMed 2007, will be hosting a video suite at the event, to conduct brief management videos with the many fi rms represented there. We’ll later stream these videos from the Stock Exchange building, opening soon, at OneMedPlace.com. So come on by and we’ll roll some tape!

OGrowth Focus, Global Reach

Shez BandukwalaGreentech & [email protected]

Joe DewsSemiconductors& [email protected]

Mihir [email protected]

Mark [email protected]

Michael Moe, CFAChairman & [email protected]

Deborah QuazzoPresident& Head of Investment [email protected]

Brian [email protected]

Chris PigottEducation & [email protected]

Steve ToberCorporate& Business [email protected]

Rick [email protected]

4 Medical Technology Investment Digest | A OneMedPlace Publication www.onemedplace.com | Medical Technology Investment Digest 5

OneMedPlace is a virtual city that contains the companies, technologies and ideas shaping the future of health and medicine

Stock Exchange: useful analytics and research on emerging companies

Resources Tower: organizations focused on serving healthcare and life sciences companies

Companies Building: global directory of over 6,000 healthcare and life sciences companies

www.onemedplace.com

The AdvaMed relationship will foster communia-tions among larger and smaller firms.

Leaders from the medical community are recognizing the value and merit of what we are attempting, and are lending their support.

Physicians will play an important role in develop-ment team, to help focus our energies on the companies that have clinically valid concepts.

Our first event will be held alongside one of the great-est assemblages of healthcare inves-tors and executives in the U.S., in January.

OneMedPlace: an idea borne out of the recognition that many promising private and public healthcare and life sciences companies don’t reach their highest potential simply because they don’t connect with the right investors, strategic partners and customers. OneMedPlace is addressing this issue by creating an effi cient communications platform for these fi rms and a community of those producing the companies and technolo-gies which will shape the future of health and medicine.

The community is growing and getting stronger. We are particularly excited about our recent alliance with AdvaMed. It is gratifying to have the world’s largest trade organization—representing 90% of the medical technology sold in the U.S. and 50% worldwide—recognize the value of our communications platform for emerging medical technology companies.

We are also excited about promoting AdvaMed’s initiatives, the newest of which you can read about beginning on page 56. Ad-vaMed 2007 will, for the fi rst time, bring the diverse elements of the industry together to share information and foster partnerships. Organized by the same team that created BIO, this event will help connect its largest and most powerful fi rms with its young-est and most innovative. It is a bold, smart initiative refl ective of the energetic new management team at AdvaMed. See profi les of president Steven Ubl and chief administrative offi cer Kenneth Mendez on page 61.

The alliance between AdvaMed and OneMedPlace is designed to give AdvaMed members a powerful com-munications tool to increase their visibility and make it easy for strategic partners, investors and customers to fi nd them. AdvaMed members receive discounts on the communications services offered by OneMedPlace, including profi les in this quarterly Medical Technology Investment Digest (MTID). MTID will regularly re-port on AdvaMed’s educational initiatives and on regulatory issues important to emerging growth companies.

It is also rewarding to have attracted extraordinary leadership from the world of health and medicine to our advisory board. William Peck, MD, is the former chair of Washington University School of Medicine which he helped lead to prominence. The medical school is consistently ranked in the top four in the nation, for general excellence and in National Institutes of Health research grants. A list of his accomplishments would consume the next two pages, but to highlight, Dr. Peck’s original clinical focus was in investigations in bone and mineral metabolism. He was the founding president of the National Osteoporosis Foundation; president of the American Society for Bone and Mineral Research (1984), and chair of the Council of Deans of the As-sociation of American Medical Colleges. We are fortunate to have his insights and guidance.

We have also added talent to our development team, including two physicians. Cindy Haines, MD, our vice president of development, has built Haines Medical Communications into a leading provider of medical communications. In addition to general development work, Dr. Haines will be developing our capacity to provide to our members advanced communications services utilizing her national network of medical writers, editors and consultants. Amy Thomas, MD, joins us as director of development and will use her training and front-line clinical experience to identify and recruit the most promising medi-cal technology and healthcare companies to occupy the Companies Building at OneMedPlace. Laurie Gatch, joined our team as vice president of sponsorships. Her background in building fast-growing Internet companies will develop our Resources Tower into the most cohesive and useful resources direc-tory for emerging healthcare and life sciences companies currently available.

And at OneMedPlace we will soon be adding some powerful new tools, including databases of every medical product licensed by FDA for sale in the U.S. We are also in the fi nal design stages of our Stock Exchange, which will aggregate information geared toward investors in public companies.

Our membership is growing. We recently added 14 new member companies, some of which are profi led in this issue. These companies offer important, innovative technologies and services. Most are largely unknown fi rms. And success stories are starting to take root. HyperMed secured its venture fi nancing due to the visibility provided by its membership and profi le within OneMedPlace and MTID. And CNS Response’s recent feature in Newsweek was fostered by exposure from our co-hosted American As-sociation of Healthcare Journalists Forum and OneMedPlace video trailer. See the Psychiatry Floor in the Companies Building for more about this fi rm.

We are also adding a conference to our communications platform. Our fi rst Emerging Company fi nance meeting will take place in San Francisco during the largest healthcare investment event in the world, the JP Morgan healthcare conference, January 7-11. In addition to member-company presentations, we’ll be organizing fi nance workshops on such topics as reverse mergers, PIPEs, SBIR grants, term sheets, and intellectual property. We hope this can be a powerful tool to help our members access investors and experts and help them grow their companies to full potential.

The fact remains that many extraordinary healthcare and life sciences companies are largely unknown. It is this type of company that you can expect to fi nd at OneMedPlace and on the pages of our publications.

If you know great companies, please send them our way.

Associations Building: health and medical associations and communities

William Peck, MD Cindy Haines, MD Amy Thomas, MD

“Many promising companies don’t reach their highest potential simply because they don’t connect with the right investors, strategic partners and customers.”

Brett JohnsonPresident & Executive EditorOneMedPlace

6 Medical Technology Investment Digest | A OneMedPlace Publication

THE PULSEOngoing coverage of medical technology companies at the forefront of innovation

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ACORN CARDIOVASCULAR CARDIOLOGY Private

FDA Okays Confirmatory TrialLast month, St. Paul, MN-based Acorn Cardiovascular received conditional approval for its confirmatory trial IDE for 50 treat-ment-only patients. It anticipates enrolling the first patient in October and completing enrollment within eight months.

In May, Acorn came to an agreement with FDA to conduct a second, smaller-scale clinical trial for its CorCap cardiac sup-port device.

The company has already completed a 300-patient prospective, randomized pivotal trial, but FDA rejected its application in June 2005. Acorn requested that a dispute-resolution panel look at its case. But again the company was sent back to the draw-ing board, when the panel decided in December 2006 that more evidence of efficacy was needed for CorCap’s approval. The company has been in ongoing negotiations with FDA and its Center for Devices and Radiological Health to determine a path for bringing the device to market.

The confirmatory trial, which will involve 50 patients, will assess a patient population that demonstrated the greatest clini-cal benefit in the pivotal trial. If Acorn meets the success criteria for the confirmatory trial, it is anticipated that FDA may be able to approve the device without engaging a third advisory panel, perhaps before the end of the second quarter of 2009.

Acorn is looking to close funding for this trial and potentially another in September.

ATS MEDICALCARDIOLOGY Nasdaq: ATSI

For additional information on any of these companies, visit the Companies Building at OneMedPlace.com

Chembio has developed a new chromatographic immunoassay technol-ogy—Dual Path Platform (DPP)—for rapid diag-nostic testing of a wide variety of analytes. This technology offers signif-icant advantages over current conventional lateral flow assays

ATS Acquires Surgical Cryoablation AssetsIn June, Minneapolis-based ATS Medical acquired the surgical cryoablation business of CryoCath Technologies. ATS paid $22 million in cash at closing, to be followed by $2 million at certain manufacturing transition milestones, $2 million two years after closing, and up to $4 million based on future sales of Surgifrost XL, a treatment for cardiac arrhythmias that’s FDA cleared and CE Marked, and planned for commercial release in the second half of 2007.

The agreement includes all products under the SurgiFrost and FrostByte names. ATS has been the exclusive representative of CryoCath for U.S. sales of these products since November 2004.

“For the remainder of 2007, this transaction will add approxi-mately $3 to $5 million in incremental revenue,” said CEO Michael Dale, “and in 2008, we expect to generate approximate-ly $16 to $19 million in total surgical cryoablation revenue.”

CryoCath’s surgical cryoablation products work by creating an

intricate pattern of lesions on the surface of the heart to block inappropriate electrical conduction circuits. These conduc-tion circuits cause the heart to be less effective when pumping blood, which can lead to stroke and heart failure. What’s unique about CryoCath’s technology is that it uses cryothermy — cold — to create the lesions on the heart surface. Other devices on the market use heat, leaving CryoCath competition-free in its approach.

New CFO Appointed In August, ATS officially named Michael Kramer to its chief financial officer post. Kramer had been acting as the compa-ny’s interim CFO since February 2007. Since September 2006, Kramer was ATS’s senior director of finance. Before that, he worked for ATS as an independent financial consultant. From 2005 to 2006, Kramer was the controller of CABG Medical, a cardiovascular device manufacturer. He has also held finance posts at Ecolab and Ernst & Young.

Chembio Inks Deal with Pall CorporationChembio Diagnostics, of Medford, NY, recently signed an R&D deal with Pall Corporation for use of Chembio’s new Dual Path Platform (DPP) immunoassay. The collaboration, announced at the end of July, will involve a two-phase funded feasibility study to determine certain performance characteristics of DPP when used in conjunction with certain markers that are of interest to East Hills, NY-based Pall.

The companies did not specify the application for which Pall is conducting tests. But in the medical arena, Pall, a filtration and purification company, is involved in such things as cell sepa-ration technology, platelet-transfusion safety and developing influenza breathing filters.

Chembio’s DPP is a lateral flow technology that employs sepa-rate membrane strips for sample migration and test reagents. The design allows for complete control of the sample flow, and as a result, the immunological reaction is much more efficient than conventional single path lateral flow (SPLF) tests. These features enable improved detectability, sensitivity and specific-ity when compared with SPLF tests.

If performance of DPP during the feasibility study meets expec-tations, Chembio anticipates that the Pall partnership would proceed to negotiation of license, development and manufacture agreements.

CHEMBIO DIAGNOSTIC SYSTEMSDIAGNOSTICS CEMI.OB

CNS RESPONSEPSYCHIATRY CNSO.OB

CNS Continues Trial for rEEG TherapyCNS Response, a Cosa Mesa, CA-based firm whose biomarker system matches mental and addiction patient physiology to treatment outcomes, has dedicated its resources to pursuing a series of infrastructure goals prior to more aggressive marketing of its referenced-EEG (rEEG) technology, a system that utilizes commonly used digital electroencephalography in conjunction with a normative database and a proprietary clinical database to identify abnormal patient physiology.

Included in these events is a key ongoing clinical trial that is now being conducted at six sites. CNS will make its first prog-ress report on this trial in the fall. This trial is based on one of eight smaller trials that have shown that rEEG-guided therapy, when used in conjunction with other standard clinical informa-tion, guided physicians to successful outcomes of these mostly treatment-resistant patients. The company is confident that the current multi-site study will show similar results and further validate its technology.

CNS Featured in NewsweekCNS Response and its Reference-EEGSM (rEEGSM) platform were featured in the September 3 issue of Newsweek. The article, “Putting Brains on the Couch,” examines the pres-ent state of psychiatric diagnosis and associated medication selection, highlighting how some psychiatrists are successfully using technology to identify the proper drug regimen for their patients’ specifi c needs.

Endocare Applies for Nasdaq ListingOn August 6, Endocare, an Irvine, CA, company that uses cryo-ablation to treat different types of cancer, announced a one-for-three reverse stock split of its common stock to satisfy the minimum bid-price requirement for initial listing on Nasdaq. The company has applied for listing; pending approval, trading could commence on Nasdaq in September 2007.

In May, at the American Urological Association Annual Meeting in Anaheim, CA, it was reported that in the first North American randomized clinical trial in 25 years comparing two definitive prostate cancer treatments, after 36 months, only 6.6% of cryo-ablation patients had positive biopsy findings, compared with 26.3% of radiation therapy patients. Also presented were results from a randomized clinical trial demonstrating that cryoablation is equally or more effective as external-beam radiation in treat-ing localized prostate cancer.

Commenting on the recent findings, Endocare CEO Craig Davenport said, “The continuing flow of quality data and rising adoption of minimally invasive procedures are leading cryoab-lation into mainstream urology and, indeed, all areas of cancer

ENDOCAREUROLOGY ENDO.OB

(Read a full profile of Acorn on page 13)

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treatment requiring minimally invasive methods. Reflecting this trend, our cryoablation procedure volumes are growing at a compound growth rate of more than 30 percent a year.”

On May 29, Endocare raised through a private placement of common stock $7 million for continuing product development and expansion into the interventional radiology and oncol-ogy markets for lung and liver cancer and pain associated with metastases.

HEMCON MEDICAL TECHNOLOGIESWOUND CARE Private

HemCon Signs Deal with Cardinal HealthHemCon Medical Technologies, a Portland, OR-based wound-care company, inked a deal in July with Cardinal Health to bring HemCon’s hemorrhage-control bandages — thus far, used pri-marily by the U.S. military for battlefield trauma — to hospitals and surgery centers.

The four-year agreement is for a new line of bandages, geared specifically for non-military settings. HemCon recently reengi-neered its bandages to meet the specific needs of civilian trau-ma and emergency medicine. The new bandages, which control severe arterial bleeding, are thinner, more flexible and sized dif-ferently than the original HemCon military bandage. The tech-nology used in the bandages is particularly useful in hospital settings, because it allows providers to standardize one hemor-rhage-control solution across multiple disciplines.

Using Chitosan, an extract from shrimp shells, HemCon Bandages control moderate to severe external bleeding within minutes of being applied directly to moderate- or high-pres-sure, high-flow external bleeds. They aggressively adhere to the site on contact with blood or moisture. This adhesive-like action forms a strong, flexible barrier that seals and stabilizes the wound.

Dental Dressing Cleared in EuropeLater in July, HemCon received clearance to sell its Dental Dressing in Europe. Armed with the CE Mark, the company will begin distributing dressings in the U.K., Germany and other EU countries.

The HemCon Dental Dressing is designed to be used by oral surgeons and dentists following tooth extractions and other oral procedures; it has also been used successfully to treat oral trau-ma. The dressing measures 10mm x 12mm and, when placed in an extraction socket, adheres to the surrounding tissue, protect-ing it and relieving pain; it dissolves within seven days.


ISTO TECHNOLOGIESORTHOPEDICS Private

Orthobiologics Firm Raises $8.8 MillionISTO Technologies, a St. Louis, MO-based clinical-stage ortho-biologics company developing products for sports medicine, spinal therapy and trauma, has raised $8.8 million as the com-pany prepares for the launch of its first product. The round, which closed in May, included new investor Ascension Health Ventures, as well as previous investors Alafi Capital, Life Sciences Partners, Mid-America Transplant Services and indi-vidual investors.

The funding will be used to launch InQu, a synthetic biomaterial to serve as a bone graft substitute, and to finance the develop-ment of other products in ISTO’s pipeline, including DeNovo ET, a tissue-engineered cartilage for the repair of damaged or injured cartilage in the knee, and NuQu, an injectable cell-based therapy for the regeneration of the nucleus of the spinal disc. The company plans to launch InQu later this year.

To date, ISTO has raised a total of about $29 million in equity.(Read a full profile of ISTO on page 52)

MINRAD INTERNATIONALIMAGING/SURGERY PRODUCTS AMEX: BUF

Sevoflurane Approved in U.S. and 7 Other AreasDuring the second quarter of 2007, Orchard Park, NY-based Minrad received regulatory approvals or acceptances for its products in seven new markets.

The largest of these new approvals (in market potential) was the U.S. approval of Sojourn (sevoflurane), a generic anesthetic. In July, RxElite, Minrad’s exclusive U.S. commercial partner on Sojourn, reported its successful launch of the anesthetic, which the companies say represents a $400 million market opportu-nity. RxElite currently markets three anesthetic gases in the U.S. in partnership with Minrad: sevoflurane, isoflurane, and enflurane.

Also in July, Minrad received approval to market sevoflurane in Brazil and Indonesia. And the company was cleared to market its SabreSource image guidance system in Mexico.

As of June 30, 2007, Minrad had the following approvals for its anesthesia and analgesia, and real-time image guidance product lines: enflurane (approved in 19 geographic markets), isoflurane (31 markets), sevoflurane (8 markets), isoflurane veterinary (7 markets), SabreSource (9 markets) and Light Sabre (6 markets).

NovaDel Grants Sublicense Rights for ZensanaNovaDel, a Flemington, NJ-based specialty pharmaceutical company developing oral spray formulations for a broad range of marketed drugs, announced in August a sublicensing part-nership with Par Pharmaceuticals. Under the agreement, Par was granted sublicense rights for the development and com-mercialization of Zensana (ondansetron HCl, oral spray), a 5-HT3 antagonist to prevent nausea and vomiting after chemo-therapy, radiation and surgery. Upon successful development

NOVADEL PHARMACEUTICALSDRUG DELIVERY AMEX: NVD

and approval, Zensana could be among the first in its class to be available in an oral spray form. The two companies anticipate collaborating on the development of a formulation of Zensana, with Par responsible for updating the New Drug Application and commercializing the product in North America.

Anti-emetic therapies constitute the largest segment of the sup-portive care market in the U.S., with estimated annual sales in excess of $2 billion. Ondansetron is by far the prescription leader in the category, with more than two million prescriptions written annually.

As part of Par’s strategy to concentrate its resources on support-ive care in AIDS and oncology markets, the company returned to NovaDel the rights to NitroMist (nitroglycerin lingual aero-sol), NovaDel’s proprietary oral spray form of the drug used to treat angina pectoris. NovaDel is currently investigating strate-gic partners for the commercialization of this FDA-approved product.

CEO Egberts ResignsIn July, NovaDel’s president and CEO, Jan Egberts, resigned, saying he believed it was “a good time to transition from the company to pursue other opportunities that have interested me for some time.”

The company’s board appointed its chairman, Steven Ratoff, to serve as interim chief while NovaDel conducts a search for a permanent replacement. Ratoff, a private investor, joined NovaDel’s board in 2004 and has served as its chairman since September 2006.

Stone-Management Device Launched PercSys, a urology device maker from Mountain View, CA, introduced its Accordion Stone Management Device, for aid-ing in the treatment of kidney stones in the ureter, at this year’s American Urological Association meeting, held in May in Anaheim, CA.

The Accordion device is an advanced microcatheter that fea-tures a proprietary film occlusion to prevent stone migration and facilitate fragment removal during endoscopic lithotripsy proce-dures. It combines the utility of multiple endoscopic stone-man-agement tools into a single device, and is designed to simplify and shorten endoscopic lithotripsy procedures.

The key feature of the Accordion device is a multi-fold film occlusion that is deployed at its distal end. Once formed, the film occlusion conforms to and fills the ureter in order to pre-vent retrograde migration of stone fragments into the kidney. During stone fragmentation, the device facilitates distal rinsing

(Read a Q&A with Endocare’s CEO on page 49)

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of smaller fragments to keep the field of view clear.

Following fragmentation, the device can easily sweep larger fragments into the bladder or a ureteral access sheath, thereby eliminating tedious and time-consuming serial basketing of indi-vidual fragments. The robust occlusion film is able to withstand inadvertent contact with holmium laser and intracorporeal litho-tripter energy.

The Accordion device is easy to place due to a hydrophilic coating that allows it to track past the stone like a guidewire. In addition, the device features radiopaque markers that enable monitoring of advancement and deployment using fluoroscopic visualization. When required, Accordion’s telescoping design enables the film occlusion to release easily from intact stones and large fragments.

PHOTOMEDEXDERMATOLOGY

Nasdaq: PHMD

PhotoMedex Eyes LashesAt the American Academy of Dermatology’s summer confer-ence in August, PhotoMedex launched an eyelash-enhancement product, MD Lash Factor. The technology-driven cosmetic pro-motes the appearance of longer, fuller, thicker eyelashes in as little as one week.

PhotoMedex, based in Montgomeryville, PA, conducted a double-blind, randomized, placebo-controlled clinical trial in which MD Lash Factor showed a maximum of 1.94 mm change in mean lash length after four weeks of treatment. All subjects experienced improved lash length, including one woman with alopecia areata and another receiving chemotherapy.

MD Lash Factor offers an alternative to daily cosmetic altera-tion and eyelash transplantation. Transplantation redistributes hair follicles from the back of the scalp into the eyelid, much like a hair transplant.

The lash enhancer, licensed in an exclusive deal with La Canada Venture, adds to PhotoMedex’s growing portfolio of prescrip-tion cosmetic products. In early 2005, the company acquired ProCyte, a biotech firm that develops products based on its Copper Peptide technology for skin and hair care.

“We expect our skin care business to grow substantially in the second half of this year,” said CEO Jeffrey O’Donnell, in a statement. “We believe that MD Lash Factor will play a large role in this growth.”

SMALL BONE INNOVATIONSORTHOPEDICS Private

SBi Debuts New ProductsNew York, NY-based Small Bone Innovations (SBi) has expand-ed its product range in 2007 to more than 60 systems, with 10 new launches, and has received FDA clearance for an additional six. This includes implants and arthroplasty products for the thumb, wrist and elbow, as well as foot and ankle external fixa-tion devices. These include the following:

Artelon Arthro and Artelon STT degradable spacers for basal thumb repair in early to mid-stage OA in the thumb. These tis-sue-sparing, function-restoring biologics have been gaining traction since the Artelon CMC-I and Artelon LG spacers were launched in 2005 and 2006. More than 4,000 spacers have been implanted to date.

SYNTHEMEDCARDIOLOGY SYMD.OB

financing. The money will help fund the U.S. launch of the company’s REPEL-CV Bioresorbable Adhesion Barrier, planned for the fourth quarter.

REPEL-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of an open heart surgical procedure to reduce the formation of post-operative adhesions (scar tissue).

FDA to Review Device that Reduces AdhesionsSyntheMed learned in June that a meeting of FDA’s Circulatory System Devices Advisory Panel has been scheduled for mid-September to review the company’s pre-market approval application for REPEL-CV. The Advisory Panel will be comprised of healthcare profes-sionals, including cardiac surgeons, who will review the clinical merits of REPEL-CV and provide their recom-mendation regarding approval for sale in the U.S. market.

SyntheMed has completed a series of clinical trials, the most recent of which was a 15-site U.S.-based, random-ized, controlled clinical trial involving neonate patients who underwent staged open-heart surgical procedures to address congenital heart defects.

In this trial, over 70% of the REPEL-CV treated patients were completely free of clinically significant adhesions, the most severe grade of adhesions measured, as com-pared to less than 30% in the control patients (p value < 0.0001). In the primary clinical endpoint assessment, the average area involved with clinically significant adhesions in the control patients was 2.5 times larger than in the REPEL-CV patients (p value = 0.0005).

New Sales Chief Appointed In anticipation of the planned U.S. market launch of REPEL-CV, SyntheMed recently recruited Marc Sportsman to the newly created executive officer position of vice president of sales. Sportsman has over 20 years of sales experience in the cardiac device industry. He most recently served as vice president of sales at ATS Medical, and previously held sales management positions with St. Jude Medical and Shiley.

SyntheMed intends to market REPEL-CV in the U.S. through a direct sales force targeting the cardiac surgical community.

The recent FDA clearance of SBi’s fixed angle and fracture spe-cific Distal Radius plates enhances the company’s wrist repair suite, which includes the STABILITY Sigmoid Notch Total DRUJ System – the only anatomic implant able to restore bio-mechanics of the wrist and forearm. The RE-MOTION Total Wrist surface replacement system requires only minimal resec-tion using SBi Precise Guidance Technology for consistent sur-gical results.

FDA clearance of the Lateral rHead adds a unique, mechanical couple for the radial head and stem components without using a set screw. SBi’s Elbow Management System includes the UNI-Elbow Radio Capitellum for use with all rHead prostheses and rHead anatomic plating, creating the first “uni-compartmen-tal” solution.

SBi’s next-generation RingFIX external fixation device for foot and ankle repair has been augmented by five other fixation prod-ucts launched at the ASSH convention in September 2007.

SBi also recently acquired a suite of fixation devices from France’s Euromedic International Group.

(Read a full profile of PercSys on page 44)

(Read a Q&A with SyntheMed’s CEO on page 19)

Physician-formulated MD Lash Factor is an eyelash conditioner that improves the appearance of natural lash length, full-ness and thickness. The initial clinical study showed a 53% increase in length after four weeks. Some patients saw improvement in as little as one week

SyntheMed Closes $2.8M Equity FinancingIn August, SyntheMed, an Iselin, NJ-based biomaterials com-pany, completed the initial closing of a $2.8 million equity REPEL-CV is placed between the epicardium and

pericardial edges to block the formation of fibrin bands which otherwise would evolve into vascular-ized, fibrous adhesions

Nasdaq: PHMD

In September, SBi launched its new Artelon STT spacer to treat arthritis in the base of the thumb


APPEARING AT ADVAMED 2007

Heart failure causes a cycle of muscle damageHeart failure is a progressive and debilitating disease that results when the heart is unable to provide sufficient blood flow to the body. The natural response to impaired cardiac function is to work harder in order to pump blood. The excessive workload on the heart stresses the muscle walls and damages the muscular structure, eventually resulting in an unhealthy enlargement of the heart. In the body’s continuous attempt to supply the body with adequate blood, the stress on the heart continues to build in a degenerative cycle of muscle damage, which eventually results in end-stage heart failure or death.

550,000 new heart-failure cases diagnosed annuallyBetween the ages of 50 and 90, heart failure prevalence nearly doubles each decade. As baby boomers age, the prevalence will increase exponentially. Currently, in the U.S., five million peo-ple suffer from heart failure; an estimated 550,000 new cases are diagnosed each year. The annual economic burden of the disease is more than $33 billion annually.

Drug treatments do not halt the progressionCurrent treatments for heart failure employ various drugs regi-mens. ACE inhibitors and vasodilators expand blood vessels and decrease resistance; beta-blockers improve how well the heart’s left lower chamber (left ventricle) pumps; digitalis increases the pumping action of the heart; and diuretics help the body elimi-nate excess salt and water. These drugs, which have various side effects, only indirectly address the stress placed on the heart’s muscular structure. To date, no drugs or medical devices have been effective at halting the eventual progression of the disease.

CorCap CSD improves heart’s structure and functionAcorn Cardiovascular’s CorCap Cardiac Support Device (CSD) is a proprietary mesh wrap that is implanted around the heart to provide gentle support. The device is intended to prevent and potentially reverse the progression of heart failure by improv-ing the heart’s structure and function. The device, the first of its kind, is designed specifically to alleviate pressure caused by an oversized dilated heart.

Evaluated successfully in clinical trialsThe CorCap CSD has been evaluated in prospective randomized clinical trials in patients with an enlarged heart and progressive heart failure despite optimized drug therapy. The results indicate that the CSD reverses the natural history of heart failure, as indi-cated by the reduction in left ventricular volumes, dimension, and the heart’s return to a more normal shape.

CE Mark granted in 2000

In the U.S., the CorCap CSD is limited to investigational use. The device received CE Mark clearance in September 2000. To date, more than 440 implants have been performed worldwide.

Going back to FDA

Acorn, a privately held company incorporated in 1996, had com-pleted a 300-patient prospective, randomized pivotal trial and submitted data to FDA in 2004. However, the two panels voted against approval for CorCap in December 2006 and June 2005, respectively, citing the need for additional clinical data.

Since the Medical Device Dispute Resolution Panel decision last year, Acorn has worked closely with Dr. Dan Schultz, director of FDA’s Center for Devices and Radiological Health, and Dr. Bram Zuckerman, director of the Division of Cardiovascular Devices, to design a confirmatory trial that would alleviate the concerns of the panels.

The confirmatory trial, which will involve 50 patients, will assess a patient population that demonstrated the greatest clini-cal benefit in the pivotal trial. If Acorn meets the success criteria for the confirmatory trial, it is anticipated that FDA may be able to approve the device without engaging a third advisory panel, perhaps before the end of 2009.

Acorn CardiovascularPrivateSt. Paul, MN

Heart Device Picks Up Where Drug Treatments Fail

Status

An additional confirmatory trial is needed before Acorn Cardio-vascular’s CorCap Cardiac Support Device can be commercially launched in the U.S. A ruling by FDA is expected sometime before the end of 2008.

Management

President & CEO: Richard Lunsford

Contact

CEO: Richard Lunsford Web: acorncv.com CFO: Tom Poe Tel: (651) 286-4800

Lunsford joined Acorn Cardiovascular as president and CEO in December 2001 from Sulzer/Spinetech. There, as president, he was instrumental in devel-oping the adoption of Sulzer Spine’s new medical device technology and diversifying the company’s entire spinal-device product line. Prior to Sulzer Spine, Lunsford was with Scimed Life Systems before it was sold to Boston Scientific.

Follow-on Offering Initial Public Offering

Follow-on Offering P.I.P.E. Transaction Initial Public Offering

Follow-on Offering

$419,647,000

Strategic sale to Actelion

Sole Financial Advisor

January 2007April 2007

$58,140,050

Follow-on Offering

Joint Book Runner

June 2007

December 2006 December 2006 December 2006

July 2006 June 2006 April 2006

Sole Bookrunner Co-Lead ManagerCo-Lead Manager

Co-Lead ManagerSole BookrunnerJoint Bookrunner

$35,887,500

Follow-on Offering

Sole Bookrunner

January 2007

Follow-on Offering

Co-Lead Manager

January 2007

$96,600,000

$174,700,000

Initial Public Offering

October 2006

Co-Manager

$38,500,000

$82,800,000 $58,850,000

Strategic acquisition of Andrx Corporation

November 2006


$1,872,000,000

$39,500,000$17,400,000 $24,000,000

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financing

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This announcement as a matter of record only

Peter Crowley, Head of Healthcare

+1.212.856.6505

East Coast Life Sciences:John Capano: +1.212.856.4112 Michael Brinkman: +1.650.234.2410Vanessa Abate: +1.212.856.3728 John Calcagnini: +1.650.234.2434Josh Muntner: +1.212.856.3740 Hutch Corbett: +1.650.234.2447Trina Smith: +1.212.856.4184 Matthew Plunkett: +1.650.234.2436

West Coast Life Sciences:

$138,500,000

Strategic Sale to Jubilant Organosys Ltd.


June 2007

$40,250,000

Follow-on Offering

Sole Bookrunner

May 2007 April 2007

$330,000,000

Senior Subordinated Notes

Co-Lead Arranger

$75,000,000

Folow-on Offering

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To form CorCap, an implant-grade polyethylene terepthalate is fabricated into a multi-filament mesh knit. The proprietary processing of the device produces a highly biocompat-ible and durable material, designed and tested for permanent implan-tation without adverse effects


Economic impact of AF exceeds $900M annuallyPost-operative atrial fibrillation (AF) is the most common com-plication of more than one million annual cardiothoracic surgery procedures, such as coronary bypass grafts and aortic heart valve repairs. Post-operative AF occurs in 20-40% of coronary bypass and 60% of heart valve repair patients. Its occurrence is associ-ated with higher morbidity and longer intensive-care hospital-ization. According to various studies, the hospitalization time of bypass patients who experience AF is increased by an average of two-to-four days that are not reimbursed to the hospital. The economic impact of this prolongation exceeds $900 million per year in the U.S. alone. Aside from the economic impact, patients with persistent postoperative AF have significantly higher risk of stroke and other cardiovascular complications.

are classified by FDA as devices and have a clear regulatory pathway, and clinical end points. Strong product pipeline with near-term potentialThe company’s initial product, Plexisyl-AF, has advanced from pre-clinical to human clinical-stage testing. Plexisyl-AF is a prophylactic method of preventing sustained post-operative AF, a common side effect of the approximately one million coronary artery bypass grafting and cardiac valve replacement surgeries performed each year worldwide.

Symphony’s second product, Algisyl-LVR, now in late-stage pre-clinical testing, reshapes the dilated hearts of patients with chronic heart disease by injecting small quantities of a biopolymer into strategic areas of the left ventricle wall. Reshaping and thickening the ventricular wall reduces wall stress and provides lasting improvement of cardiac function.

A third product, in early-stage preclinical testing, employs biotherapeutics delivered by catheter to the atrioventricular nodal region of the heart to regulate heart rate and rhythm in patients with chronic AF and other arrhythmias. The prod-uct aims to replace ineffective drug therapies, ablation tech-niques, and implantable devices such as pacemakers with a non-destructive, self-regulating biologic approach. The com-pany has a strong intellectual property position with more than 20 issued or pending patents related to its technology.

Capital-effi cient approachA capital-efficient approach toward product development has allowed Symphony to achieve significant milestones with under $20 million in venture financing. The majority of research is conducted in the university setting and at commercial labora-tories. The company’s near term goals include establishing the safety and efficacy of its biotherapeutics. To that end, two U.S. clinical studies are planned for 2008, including a first-in-man study for its heart failure product and a pivotal trial for its post-operative AF product. With solid evidence of efficacy, Symphony believes it will be able to secure optimal strategic distribution alliances and licensing partnerships to maximize the value of its technologies.

Symphony MedicalPrivateLaguna Hills, CA

Non-destructive biologic therapies to treat AF

StatusSymphony’s kit for the prevention of post-operative atrial fibrillation is undergoing a Phase II clinical evaluation at five centers in Western Europe. Trials in the U.S. are expected to begin in the near future. Thus far, in a Phase I clinical trial at one of Germany’s largest cardiac surgery hospitals, investigators determined the initial safety and efficacy of the kit, warranting further investigations.

Management

Contact

CEO: Raymond W. Cohen Web: symphonymed.com COO: Frank Ahmann Tel: (949) 348-1188

President and CEO: Raymond W. CohenCohen has more than 25 years experience in healthcare. Before joining Symphony, he was CEO of Cardiac Science, a U.S. manufacturer of public-access defibrillators that merged with Quinton Cardiology Systems in 2005 and operates today under the name Cardiac Science Corporation.

Cardiac surgeries often responsible for triggering AFPost-operative AF is an abnormal irregular heart rhythm where electrical signals are generated apparently randomly through-out the upper chambers (atria) of the heart. While the precise mechanisms of this process are not well-defined, the surgical procedure triggers an initial imbalance in the cardiac autonomic nerve system. This initial imbalance causes different areas of the atrial tissue to become uncoordinated in their conductivity; some are excitable and some are refractory. This disturbance leads to multiple re-entrant pathways for the impulses that regulate heart rhythm, and AF ensues.

Stopping atrial fi brillation at the sourceSymphony Medical, a privately-held company developing pro-prietary biotherapeutics, uses biocompatible polymers and cell therapies to treat patients with heart failure and cardiac arrhyth-mias through non-ablative and non-surgical means. This is achieved, in part, by injecting biologic material directly into specific locations of the heart during either open-chest surgery or via a minimally invasive procedure. Symphony’s products

Fibroblasts and biopolymers delivered to the heart’s AV node have a sustained regulating impact on ventricular rate in AF

Building a meaningful healthcare and life sciences company and developing a life-altering technology are, unfortunately, not enough. You need to be seen and heard. Investors, strategic partners and customers need to know who you are and what you do.

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What primary competitive advantages will Mystic’s VersiDoser drug-delivery platform provide for ophthalmic and intranasal applications?Mystic’s drug-delivery platform is exten-sible across a broad range of applica-tions in ophthalmic, intranasal, otic, oral and topical. Our primary focus is in front-of-the-eye ophthalmic and intranasal areas for both drugs and biologics.

Intranasal drug delivery is a growing sector of the market because more drugs and biologics are becoming available for this route of administration. There is a dearth of intranasal drug-delivery device companies globally and we believe we are well positioned to benefi t from this growth area.

The VersiDoser drug-delivery platform provides a novel approach for preser-vative-free, unit-dose drug delivery. Our unit-dose blister incorporates a Veloci-tyJet, which is a micropump that controls the spray plume and, in combination with the blister, enables a wide range of dose titration. This creates a unique platform drug-delivery system for nasal and ophthalmic drugs.

We have developed a proprietary aseptic manufacturing process, which enables preservative-free, liquid-fi ll unit-dose packaging in engineered lami-nates. These laminates provide superior barrier properties that better protect the drug. Blisters are pre-loaded into single or multi-dose VersiDoser ophthalmic or intranasal devices. These devices enable self-administration by the user, which reduces costs by reducing dependencies on trained caregivers. Additionally, the devices incorporate a number of ease-of-use features that improve compliance to prescribed use.

What application does the VersiDoser delivery platform have for vaccines? We have been focused on vaccine-delivery applications to address pan-demic preparedness for antigens such as H5N1 Bird Flu and bioterror agents like anthrax and smallpox. We recently participated in the Public Health Emer-gency Medical Countermeasures Workshop sponsored by the Department of Health and Human Services and its new agency BARDA, which is now responsible for funding pandemic pre-paredness programs.

Our intranasal system is ideally suited for vaccine delivery as it provides signif-icant performance and cost advantages over the current method of delivering vaccines via injection. Additionally, we have recently proposed a new concept called the Vaccine Rapid Deployment System, which leverages our single-use, disposable intranasal system to signifi -cantly reduce the costs associated with stockpiling vaccines.

We are also developing a lyophilized intranasal-delivery system that will improve stability and reduce the need for cold-chain handling of vaccines and other compounds. Discussions with various agencies within the Department of Defense and HHS about potential use of the VersiDoser platform are ongoing.

How far along are you in your branded-generic endeavors?We are developing pre-IND packages for our fi rst two branded-generic products. Our fi rst intranasal product will be an intranasal migraine application and our fi rst ophthalmic product will be a glaucoma application. We expect to submit our pre-IND packages to the FDA

for Phase III clinical trials for both of these products in early 2008.

Are you currently seeking partners?Joint ventures, strategic alliances and licensing opportunities that will combine our drug-delivery technology with existing or new drugs and biologics are a core aspect of our business model. We are actively pursuing these opportunities in the U.S., Europe and Asia.

What about investors? Are you actively seeking capital?We will initiate a Series B funding round in September 2007. This is planned as a $30 million preferred round. We are for-tunate to have signifi cant interest from a combination of funds and high net worth individuals.

IN ADDITION TO serving as Mystic Pharmaceutical’s president and CEO, Timothy Sullivan is co-inventor of the

company’s drug-delivery platforms. He plays a central role in defining both the technological and strategic direction of Mystic, which he joined after serving as principal of INFUSE Corporation, a strategy-consulting firm based in Austin, TX. He has held executive management positions with a variety of companies, including: Questor Energy, Data Retrieval Corporation, Scientific & Engineering Software, CFI, and DAZEL.

We are focused on vaccine-delivery applications to address pandemic preparedness for bird flu, and bioterror threats like anthrax.

“ “

Discovering theRight Dose

Timothy SullivanMystic Pharma

Timothy SullivanCEO, Mystic Pharmaceuticals

Mystic’s intranasal delivery system is a single-dose device that incorporates a micropump called the VelocityJet, which controls spray plume geometry and precision dosing


Robert HickeyCEO, SyntheMed

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FDA plans to review your PMA for REPEL-CV -- a bioresorbable film designed to be placed over the surface of the heart at the conclusion of surgery to reduce the formation of post-operative adhesions -- this September. And you recently hired a new head of sales. Does this mean you like your chances?In September 2006, we reported pos-itive effi cacy results from the pivotal clinical trial of REPEL-CV in neonatal patients who underwent staged, open-heart surgical procedures. We feel con-fi dent that the pivotal trial achieved its primary clinical endpoint based on the level of reduction in the extent and severity of adhesions.

In the trial, surgeons used a four-point grading system to determine the extent and severity of patients’ adhesions. Over 70% of the REPEL-CV treated patients were completely free of clinically signif-icant adhesions, the most severe grade of adhesions measured. In the primary clinical endpoint assessment, the mean extent of clinically signifi cant adhesions in the control patients was 2.5 times greater than in the REPEL-CV patients.

We have incorporated the results of this trial into the PMA application for approval of REPEL-CV in the U.S. for use in all cardiothoracic surgical pro-cedures. Typically, the primary focus of discussion at the FDA panel meeting, scheduled for mid-September, is on the clinical merits of the product. Based on extensive feedback from cardiothoracic surgeons, REPEL-CV addresses a clear, unmet therapeutic need in an effective and safe manner.

We are proceeding on the basis that the panel will concur with this consensus opinion of its surgeon colleagues. Thus, we are preparing for the U.S. commercial launch through a direct sales force.

REPEL-CV is based on SyntheMed’s proprietary bioresorbable polymer technology. Can you explain how the technology works?In an open-heart surgical procedure, fi brin in the pooled blood residing in the pericardial cavity at the end of the pro-cedure tends to bridge from the trau-matized sites to other adjacent tissue surfaces. Over time, these fi brin bands develop into vascularized, fi brous adhe-sions which make subsequent cardiac procedures much more time con-suming and risky. By placing REPEL-CV over the heart, this bridging of the fi brin is blocked and the formation of adhesions is reduced. Since there is no active bleeding at the conclusion of the surgical procedure and thus fi brin is no longer being produced, this barrier need only be in place for a short period of time. REPEL-CV serves as a temporary barrier and then completely degrades.

What is the status of REPEL-CV in countries outside the U.S.? In August 2006, we received CE Mark approval for use of REPEL-CV in all cardiothoracic surgical procedures. REPEL-CV is being marketed to cardiac surgeons through independent distrib-utors primarily in the European Union.

You’re also developing anti-adhesion products for other uses, such as gynecologic and spine surgery. What’s the status of these projects?Our objective is to develop a broad line of anti-adhesion products. Our biore-sorbable polymer technology appears to be suffi ciently versatile to allow us to design products for the different ana-tomic sites and surgical techniques.

For example, about two-thirds of gyneco-logic surgeries are performed using min-imally invasive techniques. Therefore,

ROBERT HICKEY has been SyntheMed’s presi-dent and CEO since May 1996. He’s had the additional responsibilities

of chief financial officer since March 2000. He has served as a director for the company since August 1996. Before join-ing SyntheMed, Hickey was president of Roberts Healthcare Resources, a manage-ment consulting firm that he founded. He spent 19 years at Johnson & Johnson, where he held executive positions in mar-keting, business development and finance.

We feel confident that the pivotal trial of REPEL-CV reached its primary clinical endpoint. We are preparing for the U.S. commercial launch.

“ “

Preparing forLaunch

Robert HickeySyntheMed

we are developing RESOLVE, a viscous material which can be dispensed from a syringe to create the barrier coating to block the fi brin.

Conversely, surgery on the spine typically results in a small segment of the spinal canal being exposed where the spinal nerve can become involved with adhe-sions. In this case, we are developing RELIEVE, a reverse thermal gel which, at room temperature, is an injectable fl uid that quickly transitions to a thick gel as it approaches body temperature, allowing it to reside in the small opening of the spine as an anti-adhesion barrier. These products are in preclinical testing.

Are you seeking any partnerships?We are constantly looking for ways we can further exploit our polymer tech-nology and best market our current and future products.

Are you actively seeking capital?In recent years, our funding has largely been raised from a network of European investors. We plan to expand our investor base in future fi nancing transactions. We are seeking to raise additional capital to support the build of our U.S. sales orga-nization and to fund our product devel-opment programs.



At the turn of the 20th century, St. Louis was the fourth-largest city in the U.S., the gateway to the west, and one of the country’s wealthiest cities. It was where Charles Lindbergh turned for financing when he

couldn’t find funds on the east coast. By 2000, St. Louis was the country’s 52nd largest city, and

for whatever reason, had not retained its entrepreneurial cul-ture. St. Louis had become a “big-company town,” with a conservative business culture, zero institutional venture capi-tal, and a general indifference toward supporting innovation and entrepreneurship.

But the indifference took a turn when the grandson of one of the city’s great entrepreneurs decided to change things.

“St. Louis has a history of creating businesses, we just have to do what people here have done before,” said William Danforth, MD, grandson to the founder of Ralston Purina company, and the instigator of this change.

It began when Danforth, a cardiologist at Washington University, witnessed a faculty member with a brilliant idea struggle for two years to find financing to start an Internet company. He finally gave up and moved to San Francisco, where he quickly found the financial and entrepreneurial assis-tance to launch his business, which he later sold to Cisco for $350 million.

Danforth decided this shouldn’t happen again, and set forth to make St. Louis a place where companies would once again want to stay and grow. In 2001, the Danforth Foundation backed the launch of the Coalition for Plant and Life Sciences, an organiza-tion dedicated to nurturing emerging companies.

One of the first things the coalition did was jointly commis-sion the Battelle Research Institute to study how St. Louis could build its entrepreneurial economy. Other community leaders shared Danforth’s vision and the report was funded by the St.

Louis RCGA and other civic groups. The report became a catalyst for a

comprehensive strategy, after it con-cluded that, despite a wealth of great assets, St. Louis’ lack of venture capital posed a fundamental problem to eco-nomic growth.

So, with funds from his family founda-tion, Danforth convinced another of the

St. Louis, MO—home to promising startups, renowned research institutions, and dedicated business incubators—has a thriving life sciences sector. But for guidance on how to take things to the next level, the city is looking to its past.

Back to its Roots

city’s business families, the McDonnells (of McDonnell Douglas Aviation), to kick-start the local venture capital busi-ness. With $40 million in resources from the Danforth Foundation, and additional funds from the McDonnell Foundation and Washington University, the wheels were in motion.

SYSTEMATIC DEVELOPMENT The initiative started by Danforth has resulted in a long-range,

integrated approach to building an entrepreneurial economy in St. Louis.

“We’re taking a long view of this,” says Donn Rubin, who runs the Coalition for Plant and Life Sciences. The strategy has been to systematically build every aspect — “real estate, lab space, access to venture capital, access to the scientific advances from these leading research univer-sities, mentoring and advisory tal-ent,” says Rubin. “We want to sys-tematically build all of these com-ponents to make a difference.”

The focus on plant and life sciences is a unique core compe-tency, and an area for which St. Louis is a center for some of the great advances. “We have the intellectual capital here, world-class medical and plant-science research institutions, and a very skilled scientific community,” says Rubin.

Two of the coalition’s initiatives are the BioGenerator, which seeks to commercialize technologies from local universities, and Cortex, a real estate development firm that provides appropriate space to growing firms.

CAPITAL AND FINANCING On the financial front, one of the leading names in venture cap-

ital was retained to participate in this initiative. Brooke Private Equity Advisors, which provides advisory services to the private equity markets, was asked to weigh in. This Boston-based firm

Regional ReportSt. Louis, MO

“St. Louis has a history of creating businesses.

We just have to do what people here have

done before.”

William Danforth, MD

Donn Rubin

REGIONAL REPORT ST. LOUIS, MO


age of the financing that gets companies going; the majority of funding for entrepreneurs comes from private investors. For that reason, St. Louis recently formed an angel-investor network called the Arch Angels. To qualify, investors must invest at least $50,000 per year. The two-year-old organization now has 45 private individual investors as members, to which entrepreneurs can present ideas at monthly meetings.

Another important fixture on the St. Louis financial scene is InvestMidwest, an annual conference that moves between St. Louis and Kansas City. It showcases 30 companies in life sciences and technology. These companies give 15-minute pre-sentations to an audience of about 100 private and institutional investors. The 2008 InvestMidwest meeting is set for February, in St. Louis.

COMMERCIALIZING IDEASSt. Louis’ research institutions — Washington University,

St. Louis University and University of Missouri — are per-haps its most valuable healthcare assets of all. Washington University School of Medicine consistently ranks among U.S. News and World Report’s top-four med schools in the country. The medical school, which staffs the well-ranked Barnes-Jewish Hospital, received over $377 million in research funding from the National Institutes of Health in 2005.

The problem — and opportunity — is that despite being rated the country’s fourth-leading medical research institu-tion, Washington University ranks 120th in commercializing innovations.

The school is looking to change that, in part, through recently hiring Mike Douglas, a biochemist with a business background. Douglas, as head of the university’s technology transfer office, is charged with creating a more business savvy ideas center.

In addition to knowing how to commercialize ideas, regional success depends on entrepreneurs’ ability to execute. Here also, there is a plan in motion. Innovate St. Louis, created out the St. Louis RCGA and chaired by Washington University School of Medicine’s former dean, William Peck, MD, has a mentor-ing program designed to provide entrepreneurs with access to the resources they need. Its core programs will come through a virtual Center for Innovation and Entrepreneurship, in col-laboration with academic, foundation, industry and government programs, as well as individual advisors. Innovate St. Louis will identify potential and declared innovators, and will seek to reduce barriers to translating their projects into commercially successful entities.

REAL ESTATE AND FACILITIESWith capital, ideas and mentoring in place, the next order of

business is location. From the beginning, real estate has been a

was founded by one of the most impor-tant players in the global venture capital business, Peter Brooke. In 1968, Brooke founded TA Associates, now a $10 billion venture fund. In 1984, he formed Advent

International, the first global private equity organiza-tion, which today has operations in 30 countries around world.

In 2004, Brooke Private Equity Advisors, run by Peter’s son John

Brooke (the first analyst and employee at Advent), was engaged to help attract ven-ture capital to St. Louis.

The venture firm quickly learned that St. Louis, with a wealth of research insti-tutions and talent in place, was primed for significant venture-capital opportunity.

Soon, Brooke Private Equity Advisors began working with Stifel Nicolaus, an investment bank, to create Vectis Life Sciences Fund I, for which they success-fully raised $81 million. Vectis is a fund of funds, which invests in other venture capital funds. Based in St. Louis, it gives investors the capacity to invest there, and throughout the rest of the U.S. The success of Fund I has led to the raising of Fund II.

In part due to the efforts of Vectis and others, the net result of Danforth’s initia-tive to date is over $500 million in venture funds under management in St. Louis.

The region now has five healthcare-focused funds, and six others. Funds dedicated to the life sciences space include the following:

RiverVest Partners was founded by Tom Melzer, former president of the Federal Reserve Bank of St. Louis. Melzer, who served in that role from 1985 to 1998, was the first non-economist recruited by Paul Volcker.

When Melzer left the Federal Reserve, he was presented with a lot of opportunities. He decid-ed that the venture business in St. Louis, with a focus on healthcare and life sciences, was the best idea.

“I could have done a number of things,” recalls Melzer, “but a venture fund in St. Louis to focus on healthcare and life sci-ences in the Midwest seemed like a tremendous opportunity. And I was right.”

Today, RiverVest Venture Partners invests nationwide in emerging medical device, bio-pharmaceutical and other healthcare venture opportunities. Melzer’s team of five has invested in over 15 companies.

Oakwood Medical Ventures is run by Raul Perez, a phy-sician who trained at St. Louis University. Perez became a venture capitalist after investing in a startup company called Orion Medical, which developed a device to detect contractions in women with high-risk pregnancies. Perez and others invest-ed $575,000 in the firm, and in April 1991, Baxter International bought Orion for $8.6 million. Perez has since raised four funds that focus on later-stage investments, each with increasingly large and successful returns.

Advantage Capital, a $750 million fund with offices through-out the U.S., also has a big presence in St. Louis. Other local funds include Prolog, which launched in 2001 and now has over 12 healthcare company investments, and Ascension Health Ventures, a $125 million fund.

Despite these promising and influen-tial firms, in terms of big picture, venture capital only represents a small percent-

RICH IN RESEARCHTOP MEDICAL SCHOOLS – RESEARCH MEDICAL SCHOOLS

NIH AWARDS AMONG MEDICAL SCHOOLS

TOP LAW SPECIALTIES – HEALTHCARE LAW

RiverVest seeks to build

partnerships with entrepreneurs and

scientists developing and commercializing

breakthrough technologies that

address unmet clinical needs.

Investing in lifescience innovation.

7733 Forsyth Boulevard, Suite 1650St. Louis, MO 63105

314.726.6700 www.rivervest.com

“A venture fund in St. Louis to focus on healthcare and life sciences in the Midwest seemed like a tremendous opportunity.”

John Brooke

Tom Melzer


(Read a Q&A with Innovate St. Louis’ CEO on page 37)


MIDWESTERN HEALTHCARE STARTUPS are going strong in 2007, on

track to double the amount of funding raised last year. According to the just

released BioEnterprise Midwest Health Care Venture Investment Report, young

companies in the Midwest reported $726 million in total investments across 59

companies for the fi rst half of 2007 — nearly equal the amount invested for all

of 2006, a record year.

“Coastal investors have clearly discovered the Midwest’s abundance of

investment opportunities,” said Baiju Shah, president of BioEnterprise, a Cleve-

land-based organization that helps grow emerging healthcare companies.

“The investment deals are getting larger and each region is seeing more east

and west coast venture fi rms participate.”

Ohio, Minnesota and Indiana are the region’s hottest states so far this year,

accounting for over two-thirds of total investment in the fi rst half of 2007. Ohio

is out in front, with healthcare ventures in that state attracting $244.3 million,

including a $65 million investment in Athersys. Other signifi cant fi nancings

took place in Minnesota — CVRx raised $65 million — and Indiana — Targanta

Therapeutics attracted $70 million.

Other states included in the report are Michigan, which attracted invest-

ments worth $63.4 million, Illinois ($42.5 million), Missouri ($25.6 million),

Wisconsin ($16.11 million) and Kentucky ($5 million).

By sub-sector, H1 2007

healthcare investments

are broken down this way:

biopharmaceutical compa-

nies account for $447 million,

medical device companies for

$148 million, and healthcare

software and service compa-

nies, $132 million.

While biopharmaceutical

companies still managed to

capture the lion’s share of

investments in the Midwest,

nationwide, these fi rms are

beginning to feel some heat

from device companies.

Investments in Midwest Startups Reach New Heights

—Sara Calabro

MIDWEST HEALTHCARE VENTURE INVESTMENT BY REGION

1. Harvard University2. Johns Hopkins University3. University of Pennsylvania4. Washington University in St. LouisSource: U.S. News & World Report, April 9, 2007

1. Johns Hopkins University $449.32. University of Pennsylvania $399.23. University of California — San Francisco $398.14. Washington University in St. Louis $377.6Source: National Institutes of Health, Fiscal Year 2005

1. Saint Louis University2. University of Maryland3. University of HoustonSource: U.S. News & World Report, April 9, 2007

Region First Half 2007$ Millions # of Cos.

Cleveland, OH 199.1 16

Minn./St. Paul, MN 126.0 9

Indianapolis, IN 102.8 4

Detroit/Ann Arbor, MI 63.4 3

Chicago, IL 42.5 2

St. Louis, MO 41.6 4

Cincinnati, OH 33.8 4

Wisconsin 16.1 6

West Lafayette, IN 15.0 1

Columbus, OH 11.5 6


central part of Danforth’s vision. The Center of Research Technology

and Entrepreneurial Exchange (Cortex) is a 250-acre office and research district just west of downtown St. Louis. The original goal with Cortex was to cre-ate facilities to accommodate emerging companies, but it soon evolved into a massive neighborhood redevelopment project. Now, companies that choose to locate there are offered financial incentives.

The turning point for Cortex was when Stereotaxis, a local company that makes cardiology instrument-control systems, decided to take up residence there. Previously located in the Center for Emerging Technologies, a local incubator whose companies have obtained $804 million in funding to date, Stereotaxis was ready to upgrade its office space and so set up shop in a 160,000 square foot building in the Cortex district.

The Center for Emerging Technologies remains an impres-sive facility, with 92,000 square feet of incubator/accelerator space in two rehabbed buildings, and a 60,000 square foot lab under construction.

Another important real-estate-related asset in St. Louis is the Nidus Center, a business incubator funded by Monsanto. This 40,000 square foot facility connects life sciences companies looking for seed and early stage capital with the resources they need. The Nidus Center has been instrumental in increasing the availability of venture capital resources in the St. Louis region, ranging from pre-seed through mezzanine financing.

WORKFORCE AND TALENT Human resources available to commercialize these technolo-

gies is another one of St. Louis’ considerable strengths. “The level of engineering talent in this community is

amazing,” says Carter Williams, founder and director of Boeing’s corporate venture group who is now financing and

running a large-scale device integrator.

“I’d have to say that this town is near the top. If you have an engi-neering issue, I would venture to say you can get it figured out more quick-ly here than anywhere.”

CULTURAL CHALLENGES“We’ve got this Midwestern modesty thing going,” says Bob

Calcaterra, PhD, head of the Nidus Center. Calcaterra believes that Midwesterners’ innate tendency to

downplay their success is partly to blame for the region’s under-the-radar status.

“We’re a conservative community, and our Midwestern mod-esty gets in the way of our progress,” says Calcaterra. “If you don’t let people know what you’re doing and get out and pro-mote, you’re not going to reach your potential.”

Envisioneering Envisioneering develops scanning technology

that improves accuracy and outcomes of prostate

diagnosis and treatment. The company’s first prod-

uct, the TargetScan System, uses 3-D ultrasound

technology to perform precise, targeted prostate

biopsies. Page 42

GridlogixGridlogix is a technology company whose middle-

ware application facilitates sharing of data across

proprietary information systems, commonly found

in healthcare facilities such as hospitals. Page 34

ISTO TechnologiesISTO Technologies is a clinical-stage company devel-

oping products for sports medicine, spinal therapy

and trauma. The company’s orthobiologic products

are intended to repair and regenerate damaged

cartilage in knee joints and spinal discs. Page 52

KereosKereos develops targeted molecular imaging agents

and therapeutics that seek out definitive disease

biomarkers and carry powerful payloads of proven

chemotherapeutics, making them potentially more

effective and less toxic than current treatments like

radiation. Page31

StereotaxisStereotaxis makes proprietary magnetic systems

and disposable devices for conducting precise,

image-guided, computerized remote-control

interventional procedures. Its Magnetic Navigation

System treats arrythmias, heart failure, and coronary

artery disease. Page 30

SynergeticsSynergetics designs and manufactures products to

support micro or minimally invasive surgical pro-

cedures, as well as disposable and non-disposable

supplies and accessories for use with such devices

and equipment. Page 32

“The level of engineering talent in this community is amazing. If you have an engineering issue, I would venture to say you can get it figured out more quickly here than anywhere.”

The following companies have full-page profiles elsewhere in this issue. Please visit their referenced pages to learn more. And turn to page 26 for additional firms located in and around St. Louis.

William Peck, MD

ST. LOUIS COMPANIES APPEARING IN THIS ISSUE


—Brett Johnson


What is the Nidus Center’s mission?To create a critical mass of plant and life sciences companies in the St. Louis region. We accomplish this by admitting high quality companies which will be successful by attracting top management talent and all stages of investment capital. We also commercialize technology from our part-nering local institutions as well as attract opportunities from outside the region.

Prior to joining the Nidus Center, you were with the Arizona Technology Incubator (ATI). It must have been difficult to leave your “baby,” with which you had such great success. What attracted you to St. Louis?It was hard to leave both the Boulder Tech-nology Incubator and the Arizona Tech-nology Incubator because I founded both entities and had put my heart and soul into them. However, the Nidus Center was attractive for two primary reasons: First, Monsanto’s commitment to the com-munity and to fund the center, and the community’s commitment to succeed in the plant and life sciences. This allowed me to focus completely on helping Nidus companies succeed and on building infra-structure in the region. Secondly, St. Louis has some exceptional research strengths in the plant and life sciences, represented by Monsanto, Pfi zer, Washington University and the Danforth Plant Sciences Center.

At ATI, your efforts brought $50 million and 250 jobs to the Phoenix area. Do you expect the Nidus Center to have a similar impact in St. Louis?The impact of the Nidus Center on St. Louis has far exceeded what I accomplished in Arizona. In a comparable amount of time, we have raised three times the amount

of money for our companies in St. Louis ($140 million), and 140-150 high-paying jobs. I think this can partially be attributed to the fact that we have successfully grown over a short period of time a compatible, integrated set of assets, such as research capacity, physical infrastructure, work-force and venture capital. The underlying strengths in Phoenix did not allow us to do those things while I was there.

What is the Nidus Center doing to bolster resources for the region’s existing life sciences companies?The Nidus Center was instrumental in the creation of the BioGenerator, which is a not-for-profi t, proof-of-concept venture fund, and also in the creation of the Arch Angel Network. We have also helped a couple of our local venture funds raise capital, especially in their initial fund. We were instrumental in bringing Wexford to St. Louis to build expansion laboratory/offi ce space for the region, and in par-ticular for the Creve Coeur node.

What types of things are you doing to convince new companies of the appeal of setting up shop in St. Louis?We have a strong research base, infra-structure such as incubators to assist early stage companies, additional laboratory/offi ce space for them to expand into, and multiple sources of capital. In addition, we have successfully started to attract experi-enced management talent to the region to be CEOs of our companies.

Why do you think St. Louis has not attracted as much investor attention as it probably deserves?St. Louis is no exception to the rule regarding

Tooting its Horn

the Midwest. Traditionally, the Midwest has been a fl yover area for venture com-panies from the east and west coasts. I attribute some of that to the fact that Midwesterners don’t toot their own horns enough. To counter that, we have suc-cessfully built a fairly sizable plant and life sciences venture capital community ($800 million+). This has led to a signif-icant increase in the amount of money coming into the region as a result of syn-dication of deals with our local funds. Early data suggest approximately a six-to-one leverage of that money.

I travel to conferences where I see deals from other parts of the country. Clearly our deals in this region are just as good as elsewhere. We are probably more naïve about how to raise money because of our lack of expe-rience, but that is changing very rapidly.

What St. Louis entities should the investor community, and larger medical device firms, start paying attention to? Over the past seven-and-a-half years, we have created and nurtured some very substantive companies that are well into their regulatory, prototype development, pre-clinical and clinical work. Companies such as Akermin, Apath, Divergence, Kereos, ISW Group and Orion Genomics should be quite attractive to large venture capital fi rms, big pharma and large bio-technology companies. There are also technology-based health service busi-nesses, such as Advanced ICU and Graphic Surgery, which are growing and succeeding as well. Finally, world-class research is being conducted at institu-tions such as Washington University, St. Louis University and the Donald Danforth Plant Science Center.

Robert Calcaterra, PhD, CEO of the Nidus Center, is encouraging emerging life sciences companies in St. Louis to foster a culture of self-promotion

Traditionally, the Midwest has been a fl yover area for venture companies from the east and west coasts. But that is changing very rapidly.

““Company Location Symbol Summary

Emerging Midwest

REGIONAL REPORT ST. LOUIS, MO REGIONAL REPORT ST. LOUIS, MO

The Midwest is fi lled with promising life sciences companies. The list below is not meant to be exhaustive, but rather, demonstrative of the growing number of fi rms that are popping up throughout the region.

LIFE SCIENCESCompanies

Drug discovery focused on human viral diseasesSt. Louis, MO Private

Device that monitors average blood glucose levelsOverland Park, KS Private

Remote critical care to patients in the ICUSt. Louis, MO PrivateAdvanced ICU

Affi nex

Apath

Small-molecule based radiotherapy treatments for cancerMadison, WI Private

Non-invasive imaging of electrical activity on the surface of the heartCleveland, OH Private

Proprietary carbon-coated implantable medical devicesSt. Paul, MN Private

Cardiovascular monitoringSt. Louis, MO Private

Developer of spinal implantsGarfi eld Heights, OH Private

Developing novel or improved protein-based therapeuticsSt. Louis, MO Private

Cyclodextrin-based drug solubilization technologiesLenexa, KS Private

Find cancer-specifi c biomarkers using proteomicsIndianapolis, IN Private

Therapies for improving cerebral perfusionCleveland, OH Private

Inpatient rehabilitation servicesSt. Louis, MO PrivateCenterre Healthcare Corporation

CSF Therapeutics

CS-Keys

CyDex

APT Therapeutics

AxioMed Spine

BMEYE, NA

Carbon Medical Technologies

CardioInsight Technologies

Cellectar

Genetic diagnostics for infectious diseases and cancerMadison, WI Private

Web-based surgical-education programsSt. Louis, MO Private

Recombinant human protein production using human cellsChicago, IL Private

Solutions to detect, stage and monitor ocular diseasesOklahoma City, OK Private

Neuromodulation technologies for treating brain injuries and strokeCleveland, OH Private

MRI technology for cardiovascular imagingCleveland, OH Private

Specialty products for infl ammatory skin disordersSaint Louis, MO Private

Monitor non-nutritive suck in infants born prematurelyLawrence, KS Private

Patient-safety systems to improve medication safety using peer reviewLenexa, KS Private

Drug development using Drosophila and modelingSt. Louis, MO Private

Gene expression and CGH service providerSt. Louis, MO Private

Miniaturized robots that perform numerous surgical functionsOmaha, NE Private

Genetic analysis services and systemsMadison, WI Private

Oncology diagnostic products for cancer screening and therapy selectionSt. Louis, MO Private

Implants and instruments for the foot, ankle and hand surgeonAkron, OH Private

Electrochemical biosensors to measure metabolic analytesSt. Louis, MO Private

In-home, personalized pediatric careSt. Louis, MO Private

Nucleic acid-based interfering technology for patients with cancerKalamazoo, MI Private

Tools to expand the use of mass spectrometersIndianapolis, IN Private

Electronic health records and prescriptionsSt. Louis, MO Private

Medical simulators and simulation software to train physiciansCleveland, OH Private

Spectrometer systems for process control and laboratory automationSt. Louis, MO Private

Spinal imaging for the lower backAkron, OH Private

Electrical stimulation for chronic respiratory insuffi ciencyOberlin, OH Private

Spinal implants, artifi cial discs, and surgical instrumentsAkron, OH Private

Image-guided intensity-modulated radiation therapy for cancerMadison, WI TTPY

Devices that promote the accuracy and speed of surgical proceduresMadison, WI Private

Graphic Surgery

HumanZyme

EraGen Biosciences

Inoveon Corporation

IntElect Medical

Interventional Imaging

ISW Group

KC BioMediX

MedAccuracy

Medros, Inc.

MOgene

Nebraska Surgical

OpGen

Orion Genomics

OrthoHelix Surgical

Pepex Biomedical

Personal Pediatrics

ProNAi Therapeutics

Prosolia

Purkinje

Simbionix

SpectrAlliance

SpineMatrix

Synapse Biomedical

Theken Spine

TomoTherapy

Vector Surgical

Zystor Therapeutics Therapeutics for patients with lysosomal storage diseasesMilwaukee, WI Private

Molecular detection technology for sensitive, robust immunoassaysSt. Louis, MO PrivateSingulex

Magnetically guided enteral feeding tubeWarren, OH PrivateSyncro Medical Innovations

St. Louis Few other regions exhibit the coordinated eff ort from public and private partners that it takes to nurture life sciences companies from the lab bench to the marketplace. St. Louis is committed and well-coordinated to do just that—providing what companies need to thrive, including venture capital and lab space to suit emerging companies at all stages.

Sponsored by

The Coalition

for Plant and Life Sciences

in St. Louis

Support for Company FormationBioGenerator is a privately funded, St. Louis-based non-profi t organization created to help establish life sciences companies in the St. Louis region. We provide initial funding and business expertise to launch successful companies. With up to $500,000 in fi nancial support, promising companies can hire their fi rst employees, set-up their fi rst laboratories, and begin developing their products. BioGenerator also welcomes interest from new life science fi rms desiring to re-locate to the St. Louis area. For more information, please contact Ken Janoski at (314) 812-8027.

St. Louis has made more progress in its implementation of the plant and life science strategy than any other region of the country, and is well on the road to becoming the leading center for plant sciences and a major center for the life sciences.

— Dr. Walter H. Plosila, Battelle Memorial Institute

BioGeneratorPowering Ventures into Reality

APT is developing exciting anti-platelet therapies that may one day be used as treat-ment of acute thrombosis. BioGenerator helped APT:

Meet operating cost commitments not covered by grant fundingReceive additional NIH research grants in excess of $1 million

APT TherapeuticsISW is developing dermatological products for the treatment of acute skin disorders. BioGenerator provided seed funding and expertise that helped:

Secure over $2 million in Department of Defense awardsAdvance clinical development of its initial product

ISW Group

Venganza is an AgBio company that is apply-ing gene-silencing technology to fi ght fungal pathogens in agriculture crops. With the help of BioGenerator, Venganza

Relocated from Florida to be near St. Louis’ concentration of plant science researchersRecently executed a joint research agree-ment with a major corporate partner

Venganza, Inc.

MEDROS, Inc.

MEDROS, formed with technology from Washington University, is developing a novel whole organism approach to identify prospec-tive new drugs for cancer and diabetes. After helping to form the company, BioGenerator:

Committed $500,000 in initial fundingHelped secure facilities, equipment, and additional SBIR/STTR funding

Akermin, Inc.

Akermin is developing portable biofuel cells based on the remarkable stabilized enzyme technology developed at Saint Louis Univer-sity. BioGenerator:

Aided in the formation of the companyAssisted Akermin in securing both angel investors and venture capital

Here are examples of companies assisted by BioGenerator:

““

An Urban Life Sciences DistrictGrowing life sciences companies thrive when they concentrate in close prox-imity to world-class research institutions. St. Louis’ urban life sciences neighbor-hood, with over half a billion dollars in annual NIH research funding, is the optimal place to grow an emerging startup or to locate your corporate research and development headquarters.

The life sciences district is a visionary public/private partnership physically linking some of the world’s leading research institutions.

• Washington University School of Medicine• University of Missouri – St. Louis• Barnes-Jewish Hospital of BJC Health Care

• Saint Louis University • Missouri Botanical Garden

As companies continue to cluster in the CORTEX life sciences district, the free ex-change of ideas will become the fuel that drives innovation for years to come.

Lab space is currently available in the recently completed CORTEX I building. Additional land is also available for the development and construction of new fa-cilities. For more information, please contact Barb Featherston at (314) 531-4500.

BioGenerator 893 N. Warson Rd., St. Louis, MO 63141 TEL: (314) 812-8176 Email: [email protected] Cortex 4320 Forest Park Avenue, St. Louis, MO 63108 TEL: (314) 531-4500 WEB: www.cortexstl.com Email: [email protected]


Safe, less invasive solutionStereotaxis’ systems are currently used in the cardiac catheter-ization lab. The company’s technologies treat arrhythmias, heart failure, and coronary artery disease. The magnetic, computer-ized treatment platform offers a safe, less invasive solution for complex and routine interventional cardiology applications.

Full integration of existing technologiesStereotaxis’ Magnetic Navigation System allows physicians to more effectively navigate catheters, guidewires and other magnetic interventional devices, through the blood vessels and chambers of the heart, to treatment sites. The system uses con-trolled, externally applied magnetic fields that precisely govern the motion of the internal working tip of the catheter, guidewire or other magnetic interventional device. The procedures are con-ducted with full digital integration of the technologies currently used in a cath lab.

‘Point-and-click’ control

Because the working tip of the disposable interventional device is controlled by external magnetic fields, the physician has the same degree of control regardless of the number or type of turns, or the distance traveled, by the working tip. The Stereotaxis Magnetic Navigation System provides the physician with remote instrument control through a “point-and-click” or joystick tech-nology, which can be operated from either the patient table, as in

traditional interventional procedures, or from a room adjacent to the patient but outside the x-ray fluoroscopy field.

Variable and fi nely controlled contact pressureThe GentleTouch magnetic catheters used with the Stereotaxis Magnetic Navigation System are capable of exerting a variable and finely controllable contact pressure at the working tip. Opti-mized contact enables accurate recording of electrograms and successful therapy delivery.

Company involved in all aspects of development

Stereotaxis is involved with all aspects of product development, including design, manufacturing and direct marketing. In addi-tion, a range of magnetically enabled ablation and mapping catheters are manufactured and marketed by Biosense Webster, a Johnson & Johnson company. The key components of Stereo-taxis’ product platform have received appropriate regulatory clearances and approvals and are widely available worldwide.

Comprehensive physician training

Stereotaxis provides comprehensive training to the physicians and healthcare providers who use its products. Customers include both research-oriented institutions in interventional medicine and more commercially oriented, high-volume surgical sites.

StereotaxisNasdaq: STXSSt. Louis, MO

A New Era in Cardiac Interventional Medicine

Status

Revenue for the quarter ended June 30, 2007 increased 105% to $7.8 million, compared with $3.8 million in revenue in the second quarter of 2006. Revenue from Niobe sales grew 102% to $5.8 million compared with $2.9 million in Q2 2006, reflecting an increase in the number of systems sold during the quarter and an increase in the average selling price. Disposables, services and accessories revenue also set a new record, increasing to $2.1 million in the second quarter of 2007 from $1 million for the same period last year.

Management

CEO: Bevil J. Hogg

Contact

CEO: Bevil J. Hogg Web: stereotaxis.com CFO: James M. Stolze Tel: (866) 646-2346

Bevil Hogg has more than 30 years of P&L respon-sibility. The past 14 years of his career have focused on the manufacture and sale of technologically advanced equipment for the healthcare market-place. Hogg has a long track record in commercial-izing innovative technologies, having founded or co–founded three successful companies, including Trek Bicycle Corporation and Kestrel.

Nearly a half-million people die annually from coronary artery disease, a condition in which the formation of plaque in the coronary arteries obstructs the supply of blood to the heart

The Stereotaxis Magnetic Navigation System utilizes two permanent magnets mounted on articulating or pivoting arms. These arms are enclosed within a stationary housing, with one magnet on either side of the patient table

Addressing market needEach year, more than two million people die in the U.S. from cancer and cardiovascular disease. Despite a nearly $130 billion price tag for treatment of both diseases, mortality and morbidity remains high. To tackle this challenge, physicians, and in turn drug companies, are turning towards “targeted” therapies and the diagnostics that “personalize” the choice of these therapies to the individual patient. Kereos’ targeted imaging and therapeutic products fit seamlessly with both of these thrusts.

Within oncology, Kereos’ targeted imaging agents may enable earlier and more accurate detection of tumors, as well as char-acterization for critical prognostic biomarkers. Both are features that will allow the physician to better personalize a patient’s therapy across the full range of surgical and chemotherapeutic options. Kereos’ targeted oncology therapeutics build on the

specificity of the company’s imaging agents for tumor vascular biomarkers and instead target drugs to the same tumor vascula-ture. The results are highly targeted therapeutics selective for the disease-site blood vessels critical to most solid tumors.

Vascular biomarkers are forecast to play at least as important a role in cardiovascular disease as in cancer, and the wealth of such biomarkers provides ample opportunities for targeted imaging and therapy. One especially rich area is atherosclerosis, where there are highly characteristic biomarkers of angiogenesis, reste-nosis, plaque rupture, inflammation and thrombosis. While some of Kereos’ oncology agents may prove useful because of shared pathologies, additional atherosclerosis-specific agents are being developed, such as in Kereos’ collaboration with Bristol Myers-Squibb on a targeted cardiovascular MRI agent.

Pipeline statusKI-0001, Kereos’ angiogenesis-targeted MRI agent can find tumors as small as 1-2mm in size, while also highlighting actively growing regions in the tumor margin. This ability to more readily find satellite disease sites and better character-ize the edges of primary tumors is an important improvement to current practice in staging and therapy selection. By imaging a biomarker proven to predict tumor aggressiveness, invasive-ness, and metastatic potential, KI 0001 also adds a critical new dimension of molecular prognosis by imaging to current stag-ing. Furthermore, the ability to assess angiogenesis in real-time using this biomarker opens the door to monitoring the therapeu-tic effectiveness of current and emerging cancer drugs with anti-angiogenic effects.

Both KI-1001 and KI-1003 follow on the heels of KI-0001, only using the same biomarker to deliver two different potent anti-proliferative drugs (paclitaxel and fumagillin, respectively) precisely to the leading edge of new vessel formation, while reducing potentially toxic systemic exposure. In animal models, these Kereos products have been shown to aggressively reduce angiogenesis in both tumor and atherosclerosis models, as well as inhibit tumor growth. In tandem with KI-0001, either could form a powerful diagnostic/therapeutic pair.

Kereos is collaborating with Bristol-Myers Squibb for its sec-ond MRI agent for targeted assessment of cardiovascular disease via an undisclosed biomarker. Pre-clinical studies have shown that KI-0002 can find and assess previously undiagnosed cardio-vascular disease, and should help identify high-risk patients and direct effective therapy.

KereosPrivateSt. Louis, MO

Targeted Therapeutics and Molecular Imaging

Management

President and CEO: Robert A. Beardsley

Contact

CEO: Robert A. Beardsley Web: kereos.com CFO: Catherine L. Matthes Tel: (314) 633-1879

Dr. Beardsley has served as Kereos’ president and CEO since January 2003. Prior to joining Kereos, Beardsley was acting CEO of Metaphore Pharmaceuticals, where he played key roles in two successful private equity fundraising rounds. In addition, he is the co-founder of SImile Investors, and has held a number of positions at biotechnology and life sciences firms, including bioStrategies Group and Vector Securities.

KI-0001 provides MRI-based molecular imaging of the angiogenesis signal to better identify tumors as small as 1-2 mm in size

Inherently atraumatic designConventional catheters are designed to be operated mechanically from their proximal or back end. They are necessarily stiff to allow for steering through a series of cables. In contrast, Stereo-taxis’ proprietary catheters are controlled directly at their work-ing end by a magnetic field; they are extremely soft and flexible. This inherently atraumatic design may reduce the risk of perfo-ration or damage to heart tissue or vessel walls.

Selective deliveryFounded in 1999, Kereos develops targeted imaging agents and therapeutics for cancer and cardiovascular disease. The compa-ny’s targeted, or “molecular,” imaging agents function both as classical imaging agents, improving visualization of disease; and as in vivo biomarker assays, revealing the pathology of the dis-ease in situ and monitoring response to therapies. Kereos’ tar-geted therapeutics similarly seek out disease biomarkers but use them to selectively deliver powerful payloads of therapeutics to the disease site.

Building on successBased on innovations from Barnes-Jewish Hospital and Wash-ington University in St. Louis, Kereos’ technology uses drugs already in practice – such as gadolinium chelates for MRI or various chemotherapeutics for cancer therapy – and combines them with targeted emulsions to detect and treat disease. In addi-tion to an imaging agent or therapeutic, these targeted emulsion droplets contain a targeting molecule, or “ligand,” specific for a vascular biomarker of the disease. This ligand-targeting enables the Kereos products to carry active agents directly to disease sites expressing this biomarker. In the case of Kereos’ lead can-didate, KI 0001, that targeting ligand targets the αvβ3 integrin, which is a well-characterized marker of angiogenesis, both in solid tumors and in atherosclerosis.




What is Lincoln Financial Advisors/Sagemark Consulting’s mission?We help small companies, which some-times suffer from a lack of adequate planning, adapt to rapidly changing and heavily regulated business environ-ments. Our tagline is “Clear Solutions in a Complex World.”

Have you found that emerging healthcare companies have needs unique to their sector?Healthcare companies, especially small companies going through a startup or rapid growth cycle, have several coordi-nation gaps that tend to materialize.

To identify these gaps and how to address them, the company fi rst needs to be put into context: What is the purpose of the business? Do the owners plan on creating a new medical technology, product or service with the main intent of becoming an acquisition target in the near future? Or conversely, are the owners establishing the business for long-term ownership and operation? Does the ownership have the capital to fund the startup or are they looking to bring in outside partners or venture capital? There are many more important questions that follow, but just the answers to these fundamental questions can lead to many layers of complexity.

The additional overlay that makes the challenges in healthcare even more unique is government involvement. The government is both the greatest protector of the individual’s rights (FDA oversight and industry regulation), while simul-taneously one of the biggest clients of healthcare (Medicare and Medicaid); it can be a barrier to entry as well as a real catalyst for growth. The government’s infl uence can be felt in nearly every facet

of a healthcare business, requiring that special attention be given to the implica-tions of government involvement.

What advice do you have for a small-company executive who finds himself faced with this kind of “coordination gap”? What are some initial steps companies can take?The fi rst step is to identify that there is a gap before it causes the business to suffer, or allow someone to analyze the situation to identify the gaps. Typically this has to be someone who brings a cross-disciplinary, forward-looking per-spective. They have to be able to see the entire situation for what it is so they can identify the gaps; they must also have the experience and knowledge necessary to deliver the correct solutions. Normally, the ideal person for this is someone who has a fi nancial- planning background with specifi c focus in dealing with businesses and ideally, healthcare businesses.

Can you share any case studies of how this might actually play out?We have dealt with many different sit-uations in the healthcare arena. Many times we are dealing with doctors and their medical practice and partners. The practice alone can lead to many coordi-nation gaps; add in a building, a part-nership and succession planning, and even more gaps appear. With a major focus of these business owners being on asset protection, it is of utmost impor-tance that well thought out strategies are being employed.

Another situation we run into is when a doctor, by extension of his specialty, has a secondary business that produces a product to specifi cally help in the diag-nosis or treatment of his patients. There

Coordinate the Gap

are typically many coordination gaps that occur here, as well as potential pitfalls that need to be avoided.

Finally, healthcare businesses that provide a product or service are often not positioned to adapt to the changing landscape. The business structure that worked well in the beginning can become cumbersome, ineffi cient or inef-fective as the company goes through rapid expansion. Shareholder agree-ments that were originally established with good intent are now misaligned as the business grows and gains more value. The other issue that exists here is that behind every business there is an owner, or group of owners, whose per-sonal interests need to be addressed as well. There are almost always gaps here— whether the individual’s interest and the business’s interest are in concert or con-fl ict—that need to be addressed.

You’re based in St. Louis. In speaking with colleagues from around the country, have you found that entrepre-neurs’ needs can vary by region? We have such a great opportunity here in St. Louis with research and teaching schools, fi nancial and intellectual capital, and some of the top doctors in the country. Many of our advisor partners, from attorneys to CPAs to banks, are spe-cializing more and more in healthcare and helping to navigate its distinctive landscape. This unique combination of awareness, resources and support brings us the potential for the “perfect storm,” with the Midwest emerging as one of the top regions for medical advancement, for launching new healthcare businesses, and for products and services that have the potential to improve the condition of all mankind.

Daryl Tegtmeier, managing principal of Lincoln Financial Advisors/Sagemark Consulting, is helping small healthcare companies adjust to rapid changes and regulation

The business structure that worked well in the beginning can become cumbersome, ineffi cient and ineffective as the company goes through expansion.

““2005 merger combines diverse product linesSynergetics USA resulted from the September 2005 combination of Valley Forge Scientific Corp. and Synergetics, Inc., bringing together capabilities in bipolar electrosurgical generators and hand-held microsurgical instruments. By merging two compa-nies, management sought to gain the critical mass needed for continued growth.

Synergetics’ products are designed and manufactured to supportmicro or minimally invasive surgical procedures. In addition toits surgical devices and equipment for ophthalmic and neuro-surgery applications, the company designs and manufactures reusable and disposable supplies and accessories for use with such devices and equipment. It also makes bipolar electrosur-gical generators and other generators, based on its DualWave technology, and complementary instrumentation and disposable products for use in neurosurgery, spinal surgery, pain manage-ment and dental work.

Neurosurgery market and the DualWave PlatformSynergetics’ neurosurgery product catalogue includes over 500 neurosurgical items, including capital equipment, disposable and reusable instru-ments. Notable among these is the Omni ultrasonic aspira-tor, which, once attached to a hand piece, emulsifies bone and tissue, and then, using an integrated suction, removes bone and tissue fragments. Synergetics distributes the

aspirator in the U.S., Canada, Latin and most of South America, most of Europe, South Africa, Australia and New Zealand.

The Spetzler Endoscopic Micro Forceps are just one of 500 nerosurgery products offered by Synergetics. Also in the neuro-surgery market, the company offers the Advantage, a DualWave bipolar generator capable of performing the two separate func-tions of cutting and coagulation. The DualWave device virtually eliminates heat and electrical current seepage, making it safe for use near nerves, bones, blood vessels and metal implants.

Ophthalmic surgery productsIn the ophthalmic and vitreoretinal surgical markets, Synergetics offers instruments designed to treat acute subretinal pathologies, including histo-plasmosis and age-related macular degeneration. Synergetics offers more than 2,000 retinal surgical instruments,

including the Photon light source, laser probes, scissors, retrac-tors, cannulas, forceps and other disposable surgical products.

In June 2006, the company entered a three-year distribution agreement with Quantel. The agreement allows Synergetics to distribute Quantel’s Vitra, a portable laser, to ophthalmic sur-geons in the operating room and the physician’s office.

The Synergetics’ Photon is used in vitreoretinal surgery. An improved visual field enables physicians to see better, perform bimanual surgeries more easily, and incorporate laser and illumi-nation through Synergetics’ Bullseye laser illuminators.

Pain management portfolioIn the pain management market, Synergetics manufactures a lesion generator used for minimally invasive pain treatment. The generator is supplied to Stryker under the terms of a supply- and-distribution agreement signed in October 2004. Synergetics is developing an international version of the device; the com-pany shipped the first prototypes to Stryker in July 2006.

Dental markets utilize DualWaveIn the dental market, Synergetics offers the Bident Bipolar Tis-sue Management System, which employs the DualWave plat-form. Bident cuts and coagulates blood vessels via an array of disposable bipolar hand-held instruments. As in neurosurgery, the DualWave generator lessens the collateral tissue damage caused by electrical current spread and heat. Synergetics’ dental products are sold directly to dentists and through distributors.

Synergetics USASURGO’Fallon, MO

Surgery-Products Company Garners Critical Mass

StatusSynergetics is actively growing its disposable revenue stream by devel-oping a full offering of disposable adjuncts – including instruments, adapters and fiber optics – to its capital equipment offerings. The company is emphasizing disposables that are designed to eliminate hospital repair costs and minimize patient-to-patient disease transfer. Synergetics has developed a new multi-functional bipolar electrosur-gical system, marketed as the Malis Advantage.

Management

President and CEO: Gregg D. Scheller

Contact

CEO: Gregg D. Scheller Web: synergeticsusa.com CFO: Pamela G. Boone Tel: (636) 939-5100

The Spetzler Endoscopic Micro Cup Forceps are just one of 500 neurosurgery prod-ucts offered by Synergetics

The Synergetics Photon is used in intraocular laser and illumination. An improved visual field enables physicians to see better, perform bimanual surgeries more easily, and incorporate laser and illumination through Synergetics’ Bullseye laser illuminators

Scheller co-founded Synergetics in 1992 and has served as president and CEO ever since. He was named chairman of the board in 2005. From 1990-1992, Scheller was vice president of engineering for Infinitech. And from 1986-1990, he served as president of Advanced Surgical Products.



connected to existing proprietary, semi-proprietary or IP-enabled devices. EnNET integrates all building automation systems into a single, virtual real-time information source. Gridlogix creates value by connecting the enterprise to operations in real-time. With this new visibility and unification of facilities, customers are able to increase operational efficiencies, reduce risk, and bet-ter manage compliance and security issues.

Energy conservation has fueled operations to date

To date, Gridlogix has focused on energy conservation. In large facilities, the company has been able to cut energy costs by an average of 20% by integrating and then more accurately fine tuning HVAC controls. On average, energy and maintenance savings provide a 12-month ROI for the customer.

Gridlogix has also had success in integrating facility control sys-tems with asset and work-order management systems and supply chain partners. Gridlogix is able to eliminate redundant manual data input into these various systems. Easier access to informa-tion streamlines routine maintenance and emergency repair and has led to a savings of 20-40% annually.

GridlogixPrivateSt. Louis, MO

Total Device Integration for the Extended Enterprise

Status

Gridlogix has a $60 million pipeline, including a project for the State of Missouri that involves integrating 28 million square feet of facility space and several of the state’s hospitals. In August, the company was named the Governor’s 2007 Technology Company of the Year by the Missouri Technology Corporation and the Department of Economic Development.

Management

CEO: Hal Gentry

Contact

CEO: Hal Gentry Web: gridlogix.com President: J. Carter Williams Tel: (314) 843-3343

Gentry brings over 20 years of software-development and executive-management experience to Gridlogix. Prior to joining the company, he was CEO of Gentry Systems, a company he founded that focused on Geographic Information System and Operations Management technology for the electric-utility industry. Under Gentry’s leadership, that company provided services to over 300 utilities.

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Platform technology integrates disparate processersThere are some 500,000 personal computers and 40 billion microprocessors operating worldwide today. These micropro-cessors exist in devices that manage many aspects of our daily lives, including our comfort, health and safety. Less than 5% of these 40 billion devices are currently connected to a network or accessible by other applications.

Gridlogix has developed a middleware application that is able to communicate with many of these proprietary systems, com-monly found in healthcare facilities. The technology is able to transform data (in real-time) into a non-proprietary format using Extensible Markup Language or XML Web services. This is a general-purpose platform that facilitates the sharing of data across different information systems and the Internet.

Healthcare offeringsIn healthcare facilities such as hospitals, Gridlogix’s offering helps manage energy utilization and facility-maintenance costs.

For the medical director, Gridlogix’s integration into RFID and wireless sensors assures uptime of critical care equipment while keeping patients safe. The company’s unified real-time data col-lection capability allows health professionals to maintain a per-manent log of all points of care, without intruding on employees’ processes or procedures. Other applications include the tracking of medical equipment, temperature and environmental monitor-ing of drugs, operations-center integration and patient tracking.

EnNET reduces operating costs, increases effi ciencyFor enterprises trying to increase customer satisfaction and lower operating costs, Gridlogix helps customers manage energy, maintenance, compliance and security. Gridlogix provides a low-cost solution to link enterprise systems to all the data gener-ating devices throughout a facility, enterprise, and supply chain.

The core of every Gridlogix integration solution is the EnNET framework. EnNET provides a unified, standards-based inte-gration framework that enables companies to rapidly integrate existing monitoring and control systems. EnNET is designed to expose real-time data sources, but it can also be used to supple-ment the weaknesses found in many legacy systems. Developers can more easily add functionality not found in the underlying system. Application developers can use EnNET to transform a device originally intended to take advantage of a simple feature set into a fully featured application that can take advantage of alarming, calendars, schedules and trends.

The Gridlogix EnNET platform is a unified enterprise solution


What is Innovate St. Louis’ mission?Innovate St. Louis’ goal is to signifi cantly raise the level of innovation and entrepre-neurship in our bi-state region. While St. Louis is already doing many good things in these areas, more is needed for the long term.

Innovate St. Louis hopes to help secure our region’s future by working to attract and keep three of the ingredients needed for a sustained fl ow of fresh ideas and the ability to translate them into value for people: brains, bucks and business. In so doing, we want to ultimately raise the quality of life for the people who live and work here.

Our work falls into three general cat-egories: initiating programs that help the development of business startups, building coalitions that leverage our assets in key industry areas, and creating an infrastructure that encourages entre-preneurship across all sectors.

What’s your background and how did you arrive at the organization?In the mid-80s I was intrigued with the potential of the then-emerging area of life sciences and spent nearly two decades at Monsanto Company. Among my assign-ments there was helping the St. Louis region start some initiatives in the half dozen or so areas that were recognized as critical national technologies. After my retirement in 1999, I continued to be involved in tech-nology-driven economic development through serving on such boards as the Missouri Biotechnology Association, the Missouri Technology Corporation and the Missouri Research Corporation. I was also lucky enough to participate in putting together St. Louis’ strategy that served as a blueprint for our growing plant and life sciences sector. Thus, when I heard about the opportunity with Innovate St. Louis, it seemed to be a natural fi t with some of the things I had been doing.

Since being founded in May 2006, what are the some of the key things Innovate St. Louis has accomplished?By the time I joined Innovate St. Louis just over two months ago, our board chairman, William Peck, MD, who is director of the Center for Health Policy at Washington University and former dean of its medical school, had already done a remarkable job of recruiting a board of the region’s civic leaders, securing initial funding, and starting several key programs. We’ve started a community-wide venture men-toring service modeled after the successful program at MIT. It assembles teams of mentors to help our region’s startups. Now, less than three months into the effort, some 30 experienced mentors are at work with nearly a dozen companies.

Innovate St. Louis also has under its wing the Information Technology Coalition. Among its efforts, the IT Coalition is working on pooling our region’s IT entre-preneur-support resources into a virtual incubator that can serve IT startups, whether they operate out of someone’s home or in traditional incubator space.

We are also actively sponsoring several series of regular networking and education events. And we have just partnered with a group that has run programs for entrepre-neurs for over two decades.

We’d also like to use our region’s entre-preneurial know-how to help the non-profi t sector. St, Louis has the nation’s sixth largest United Way, along with some of the nation’s top social entrepreneurship academic pro-grams. We’ve begun a dialogue on how we can contribute to improving the many chari-table endeavors that operate here.

What makes St. Louis attractive for an emerging med tech company?There are the obvious reasons why St. Louis has been attractive for healthcare startups -- the fi ve life sciences focused

Sustaining Innovation

venture funds, the medical schools, the teaching hospitals, and the univer-sities with over $400 million-plus in NIH research conducted annually. But it’s the longer term competitive advantages, as mature companies, that keep them here. Companies can fi nd entry-level job candi-dates trained by the community colleges, up through PhDs experienced in running clinical trials at Washington University.

The cost of operations and future devel-opment is lower because cost of living for the talent pool is lower, and it is an excellent location logistically. The St. Louis campus of Pfi zer, for example, just broke ground on a $50 million expansion to double the size of a pilot plant for biologic drugs for clinical trials, on top of a $200 million research center also under con-struction—at a time when Pfi zer is aggres-sively cutting costs everywhere else.

Can you tell us about some future projects?One thing we’re considering is an idea that originated in Kansas City and was ini-tially funded by the Kauffman Foundation there. The resulting program addresses the problem of how a new entrepreneur gets linked with the help and services needed to be successful. Sadly, this can all too often be a random, time-consuming process that may be frustrating and not always yield the best result. The program that was put together identifi ed all those organizations that provided advice and help to entrepreneurs -- well over 100 of them; set up a help line and a parallel sophisticated Web site to route the startup to the best source for help, and then fol-lowed up periodically with the business to make sure it got the level of support it needed. We know this will help our St. Louis life sciences startups and others improve their success rates.

Once this is in place, there are lots of other ideas in the queue. Stay tuned.

Frank Stokes, CEO of Innovate St. Louis, is helping to attract to the region three important ingredients: ‘brains, bucks and business’

There are obvious reasons why St. Louis has been attractive for startups. But it’s the longer term competitive advantages that keep them here.

““



Augusta Medical SystemsAugusta, GA

Private

Belair Instrument CompanySpringfi eld, NJ

Private

Best Medical InternationalSpringfi eld, VA

Private

BiolitecEast Longmeadow, MA

ISIN/Frankfurt Exchange

B-K MedicalHerlev, Denmark

Private

BSD Medical CorporationSalt Lake City, UT

BSMAMEX

CADsciencesWhite Plains, NY

Private

Caldera MedicalAgoura Hills, CA

Private

Carbon Medical TechnologiesSt. Paul, MN

Private

Celsion CorporationColumbia, MD

CLNAMEX

CIVCO Medical InstrumentsKalona, IA

Private

ColoplastHumlebaek, Denmark

COLOCPH

Cook GroupBloomington, IN

Private

CytoCoreChicago, IL

CYCR.OB

DiagnoCureQuébec, Canada

CUR.TSX

DIANON SystemsStratford, CT

Private

Dornier MedTechWessling, Germany

Private

EDAP TMS S.A.Vaulx-en-Velin, France

EDAPNasdaq

EMS Electro Medical Systems S.A.Nyon, Switzerland

Private

EndocareIrvine, CA

ENDO.OB

Envisioneering Medical TechnologiesSt. Louis, MO

Private

Envisionier Med TechRockville, MD

Private

Ethicon Endo-SurgeryCincinnati, OH

Private

Focus SurgeryIndianapolis, IN

Private

GaeltecIsle of Skye, Scotland

Private

Galil Medical USAPlymouth Meeting, PA

Private

Greenwald Surgical CompanyLake Station, IN

Private

G-U Tek (Genito-Urinary Technology)South Plainfi eld, NJ

Private

Gyrus ACMISouthborough, MA

Private

HealthTronicsAustin, TX

HTRNNasdaq

IBtSeneffe, Belgium

IBTB/Brussels Stock Exchange

Vacuum therapy systems for the treatment of Erectile Dysfunction.

Surgical tissue biopsy processing instruments, laboratory planning and consulting.

Radiation seeds utilizing various isotopes, catheters, needles, templates and accessories.

Specialized medical and dental lasers and fi ber optic delivery systems.

Urological, surgical and diagnostic ultrasound systems.

Systems to treat cancer and benign diseases using heat therapy.

Computer-assisted modeling to facilitate the analysis, interventional planning and reporting of breast and prostate MRI.

Products for the gynecology, urology and urogynecology specialties.

Proprietary carbon-coated implantable medical devices, treatments for stress urinary incontinence.

Heat-activated treatments for benign prostatic hyperplasia.

Products for patients undergoing radiation oncology, interventional radiology, ultrasound and urology services.

Ostomy, urology and continence care, wound and skin care.

Minimally invasive medical devices for diagnostic and therapeutic procedures.

Screening systems to assist in the early detection of cervical cancer.

Tests for the early cancer detection including bladder cancer.

A portfolio of serum tumor markers to help detect disease and monitor therapy.

Orthopedic shock wave devices, medical aesthetic lasers, lithotripters and digital urology imaging systems.

Minimally invasive medical devices for the treatment of urological diseases.

Micromechanical devices and shockwave therapy devices for intracorporeal and orthopedic use.

Cryoablation technology for the minimally invasive treatment of prostate and renal cancer; tumors in the kidneys, lungs, and liver.

Diagnostics for detecting cancer and other diseases of the prostate.

Hand-held endoscopic video camera.

Minimally invasive surgical devices for use in general and bariatric surgery, gynecology and surgical oncology.

Non-invasive treatment for BPH using High Intensity Focused Ultrasound.

Catheter tip transducers for gastroenterology, urology, esophageal manometry and ano-rectal manometry.

A cryotherapy platform as a minimally invasive alternative to some surgeries, including prostate surgery.

Urological and electrosurgical instruments and accessories.

Urological products for hospital use.

Imaging and surgical equipment for use in gynecological and urological procedures.

Urology imaging and therapeutic products.

Interstitial implants used in the treatment of cancer.

Sym/ExchangeCompany/Location Summary

AbbeyMoor MedicalMiltona, MN

Private

AcuPath LaboratoriesPlainview, NY

Private

Advanced Endoscopy DevicesCanoga Park, CA

Private

Advanced Meditech InternationalFlushing, NY

Private

AesculapCenter Valley, PA

Private

Allwin Medical DevicesAnaheim, CA

Private

AlokaWallingford, CT

Private

American Medical EndoscopyMiami, FL

Private

American Medical SystemsMinnetonka, MN

AMMDNasdaq

Andromeda Medizinische Systeme GmbHTaufkirchen, Germany

Private

Applied Medical ResourcesRancho Santa Margarita, CA

Private

Applied Medical TechnologiesCleveland, OH

Private

ArizantEden Prairie, MN

Private

Ascension Technology CorporationBurlington, VT

Private

AST Advanced Shockwave TechnologyJena, Germany

Private

Astra TechMölndal, Sweden

Private

Augusta Medical SystemsAugusta, GA

Private

Management of male urinary voiding dysfunction.

Pathology, molecular and cytogenetic analysis.

Manufacture, repair and servicing of endoscopic instruments.

Minimally invasive vasectomy and norplant removal instruments.

Surgical instruments for the core processes in the operating theater and cath lab.

Products for urology, gastroenterology, nephrology and radiology.

Medical imaging and ultrasound equipment with high spatial and contrast resolution.

New and refurbished endoscopic and specialty surgical equipment.

Medical devices and therapies that help restore pelvic health.

Urodynamic measurement systems and disposables.

Products to enhance minimally invasive surgical techniques including ureteroscopy, endopyelotomy and nephrectomy procedures.

Drug delivery, mass transport, soft tissue interaction, devices for hard tissue attachment, feeding devices, and surgical instrumentation.

Temperature management systems for surgical patients.

3D tracking devices for medical guidance, minimally invasive surgery, real-time visualization, and target acquisition.

A shockwave source for urological use.

Urological devices and a line of dental implants.

Vacuum therapy systems for the treatment of Erectile Dysfunction.


Ones to Watch

UROLOGY FOCUS THE LIST

ccording to Millennium Research Group’s US Markets for Urological Devices 2007 report, the urological

device market is expected to grow from $1.8 billion in 2006 to $2.6 billion in 2011.

Public education campaigns, launched to increase awareness about conditions like urinary incontinence, benign prostatic hy-perplasia, prostate cancer, and erectile dys-function, will play a signifi cant role in driv-ing the market. But no factor will be a greater contributor to growth than innovation. Consumer and sur-geon demand for minimally invasive treat-ments -- and insurance companies’ favorable response to products that cut down on hospital stays -- has resulted in a number of new de-vices that address urological conditions.

In the chart below are 110 urology fi rms. The list is not exhaustive, but we hope useful for getting to know an exciting sector. In addition, the pages that follow contain full-page profi les on fi ve OneMedPlace member companies:

For full profi les on the companies listed below, visit the Urol-ogy Floor in the Companies Building at onemedplace.com

Envisioneering, of St. Louis, MO, has devel-oped a system for 3D prostate imaging and biopsy. The system allows a physician to gen-erate a true 3D image, manipulate it, and pre-cisely plan a multi-sample biopsy of a targeted tissue mass in the prostate. See page 42

SRS Medical, of Redmond, WA, is developing an alternative to urinary catheters. Catheters represent a $1 billion dollar per year business, but one that creates an estimated $1.85 billion in hospitals costs. See page 43

PercSys, of Mountain View, CA, develops devices that make urologic and endoscopic procedures easier, less traumatic and more ef-fective therapeutically. Many of the company’s products facilitate the introduction of catheters and other instruments for procedures that are moving from the hospital into an office envi-ronment. See page 44

Ikonisys, of New Haven, CT, is a privately held biotechnology company developing non-invasive cell-based diagnostic products, in-cluding ones to diagnose bladder cancer. The

company’s offerings provide laboratories with an economical solution to the challenge of ex-panding test volume capacity during an indus-try-wide shortage of trained technical person-nel. See page 45

Colby Pharmaceuticals, of Menlo Park, CA, is an early stage drug company develop-ing small-molecule therapeutics for oxidative stress-induced human diseases, with a special focus on prostate cancer. See page 48

Also read interviews with Craig Davenport, CEO of Endocare (page 49), and Cathy Naughton, MD, founder of St. Louis’ Center for Sexual Health (page 46).

A

UROLOGY FOCUS THE LIST



IDL BiotechBromma, Sweden

IDLBStockholm

IkonisysNew Haven, CT

Private

Implant Sciences CorporationWakefi eld, MA

IMXAMEX

InnerVision Medical TechnologiesAlberta, Canada

Private

IsoRay ProductsPort Saint Lucie, FL

ISRAMEX

Karl StorzTuttlingen, Germany

Private

Kosin TechnologiesValparaiso, IN

Private

Laborie MedicalWilliston, VT

Private

Lakewood Pathology AssociatesLakewood, NJ

Private

Laser PeripheralsGolden Valley, MN

Private

LifesignSomerset, NJ

Private

Life-TechStafford, TX

Private

Lumenis Ltd.Santa Clara, CA

LUME.PK

Matritech, Inc.Newton, MA

MZTAMEX

Medical Measurement SystemsDover, NH

Private

MediIFixMorton Grove, IL

Private

MedisonSeoul, KOR

Private

MediwatchWarwickshire, United Kingdom

MDWLSX

MedradWarrendale,, PA

Private

Microsurgery InstrumentsBellaire, TX

Private

MisonixFarmingdale, NY

MSONNasdaq

NDS Surgical ImagingSan Jose, CA

Private

New Star LasersRoseville, CA

Private

North American Scientifi cChatsworth, CA

NASINasdaq

Novadaq TechnologiesMississauga, Ontario

NDQ.TSX

Novasys MedicalNewark, CA

Private

Novostent CorporationMountain View, CA

Private

Omni-Tract SurgicalSt. Paul, MN

Private

OncoMethylome SciencesDurham, NC

ONCOBEBR

OncuraArlington Heights, IL

Private

Opticon MedicalDublin, OH

Private

Cancer and bacteria diagnostics and various tumor markers.

Robotic digital microscopy platform for cancer diagnosis and management, prenatal detection of genetic disorders, and fertility testing.

Surface treatment technologies for medical devices, radioisotope treatments for cancers.

High resolution, instant-capture, acoustic based imaging systems.

Brachytherapy seed for the treatment of prostrate cancer and other solid cancer tumors.

Endoscopic equipment for human and veterinary medicine.

A universal irrigation system for urologists.

Computerized urodynamic equipment for the diagnosis and treatment of incontinence.

Anatomical pathology services tailored to the outpatient needs of surgeons.

Laser fi ber optic delivery systems.

Rapid, point of care diagnostic testing.

Electronic medical devices and disposables for a number of specialties.

Laser and light-based technologies for medical and aesthetic applications.

Proteomics-based diagnostic products for the early detection of cancer.

Functional diagnostics in the fi eld of urodynamics, gastroenterology and neurology.

Rigid and semi-rigid endoscopes.

Medical devices for digital imaging technology.

Medical diagnostic equipment manufacturer and supplier.

CT injectors, MR injectors and coils, MRI compatible infusion catheters.

Microsurgery and other delicate surgical products.

High Intensity Focused Ultrasound technology used in several medical applications including treatment of prostate cancer.

Medical imaging systems used in surgery.

Nd:YAG and Ho:YAG medical lasers for aesthetic, endovenous, general and cardiovascular surgery.

Radioisotope products for the treatment and diagnosis of disease.

Real-time imaging to assess organs, tissues and vessels during surgery.

Non-surgical treatment for female stress urinary incontinence.

Helical stent technology for a range of vascular therapies.

Table-mounted retractor systems for various exposure requirements.

Gene methylation tests to detect early stage cancers.

Prostate cancer treatment using brachytherapy.

Urinary management and chronic urinary incontinence devices.


Oxford InstrumentsAbingdon, United Kingdom

OXIG.L

Percutaneous Systems (PercSys)Mountain View, CA

Private

Physion Inc.Fairfi eld, NJ

Private

Predictive DiagnosticsVacaville, CA

Private

ProstaLund OperationsUppsala, Sweden

Private

ProUroCare MedicalGolden Valley, MN

PRRC.OB

Qualigen, Inc.Carlsbad, CA

Private

Richard Wolf Medical InstrumentsVernon Hills, IL

Private

Rochester Medical CorporationStewartville, MN

ROCMNasdaq

Roei Medical Technologies Israel

Private

SonometricsLondon Ontario, Canada

Private

Spirus Medical, Inc.Stoughton, MA

Private

SRS Medical Corp.Billerica, MA

Private

SurgRx Inc.Redwood City, CA

Private

Theragenics CorporationBuford, GA

TGXNYSE

Thompson Surgical InstrumentsTraverse City, MI

Private

Timm Medical TechnologiesEden Prairie, MN

Private

Trimedyne, Inc.Lake Forest, CA

TMED.OB

Tuebingen Scientifi c MedicalTübingen, Germany

Private

UroCor LabsOklahoma City, OK

Private

UroGyn MedicalValparaiso, IN

Private

Urologix, Inc.Minneapolis, MN

ULGXNasdaq

UroMed CorporationAlpharetta, GA

UOMD.OB

UromedicaPlymouth, MN

Private

Uroplasty, Inc.Minnetonka, MN

UPIAMEX

Urovalve, Inc.Newark, NJ

Private

Utah Medical ProductsMidvale, UT

UTMDNasdaq

Vascular TechnologyNashua, NH

Private

Verathon MedicalBothell, WA

Private

Viking SystemsSan Diego, CA

VKSY.OB

Vision SciencesNatick, MA

VSCINasdaq

Technology solutions and chemical analysis.

Devices to make urologic and endoscopic procedures less traumatic and more effective.

Iontophoretic treatment for Peyronie’s Disease (Induratio Penis Plastica).

Diagnostics to identify biomarker fi ngerprints for cancers including prostate or ovarian varieties.

Non-surgical treatment of benign prostatic hyperplasia.

Minimally invasive techniques to identify tissue abnormalities in the prostate.

Blood testing systems that provide rapid, quantitative immunoassay test results.

Products for use in endoscopic procedures.

Latex-free urological and urinary continence care products.

Endoscopic urological procedures including transurethral resections.

Sonomicrometer hardware and software for use in various scientifi c applications including uro-genital measurements.

Medical devices the treatment of gastrointestinal disorders; currently under devel-opment - applications for the technology in the fi elds of urology and gynecology.

Diagnosis and conservative treatment of incontinence.

Products to seal and transect small to large vessels, large pedicles and tissue bundles

Implantable radiation devices used in the treatment of cancer, including prostate cancer.

Surgical instruments and specialized mechanical retractors.

A vacuum treatment for erectile dysfunction.

Lasers and disposable fi ber optic delivery devices.

Instrumentation for minimally invasive surgery.

Diagnostic services to assist in detecting and managing prostate and bladder cancer, kidney stones and other urologic disorders.

RF electrodes for resection and ablation procedures in urology and gynecology.

Devices for the treatment of urological disorders including BPH.

Disposable medical products for people suffering from incontinence.

Minimally invasive treatments for post-prostatectomy and stress incontinence.

Minimally invasive products to treat urinary incontinence and overactive bladder symptoms.

Products to improve urinary tract function for people with spinal cord and related injuries.

Disposable and reusable specialty medical devices and surgical instrumentation.

Disposable Doppler Probes to locate and identify blood vessels.

Noninvasive instruments for bladder volume measurement.

Imaging technologies to enhance minimally invasive surgeries.

Flexible endoscopic instruments for use in urology, gastroenterology and otolaryngology.

UROLOGY FOCUS THE LIST UROLOGY FOCUS THE LIST


Focused on incontinence, a growing global problemSRS Medical designs, manufactures and markets proprietary medical devices for the diagnosis of lower urinary tract symp-toms and for conservative treatments of urinary incontinence.

SRS Medical’s products are protected by numerous patents (23 U.S. patents plus foreign counterparts). The company’s man-agement team averages 20+ years experience in the urology/gynecology market and in medical-device manufacturing. SRS Medical has internally funded all activities to date (including its four acquisitions and all product development) and its operations are profitable.

The company has two business units: SRS Medical Corp., whose products for physicians include the EasyPro3 in-office urody-

namics system, and the about-to-be-introduced UroCuff CT3000, a patented system for non-inva-sive diagnosis of male bladder function; and Personal Medical Corp., whose products for patients include the In-Flow device and other technologies for female uri-nary health.

Transformational technol-ogy for bladder drainageThe In-Flow device addresses one of the most significant problems in urologic practice: how to pro-vide safe, effective and dignified bladder drainage, particularly for extended periods. Bladder drain-age is now done with urinary cath-eters, which may be the simplest medical devices, usually consist-ing of nothing more than a tube to empty the bladder. They are among the most commonly used medical supplies, despite the fact that they cause serious problems, notably life-threatening infections and low quality of life.

The In-Flow employs a new approach to bladder drainage. Unlike other urinary catheters, which rely on gravity to passively drain the bladder, the In-Flow has a miniature turbine pump that spins at 10,000 RPM and actively empties urine. This ensures that the bladder is fully emptied and maintains the “flush mecha-nism” that the body normally uses to protect itself against the

build up of bacteria and infection. The technology involved is considerable and has been clinically proven to result in signifi-cant advantages:

Lowest UTI rate of any indwelling device—equal to or better than the UTI rate for intermittent catheters.

Highest quality of life, due to the following: the In-Flow elimi-nates tubes and bags, improving body image (as well as hygiene); it allows most patients to void without assistance, increasing self-reliance; and it allows most patients to use a toilet again, a psychologically significant benefit since that is the “normal” way to void.

At this time, five clinical studies (total n=495) concerning use of the In-Flow device have been published in peer-reviewed journals. In-Flow is CE Marked and was recently approved for reimbursement in Germany; approximately 12,000 devices (rep-resenting 1,000 women-years of use) have been sold to date, mostly in Europe. The device is awaiting approval by FDA.

SRS MedicalPrivateRedmond, WA

Innovative Methods of Tackling Incontinence

Status

In late 2006, the company moved its east and west coast operations to expanded facilities in order to support ongoing and anticipated growth. In January 2006, SRS Medical acquired all assets related to devices for the treatment of severe female incontinence from Eutech Medical AB of Gothenburg, Sweden. In October 2003, SRS Medical acquired all assets related to the Timm Medical urodynamic products and certain incontinence treatment devices from Endocare. Prior to that, the company acquired substantially all assets of Asbrook/Eris, a Ventura, CA, manufacturer of urodynamic products, and the In-Flow device from American Medical Systems.

Management

CEO: Kevin M. Connolly

Contact

CEO: Kevin M. Connolly Web: srsmedical.comEVP, S&M: David Mahoney Tel: (800) 442-4144

Connolly is a serial entrepreneur who has spent his career in the medical device industry. He is the architect of SRS Medical’s product and market strategy and is responsible for its acquisitions. He has twice presented to the MCAC (Medicare) Executive Committee concerning procedural aspects of evidence-based medical review and the first national coverage decision for biofeedback treatments of incontinence.

EasyPro3 was designed to meet physician and patient needs for an accu-rate, easy-to-use in-office urodynamics system

SRS Medical believes that the In-Flow device is a disrup-tive technology with the potential to replace a significant portion of the $850 million urinary catheter market

Answering physicians’ callsIn a 2003 Reviews in Urology report, Samir Taneja, MD, direc-tor of urologic oncology at New York University Medical Cen-ter, wrote, “…an optimal strategy for accurate and judicious detection of early prostate cancer is imperative.”

Four years later, Dr. Taneja may have found the answer to his call. As the co-primary investigator for a clinical trial, today Dr. Taneja and a team of researchers from across the country are testing Envisioneering Medical Technologies’ TargetScan, the first complete system to diagnose and treat prostate disease. Pre-liminary tests indicate that TargetScan can improve physicians’ ability to detect prostate cancer, which in turn could lead to more targeted treatments that reduce life-altering side effects, includ-ing impotence and incontinence.

Time for changeDr. Taneja and his international colleagues aren’t alone in their desire for improved prostate-cancer detection and treatment. Pre-senting the highest incidence of male cancer, more than 218,000 men are diagnosed with prostate cancer each year in the U.S., and prostate cancer remains the second-leading cause of cancer death. With an aging and educated baby-boomer population, TargetScan addresses patients’ angst with current detection systems that ren-der false negatives, inconclusive positives and leave patients with the confounding circumstance known as “watchful waiting.”

Medical community’s viewUnlike conventional technology, TargetScan combines 3-D image acquisition with a hands-free, stationary probe to sup-port planned and executed prostate biopsies. With the stationary probe in place, TargetScan generates a 3-D image in a matter of seconds. TargetScan’s proprietary software then calculates the planned biopsy sampling sites to ensure an even distribution of sampling throughout the prostate gland.

During the biopsy procedure, TargetScan’s fixed probe prevents prostate movement while its attached proprietary guide and bendable NITINOL prostate biopsy needle allows for method-ical prostate sampling. The system records exactly where a biopsy sample was taken to ensure, for the first time, accurate sampling of the entire gland, and to allow for repeatable biop-sies as needed. For physicians and their patients, this means that TargetScan biopsies can more accurately identify the extent, location and the grade of cancer, as reported in the Washington University School of Medicine 2005 study “Evaluation of Tar-getScan Device in Prostate Cancer Detection.”

In contrast, current prostate biopsy procedures require urologists to hold and pivot a probe with one hand while performing a nee-dle biopsy with the other hand. According to some leading urol-

ogists, the inherent variables of this existing biopsy technique can force doctors to miss potential cancers. As more physicians move toward focal therapies, the need for TargetScan technol-ogy that can pinpoint and map clinically significant cancerous cells will continue to grow.

Targeted cancer treatmentsTargetScan’s precise prostate sampling also supports treatment planning. Radiation oncologists rely on TargetScan’s stationary probe to precisely deliver prostate-sparing cancer treatments to pre-planned targets. TargetScan’s treatment applications sup-port the medical community’s growing demand for less-invasive options, includ-ing brachytherapy, cryotherapy and high-dose localized radiation. These procedures call for precise needle placement into tar-geted cancer sites of a stabilized prostate to reduce the risk of impotence, incontinence and other side effects.

Future demandA multi-center study is underway at New York University Medical Center, the University of Michigan, Duke, University of Southern Califor-nia and Washington University in St. Louis, testing 250 patients to compare TargetScan’s ability to detect cancer to conventional technologies. The preliminary findings validate TargetScan’s diagnostic and treatment benefits and have led to higher reim-bursements for physicians who employ TargetScan to undertake planned prostate biopsies. The indications of clinical success and higher reimbursements are prompting early sales of the device across the country.

With the study underway and initial sales success, Envisioneering is creating a manufacturing system that supports ongoing technology enhancements and higher sales volumes for the TargetScan system.

EnvisioneeringPrivateSt. Louis, MO

On Target

StatusEnvisioneering is advancing its transition from technology developer to marketer and manufacturer. The European market is now open for TargetScan sales as Envisioneering has cleared regulatory hurdles and reached a European distribution agreement. Envisioneering’s efforts were recognized with an invitation to present at the 2007 Invest-Midwest conference, which highlights the region’s successful late-stage medical companies. TargetScan’s utility continues to expand and now includes technology integration with Varian Medical Systems, a treatment-planning software company. TargetScan also offers a new brachytherapy feature, whereby the surgeon can easily locate and track needle movement.

ManagementPresident: Robert G. Mills

Contact

President: Robert Mills Web: envisioneeringmedical.com CFO: Mark Crawford Tel: (314) 429-7367

Mills offers more than 20 years experience in the medical products industry. Prior to Envisioneering, Mills served as vice president and general manager for Endovascular, a division of Mallinckrodt. He also has held positions at Boston Scientific and Johnson & Johnson.

Envisioneering’s TargetScan System uses 3D ultrasound technology to perform precise, tar-geted prostate biopsies

UROLOGY FOCUS COMPANY PROFILE UROLOGY FOCUS COMPANY PROFILE


Procedures shift from the hospital to the offi cePercutaneous Systems (PercSys) develops devices that make urologic and endoscopic procedures easier, less traumatic and more effective therapeutically. Many of the company’s products facilitate the introduction of catheters and other instruments for procedures that are moving from the hospital into an office envi-ronment.

Newly introduced stone-management device cuts down on operating time, maximizes comfortApproximately five percent of Americans will be affected by urinary stones at some point in their life. Stone disease is among the most painful and prevalent of urologic disorders.

If a stone becomes large enough, it can block or otherwise cre-ate pressure, pain and infection in the kidney or ureter, the tube that carries urine from the kidneys to the bladder. Many patients experiencing urinary stones can be managed with medications

and large amounts of fluids. In those patients with larger stones, external or minimally invasive surgical intervention may be required.

The PercSys Accordion Stone Management Device can be used to entrap and remove stones and other foreign objects from the ureter. The device combines the utility of multiple endoscopic stone- management tools into a sin-gle device. The Accordion

tracks past the stone like a guidewire and can be monitored with fluoroscopic or endoscopic imaging. Once formed, the device’s film occlusion conforms to and fills the ureter, and is designed to prevent retrograde migration of stone fragments. During stone fragmentation, the Accordion device facilitates distal rinsing of smaller fragments to keep clear the field of view. Following frag-mentation, the device can easily sweep larger fragments into the bladder or a ureteral access sheath, thereby eliminating tedious and time-consuming serial basketing of individual fragments. These benefits combine to simplify and shorten endoscopic lith-otripsy procedures.

Strong IP positionIn support of the Accordion device as well as PercSys’ innova-tive pipeline of future products for the urology marketplace, the company has licensed six U.S. and foreign patents and currently has 16 U.S. patent applications pending.

PercSysPrivateMountain View, CA

New Solution for Managing Urinary Stones

Status

PercSys is in the midst of driving a five-year series of unique product introductions for urology and urogynecology. The company’s first product was launched in mid-2007 at the American Urological Associ-ation meeting.

Management

CEO: Robert S. Behl

Contact

CEO: Robert Behl Web: percsys.com Tel: (650) 969-8800

Robert S. Behl is a serial entrepreneur in the medical-device marketplace. After successful line-management experience in R&D, marketing, and business development for three major medical device companies, Behl founded and served as general manager for Sybron’s clinical technology/Bovie division (purchased by Maxxim), accom-

plished a major turnaround as CEO of Menlo Care (now part of Johnson & Johnson), and founded and served as first CEO at both InnerDyne (now part of U.S. Surgical/Covidien) and RadioThera-peutics (now part of Boston Scientific). Behl currently serves on the board of Guided Delivery Systems, a pioneering cardiology company, and is active in Life Science Angels. He holds a BS in mechanical engineering, a MS in biomedical engineering, and a MBA in economics and finance from the University of Rochester ‘s William E. Simon Graduate School of Management.

The PercSys Accordion Stone Management Device combines the utility of multiple endoscopic stone management tools into a single device

Radiopaque markers allow easy monitoring of advance-ment and deployment using fluoroscopic visualization

TRACKS

Telescoping design enables the Accordion to release easily from intact stones when required

SECURES

Compliant occlusion film enables the device to easily dis-engage from stone fragments that are too large for extraction

CLEARS

Automated solutions for busy laboratoriesIkonisys is a privately held biotechnology company develop-ing non-invasive cell-based diagnostic products. The company’s current offerings provide laboratories with an economical solu-tion to the challenge of expanding test volume capacity while there continues to be an industry-wide shortage of trained tech-nical personnel. Future products will enable customers to per-form novel, new tests based on rare cell detection.

Ikonisys’ CellOptics technology platform emerged from the fusion of cell and molecular biology, microscopy, artificial intel-ligence and informatics. The system’s approach facilitates the accurate detection of cells and subcellular characteristics, lead-ing to the development of needed diagnostic products.

In 2006, the company obtained FDA clearance for fastFISH amniocyte, an imaging application for the Ikoniscope that pro-vides for the automated identification, enumeration and analysis of chromo-somes 13, 18, 21, X, and Y in amniotic cells by FISH. Numerical aberrations of these chromosomes are associated with common birth defects including Down syndrome.

In early 2007, Ikoni-sys obtained clearance for oncoFISH bladder, an imaging application for the Ikoniscope that detects aberrations for chromo-somes 3, 7, 9, and 17 in cells found in urine sedi-ment to aid in the initial diagnosis of bladder can-cer in patients with hematuria (blood in the urine) and the sub-sequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

Promising pipeline

The Ikonisys imaging application pipeline includes several prod-ucts in cancer diagnostics and monitoring, including oncoFISH breast, which is being developed for the automated analysis of chromosome FISH signals associated with the amplification of the HER-2/neu gene in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. In addition, the company has several potential products in the development pipeline with near-term deployment times.

IkonisysPrivateNew Haven, CT

Diagnostics Through CellOptics

Status

To date, Ikonisys has raised $37.5 million in financing, including a $15.5 million Series D financing led by Trevi Health Ventures. Ikonisys has established formal and informal relationships with a variety of leading life sciences companies, including license and supply agree-ments with Abbott Labs, and a research collaboration with Cancer Research Technology, LTD.

Management

Contact

CEO: Petros Tsipouras Web: ikonisys.com CFO: Paul C. White Tel: (203) 776-0791

Chairman and CEO: Petros Tsipouras, MDDr. Tsipouras obtained his medical degree summa cum laude from the National University of Athens, Greece. Following graduation he trained in pediatrics at Yale University, clinical genetics at McGill University, and molecular genetics at UMDNJ-Rutgers Medical School. Before founding Ikonisys, Tsipouras was on faculty at the University of Connecticut Health Center.

The Ikoniscope, a proprietary digital, robotic microscopy system, will address areas of cancer diagnosis and management, prenatal detection of genetic disor-ders, and fertility

UROLOGY FOCUS COMPANY PROFILE UROLOGY FOCUS COMPANY PROFILE

Flexible system handles a multitude of testsUsing CellOptics technology, the Ikoniscope, a proprietary dig-ital, robotic microscopy system, will address areas of cancer diagnosis and management, prenatal detection of genetic dis-orders, and fertility, providing laboratories with cost-effective, “walk-away” functionality. The system is adaptable to a vari-ety of test-specific applications and has been optimized to meet the demands of the busy clinical laboratory environment. Opera-tor handling errors are minimized through the use of bar-coded slides and bar-code readers within the system; a touch-screen operated, user-friendly interface reduces operator training time.

FDA-approved product lines focused on diagnosticsIn addition to its platform technology, Ikonisys is developing two product lines: oncoFISH for cancer diagnostics and fastFISH for the prenatal detection of genetic disorders, both of which use the Ikoniscope system.


(most people equate Midwest with con-servative ideals), it is a forerunner on the implementation of innovative ideas, mainly due to innovative people who have the courage and strength to push through novel concepts. I think of it as an East-coast Midwestern city.

(For more on St. Louis’ life science industry, see the regional report that starts on page 20.)

What general trends are happening right now in the field of urology/sexual health that didn’t exist 10 – even 5 – years ago?

I think female sexual dysfunction is similar to what female urinary incontinence was 20 years ago, when urinary incon-tinence was something to be ashamed of, to keep secret. Now, you cannot go into a supermarket or drug store without rows and rows of Depends. It’s out there! And although some patients, especially women, are told, “this is a normal part of aging,” more and more patients are demanding treatment options.

Similarly, female sexual dysfunction is just now coming into the limelight, where women are expressing their dissatis-faction and also demanding evaluation and treatment.

I believe the advent of Viagra and other oral agents for male erectile dysfunction was the beginning of a snow-ball effect, where [discussion about and doctor’s visits for] male erectile dysfunction had a signifi cant increase because a treatment was now available. Women are now demanding consideration of female sexual dysfunction.

What factors are influencing/causing those trends?

Evaluation and treatment of non-life- threatening conditions have always been a struggle when it comes to insurance coverage.

For example, typically, many insurance companies will cover the evaluation of male infertility, but not reimburse for treatment. Insurance companies con-sider this a “luxury,” almost like plastic surgery. But consider the patient with childhood cancer who requires radiation and/or chemotherapy that will most likely compromise future fertility. And future fer-tility, which is often considered a quality-of-life issue, may cause other medical conditions, such as depression.

Another example: Many insurance companies will pay for vasectomy, but not vasectomy reversal. My guess is because preventing conception will ulti-mately cost the insurance companies less money, as they will not need to pay for prenatal and pregnancy care, whereas vasectomy reversal may result in pregnancy.

If treatment of male erectile dysfunction is based on “organic” or “medical” cause, it is usually covered by insurance. It will be interesting to see how well insurance companies handle reimbursement for female sexual dysfunction.

What segments within urology have gotten a lot of attention lately?

I call it “Boys and their Toys.” Urology is male-dominated and traditionally has lots

of gadgets, like endoscopes and wires. New devices — laparoscopic equipment, endoscopies, smaller scopes, robotics, etc. — are always of interest. Fields gaining attention include minimally invasive surgery (laparoscopy), andro-pause, prostate-cancer screening, and women’s health (female sexual function, incontinence, vaginal prolapse).

Female sexual dysfunction is big. Some male urologists (and other physicians) don’t believe it truly exists; many physi-cians are simply “tuned in” to see new developments and treatment options.

If you had to predict, what segments will be hot 10 years from now?

Minimally invasive surgery will continue to be big. It’s less invasive for the patient, which means less convalescence and more time to enjoy life. The fi eld of male and female sexual health will continue to grow, because it’s a quality of life issue. Another important area will be robotic surgery. Technologies in this area will allow education — and potentially opera-tions — to occur with surgeon and patient in two separate locations.

Are there any med tech companies that stand out from the pack in terms of innovation in urology products?

In women’s health, Ethicon is focusing on stress urinary incontinence and vaginal prolapse, and their impact on female sexual health. Genital Sensory Analyzer makes diagnostics for neu-rologic assessment of female sexual dysfunction.

s one of only two female urologists in St. Louis — and 365 nationwide — Dr. Cathy Naughton has a somewhat

unique take on her fi eld. In treating male infertility and sexual dysfunction, two of the most commonly presented uro-logical conditions, Naughton remembers that it takes two to tango. Her approach, designed after identifying what she says is an unmet need in the fi eld, is couples-based and in favor of taking quality of life issues seriously.

Naughton recently founded the Center for Sexual Health, a St. Louis-based urological care facility for patients and couples looking to optimize their sexual health “without embarrassment, guilt, or judgment,” says Naughton. On track to open in September, the center addresses urological subspecialties that have tra-ditionally fl own under the radar, such as female sexual dysfunction, or been treated ineffectively.

Where did the idea for the Center for Sexual Health come from?

It was a combination of factors:

1) My subspecialty clinical training was in male infertility and microsurgery. Unlike any other subspecialty focus of adult urology (of which there are several

— oncology, female, endourology, lap-aroscopy, erectile dysfunction), most urologists specializing in male infer-tility will evaluate male patients with their partners. In contrast, male patients seeking treatment for erectile dys-function will visit the urologist without their partner. But comprehensive eval-uation of male erectile dysfunction, like male infertility, includes assessment of the partner as well as the patient. Thus, I saw an unmet need for a couples-based practice.

2) The “coming out” of female sexual dys-function as a condition that should and could be embraced by urologists [was a factor]. Unfortunately, most urologists and even gynecologists are not interested in addressing, managing, and treating this condition – mainly, I believe, due to the fact that not much is known about etiology of female sexual dysfunction; therefore, not much is known about how to diagnose and/or treat it.

3) As one of only roughly 365 board-cer-tifi ed female urologists in the country, and only one of two in St. Louis, it was clear to me that my interest in female sexual dysfunction would be a benefi t to female patients who typically seek female physicians, especially for such a sensitive subject.

4) Based on my experience with couple-directed evaluation for male infertility, I felt strongly — and this has been shown in the literature — that female sexual function impacts, and is impacted, by male sexual function. The center pro-vides couple-integrated evaluation and treatment for sexual health.

5) Based on my expertise, passion, interest, and being a female urologist, the conditions I found drawn to the center — male infertility, male and female sexual dysfunction, couple’s sexual health, and urinary incontinence — appeared to have something in common: These urological conditions were not necessarily life-threatening, but they impacted quality of life of the individual (and thus, the quality of life of their partner if applicable).

6) This concept of optimizing quality of life is represented in the center’s logo, which I designed to represent the circle of life, composed of four colors that rep-resent the four elements of life — earth (brown and green), wind (transparent), water (blue), fi re (red). Thus the tag line: where life’s elements come alive.

Any particular reason you set up shop in St. Louis?

It’s mainly because my practice is based in St. Louis. But frankly, for a Midwest city

If treatment of erectile dysfunction is based on ‘medical’ cause, it is usually covered. It will be interesting to see how well insurance companies handle reimbursement for female sexual dysfunction.

Takes Two to Tango

A

UROLOGY FOCUS INTERVIEW

“Female sexual dysfunction is similar to what female urinary incontinence was 20 years ago—something to be ashamed of, to be kept secret.”

“ “

Cathy Naughton, MDCenter for Sexual Health


How does Cryocare CS, a minimally invasive system for treating prostate cancer, work?Called Targeted Cryoablation of the Prostate, or TCAP, the technology involves the following: 1) Six to eight slender probes are inserted through the skin. 2) Ultrasound and three-dimensional mapping software is used to strategi-cally place the probes in the cancerous tissue(s). 3) A freezing mechanism, via the probes, delivers a lethal temperature of -40° Celsius to the cancerous cells. 4) The resulting ice ball that forms ensures that all cancer cells are immediately destroyed regardless of how aggressive the cells are/were. 5) A warming catheter protects the urethra during this process. 6) Either general or epidural anesthesia is applied.

This treatment is highly effective for low-, moderate- and high-risk, localized prostate cancers, and, unlike radical prostatectomy or radiation therapy, cryoablation can be repeated if necessary.

How does cryoablation address some of the trends happening right now in the field of urology?As a minimally invasive treatment (for prostate cancer), Endocare cryoablation allows patients to avoid radical surgical procedures, and associated trauma and complications. The ability to specifi cally target cancerous cells, and preserve organ and surrounding tissue, enables the shortest recovery period of any defi nitive prostate-cancer therapy. Cryoablation can also reduce the frequency and severity of side effects such as impotence and incon-tinence; if impotence does occur, the rel-atively less-invasive and less-traumatic nature of cyryoablation creates potential for regaining potency through therapy. As a result, cryoablation enables patients to sustain the highest quality of life possible.

Until recent years, prostate cancer was absent from public discourse, but as awareness of this life-threatening disease has grown, demand for both early detection and improved treatment alternatives has increased.

In addition, early detection has resulted in treatment at younger ages, which in turn has resulted in greater needs to pre-serve function and potency, which is an indicated benefi t of cryoablation. Fur-thermore, Endocare cryoablation is the fi rst minimally invasive procedure that urologists can perform themselves, which addresses a general trend for physicians to “refer less and retain more.”

You’ve stated plans to expand into the lung and liver cancer markets, as well as pain management. How far along are you with each of those? Endocare cryoablation has broad FDA clearance for tumor and tissue ablation anywhere in the body. However, to obtain reimbursement by Medicare and private insurers, we are conducting clinical trials in these three areas of application with large academic medical centers. For example, palliative use of cryoablation to manage pain associated with cancer metastases into bone has undergone a series of trials headed by physicians at the Mayo Clinic. Those trials are now expanding to multiple centers, and multi-center data is expected to be published next year. Should data continue to be positive, and our cryoab-lation procedures hit the required end-points, the procedure could be assigned reimbursement codes by late 2008.

And in May, you raised $7 million, some of which you said would be used to further the company’s efforts in the prostate and renal areas. What specifi-cally do you have underway?In our urology market, which we char-acterize as emerging-growth, our phy-sician customers primarily treat prostate and renal cancers, so we’re focusing our efforts and investment on increasing the number of trained physicians that can become cryosurgeons. The clinical data supporting prostate and renal cryoablation have encouraged a number of physicians to add minimally invasive cryoablation to their treatment options, so we intend to capitalize on that trend.

Our interventional radiology market includes market segments with large opportunities: treatment of renal, liver and lung cancers, and palliative inter-vention for pain associated with cancer metastases into the bone. However, reim-bursements for those indications have not yet been granted, so our focus is to fund clinical studies that can achieve, or accelerate the process of gaining reim-bursement grants.

We’re also enthusiastic about the devel-opment of our next-generation cryoab-lation system for interventional radiology and international markets. This system is based on critical nitrogen, as opposed to high-pressurized argon used in our current system. This difference could result in enhanced freezing power, wider avail-ability, and lower cost. The system is in prototype, and we are in the early stages of developing our commercialization plan. We believe critical nitrogen has a prom-ising role in the future of cryoablation in the interventional radiology and interna-tional markets.

Are you seeking partnerships?Yes, we are exploring a number of licensing and strategic partnerships, especially in interventional radiology and cardiology, where cryoablation has been proven to be a safe and effective means of destroying tumors and manipulating tissue characteristics.

As awareness [of prostate cancer] has grown, demand for early detection and improved treatment alternatives has increased.“ “

Next-GenerationProstate Care

Craig Davenport

Endocare

Three in-licensed drug candidatesColby Pharmaceuticals, a small company founded by University of Wisconsin researchers, is developing small-molecule thera-peutics for oxidative stress-induced major human diseases. The company currently has three in-licensed prostate-cancer drug candidates and two other internally generated New Chemical Entities in pre-clinical development. In 2008, Colby is taking its lead drug, CPC-100, into the clinic. CPC-100 is for men who have already been treated with surgery or radiation for their pri-mary tumor and have subsequently failed Androgen Depletion Therapy (ADT), the current standard of care.

Pre-clinical animal effi cacy trials promisingCPC-100 has multiple-targets. It’s an anti-inflammatory and anti-androgenic oxidative stress inhibitor. It’s used to treat mid-stage, androgen-dependent or androgen-independent prostate cancer in patients previously treated for primary prostate cancer who are returning to the clinic with rising Prostate Specific Anti-gen levels, but without evidence of tumor metastasis in bone or soft tissue.

Pre-clinical animal trials with oral CPC-100 drug administra-tion indicate that CPC-100 is more effective than the largest sell-ing competitive anti-androgens on the market -- up to 225 times more effective in experimental animals. CPC-100 reduces a sub-ject’s time-to-tumor progression and reduces or eliminates the pro-estrogenic side effects commonly seen in non-steroidal anti-androgen therapeutics used in clinics today.

Existing multi-billion-dollar market

There is an existing billion-dollar-plus market in drugs for patients with mid-stage prostate tumors. If clinical trials are suc-cessful, CPC-100 sales would strongly compete in this market. CPC-100 acts on multiple targets and benefits both androgen-dependent and androgen-independent prostate cancer. Com-petitive drugs lack therapeutic effect in androgen-independent prostate cancer.

Other promising drugs in the pipelineNext up in Colby’s pipeline is CPC-200, a first-in-class drug for patients who have been treated by surgery or radiation for their primary tumor and have returned to the clinic with rising PSA levels, but who have not yet been treated with ADT and have no radiographic evidence of metastasis. CPC-300 is a pro-apoptic drug for treating metastatic ADT-resistant prostate tumors prior to chemotherapy. And CPC-410 is for the treatment of advanced metastatic ADT-resistant and chemotherapy-resistant prostate tumors for which currently there is no approved drug.

Strong IP position and partnershipsColby’s intellectual property includes the following: novel com-positions of New Chemical Entity drugs; novel methods of drug uses for the treatment of prostate and other cancers, and different oxidative stress diseases; novel pharmaceutical Oxidative Stress Regulator Rx (OSRx) drug formulations; and novel, commer-cially enabled and scalable OSRx drug syntheses.

The company has established relationships with the Univer-sity of Wisconsin’s Paul C. Carbone Cancer Center and Stan-ford University’s Chemistry Department. In addition, Colby is accessing data generated by grants from the National Insti-tutes of Health, the Department of Defense, Prostate Medical Research, the National Cancer Institute and the Prostate Cancer Research Foundation.

Seasoned managementAll members of Colby’s management team have bio-business and pharmaceutical industry backgrounds. The co-founders and current management have experience bringing small molecule drugs through clinical trials and to market.

Colby PharmaceuticalsPrivate Menlo Park, CA/Madison, WI

Prostate Cancer Pipeline Shows Promise

Status

The first two of Colby’s four prostate-cancer drugs, CPC-100 and CPC-200, are now undergoing IND-enabling, National Cancer Institute-funded measurements in order to enter a Phase I/IIa human clinical trial of CPC-100 in 2008 and of CPC-200 in 2009.

Management

CEO: David Zarling

Contact

CEO: David Zarling Web: [email protected] Drug Dev. Head: Ken Narducy Tel: (650) 333-3150

Zarling has several years experience in pharma-ceutical drug development and target validation. Before joining Colby Pharmaceuticals, he was at the University of California and previously was executive vice president and then CEO of PGC, a genomic services spin-out from SRI International’s Pharmaceu-tical/Genomics/Cancer Programs.

Prostate tumor cells have oxidative stress from oxygen-free radicals, which mutate the prostate cells. Colby’s leading drug candidate is anti-androgenic, anti-inflammatory and an oxidative stress inhibitor

UROLOGY FOCUS COMPANY PROFILE

Prostate cancer a leading cause of death in menProstate cancer is the most commonly diagnosed cancer in men and the leading cause of cancer fatality among American men. In the U.S., over 234,000 cases were diagnosed in 2006. The dis-ease is to blame for roughly 27,000 deaths each year. Currently, there is no effective therapy for advanced prostate cancer.

UROLOGY FOCUS INTERVIEW

DAVENPORT WAS named CEO of Endocare in December 2003 and chairman in January 2004. From August 2003 to December

2003, he served as a consultant to the company. From 1994 to 2003, he was CEO of The D.W. Group, a private health-care investment company. From 1985 to 1993, he was president and COO of Tokos Medical Corporation. Davenport began his healthcare career at American Hospital Supply Corporation.

Craig DevenportCEO, Endocare


Ortho Industry Trends Private equity playThe changing landscape in the orthopedics sector is in part being driven by the recent growth in private equity funds. In the last six months we’ve seen the privatization of Encore and BioMet. And with fi rms like KKR and Blackstone starting to look at the space, don’t be surprised to see more of this. The private equity players are seeing that there is a lot of opportunity in orthopedics companies. They see companies that have both high margins and capacity for cost reduction. The typical strategy is to take these fi rms private at their current value, lower the cost structure, combine with other fi rms and then take them public again. De-mographics are also playing into the appeal of this sector. Baby boomers are increasing demand for a wide range of orthopedic products. Furthermore, emerging economies such as India’s and China’s allow for additional growth.

Medtronic–Kyphon deal to have long-range impactMedtronic’s $1 billion acquisition of Kyphon is signifi cant be-cause it consolidated an important part of the spine market -- this will have long-range impact on the whole sector of orthopedics. The deal will also create a lot of wealth for Kyphon executives,

many of whom will cash out and start spine companies. This means a lot of talented people with ideas and capital will be entering the market. The holy grail in the spinal business is solving the issue of what causes back pain. A countervailing fac-tor is that there is a lot of conser-vatism in the spine market these days. A lot of people got burned

on the total disc business, so big valuations on these companies might be diffi cult.

Valuations remain healthy in most segmentsValuations in orthopedics continue in the three-to-fi ve-times-reve-nue range. This is healthy, but the biologics side of the sector has not kept pace. Integra recently acquired Isotis for a little over one times earnings, which industry experts regard as surprisingly low.

Sports medicine increasingly importantProspects for fi rms in the sports medicine market are good. Smaller procedures are trendy, and the sport-medicine fi rms which are tuned in to doing surgery through a keyhole will be well positioned. In general, fi rms that are developing minimally invasive approaches to dealing with tissue are well positioned. TranS1, for example, has a minimally invasive approach to spine surgery that is gaining considerable traction (see page 53).

Supplier consolidationOn the supplier side, orthopedics has historically been a very mom-and-pop type of industry. The supplier market will contin-ue to consolidate. There have been a lot of acquisitions recently, such as Paragon Medical’s purchase of OMC Precision Products and Tutela Medicus earlier this year. In the long term, watch out for smaller design shops, the OEMs, coming out with their own lines. They will go direct to major users, offer discounts and push down margins.

New leadershipRelatively new senior management at many of the top compa-nies — Zimmer, BioMet, Orthofi x, Wright Medical — could impact the whole industry. The old guard has retired. Many are serving as advisors to private equity fi rms.

ORTHOPEDICS UPDATE

We’re pleased to welcome into membership four emerging orthopedics companies, all of which have taken up residence on the Orthopedics Floor within the Companies Building at OneMedPlace. Full profi les on all four can be found there.

TranS1, of Wilmington, NC, has de-

veloped a minimally invasive solution to treat lower back pain. St. Louis, MO-based ISTO Technologies is working on a platform for growing cartilage. Clearant, of Los Angeles, CA, is using tissue-sterilization technology to elimi-nate the risk of infection. And Somer-set, NJ-based Juvent has developed

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Monitoringthe Pulse of MedicalTechnology

ISTO Technologies St. Louis, MO TranS1 Wilmington, NC Clearant Los Angeles, CA Juvent Somerset, NJ

New ‘Residents’ of the Orthopedics Floor at OneMedPlace

a treatment for reversing the effects of osteoperosis.

In the process of researching promis-ing companies in the orthopedics space, we are able to speak with many industry experts and thought leaders. Below are some insights gathered while compiling this issue.

Visit the Orthopedics Floor at onemedplace.com


Underserved marketWithin the sports medicine and spinal markets, repair of carti-lage injuries in the knee and spinal disc represents one of the greatest unmet medical needs. Each year in the U.S., orthopedic surgeons detect approximately 500,000 cartilage lesions in knee joints alone. Cartilage protects joints, including spinal discs, from the wear and tear encountered during motion. Because adult cartilage cells cannot fully regenerate tissue and repair injuries, lesions left untreated worsen over time and can prog-ress to post-traumatic osteoarthritis. Subsequent degeneration of cartilage in joints and spinal discs often leads to irreversible damage, causing pain and disability. Currently, the only FDA-approved biologic product for repairing knee cartilage uses the patient’s own cartilage cells in a two-step surgical process. Simi-lar strategies are also used in Europe. These products are inher-ently expensive. Furthermore, cells derived from adult patients have poor regenerative capacity.

Cartilage regeneration is ‘holy grail’ of orthopedicsISTO Technologies is a clinical-stage company developing products for sports medicine, spinal therapy and trauma. The company’s orthobio-logic products are intended to repair and regenerate damaged cartilage in knee joints and spinal discs. Carti-lage regeneration is often called the “holy grail” of orthopedics because of its potential to renew cartilage

and restore function to damaged joints (versus the more inva-sive option of surgical intervention). ISTO’s patented technol-ogy allows expansion of juvenile cartilage cells that can be used to produce a cartilage graft in vitro for transplantation; alterna-tively, these cells can be implanted directly to generate cartilage in situ.

Phase III clinical trials pendingISTO’s lead cartilage product, DeNovo ET, is a cartilage graft grown from juvenile chondrocytes using the company’s cell-based platform technology. DeNovo ET is a scaffold-free living cartilage graft offered as an off-the-shelf product for repair and regeneration of knee cartilage. DeNovo ET is in Phase I/II human clinical trials at three sites in the U.S. Pending FDA agreement, the company anticipates entering Phase III clinical trials in 2008. Spine product to regenerate damaged spinal discsThe company is also developing NuQuTM, a cell-based inject-able formulation of juvenile chondrocytes for nucleus regenera-

tion of the spinal disc. Back pain, mostly due to degeneration of the spinal disc, represents one of the most prevalent medical conditions worldwide. To date, no therapy exists that can reverse or heal damaged cartilage in a degenerated disc, leaving surgi-cal intervention as the only option. In the U.S. alone, surgeons perform more than 400,000 lumbar discectomies and 450,000 spinal fusions each year. Neither procedure addresses the under-lying conditions that lead to irreversible disc degeneration; both procedures have significant drawbacks, such as restricted mobil-ity and continued degeneration of affected discs.

ISTO TechnologiesPrivateSt. Louis, MO

Orthobiologics for Sports Medicine and Spinal Repair

StatusIn January 2002, ISTO Technologies began collaborating with Zimmer, to develop DeNovo ET. Under the terms of this agreement, Zimmer will conduct clinical trials for DeNovo ET, and ISTO will be responsible for regulatory filings. Upon commercialization, ISTO will manufacture DeNovo ET, with Zimmer serving as the exclusive distributor.

Management

President and CEO: Mitchell Seyedin, PhD

Contact

CEO: Mitchell Seyedin Web: istotech.com Controller: Mary Vonesh Tel: (314) 995-6049

Seyedin joined ISTO in 2003 with more than 25 years of experience in the medical technology field, concen-trating on developing orthobiologic products. He has been the visionary and driving force for several startup companies, including Metra Biosystems (acquired by Quidel) and Orquest (acquired by Johnson&Johnson).

Existing treatments for cartilage repair involve shaving, debridement and microfracture

The projected number of nucleus regeneration procedures may surpass 300,000 by 2010

Lower-back disorders common in populationLower-back disorders affect 15-20% of the U.S. population and result in approximately 6.5 million doctor visits each year. These visits are often caused by degenerative disc disease, a painful condition characterized by chronic lower back pain. The specific etiology of degenerative disc disease is unknown. It is believed to be caused by a number of factors, including mechanical, chemical, and age-related changes, autoimmune response, and hereditary factors.

The outcome of this degenerative process is that the disc no lon-ger transmits force normally. This requires the load-distribution function to be transferred to other structures, such as the fac-ets, ligaments, or annulus, which expands the degenerative pro-cess. For patients, this means chronic back pain, radiating pain (if a nerve is affected), muscle weakness and decreased range of motion.

Minimally invasive solution to treat lower back painTranS1, a privately held medical device company, has developed a minimally invasive solution to treat lower back pain. TranS1’s percutaneous access and fusion system enables lum-bar fusion to be performed with complete preservation of the annulus and all para-spinal soft-tissue structures. AxiaLIF (Axial Lumbar Interbody Fusion) offers a reproducible pre-sacral access route to the L5-S1 vertebral bodies and can be performed through an out-patient surgical procedure, allowing for a rapid return to normal activities.

Minimally invasive procedure expands market

Despite an estimated six million low back pain patients, only 225,000 are operated on because of the invasive nature of lumbar fusion, which can result in hospital stays of three-to-five days, and an inability to return to work for several months. As more minimally invasive procedures evolve, the market will grow at the expense of conservative care. And unlike traditional proce-dures, minimally invasive surgery is a viable option for older patients, who in the past could not tolerate a major operation.

Shorter hospital staysTranS1’s minimally invasive approach allows patients to be discharged from the hospital the day after surgery, and return to work in 15 days on average. This is a dramatic reduction in hospital stay, which can otherwise run three-to-five days, fol-lowed by a one-to-two month recovery period before returning to work.

Almost 2,000 patients have used AxiaLIFThe AxiaLIF System includes proprietary devices used to access the spine, remove the diseased disc material, re-estab-lish normal disc height, and stabilize the spine to enable lumbar fusion. This procedure is performed via an incision of about one inch in length, mitigating potential soft tissue trauma.

Exclusive distribution agreement

In September 2006, TranS1 signed an exclusive agreement with ApaTech for distribution of its AxiaLIF system in the U.K. and Ireland. TranS1 is also developing two mobility platforms – a disc replacement and a prosthetic disc nucleus; both are deliv-ered using the percutaneous, trans-sacral approach.

Strong revenue growth

Trans1 is currently performing 130-160 procedures per month. The system costs $10,000; while AxiaLIF has a higher upfront cost, studies have found that the AxiaLIF system reduces over-all costs.

TranS1PrivateWilmington, NC

Less Invasive Solution to Lumbar Fusion

Management

Contact

CEO: Rick Randall Web: trans1.com CFO: Mike Luetkemeyer Tel: (203) 776-0791

President and CEO: Rick RandallPrior to joining Trans1 in 2002, Randall served as president and CEO of both Incumed, a medical device incubator he founded, and Innovasive Devices, a sports medicine firm. He was also president, chairman and director of Target Therapeutics, a medical device company which pioneered the interventional neurosurgery market.

The TranS1 AxiaLIF System is a multi-component system including titanium implantable devices as well as instrumentation made of biocompatible materials such as titanium alloy, stainless steel, and nitinol

AxiaLIF, combined with pedicle screws or facet screws, provides a completely percutaneous 360-degree fusion at L5-S1

ORTHOPEDICS COMPANY PROFILEORTHOPEDICS COMPANY PROFILE

NuQu offers a therapeutic solution for early intervention of disc degeneration. Degeneration of disc cartilage begins in the nucleus, the innermost disc component, and is accompanied by cell death and tissue destruction. Recent pre-clinical data sug-gest that NuQu injected into the nucleus can regenerate cartilage in the disc nucleus. NuQu has been developed for use in con-junction with a minimally invasive procedure. ISTO intends to complete preclinical studies by the second half of 2007 and file for an IND in early 2008.

FDA-approved product to fund future growthISTO’s InQu, which is being developed for the trauma and spinal fusion markets, is the company’s first-to-market device product, offering an early revenue opportunity. InQu, which has received 510(k) clearance as a bone graft substitute, is a biomaterial scaf-fold of synthetic and biologic polymers. The company intends to leverage sales of the InQu product line to generate early revenue and sustain its business over the long term. InQu will launch in the second half of 2007 and will be distributed through indepen-dent sales reps. The company is also exploring additional appli-cations in the soft-tissue and osteochondral markets.


Bone and muscle loss major health concernsBone loss and muscle loss are major health concerns. In the last 25 years, a better understanding of the relationship between muscle and bone has emerged. It is known that exercise and bone maintenance are interrelated.

The musculoskeletal system relies on muscle quality and strength for support and balance. In research by space scientists, not only was bone loss in a weightless environment quickly detected, but severe atrophy in the muscles that support posture became appar-ent — the most severely affected being the soleus muscle in the calf which controls postural stance and balance. These findings demonstrate a rapidly occurring phenomenon that is mimicked in humans gradually with the aging process.

Muscle strength diminishesIn recent experiments, it has been shown that soleus muscle activity gradually diminishes with each decade starting in the 20s, and advances in severity by the 70s to a point where balance is severely affected. Although exercise is strongly advocated for numerous health benefits, it is not always practiced by those who need it most.

Conditioning improves balanceJuvent Medical, a provider of non-invasive therapies for the pre-vention and treatment of bone loss associated with primary and secondary osteoporosis, stimulates calf muscles with low magni-tude signals to increase muscle contractions. The resulting con-ditioning effect increases strength and improves postural stance and balance. The Juvent 1000 delivers stimulation to muscle fibers without any strenuous effort on the part of the user.

Initial research focused on delivering specific low magnitude signals to bone to maintain bone mass in various animal mod-els. In order to deliver the signals to humans, a platform was

developed that delivered these signals through the soles of the feet. In studying the effects on bone, it was observed that these very low magnitude signals also increased muscle mass and improved balance. Balance mitigates injuryWith the aging population, balance is of paramount impor-tance in minimizing the risk of falls leading to fractures. Juvent addresses the entire musculoskeletal system in its approach to maintaining a mobile lifestyle for the aging population by main-taining muscle strength, function and balance. The Juvent 1000 uses very small and gentle vertical displacements appropriate for any person who can stand for up to 20 minutes at a time.

Technology acquired from Smith & NephewJuvent’s management team began the development of this unique, patented biomechanical technology over 10 years ago during their tenure as principals at Exogen (Exogen produces medical devices for the non-invasive treatment of musculoskel-etal injury and disease). They continued to refine the technology after Exogen was acquired in 1999 by Smith & Nephew. Juvent acquired the worldwide rights to this technology from Smith & Nephew in November 2003.

Juvent MedicalPrivateSomerset, NJ

Reversing Osteoporosis

Status

In January 2007, Juvent was issued a patent from the U.S. Trademark Office for its mechanical vibrational apparatus. The issuance of this patent constitutes another significant addition to Juvent’s existing patent portfolio for this technology. The patent covers many unique methods of incorporating DMT technology into various types of exercise equipment, including standard exercise devices such as rowing machines, stair-climbing machines, elliptical trainers, bicycles, cross-country ski trainers, treadmills, or weight trainers.

Management

Contact

CEO: John J. Moroney Web: juvent.comCOO: Roger J. Talish Tel: (732) 748-8866

President and CEO: John J. MoroneyMoroney has over 25 years of experience in both the funding and operational management of life sciences companies. He was primarily responsible for negotiating the terms of Juvent’s management buyout from Smith & Nephew in November 2003, and has served in an executive capacity since that time. Moroney currently serves as chairman of EyeGene Biosciences and as an advisory director of the Infinity Capital Group.

The Juvent 1000 delivers a signal that is equivalent to one-third the force of gravity

Dangerous pathogens can be found in biologicsCurrently during a tissue-implant procedure such as an ACL repair, human tissue is donated by a cadaver or donor. Although allografts offer several advantages over autografts — such as a sin-gle surgical site, reduced discomfort and post-operative problems, decreased recovery times, and increased availability — there are safety concerns that have impeded wider usage of allograft tissue.

While actual infections are rare, a recent study by the Centers for Disease Control and Prevention found that 70% of allografts tested revealed positive cultures for micro-organisms that exist, largely due to the lack of standardized procurement and emerg-ing pathogens.

In 2006, the concern over tissue quality and safety rose as two major tissue suppliers were closed down due to serious deficien-cies and difficulties in maintaining appropriate tissue testing and processing quality. FDA ordered a recall of tissue from these tis-sue banks due to the possible illegal harvesting of cadavers pro-vided to several tissue banks for processing. Another FDA tissue recall occurred in 2006, when the Musculoskeletal Transplant Foundation (MTF) tested positive for Chyseobacterium meningo-septicum, which has been reported to be fatal. This recall totaled 4,805 allografts distributed nationwide, in Canada and Mexico.

Sterilization process addresses safety concernsClearant is a developer and marketer of proprietary sterilization processes used in biomedical products. The Clearant Process is a pathogen-inactivation method designed to substantially reduce all types of pathogens in biological products. Using a combination of patented technology based on gamma irradiation, the Clearant Process tackles all types of pathogens, including viruses, bacteria, fungi and spores. The treatment inactivates all types of viruses, including HIV, and hepatitis A and C, and achieves a level of microbial sterility that meets or exceeds the level of medical-device sterility without damaging the integrity of the tissue

Gamma irradiation is inherently reliable, predictable, non-toxic, penetrating and scalable. Traditional uses of gamma irradiation have been proven to be among the best methods for inactivating pathogens that contaminate inanimate material medical devices.

In procedures when the Clearant Process is not used, generally this tissue is cleaned by treating the outside of the tissue with chemicals. This process does not remove the bacteria or viruses from the inside of the tissue and does not sterilize the tissue to the standard of a medical device.

Poised to benefi t from higher FDA safety standards

In May 2005, FDA enacted the Good Tissue Practice, which

recommends much higher levels of sterility in donor tissue for implantation. The Clearant Process has been reviewed by FDA and not only achieves the sterility standards that the agency applied to devices, but also meets the viral safety standards applied to pharmaceuticals and plasma products.

Currently, Clearant is penetrating the orthopedic allograft seg-ment by marketing allografts used in tissue implants. Clearant obtains tissue from accredited tissue banks, sterilizes the tissue and then distributes the tissue to the surgeon. Clearant is mar-keting to orthopedic surgeons by educating them that a safer standard of care is available and to use Clearant tissue versus non-sterile tissue.

Successful patient outcomes driving demandThe Clearant Process can be applied at various stages of product processing, including the final sealed container. This gives doc-tors and patients the added confidence that products inactivated in the final container arrive for use in medical procedures free of intermediate contamination.

According to Healthpoint, the combined orthopedic, spine and orthopedic biologic market was $19.9 billion in 2004.

Platform technology to address multiple marketsThe Clearant Process is a platform technology, similar to a phar-maceutical company that has many potential applications and opportunities. Potential uses for the platform, outside of the orthopedic allograft implant market, include combination bio-logic and non-biologic medical devices, plasma protein thera-peutics, and recombinant drug products.

In addition, the company is exploring acquisitions, consolida-tions and partnering opportunities in the U.S and internationally. The Clearant Process is protected by approximately 100 patents or patents pending.

ClearantCLRI.OBLos Angeles, CA

Powerful Pathogen Inactivation Technology

StatusClearant more than doubled revenue for the six months ended June 30, 2007 compared with the same period in 2006. The company recorded record revenue for the six months ended June 30, 2007 of $603,000, a 103.7% increase over the same period in 2006. Direct distribution revenue grew to a record $304,000 for the first six months in 2007, compared with $223,000 in the last six months of 2006. In line with guidance previously issued by the company, as result of not completing the capital raise until April 2007, 2Q ‘07 revenue decreased to $168,000 from $275,000 (excluding one-time non-recurring contract research and milestone revenue of $160,000) for the first quarter 2007. Management believes that this will be a temporary fluctuation, and will more aggressively pursue additional sales and supply efforts.

Management

Contact

CEO and CFO: Jon M. Garfield Web: clearant.com Tel: (310) 479-4570

President and CEO: Jon Garfi eldGarfield has served as president and CEO of Clearant since January 2007. He joined the company in August 2005 as CFO. Prior to joining Clearant, Garfield had served as CFO of a telecom service provider and a software developer, and VP of Coach USA, a ground transpor-tation consolidator. From 1991 to 1996, Garfield served as Corporate Assistant Controller of Maxxim Medical.

ORTHOPEDICS COMPANY PROFILEORTHOPEDICS COMPANY PROFILE

Juvent 1000 stimulates muscles with its low magnitude signals to increase contractions. Reconditioning leads to increased strength and improved postural stance and balance



AdvaMed 2007 is being held October 1-3 at Washington, D.C.’s Ronald Reagan Center

hether or not we can duplicate the success of BIO, only time will tell, but we are getting off to a good start,” says Ray Briscuso, general

manager and co-founder of AdvaMed 2007, an upcoming event that’s expected to draw roughly 800 senior-level ex-ecutives representing 500 med tech companies from 30 states and 16 countries.

The first-year event, as its tagline – by industry for industry – suggests, is designed to address issues that affect all medi-cal technology companies, regardless of size. In addition to general programming that will cover such universal topics as reimbursement, intellectual property and global market opportunities, AdvaMed 2007 will connect emerging com-panies with potential partners and investors. Registrants can review online the companies and technologies that will be represented at the event and then request private meetings with attendees of interest. There also is an entire day dedicat-ed to small-company presentations, during which emerging companies that are looking to raise capital or initiate strategic alliances can present to a captive audience of business devel-opment executives and financiers.

Briscuso is credentialed in building healthcare conferences. Prior to founding Life Sciences Conference Group earlier this year, he was the executive director of BIO, the industry organization, where he served for 14 years and built an annu-al event into one of the largest healthcare events in the world. In 2007, over 20,000 people attended BIO in Boston.

Although pleased with the success of BIO, Briscuso has a more modest outlook for AdvaMed 2007, being held Octo-ber1-3 at the Ronald Reagan Center in Washington, D.C.

“I think we could get to 6,000 attendees in five years,” he says.

It appears he has a good chance of achieving that vision. His

inaugural program has secured significant sponsorships and impressive presenting companies.

Origins The creation of this conference reflects an infusion of energy brought to AdvaMed by a new management team. Steve Ubl was named CEO of the organization in mid 2005, and shortly thereafter, Kenneth Mendez was appointed chief administra-tive officer.

Soon after joining AdvaMed, Ubl invited Ray Briscuso to dis-cuss the possibility of doing a conference similar to BIO’s.

“I had always had a friendly relationship with AdvaMed and had suggested they do something similar in the past,” recalls Bruiscuo. “Having recently left BIO, I was in a position where I could help. Ubl indicated that as soon as he filled the key operat-ing management, we’d talk again.”

Before long, Ubl coordinated a meet-ing between Bris-cuso and Mendez, who was recruited to help build Ad-vaMed’s member-ship and programs. Mendez brought a history of success in building orga-nizations. After a short career on Wall Street at Mer-rill Lynch and then in development at Walt Disney Company, he joined the non-profit Trout Unlimited. During his time there, he grew the organization’s budget from $2.5 million to $20 million and tripled membership.

AdvaMed, the world’s largest medical technology trade group, is creating a conference that connects companies of all sizes

The first-year event is designed to address issues that affect all

med tech companies, regardless of size. Programming will

cover reimbursement, intellectual property

and global market opportunities.

SPECIAL SECTION ADVAMED 2007

“W

By Industry For Industry


“I learned the importance of creating tangible benefits to grow membership and revenue,” says Mendez. “Creating an event [at AdvaMed] clearly made sense. We wanted to do an event that took full advantage of the wealth of talent in our mem-bership, and to make it something that was exactly what our members wanted and needed. Thus the tagline, ‘by industy for industry.’”

Briscuso says AdvaMed 2007 stands apart from other confer-

ences. “Most trade shows are run by professional management companies that specialize in running conferences and shows of all types,” he says. “BIO and AdvaMed are exceptions. For-profit groups can’t get the same level of participation that an association can. It’s a dif-ferent model, but enables us to get much more ac-tive involvement.”

Briscuso says AdvaMed has over 100 volunteers who have worked on the event. “Our core philoso-phy is to organize com-mittees and let them tell us exactly what they want,” says Briscuso. “That drives the programming process. Each of our committees meets monthly. The program was developed by our members for our members.”

Focus on partneringAnother of thrust of AdvaMed’s new management team is a commitment to creating value for its smaller-company mem-bers. A key strategy going forward is to help connect the small companies with the larger firms.

“The big companies need to keep their pipelines filled,” says

• Best Practices in Global Compliance Management• Can International Harmonization Ever Be Achieved?• The Challenges for Innovation Facing Emerging

Growth Companies• Changes to EU Medical Device Regulations• China’s Healthcare Crisis: Danger or Opportunity? • Device and Diagnostic Development: The Bridge from

Bench to Bedside• Emerging Markets: Will They Learn from Our Mistakes? • Emerging Opportunities for Medical Devices Used in

Advanced Therapies • Everything You Need to Know About FDA Regulation

& Compliance• Focus on Ophthalmology• Focus on Wound Care• The Future of Health Entitlements• Global Trends in Governmental Coverage of Medical

Technologies • Have It Your Way: Innovative Strategies to Integrate

Development, Manufacturing & Commercialization of Customized Medical Devices

• Health Reform• How Flat is Your World?• How to Access more than $1B in DoD and NIH SBIR

/ STTR Funds: Getting Capital Without Giving Away Equity

• How to Work with the U.S. Army to Develop Needed Medical Products

• IPO Ultimate Survival Guide• International DRGs: Can Innovation and Quality Be

Encouraged?

• Japan Reimbursement: What Does the Future Hold?• Medical Technology Tendering: How Low Can You Go?• Opening the Door to Value-Based Payment for

Diagnostics through Personalized Medicine• The Power of Public/Private Partnerships: Creating

Greater Access to Healthcare in Underserved Markets• Innovation by Design in Manufacturing: Best Practices

& Case Studies from Innovators in the Medical Device Industry

• Recommendations on Creating a CMS Reimbursement “Critical Path” for Novel Technologies

• Strategic Outsourcing and the Rise of the Virtual Medical Device OEM

• Value Creation: It’s Not the Technology• Value of Medical Technology: Innovation, Patients,

Society• What Buyers Are Looking For

Briscuso. “They need to meet the emerging companies with interesting new ideas, products, and technologies. And the small companies need to meet the large companies that can invest, license, distribute and partner. AdvaMed 2007 is a fo-rum where they can meet. We expect that virtually every major company will have a representative there. It’s a who’s who in terms of business development in medical technology.”

To facilitate this kind of partnering, AdvaMed 2007 is using a software system developed by EDB group of Switzerland, and the engine behind the BIO’s successful partnering program.

The Web-based interactive system facilitates one-on-one meetings between conference attendees at the event. Partici-pants can select potential partners by viewing profiles of every registered company through a password-protected section of the partnering Web site. Search features facilitate identifying potential partners or clients.

Through an internal messaging system, participants can submit up to 50 requests to meet with representatives of other compa-nies. If the request is accepted, a private meeting is scheduled. Meetings are arranged in 25-minute slots.

“It provides a very strategic use of people’s time and a means by which all companies can efficiently meet those with whom they may collaborate,” says Briscuso. “The value continues beyond the event, and the system is left up for six months.”

Any company can participate in the partnering program; regis-tration is left open until the conclusion of the event. Briscuso estimates that about 200 companies will participate.

Advanced Liquid Logic Research Triangle Park, NC

Droplet-based liquid handling technology for reliable, rapid, and cost eff ective results in a diverse range of diagnostic and other ap-plications. These incredible products improve the human condition by bringing liquid handling into the digital age.

Alcon Hunenberg, Switzerland

Ophthalmic pharmaceuticals, ophthalmic surgical equipment and devices, contact lens care products and other consumer eye care products that treat diseases and conditions of the eye. With the ex-ception of eye-glasses and contact lenses, they operate in all areas of ophthalmology.

Axial Biotech Salt Lake City, UT

Development of minimally invasive fusionless devices to advance the diagnosis and treatment of diseases and deformities of the human spine. Using genetics, has made signifi cant progress in locating the origin of adolescent idiopathic scoliosis.

BeneChill San Diego, CA

Non-invasive cooling technology for the treatment of cerebral isch-emia. Use of targeted therapeutic hypothermia in ambulances or ER’s may help patients suff ering from a cerebral ischemic episode, by delivering rapid, selective cerebral cooling.

CardioMag Imaging Schenectady, NY

Coronary artery disease diagnostic devices called MagnetoCar-dioGraphs, which records the magnetic fi eld associated with the electrical activity of the heart using highly sensitive superconduct-ing sensors. Goal is to detect the onset of coronary artery disease at its earliest stages.

Chembio Diagnostics Medford, NY

Rapid tests to aid in the detection of infectious diseases, including HIV and tuberculosis. Focus is on the development and manufactur-ing of simple and cost-eff ective tests which will lead to eff ective prevention and treatment of infections diseases.

Cytonome Boston, MA

A state-of-the-art cell sorter that combines an ultra-high through-put optical cell sorting system (the Gigasort Instrument) with a single-use, sterile, disposable cartridge (the Gigasort Cartridge). The revolutionary microsorter operates at 10 times the speed of similar devices.

Deltex Medical Group plc Chichester, West Sussex, UK

CardioQ provides non-invasive, beat-to-beat information on how well the heart is functioning, on how eff ectively patient fl uid levels are being maintained, and on the impact of therapeutic interven-tions. The CardioQ monitor is proven eff ective in reducing hospital stays and improving the outcome of patients.

GlucoLight Corporation Bethlehem, PA

Photonic products for diabetes care including a noninvasive con-tinuous glucose monitor utilizing Optical Coherence Tomography technology. Provides a cost-eff ective and accurate way of moni-toring blood glucose levels, using a disposable patch affi xed to a patient’s skin.

Ivivi Technologies Northvale, NJ

FDA-cleared, non-invasive electrotherapy devices for diverse markets. Research is targeted at the wound, post-surgical, pain and related markets. The device induces a micro-current into injured tis-sue with a simple applicator that can go over the clothes or dressing.

Kinetic Concepts San Antonio, TX

The V.A.C. Therapy System promotes wound healing while helping to decrease length of stay and incidence of complications. Helps protect the wound by removing infectious materials and fl uids and also speeds up the wound healing process.

AdvaMed 2007 Panels

Business Development CommitteeDavid DouglassGeneral Partner, Delphi Ventures

Lewis Geffen Esq.Member, Mintz Levin

Robert Hallenbeck (co-chair)Vice President, BD

Jason HillenbachGlobal Biotech Knowledge Manager, Ernst & Young

Russell Hirsch, MD, PhDManaging Director, Prospect Ven-ture Partners

Wilfred Jaeger, MDPartner, Three Arch Partners

Mudit Jain, PhDPrincipal, Synergy Life Science Partners

Brett JohnsonPresident & Executive Editor, OneMedPlace

Karen KatzBusiness Development Director, Mintz Levin

Ellen KoskinasPartner, InterWest Partners

Noah Kroloff NGN Capital

Jack LapidasVice President, Cytonome

Jack LassersohnGeneral Partner, The Vertical Group

Doug LaVigneSr. VP of Business Management, Seimens

Brendan O’Leary, PhDPrism Venture Partners

Nino PionatiSr. VP, Global Marketing & Business Development, Convatec

Jane E. RadyExecutive VP, Strategy & Corp Devel-opment, Advanced Medical Optics

Matt Rieke M.D (co-chair)Partner, Quaker BioVentures

Jonathan RootGeneral Partner, US Venture Partners

Ryan SchwarzPartner, The Carlyle Group

Kelly SloneDirector, Federal Life Science Policy, National Venture Capital Association

Gerard Van Hamel PlaterinkManaging Director, Accuitive Medi-cal Ventures

Bess WeathermanManaging Director, Healthcare-Med-ical Devices, Warburg Pincus

Bob WhiteChief Development Officer/VP, Cor-porate Development, Medtronic

Bryant ZankoVice President, Business Develop-ment, Stryker

AdvaMed 2007 Presenting Companies*

The partnering program is a

strategic use of people’s time. It’s a means by which

all companies can efficiently meet potential collaborators.

Ray Briscuso knows a thing or two about

putting on a good healthcare conference --

as former executive director of Biotechnology

Industry Organization, he’s credited with

creating that organization’s now hugely suc-

cessful annual event. Now, his attention is

turned toward AdvaMed 2007.

Briscusco has been in life sciences since

1991, and today runs a Bethesda, MD-based

event-planning firm, Life Sciences Conference

Group. A Georgetown Law graduate, Briscuso left private practice

in 1987 to work for George H.W. Bush’s presidential campaign;

he served as the executive director in Maryland for the 1988

primary and general election campaigns. In 1990, Briscuso ran

unsuccessfully for U.S. Congress in Maryland’s first Congressional

District. In 1991, after returning briefly to the practice of law, he

joined BIO, where he worked until August of 2005.

Ray Briscuso

Former BIO Exec Takes on AdvaMed 2007


(Cont. on page 62) More companies on next page »


Advanced Liquid Logic Research Triangle Park, NC

Droplet-based liquid handling technology for reliable, rapid, and cost eff ective results in a diverse range of diagnostic and other ap-plications.

Micronics Redmond, WA

Stand-alone lab cards and a unique fl uidic pump system for devel-oping assays. Employs patents on microfl uidics which miniaturize complex tests for infectious disease diagnosis to credit card size devices, eliminitating extensive laboratory processes.

Nanomix Emeryville, CA

Nanoelectronic detection portfolio launching devices based on Sensation technology. These devices use carbon nanotube detection elements combined with proprietary chemistries. They can be de-ployed across high value respiratory and biodetection applications.

Nanospectra Biosciences Houston, TX

Medical device which incorporates a new class of microparticles to selectively destroy solid tumors. AuroShell micro particles are delivered systemically and then activated by a near-infrared laser, resulting in the thermal destruction of the tumor.

Neuronetics Malvern, PA

Noninvasive therapies to treat signifi cant, chronic psychiatric and neurological disorders. Neurostar therapy treats depressed patient who have had an inadequate response to previous therapies. Short pulses of magnetic energy travel from the device to stimulate nerve cells in the patient’s brain.

NeoMatrix Irvine, CA

The HALO Breast Pap Test is the a fully automated, noninvasive breast disease screening device designed for use in the Primary Care setting as part of an annual check-up. Use of the HALO system enables doctors to monitor the cellular changes in the breast ducts before they potentially develop into cancerous lesions.

Orqis Medical Corporation Lake Forest, CA

The HALO Breast Pap Test is the a fully automated, noninvasive breast disease screening device designed for use in the Primary Care setting as part of an annual check-up. Use of the HALO system enables doc-tors to monitor the cellular changes in the breast ducts before they potentially develop into cancerous lesions.

Stereotaxis St. Louis, MO

Proprietary magnetic systems and disposable devices to conduct precise, image-guided, computerized remote control interventional procedures. The Magnetic Navigation System revolutionizes treat-ment of arrythmias, heart failure, and coronary artery disease.

SyntheMed Iselin, NJ

Anti-adhesion and drug delivery products. The company is focused on the advancement and expansion of its proprietary bioresorbable polymer technology, i.e. those polymers that serve a short-term function in the body and then degrade naturally.

TissueLink Medical Dover, NH

Technology that uses fl uid to deliver radio-frequency energy directly to tissue. The fl uid controls the temperature at the interface, as well as shrinking the collagen, closing the vessels, and stopping bleeding, allowing tissue to seal without burning, charring or perforation.

Victhom Human Bionics Quebec, Canada

Products for the orthotics and prosthetics market, the development bionic devices, such as sensors, artifi cial intelligence modules and dedicated stimulators, and biomaterials and biocompatible active materials used to restore damaged musculo-skeleton structures.

Xthetix Mesa, AZ

Therapeutic ultrasound products for the over-the-counter aesthetics market. Products include devices for acne treatment and prevention along with devices addressing facial skin rejuvenation, by heating skin tissue at a targeted depth while not heating the skin’s surface.

Making it easy to access the most important registery of clinical trials in the world.

This exciting new product contains all of the clinical trials information found in the NIH site, clinicaltrials.gov.

Clinicaltrials.gov is the most important registry of clinical trials in the world with over 30,000 trials listed. About 8000 trials are posted annually.

It has grown signifi cantly as a result of considerable pressure on Pharmaceutical and Biotech companies from governments and from the International Commit-tee of Medical Journal Editors to list all of their ongoing trials with a registry.

The problem is that it was not set up with the business user in mind, and is very diffi cult to use.

Clinical Trials Plus has solved this problem. It allows fl exible searching by date, phase, clinical area, status, and word or phrase, and a choice of outputs. It has an e-mail alert function which lets the user auto-matically track new clinical trials, and a report generator which formats the results of searches into PDF and Word documents.

Clinical Trials Plus can be used in many ways.

+ Find all trials in a clinical area registered during a specifi c time period

+ Find all trials involving any particular company + Find investigation sites and principal investigators + Keep track of specifi c phases or diseases

It is provided by DMS Data, the providers of the easy to use Biomedical NewsAnalyzer and Biomedical IndustryAnalyzer.

If you would like additional information, or would like to schedule an on-line demo of Clinical Trials Plus, please contact Mike Marini, VP Sales at 781-681-9344.

Clinical Trials Plusfrom

www.clinicaltrials.com

Joe Almeida

President, International

Tyco Healthcare

Peter Arduini

Corporate Vice President,

President, Medication Delivery

Baxter Healthcare Corporation

Christopher B. Begley

Chief Execuitve Offi cer

Hospira

Ann Bunnenberg

President and Sales Manager

EGI

Catherine Burzik

President & CEO

Kinetic Concepts

Arthur D. Collins, Jr.

Chairman and Chief Executive Offi cer

Medtronic

Michael D. Dale

President & Chief Executive Offi cer

ATS Medical

J. Raymond Elliott

Chairman, President & CEO

Zimmer Holdings

Martin J. Emerson

Chief Executive Offi cer

American Medical Systems

Stuart Essig


Integra Life Sciences Corporation

David D. Fleming

Group Senior Vice President

Genzyme Corporation

Scott T. Garrett


Beckman Coulter

Christopher Gleeson


Ventana Medical Systems

Joseph Hogan


GE Healthcare

Gary Hutchinson

President & CEO

Precision Dynamics Corporation

David I. Johnson

President

ConvaTec

Heinrich Kolem

President & CEO

Siemens Medical Solutions USA

Paul LaViolette

Chief Operating Offi cer

Boston Scientifi c Corporation

Edward J. Ludwig

Chairman of the Board, President & CEO

BD

Michael A. Lynch

Group President of Manufacturing

Cardinal Health

Stephen P. MacMillan


Stryker Corporation

Caren Mason

President & CEO

Quidel Corporation

James A. Ralston, Esq.

EVP & Chief Legal Offi cer

Smith & Nephew

Cary R. Rayment


Alcon Laboratories

Timothy Ring

Chairman & Chief Executive Offi cer

C. R. Bard

Steve Rusckowski

C.E.O., Cardiac & Monitoring Systems

Philips Medical Systems

Peter H. Soderberg

President & CEO

Hill-Rom Company

Daniel J. Starks


St Jude Medical

James R. Stitt

President

Smiths Medical MD

Michael J. Thomas

President & CEO

Sleep Solutions

Stephen J. Ubl

President

AdvaMed

Nick Valeriani

Worldwide Chairman

Medical Devices & Diagnostics

Johnson & Johnson

Les C. Vinney


STERIS Corporation

2007-2008 AdvaMed Board of Directors James V. Mazzo


Advanced Medical Optics

Michael R. Minogue


ABIOMED

Michael Mussallem

Chairman & Chief Executive Offi cer

Edwards Life Sciences

Richard G. Nadeau, Ph. D.

Director

IRIS International

Koji Nakao

President & CEO

Terumo Medical Corporation

Caroll H. Neubauer

Chairman & CEO

B. Braun Medical

Niles L. Noblitt

Chairman

Biomet, Inc.

Henry L. Nordhoff

President & CEO

Gen-Probe Incorporated

Tiff any Olson

President & CEO

Roche Diagnostics Corporation

Kathy Ordonez

President

Celera Diagnostics

David B. Perez

President & CEO

Gambro BCT

Stephen Ubl has

been CEO of AdvaMed

since July 2005.

Recognized as a lead-

ing healthcare advocate

and policy expert, Ubl

has been cited by The

Hill and Legal Times as

one of Washington’s top

advocates, having helped

pass landmark reforms related to FDA’s product-review

process and Medicare’s coverage of medical technolo-

gies. He first joined AdvaMed in 1998 as executive vice

president of federal government relations. He left in

2004 to open his own healthcare consulting firm, but

was recruited back to the trade organization in July

2005 as its president and CEO. Prior to AdvaMed, Ubl

was vice president of legislation for the Federation

of American Hospitals. He earlier worked as vice

president of government relations for U.S. Strategies

Corporation, a healthcare consulting and strategic

planning firm. Ubl started his career in Washington,

D.C., working for U.S. Senator Charles E. Grassley (R-IA).

Frank Wilton joined

AdvaMed as associate

vice president, member-

ship, in January of 2001

and was promoted one

year later to his current

role as vice president

of membership. He is

responsible for member-

ship recruitment and

retention and serves as the primary liaison to the

Board Membership, Nominating and Governance

Committees. During his tenure at AdvaMed, mem-

bership revenue has increased by 50 percent and

overall membership by 18 percent. Wilton served

at AdvaMed (then HIMA) in 1992 as a management

fellow, while working as director of public affairs for

Ethox Corp. From 1996-2000, he was executive direc-

tor of the Label Printing Industries of America and

director of special projects for the Web Offset & Web

Printing Associations. And from 1994 to 1996, he was

director of member benefits for the Association of

Health Insurance Agents.

Kenneth Mendez joined AdvaMed as chief

administration officer in

February 2006 from Trout

Unlimited, the country’s

largest conservation

organization dedicated to

conserving and protect-

ing trout and salmon. As

chief operating officer of

that organization since 1992, Mendez tripled member-

ship and grew the budget from $2 million to over $20

million. Before Trout Unlimited, Mendez spent time in

the entertainment business and on Wall Street. After

receiving his MBA in marketing and international busi-

ness from Columbia Business School, he worked at

The Walt Disney Company in the direct marketing and

magazine publishing business units. Prior to business

school, Mendez worked in the Asia Pacific invest-

ment banking group of Merrill Lynch Capital Markets

and as an analyst in the corporate finance group at

Credit Suisse First Boston. He graduated from Harvard

College in 1982.


AdvaMed Executive Management

Host Sponsors

*There will be 38 total presenting companies. At press time, only 22 had been selected. Presentations will take place on October 3.


Schedule of Events

Sept. 15-18 European VitreoRetinal Society 7th Meeting Venice, ItalySept. 17-21 43rd Annual Meeting of the European Association for the Study of Diabetes Amsterdam, Netherlands Sept. 18-19 A.G. Edwards Emerging Growth Conference New York, NY Sept. 25-28 VIVA Vascular Interventional Advances Medical Media Communications Conference Las Vegas, NVSept. 25-29 American Society of Bariatric Physicians 57th Annual Obesity & Associated Conditions Symposium Las Vegas, NVSept. 26-30 International Society of Hair Restoration Surgery 15th Annual Meeting Las Vegas, NVSept. 27-29 American Dental Association World Marketplace Exhibition San Francisco, CASept. 27-30 Asia-Pacific Association of Cataract & Refractive Surgeons 20th Annual Meeting Hanoi, Vietnam

Oct. 1-3 AdvaMed 2007: The MedTech Conference Washington, DCOct. 2-4 Medtrade 2007 Orlando, FLOct. 3-5 Investment In Innovation (In3) East: A Preview of Early-Stage Medical Technology Companies Boston, MAOct. 4-7 The 45th Annual Meeting of Infectious Disease Society of America San Diego, CAOct. 7-10 American Neurological Association 132nd Annual Meeting Washington, DCOct. 8-10 Cardiorespiratory Diagnostics 2007 Las Vegas, NVOct. 9-10 SG Cowen and Co. 10th Annual Therapeutics Conference New York, NYOct. 9-13 Cygnus Business Media EMS Expo Orlando, FLOct. 15-17 International Symposium on Virtual Colonoscopy Boston, MAOct. 16-19 American Association of Oral and Maxillofacial Surgeons Meeting Las Vegas, NVOct. 18-20 European Society of Cardiac Imaging Annual Scientific Meeting Rome, ItalyOct. 18-21 American Society of Clinical Pathology 2007 Annual Meeting San Diego, CAOct. 20-25 American College of Chest Physicians CHEST 2007 Chicago, ILOct. 20-25 Cardiovascular Research Foundation Transcatheter Cardiovascular Therapeutics Meeting Washington, DCOct. 21-24 Annual Meeting of the American Association of Blood Banks Miami, FLOct. 22-27 American College of Veterinary Ophthalmologists 2007 Annual Conference Kona, HawaiiOct. 23-27 American Association of Blood Banks Annual Meeting and Expo Anaheim, CAOct. 25-27 Diabetes Technology Society Meeting San Francisco, CAOct. 26-31 American Society of Plastic Surgeons Plastic Surgery 2007 Baltimore, MDOct. 27-29 American Academy of Pediatrics 2007 National Conference & Exhibition San Francisco, CAOct. 28-Nov. 1 American Society for Therapeutic Radiology & Oncology 49th Annual Meeting Los Angeles, CA

SEPTEMBER 2007

OCTOBER 2007

NOVEMBER 2007

Dec. 1-3 The American Association for Respiratory Care International Congress Orlando, FLDec. 1-4 American Association for Respiratory Care Meeting Orlando, FLDec. 9-12 48th Annual Meeting of the American Society of Hematology Orlando, FL

DECEMBER 2007

Nov. 5-7 Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference New York, NYNov. 5-7 CIBC World Markets 18th Annual Healthcare Conference New York, NYNov. 7-10 Association for Molecular Pathology 2007 Annual Meeting Los Angeles, CANov. 9-10 American Society of Ophthalmic Plastic and Reconstructive Surgery Fall Scientific Symposium New Orleans, LANov. 9-11 American College of Phlebology 21st Annual Congress Tuscon, AZNov. 9-14 American College of Asthma, Allergy and Immunology Meeting Dallas, TXNov. 10-11 Infusion Nursing Society Fall National Academy of Infusion Therapy Meeting Anaheim, CANov. 10-12 American Society of Ophthalmic Registered Nurses Annual Meeting New Orleans, LANov. 10-13 American Academy of Ophthalmology Annual Meeting New Orleans, LANov. 11-15 American Association of Pharmaceutical Scientists 2007 Annual Meeting and Exposition San Diego, CANov 12-15 Credit Suisse 2007 Healthcare Conference Phoenix, AZNov. 13-15 UBS Global Technology and Services Conference New York, NYNov. 14-17 MEDICA International Trade Fair for Health Care and Medical Instrumentation Düsseldorf, GermanyNov. 14-18 VEITHsymposium New York, NYNov. 16-18 Georgia Chapter of the ACC 2007 Annual Scientific Session Lake Oconee, GANov. 25-30 Radiological Society of North America 2007 Meeting Chicago, ILNov. 27-29 The Wall Street Analyst Forum Biotechnology & Specialty Pharma Technology Conference New York, NYNov. 27-29 Piper Jaffray 19th Annual Health Care Conference New York, NYNov. 28-Dec. 1 Cervical Spine Research Society 35th Annual Meeting San Francisco, CA

Investment-related conferences

Presenting companiesAnchoring the partnering program will be formal, 14-minute presentations by 38 companies, selected by an AdvaMed-ap-pointed business-development committee (see page 59) from 75 applications.

To be considered, companies had to complete an online profile at the AdvaMed 2007 Web site. Profiles of applicants were then reviewed by the committee, comprised of leading indus-try and finance experts, and graded according to the follow-ing numbering system: 1) Should definitely receive a spot. 2) Should receive a spot. 3) Hold for consideration on next round. 4) Should not be selected.

Those with the best scores, which were determined based on appropriateness and stage of development, were invited to present.

“We’re very pleased with the quality” of the applicants, says Carolyn Ruggeiri, who orchestrated the process.

At press time, 22 companies had been selected (see page 59).

NetworkingInformal network-ing is often the most productive time at industry events. Ad-vaMed 2007 pres-ents the following networking opportu-nities:

On Sunday, the night before the event offi-cially begins, space is reserved for informal meetings. There also will be a recep-tion for the executive directors, and a cocktail party for the state and regional associations.

Monday night is a reception in the U.S. Capitol Cannon House’s Caucus room. Key members of Congress will be in-vited, presenting an opportunity for company executives to meet important legislators.

SponsorsFrom multiple angles, the event should prove to be an excel-lent way of connecting. Sponsors are given the opportunity to connect with companies that may sometimes be difficult to reach in a highly regulated industry.

Host sponsors include Johnson & Johnson, Covidien (formerly Tyco Healthcare, Kaplan Eduneering and Ernst & Young.

“Creating an event on this scale has not been easy, but the commitment of AdvaMed management, the board, and the volunteers has been terrific,” says Briscuso. “It bodes well for our goal of making this the preeminent medical technology conference in the world.”


(Cont. from page 59)

“The commitment of AdvaMed management,

the board, and the volun-teers has been terrific.

It bodes well for mak-ing this the preeminent

medical technology con-ference in the world.”

—Brett Johnson

OneMedPlace is a virtual community and home to those creating, building and fi nancing the companies and technolo-gies shaping the future of health and medicine.

AdvaMed has teamed up with OMP to give medical technol-ogy companies a platform for reaching a global audience of strategic partners, investors, and customers through various media tools for which AdvaMed members receive discounts:

♦ Listings in the Global Database of almost 6,000 healthcare and life sciences companies, divided into 26 clinical fl oors

♦ Profi les and ongoing coverage in Medical Technology Investment Digest and Med Tech Sentinel

♦ A one-stop shop of resources focused on medical technology and healthcare companies at the Resources Tower

♦ Participation in OMP’s annual Finance Conference

Learn more about the Membership Program for AdvaMed Companies

Visit each of the buildings at the ever growing OMP community to access information that can help grow your company.

AdvaMed is committed to helping its emerging companies prosper through access to resources like OneMedPlace.

AdvaMed + OneMedPlace

www.onemedplace.com/advamed

a publication by medical technology investment digest · 2007. 9. 18. · | medical technology...

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