med -tech innovation in · pdf filecompany news, regulatory activity, legislative actions,...

Medical device daily™

M E D - T E C H I N N O VAT I O N

I N M O T I O N MDD TAKES A LOOK AT

EMERGING PLAYERS IN THE MARKET

Medical device dailyTM: Med-Tech innovaTions in MoTion: Mdd Takes a look aT eMerging Players in The MarkeT is published by AHC Media, 3525 Piedmont Road, Building Six, Suite 400, Atlanta, GA 30305 USA. Opinions expressed are not necessar-ily those of this publication. Mention of products or services does not constitute endorsement. AHC Media is a division of Thompson Media Group LLC. Copyright © 2012 AHC Media. All Rights Reserved. No part of this publication may be repro-duced without the written consent of AHC Media. (GST Registration Number R128870672)

Managing Editor: Holland Johnson. Senior Production Editor: Robert Kimball.

Washington Editor: Mark McCarty.Staff Writers: Omar Ford, Amanda Pedersen.Senior Vice President/Group Publisher: Donald R. Johnston. Director of Product Management: Susan Woodard. Product Marketing Manager: Sarah Cross.Account Representatives: Matt Hartzog, Chris Wiley.Customer Service: (800) 888-3912 or (404) 262-5547

For more information, please see our websites: www.medicaldevicedaily.com and www.bioworld.com

Medical device daily’s Med-Tech innovaTion in MoTion: Mdd Takes a look aT eMerging Players in The MarkeT

Copyright © 2012Medical Device Daily™ AHC Media 3525 Piedmont RoadBuilding Six, Suite 400Atlanta, GA 30305 U.S.A.

All rights reserved. Printed in the United States of America. Except as permitted under the United States Copyright Act of 1976, no part of this publication may be reproduced or distributed in any form or by any means, or stored in a database or retrieval system, without the prior written permission of the publisher.

Please note:Medical Device Daily has made every effort to ensure that the information in this report is accurate and up-to-date, but cannot be responsible for errors, inaccuracies or changes in the data. If the reader identifies any information that is incorrect or has changed, please notify Medical Device Daily so that it can be corrected for future editions. Send an email to Managing Editor Holland Johnson at [email protected].

Notice:This report is an information tool, and the user should make business decisions based on an independent investigation, verification and evaluation of this as well as other information relevant to the user’s business interest. Medical Device Daily has gathered information for this work from many different sources and quotes information which has been gathered by other sources. Although Medical Device Daily has taken reasonable steps to ensure the accuracy of this report, due to the tremendous amount of information, and the third-party control of some information, Medical Device Daily cannot verify the accuracy of all information that it gathers and reports and thus does not warrant that the information is error-free. AS A RESULT, MEDICAL DEVICE DAILY DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE.

Medical Device Daily is the news service of record for the medical technology industry and is

relied on by thousands of industry insiders every business morning. This business-focused intel-

ligence service is the flagship publication of AHC Media’s med-tech group. Much like its sister

publication BioWorld Today, Medical Device Daily offers unbiased business-focused news to an

executive audience striving to stay ahead of the curve in this fast-paced industry.

Launched in 1997 as a weekly publication and converted to a daily in 2001, Medical Device

Daily keeps industry insiders alerted to vital information, such as new product developments,

company news, regulatory activity, legislative actions, strategic alliances, sales and mergers,

market updates, and much more, every business morning. In addition to its daily news reporting

online, Medical Device Daily offers an extensive searchable database with articles dating back to

2005 – perfect for compiling a customized report or searching for specific information on a

company, product or person.

Medical Device Daily subscribers can expect daily coverage to include:

• Washington and FDA regulatory news

• Profiles of new and mature medical device companies

• European and International company developments

• Corporate financings, both public and private

• Strategic alliances, mergers and acquisitions

• Health information technology updates

• Industry and clinical R&D approvals

Additional med-tech information solutions offered by AHC Media include:

Medical Device Daily Perspectives

A free weekly med-tech e-zine

Published by the editors of Medical Device Daily, this free, weekly e-zine offers unique view-

points on developments within the medical technology industry. We deliver a fresh outlook on

topics you can’t find elsewhere, and you can read a variety of opinions and shared insight on the

companies, trends, people and events taking place in med-tech today. It’s a chance to gain bet-

ter understanding of the meaning behind the news, to make it more relevant, and to see more

clearly how it affects you and the industry.

Sign up for free at www.medicaldevicedaily.com.

About Medical Device Daily

The Medical Device Daily Perspectives Blog Medical Device Perspectives Daily is the official MDD blog for critical news, analysis, debates,

commentary and camaraderie related to the medical technology field. Visit mdd.blogs.medicaldevicedaily.com for more information. Registration is free, and com-

ments are encouraged.

The Medical Device Daily Book of Interviews An exclusive collection of insightful one-on-one conversations with 33 of med-tech’s most expe-

rienced, legendary and successful players th at influence, regulate, finance and define the med-tech market. This knowledge-rich report imparts the valuable observations, caveats, projections and best practices of a who’s who list of market-related VIPs.

The BioWorld & Medical Device Daily Obesity Report: Tipping the Market Scales with Biotech & Med-Tech Regimens

An innovative report that will tip the market scales in your favor with business acumen that can optimize your R&D and medical efforts in fighting the latest Battle of the Bulge.

The Medical Device Daily State of the Industry Report 2011: Med-Tech Market Trends, Strategies and Insight

This indespensable report provides a thorough compendium of the market-bearing news that has impinged on every key sector of the med-tech industry. Additionally, it presents perceptive analyses from several market players, thought-leaders and observers on today’s important issues.

Customer ServiceIf you have any questions about this product or any of our other resources, please feel free to

contact a customer service representative at (404) 262-5547 or (800) 888-3912. You also can

e-mail us at [email protected].

For more information on Medical Device Daily, please contact:

Holland Johnson, Managing EditorMedical Device Daily™

AHC Media3525 Piedmont RoadBuilding Six, Suite 400Atlanta, GA 30305 USAPhone: 404-262-5540E-mail: [email protected] or [email protected]

Website: www.medicaldevicedaily.comTwitter: @MedDevicesDaily

Table of ContentsMed-tech innovation continues, but may be heading overseas . . . . . . . . . . . . . . . . . . . . . . . 1

AirXpanders gets IDE to study AeroForm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Apollo Endosurgery raises $47 .6M in Series B round . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

New device may offer hope for ‘suicide headache’ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Avinger enrolls first U .S . patient in CONNECT II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Bluegrass Vascular focuses on Surfacer ‘inside out’ catheter . . . . . . . . . . . . . . . . . . . . . . . . . . 11

New combat clamp device stops groin area bleeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

CardioComm earns FDA clearance for OTC heart monitoring system . . . . . . . . . . . . . . . 15

Case Medical study uses fMRI to investigate dystonia . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

HeartLight EAS lights the way for catheter ablation of AF . . . . . . . . . . . . . . . . . . . . . . . . . 19

CerebralRx enters market with vagus nerve stimulation device . . . . . . . . . . . . . . . . . . . . . . 21

CerviLenz offers screening tool for preterm birth risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

ChromaGen’s lenses help aid color blind patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Clarimedix gains traction despite rough VC landscape . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

CytoPherx gets $34 million in funding for kidney therapy . . . . . . . . . . . . . . . . . . . . . . . . . 28

Dune to provide realtime analysis of cancer margin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Ellipse uses ‘MAGEC’ for treatment of scoliosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Haldor launches ORLocate in U .S ., for instrument tracking . . . . . . . . . . . . . . . . . . . . . . . 33

ImageIQ’s partnership with NASA could boost profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Ivantis enrolls first patient in Hydrus Microstent study . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

iWalk robotic prosthetics to have ‘profound’ impact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Kelyniam switches to med-tech industry, with skull implants . . . . . . . . . . . . . . . . . . . . . . . 43

Simple device could solve complex problem of acid reflux . . . . . . . . . . . . . . . . . . . . . . . . . 45

MindFrame ischemic stroke device successful in human procedure . . . . . . . . . . . . . . . . . . . . . . . 47

Neuronetics seeks to corner market on treating depression . . . . . . . . . . . . . . . . . . . . . . . . . 49

NeuroSigma licenses UCLA patents to form NSVascular . . . . . . . . . . . . . . . . . . . . . . . . . . 51

OvaScience secures $37M Series B funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

PhysioSonics sees nICP device as game-changer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

PreviMed thrives while avoiding the traditional VC funding route . . . . . . . . . . . . . . . . . . . . . 55

Researchers fuse vessels together without sutures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Heart tissue stimulation could lead to light-guided pacemakers . . . . . . . . . . . . . . . . . . . . . 59

TSI set to launch Phantom MIS hip retractor system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

TransEnterix develops laparoscopic vessel sealer, stapler for Spider . . . . . . . . . . . . . . . . . . . 62

UCLA researchers develop hologram microscope device . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Fear of unknown, not money, slows technology adoption . . . . . . . . . . . . . . . . . . . . . . . . . 65

InterVapor vows ‘no implant left behind’ in emphysema patients . . . . . . . . . . . . . . . . . . . . . . 67

VasoStitch set to solve PCI access/closure challenge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Velomedix gets IDE to evaluate rapid cooling system for AMI . . . . . . . . . . . . . . . . . . . . . . 71

World Micro sets sights on medical device market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Index of companies featured in this publication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Med-Tech Innovation in Motion

MDD Takes a Look at Emerging Players in the Market 1

To subscribe to any of our products, please call Medical device daily™ Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2012 AHC Media. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com

Introduction

Med-tech innovation continues, but may be heading overseas

We’ve been hearing a lot about the death of innovation in the field of medical technology for the past few years, a victim, it would appear, of a sluggish worldwide economy and more stringent regulation and reimbursement policies. However, a closer look reveals that medical device innovation is still very much alive, it may just be relocating from its former stronghold in the U.S.

A report from PricewaterhouseCoopers (PwC) released last year asserts that the traditional pillars of medical innovation in the U.S. are changing to more of a global focus, in part because of domestic financing and regulatory challenges, but also because of the efforts being put forth in other countries.

Albert Malvehy, MD, global account director of PwC’s Healthcare Group, discussed the firm’s Innovation Scorecard, which assessed the innovative capabilities of nine countries, at the 10th annual MedTech Investing Conference in Minneapolis.

The nations involved in the scrutiny included traditional global leaders such as the U.S., Germany, Japan, France and the UK, but also included device-development hotbed Israel and up-and-comer global markets China, India and Brazil.

While the countries that make up the largest European markets share a history of med-tech history with the U.S. and are benefitting from the growing trend by U.S. firms to do clinicals in Europe and seek the CE mark as an initial commercialization strategy, Malvehy cited the “emerging growth market” countries as places where innovation is making the largest relative strides.

At the opposite end of the scale from the U.S., which he said is “experiencing the most rapid relative decline” in medical innovation, he said China, India and Brazil are “accelerating relatively faster.”

And, while it’s true that the twin issues of increasingly tall regulatory hurdles and shortages of financial options are helping developing companies make the decision to pursue clinical paths elsewhere, Malvehy said it’s also true that “the U.S. has slipped a little bit and other markets have picked up a little bit.”

In the financial incentives area, the U.S. continues to lead – by a sizable margin – in healthcare spending, some 19.3% of gross national product (GNP), compared to 17.9% in Germany, 16.7% in France, 16.7% in the UK and 9.9% in China. But the last figure is misleading, because the growth of healthcare spending in the latter country is growing by leaps and bounds. Malvehy said that by 2020, China will be No. 2 in percentage of GNP spent on healthcare – a remarkable growth rate by any measure.

Malvehy said the U.S. “will continue to lead in R&D spending, but China has passed Japan and is closing fast,” now ranking second worldwide in both R&D and the resulting patents.

As for the third pillar, the regulatory framework, he said the U.S., long the leader in new medical technology, now ranks third in new-product approvals and a distant seventh in “ease of approval.”

He said that one of the key differences between the U.S. and Europe regulatory climate is that the U.S. experience is noteworthy for “the capriciousness and uncertainty in reviews,” as well as elevated requirements for clinical data.

As for price-insensitivity, well, that’s going the way of the Dodo bird. PwC says the U.S. spends five times as much on patients’ hospital stays as even its relatively similar European industrialized counterparts. That’s changing, Malvehy said, to a push to move patients out of the hospital earlier or not go in the hospital at all.

The final pillar, the investment community, also is changing significantly, he said, with emerging markets now becoming more and more entrepreneurial. At the same time in the U.S., med-tech has


2 MDD Takes a Look at Emerging Players in the Market


fallen from its usual status as No. 2 or No. 3 as a sector of interest to VCs to No. 4 on the list.In a bid to preserve the United States’ position as a leader in medical technology innovation,

the Advanced Medical Technology Association (AdvaMed; Washington) recently released a set of policy recommendations that it hopes will preserve America’s position as a leader in medical technology innovation, which it said is threatened by overseas competition and an insufficient regulatory system.

AdvaMed’s Competitiveness Agenda is actually a six policy initiative that is aimed at promoting early stage R&D and creating a stage for predictable FDA regulation, and fair access to foreign markets.

The organization said part of the issue surrounding the medical device industry is the lack of new public policies to provide a level playing field between the U.S. and foreign competitors.

“If you look back over the last 20 years we’ve been a really powerful engine for improving public health,” said Stephen Ubl president/CEO of AdvaMed. “There are some red flags on the horizon that need to be addressed. Venture capital investment is down by a third. The FDA once set the global standard for regulatory agencies but now approval for new devices takes so long that many entrepreneurs are launching their products in Europe before the U.S. While we do have a positive trade balance our trade balance has been cut by two thirds in the last 10 years.”

AdvaMed said that innovation in the life sciences must be a government priority.“We’re advocating for an office for medical innovation in the White House to serve as our

advocate across the government,” Ubl said. “We’re also advocating for an innovation impact statement much like an environmental impact statement, to show how rules and regulations impact competitiveness.”

Other important areas that AdavaMed targeted include:• The FDA review process must be reformed to reduce total review times.• Payment policies of Medicare, Medicaid and private insurers must support medical

innovation and not penalize early adopters of new treatments and procedures.• A vigorous trade policy must support export growth and provide a level playing field for

U.S. based manufacturing.• Strategic tax policies to level the playing field must be implemented, including

improvements to the R&D tax credit to keep it competitive with other countries.• The American research and development infrastructure must be sustained and

improved. Special emphasis must be placed on creating research structures that support the commercialization of the R&D.

No matter what happens on the U.S. innovation front, an increasingly large aging population in the U.S. will continue to demand the latest and greatest innovations in healthcare. Other long term trends, such as large unmet medical needs and increasing prosperity in emerging markets, spell growing demand for healthcare and medtech products. Additionally, larger companies that have recently slashed their R&D budgets may increasingly rely on innovative small companies for their breakthrough products of the future.

Of the hundreds of front-page stories published each year in Medical Device Daily, the largest response often is accorded those in which our writers report on the product-related activities of development-stage and emerging companies. These stories provide an insight into the innovative activities occurring at firms that are no yet household names.

These stories by MDD staff writers Omar Ford, Amanda Pedersen and Robert Kimball, and other staff members and contributors offer insight into some of the innovative activities taking place at the young or modestly-sized older companies whose products help fill the pipeline of new technology.

As the daily newspaper of the med-tech industry, Medical Device Daily comes in contact with both people and product ideas from companies across the entire spectrum of the sector – from the smallest start-up to the Goliaths of the med-tech industry. This collection of stories from recent issues of Medical Device Daily touch on some of the most interesting developments that have caught our attention.

– Holland Johnson, Managing Editor




AirXpanders gets IDE to study AeroFormBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

There has to be a better way.That sentiment is what inspired the development of a new breast tissue expansion device

for mastectomy patients undergoing breast reconstruction. The device, called AeroForm, was developed by AirXpanders (Palo Alto, California), which recently received an investigational device exemption from FDA to move forward with a clinical trial evaluating the technology.

The prospective, randomized, controlled, open-label pivotal study, XPAND (AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction), will be conducted at multiple centers across the U.S. AirXpanders said the results will be used as the basis for its AeroForm 510(k) filing with the FDA.

Scott Dodson, president/CEO of AirXpanders, told Medical Device Daily that the current method for undergoing breast reconstruction following a mastectomy is a procedure during which the surgeon creates a space for a permanent implant. To do this, the surgeon makes a small incision into the woman’s pectoral muscle, inserts a silicone bag. Then, during weekly office visits, the surgeon inserts a needle through the skin into the tissue expander’s port to inject saline into the temporary implant. These weekly injections continue for upwards of four months, Dodson said.

So Daniel Jacobs, MD, a practicing plastic surgeon and one of the co-founders of AirXpanders, decided there had to be a better way.

What AirXpanders ended up coming up with was a breast tissue expansion device that would address the limitations of traditional saline expanders. The AeroForm tissue expander consists of a technologically advanced self-contained tissue expander and a small hand-held wireless remote control. Dodson said the system uses compressed carbon dioxide that is gradually released through a small internal valve, in place of invasive saline injections, to fill the expander. After a standard procedure to implant the expander, the patient is able to inflate the expander herself at home using the remote control, eliminating the need for weekly doctor visits and needle-based saline injections.

The patient can inflate the expander up to three times a day with a three-hour lock-out between doses. “We thought if we could expand the patient on a gradual daily basis we could get her there quicker,” Dodson told MDD.

The way the remote control part of the system works is that the patient waves it over the implant area to allow it to communicate with the implant.

“It’s like using a stud finder on the wall to find out where a stud is,” Dodson said. “This dose controller communicates when it is over the implant . . . once you’re in the sweet spot you simply press the button and immediately a 10 cc dose is delivered.”

He said the company recently completed its feasibility trial in Australia which showed that the implant was able to reach full expansion in about two weeks using the new device.

“This is a significant event in the fact that women want to get on to the recovery phase after they’ve gone through this horrible ordeal with cancer . . . we validated that we can help get them there quicker,” Dodson said. AirXpanders noted that the randomized, controlled clinical trial is designed to directly compare the outcomes of tissue expansion using the traditional saline expansion method to the investigational AeroForm, remote-controlled, needle-free tissue expander. Enrollment will continue until a total of 92 AeroForm devices have been implanted and 46 saline expanders have been implanted. Dodson said the company expects the trial to take six to eight months to complete.

Participating sites include hospitals in Atlanta, Boston, New York, St. Louis, San Diego and other cities across the U.S., the company noted.

“We’re very blessed to have some great sites on board with this study, we have not been




told no by anyone, there has been great physician receptivity to this trial, which in my 25 years of working with medical devices that’s very rare . . . it’s such a dramatic improvement on what’s been done,” Dodson said. He added that reimbursement is already in place for the technology through the Women’s Healthcare Act of 1998.

“We’re pleased the FDA has granted us approval to start our pivotal study,” Dodson said. “We see an opportunity to help mastectomy patients restore their shape after the devastating effects of breast cancer and put some degree of control over recovery in their hands. We look forward to beginning study enrollment and collecting the data that will be submitted to the FDA in support of our 510(k) application.”

He added that, given the positive momentum for the company at this time, AirXpanders is initiating a new round of financing to support clinical and commercial activities for the near term and are soliciting new investors to participate with the company’s existing investors.

“We are fortunate to have such committed investors and expect full insider participation,” Dodson said. “It’s always good, however, to improve the capacity around the table, which is what we will seek to do with this round.”

AirXpanders has previously raised $8 million through a $5 million Series C financing led by GBS Ventures in April 2010 and an additional $3 million working capital line from Oxford Finance in February.




Apollo Endosurgery raises $47.6M in Series B roundBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

Apollo Endosurgery (Austin, Texas) raised $47.6 million in its Series B financing round in February 2012. New investors Novo A/S, Remeditex Ventures, and CPMG joined existing investors PTV Sciences and H.I.G. BioVentures in the round. Proceeds were targeted for the commercial launch of the second generation OverStitch endoscopic suturing system and other Apollo endosurgery flexible surgical tools designed to allow surgeons and interventional endoscopists to perform numerous procedures without making incisions into the patient’s skin.

As part of the financing, Jack Nielsen of Novo A/S, John Creecy of Remeditex and Kent McGaughy of CPMG will join Apollo’s board.

“We are pleased to have this strong financial support from both our new and existing investors, which will enable a successful launch of the OverStitch platform and the broader adoption of flexible surgical approaches for numerous medical conditions,” said President/CEO Dennis McWilliams. “This new financing will enhance Apollo’s leadership position as an innovator and a driving force in advancing this new class of less invasive therapies.”

McWilliams told Medical Device Daily that being able to raise such a significant round of funds in the current financial environment is a testament to Apollo’s technology, the OverStitch, as well as the size of the opportunity the company is targeting. The company has been fortunate to have the continued support it has received from its existing investors, he noted.

“The past three years have been very challenging in the fundraising environment ... and that’s constrained a lot of companies to build their businesses and grow,” McWilliams said. “We put our heads down and focused on preserving our cash and continuing to hit the milestones, but we maintained our vision to develop the Overstitch.” He added that the current financing is a testament to the size of market the company is going after.

“There are huge opportunities that have not been very well tapped,” he said. This latest round, combined with Apollo’s earlier round of $11 .7 million, adds up to a total raised of $59.3 million.

Apollo’s OverStitch platform combines the flexibility of endoscopy with the precision of surgical suturing, allowing physicians to access, manipulate and suture internal tissue without making incisions through the skin, the company says. The platform therefore allows physicians to develop less invasive options for the patient.

Ted Stephens, global marketing director at Apollo, told MDD that the second generation OverStitch is clinically very similar to the first generation of the device. “The second generation device was really designed to allow much easier, improved experience from the clinician’s perspective,”

Stephens said. “It’s much easier to use, it allows for more precision in placing sutures than the first generation device.” McWilliams added that Apollo built the OverStitch device to commercial scale, which is unique these days among medical device companies, he said. “Not many companies take that approach out of the gate, which is a testament to new times in medical devices,” McWilliams said.

With exit margins not being very solid in the industry over the last few years, McWilliams says companies need to build their businesses to have products built to scale from the start. With that in mind, he said Apollo has been built to be a self sustaining company because the traditional model of building a prototype device, running a clinical trial, and getting acquired is no longer as easy as it once was. “They really want to see traction in the market place and you really have to build your company like that from the start,” he said, referring to companies looking at acquiring smaller start-ups.

Apollo also recently received FDA clearance for its SuMO platform designed to help




surgeons remove large, flat pre-cancerous gastrointestinal lesions and polyps. The company now has 11 products cleared by FDA, McWilliams said. In general, this new class of flexible surgery procedures may allow patients to benefit from reduced risk of infections and associated complications, no visible scarring and faster recovery times compared to those who undergo more traditional laparoscopic and open procedures.

With the assistance of the Apollo Group, a flexible endoscopy think tank and other top surgeons and gastroenterologists across the globe, these devices are being used to create less invasive approaches to surgery for obesity, early-stage gastrointestinal cancers, and numerous other GI conditions.

“Scarless surgery represents the convergence of therapeutic endoscopy and minimally invasive surgery, and we’re confident that Apollo Endosurgery’s OverStitch platform will be the enabling device to truly drive this emerging market,” Novo A/S’s Nielsen said. “We are excited to invest in a company with a vision to dramatically change the field of minimally invasive surgery, thus having a profound impact on patient care.”

Apollo Endosurgery was cofounded with the Apollo Group, a unique collaboration of physicians from the Mayo Clinic (Rochester, Minnesota), Johns Hopkins University (Baltimore), the Medical University of South Carolina (Charleston), the University of Texas Medical Branch (Dallas) and the Chinese University of Hong Kong. This collaboration resulted in a significant portfolio of patents in the field of flexible endoscopy and minimally invasive surgery that became the foundation of Apollo Endosurgery. The company has also received a grant from the Cancer Prevention Research Institute of Texas.




New device may offer hope for ‘suicide headache’By AMANDA PEDERSEN Medical Device Daily Senior Staff Writer

It’s not a very common condition but the people who suffer from what is called cluster headaches understand quite well why this particular form of headache pain is often nicknamed “suicide headache.”

Hope of treating and possibly even reducing the frequency of these debilitating headaches may be on the way, however, in the form of an almond-sized implantable device that delivers neurostimulation when activated by placing an external remote control up to the patient’s cheek.

Autonomic Technologies (Redwood City, California) says it is seeing positive preliminary results from a study evaluating the safety and efficacy of its implantable neurostimulation device for the treatment of cluster headache.

Cluster headache is a highly disabling neurologic condition characterized by intense stabbing pain in the area of one eye, often accompanied by swelling, tears and nasal congestion. The pain inflicted by the condition is recognized as amongst the most severe known to man, the company noted. Sufferers can have headache attacks multiple times a day, each lasting 15 minutes to three hours. Roughly one in one thousand people suffer from these headaches.

“The clinical community that cares for these patients . . . they have been desperately seeking good treatments and alternatives for these patients because they’re the types of patients that they don’t know what to do with,” Mary Bellack, executive VP of marketing, clinical, regulatory & quality at Autonomic Technologies, told Medical Device Daily. She said some clinicians have even resorted to off-label use of devices that are approved for other indications for these patients. What Autonomic Technologies is doing, she says, is coming up with a new technology designed specifically for headache. “Something that is more applicable and, we believe, more likely to result in fewer device-related complications.”

The company’s neurostimulation system is a miniaturized implantable stimulator about the size of an almond that is designed for the treatment of severe headache, including cluster headache and migraine. The neurostimulator is delivered through a surgical incision in the gum, leaving no external scars or cosmetic effects. The lead tip of the implant is placed at the sphenopalatine ganglion (SPG) nerve bundle behind the cheekbone. For years clinicians have targeted the SPG to relieve severe headache, primarily by applying lidocaine and other agents to the SPG to achieve a nerve block, the company noted.

Using an external remote controller similar in size to a large cell phone, patients deliver stimulation as needed to relieve the headache. When the headache is treated, the remote controller is simply removed from the cheek, turning off stimulation therapy.

The multi-center Pathway CH-1 study includes seven headache centers from six countries across Europe and will ultimately include up to 40 patients. An initial ‘titration’ period of stimulation allows the stimulation settings to be set and refined for the patient. This is followed by an experimental period in which patients’ headaches are randomized to one of three ‘doses’ of stimulation, including a placebo – a rigorous trial design used in headache studies.

Autonomic recently reported that 22 of about 40 planned patients have been enrolled in the Pathway CH-1 study. Of those, stimulation data from the therapy ‘titration’ period are available for seven patients. The primary endpoint of pain relief within 15 minutes was met in 67% of headaches treated (48 headaches), the company said.

Importantly, more than 70% of patients experienced a reduction in the frequency of their headaches by 50% or more as compared to the four-week period prior to study enrollment. This effect was only seen once patients began using stimulation, Autonomic noted.

“The results are better than we could have hoped,” Ben Pless, president/CEO of Autonomic Technologies, told MDD. He said the device was originally positioned to be what the company




calls an electronic Triptan. Triptans are the most commonly used drugs to treat cluster headaches. “We positioned this product as being like an electronic Triptan,” Pless said, explaining that the patient would deliver stimulation as needed to relieve their headache. “But we were pleasantly surprised to find that in addition, the number of headaches the patients get seem to be going down in a significant way . . . that was a benefit we hadn’t predicted but it’s great to see.”

Jean Schoenen, MD, coordinator of the Headache Research Unit at University of Liege (Liege, Belgium) recently presented the findings at the Congress of the International Headache Society in Berlin.

“These results are extremely encouraging,” Schoenen said. “Chronic cluster headache sufferers are highly disabled by their condition, which causes immense pain and often prevents patients from leading a normal life. The investigators and I look forward to continuing to study this novel therapy in cluster headache, as well as future research in severe migraine.”

Schoenen presented the initial results on seven patients from the titration phase; results from the randomized phase have not yet been presented.

Pless said cluster headaches is a severe enough disorder that some clinicians have even tried treating their patients with deep brain stimulation, which he says has worked for about half the people who have received the therapy.

“There are few treatment options today that serve cluster headache patients well,” said Arne May, MD, a neuroscientist at the University Hospital Hamburg-Eppendorf and president of the German Migraine and Headache Society. “Current treatments include preventive and acute abortive drugs, including expensive injectable medications and inhaled oxygen. Some patients are not candidates for these medications, and others experience significant side effects or have cardiovascular risk factors that place them at risk for taking them. I am hopeful that this novel approach might offer promise for many cluster headache patients.”

Pless said the company also plans to do a study involving the use of the device for patients who suffer migraine headaches. “We look forward to continued studies of our technology for cluster headache as well as for migraine, with the hope that our work may one day offer relief to millions of people,” he said.

The company is backed by blue chip investors Kleiner Perkins, InterWest, Versant Ventures and the Cleveland Clinic.

More patients have been enrolled in the study since the preliminary results were first reported, bringing the total number of patients implanted to date to 27. “It’s still early, but we were very, very excited in seeing the preventive effects it appears the stimulation is having,” Bellack said.

She noted that the company, which was founded in 2007, has been “extremely nimble and quick moving.” It only took three years to implant the first human with the device which, she noted, is “pretty impressive.”




Avinger enrolls first U.S. patient in CONNECT IIBy AMANDA PEDERSEN Medical Device Daily Senior Staff Writer

Treating peripheral artery disease (PAD) can be a bit like trying to walk down the stairs in the dark. You can usually get down them, but it’s an awful lot easier if you have the lights on and can see what you’re doing.

With that analogy in mind, Matt Ferguson, chief business officer at Avinger (Redwood City, California), told Medical Device Daily his company’s CTO crossing catheter, the Ocelot, is like turning on those lights for the physician treating PAD.

Avinger reported the enrollment of the first U.S. patient in its CONNECT II trial. Ian Cawich of Arkansas Heart Hospital (Little Rock) enrolled the first U.S. patient. According to the company, the Ocelot is the first CTO crossing catheter to use real-time intravascular imaging technology – optical coherence tomography (OCT) – to cross completely blocked arteries, also known as chronic total occlusions (CTOs), in the legs while simultaneously using OCT to navigate inside the arteries.

“We are participating in CONNECT II because our patient, if treated with other current options on the medical market, could face amputation and death,” Cawich said. “With Avinger’s Ocelot, we believe this patient can be saved right now from both. The timing of this trial feels like a bit of miracle to our patient.”

Ferguson said examples like Cawich’s patient are exactly why Avinger is working in this space. “It’s why we’re doing what we’re doing, to help as many patients as we can who are in that situation,” Ferguson said. “So to hear that kind of validation from a physician using the product is incredibly rewarding and motivational.”

The first U.S. patient enrolled in the trial comes just two weeks after the first European patient was enrolled in the trial by Bernhard Reimers, MD, at Ospedale di Mirano (Mirano, Italy).

The device received a CE mark in 2011. Also last year, Avinger, founded in 2007, reported raising $25 million to accelerate its Wildcat and Kittycat guide wire support catheters and to complete development of devices like the Ocelot.

CONNECT II is a multi-center, non-randomized global clinical study designed to evaluate the safety and efficacy of Ocelot. According to Avinger, the device uses OCT technology as a navigation tool with the goal of traversing CTOs more safely and effectively as part of a procedure to restore blood flow back to normal in the legs. It allows physicians, in real time, to see what’s happening inside the arteries during the actual intervention, giving patients a better chance to receive the best treatment possible during a single hospital visit.

“We hope that physicians using Ocelot can now help prevent even more leg amputations in people suffering from PAD,” said Avinger’s founder/CEO John Simpson, PhD, MD. “The team here at Avinger has been working really hard and I’m excited to see our efforts now go directly towards helping these patients.”

The technology provides a cross-sectional image generated right at the point of the drilling, or the corkscrew element, at the end of the catheter, which creates a 360-degree image so that the physician knows exactly where the device is, Ferguson said.

“We’re excited to move through enrollment, see the results from the trial, and ultimately submit those results to the FDA to try to make the device available here in the U.S.,” he said. “The technology that we have, the combination of OCT imaging combined with a therapeutic catheter really is completely unique – there really isn’t anything else like it out there.”

PAD currently affects between eight and 12 million adults – and it is the leading cause of amputation in patients older than 50. Hospitalization costs of PAD alone are estimated to exceed $21 billion a year.




CONNECT II is a prospective study designed to evaluate 100 PAD patients with femoropopliteal CTO lesions at 17 sites, including three in Europe. An independent group of physicians will review the angiography results to determine Ocelot’s crossing efficacy and safety, the company noted. Avinger received conditional FDA approval to conduct the study in January.

“PAD is a huge problem and not well recognized,” Ferguson said. “There is a tremendous need for not only better tools to treat it,” but also better ways to diagnose the disease.

He noted that the symptoms of PAD are often misdiagnosed as being arthritis-related or simply the aging process itself – but often times that is not the case. “It’s the lack of blood flow getting to the feet and legs and it’s just like having a leg cramp or a leg fall asleep . . . it’s going to hurt,” Ferguson said.




Bluegrass Vascular focuses on Surfacer ‘inside out’ catheterBy ROBERT KIMBALLMedical Device Daily Staff Writer

Medical technology incubator Therix Medical (Lexington, Kentucky) reported the launch of spin-out Bluegrass Vascular Technologies, a stand-alone company specializing in life-saving devices and methods that address shortcomings in vascular access procedures. Bluegrass Vascular Technologies’ flagship product is the Surfacer inside-out access catheter system, an instrumentation set that allows physicians to perform a novel “inside-out” approach to gain venous access.

The Surfacer was developed to provide a new option for patients with upper extremity venous occlusion (or blockage in the vein) that makes the vein impenetrable by a guidewire or standard access techniques. This condition develops most frequently in patients treated with central venous catheters, access devices that are used to deliver dialysis or nutrition, to implant pacemakers, and to administer intravenous chemotherapy for cancer. Bluegrass Vascular anticipates completion of a first-in-man study using the Surfacer by the end of the year. “The company expects to complete the ten-patient feasibility study in 2Q12,” James Clifton, CEO of Therix Medical and president of Bluegrass Vascular Technologies told Medical Device Daily.

Explaining the importance of the product, Clifton told MDD that “when a central venous occlusion forms, it can develop into a chronic occlusion that is impenetrable by a guidewire or standard access techniques. When this occurs, the vein becomes compromised and unusable for further access, requiring the physician to seek an alternative vein. If all four central veins become occluded and compromised, more invasive surgical access through the chest or torso is required, both with greater cost and morbidity. Risks of these alternate access options include arm/face edema, infection, thrombosis, catheter failure/dislodgement, punctured lung, collapsed lung, and blood that seeps into the cavity containing the lungs and heart [hemothorax]. The Surfacer was designed to offer an alternative to these invasive techniques with its unique ‘inside-out’ approach,” Clifton added.

Using the system, physicians insert a guidewire through the femoral vein in the groin area and, using fluoroscopy, navigate it up through the torso with an exit point in the jugular vein in the neck or the subclavian vein under the collar bone. The procedure is performed while the patient is under conscious sedation, as with other vascular access procedures.

“The idea for the Surfacer was born from seeing many patients with obstructed central venous systems who needed life-saving vascular access therapies, whether that be pacemakers or defibrillators or dialysis access,” said John Gurley, MD, practicing interventional cardiologist at the University of Kentucky Albert B. Chandler Hospital, chief medical officer of Bluegrass Vascular Technologies and inventor of the Surfacer. “Our unique system offers physicians an innovative yet simple solution. If the veins are obstructed and you can’t put a needle in from the outside, you can now go inside the body and direct the needle out.”

The company says the potential market size and need for the Surfacer is substantial. Bluegrass Vascular estimates that more than three million patients require central venous access for medical treatment in the U.S. alone.

Bluegrass Vascular Technologies estimates the market opportunity for the Surfacer and related products to be in excess of $1 billion, with the total market opportunity for general venous access approaching $2.5 billion.

“We believe the Surfacer has the potential to bring tremendous clinical and economic benefit to the healthcare community, as it offers a totally novel approach for venous access that is intended to address a significant unmet clinical need among a very sick patient population,” said Clifton. “The launch of Bluegrass Vascular marks a very exciting achievement for Therix Medical, which is singularly dedicated to taking ideas for novel, high-value therapeutic concepts




like the Surfacer from the bedside to the commercial market.”The launch of Bluegrass Vascular Technologies follows Therix Medical’s $2.5 million Series

A financing, which closed in August. Select proceeds of the funding round have been dedicated to support the new spin-out company.

Bluegrass Vascular Technologies is a medical technology company dedicated to developing and commercializing life-saving devices and methods that address shortcomings in vascular access procedures. Therix Medical is a medical technology company focused on enabling the transfer of novel, high-value therapeutic concepts from the bedside to the commercial market.




New combat clamp device stops groin area bleedingBy AMANDA PEDERSEN Medical Device Daily Senior Staff Writer

A new medical device designed to dramatically suppress uncontrolled bleeding in the groin and inguinal areas of wounded troops is being deployed to the battlefield. The Combat Ready Clamp (CRoC) is a vise-like tourniquet designed to manage difficult bleeds when hemorrhage control in tactical environments is not possible with traditional methods and standard tourniquets.

Combat Medical Systems (CMS; Fayetteville, North Carolina), maker of the CRoC, said it recognized the need for an atypical tourniquet device to tackle injuries occurring below soldiers’ body armor in the pelvic and groin area as a result of gunshot wounds and Afghan insurgents’ use of improvised explosive devices.

According to the company, the CRoC is easily employed and removed, and the mechanism is a slip-proof expandable aluminum clamp that is durable, collapsible, lightweight and compact.

A recent article in the U.S. Army Medical Department Journal reported that stemming uncontrolled bleeding could prevent the deaths of as many as three soldiers a month.

The FDA has approved the CRoC and the device is already being fielded to medics in Afghanistan, CMS noted.

According to the company, hemorrhage is the leading cause of preventable death on the battlefield. Roughly 25% of potentially survivable deaths are due to uncontrolled junctional hemorrhage, the majority of which are pelvic hemorrhage. The clamp provides compression to large vessels and direct pressure to difficult wounds thus controlling hemorrhage and eliminating the need for manual pressure, CMS said.

The company was founded in February 2008 by a team of experienced military medical personnel and industry product specialists. Its primary goal is to simplify tactical medicine in order to decrease pre-hospital mortality.

Located just outside Fort Bragg, North Carolina, the company is able to stay current with military medical trends in order to identify those requirements.

CMS also makes AllEvac Compact Litter Stands designed for fast mobile contingency operations. The stands fold small enough to fit in a Pelican 1650 deployment case or the LBT Medium Load Out Bag, the company noted. Similarly, the company makes the AllEvac Mantis tri-fold evacuation board ideal for vehicle extraction because of its compact size and rapid employment.

Other products from CMS include a Battle Wrap, a clear, flexible, self adhering, extreme strength, compression wrap designed to allow for visualization of bleeding and providing pressure with no distal slipping, and a variety of burn dressings.

The growing number of wounds and fatalities in Iraq and Afghanistan in the past decade has led to several new developments aimed at improving battlefield medicine.

Idaho Technologies (Salt Lake City), is developing tests to detect diseases service members contract in combat zones or third world countries that they would not otherwise have contracted, such as Q fever, an emerging infectious disease among soldiers serving in Iraq and other countries around the globe. In June the FDA cleared the first nucleic acid amplification in vitro diagnostic test designed to detect Coxiella burnetii, the bacteria that causes Q fever, within four hours. The test will be used to test military personnel suspected of contracting the disease and run on the Joint Biological Agent Identification and Diagnostic System (JBAIDS), used across all branches of the U.S. military for diagnostic testing. Use of the test is limited to designated DoD laboratories equipped with the JBAIDS, the company noted.

The test itself is fairly straightforward, based on rapid PCR technology the company licensed from the University of Utah (Salt Lake City). The Department of Defense funded the




project because it directly affects the troops.Because medical devices for the military need to be designed specifically for the tough

demands of battlefield medicine, Zoll Medical (Chelmsford, Massachusetts) brought a monitor/defibrillator to market last year that is lightweight and seeks to meet the need of military personnel on the front lines.

The Propaq MD Monitor/Defibrillator has received FDA approval.Another device that has been especially popular on the battlefield is the Thermal Angel

blood and IV infusion warmer. It has been so popular, in fact, that Estill Medical Technologies’ (Dallas) president, Jay Lopez, told Medical Device Daily in 2009 that the company has struggled to keep up with the demands of the military.

According to Estill, the Thermal Angel is crucial to critical care administration. In emergency medicine, the “golden hour” refers to the first 60 minutes after the occurrence of a multi-system trauma. It is widely believed that the victim’s survival chances are greatest if they receive definitive care within this first hour of injury, the company said.

“We got picked up by the military a few years ago and they’re very aggressive about trying to find ways to push the care as far forward as possible so they can give patients care in that golden hour,” Lopez told MDD.




CardioComm earns FDA clearance for OTC heart monitoring systemA Medical Device Daily Staff Report

A new technology cleared by the FDA in January 2012 should give consumers access to one of the most compact remote over-the-counter (OTC) heart monitoring technologies ever developed. CardioComm Solutions (Victoria, Canada), a global medical provider of ECG acquisition and management software solutions, reported receiving clearance from FDA for OTC sales and marketing of their consumer-based, hand-held heart rhythm monitor known as the HeartCheck Pen Handheld ECG.

The clearance also included CardioComm Solutions’ GEMS (Global ECG Management System) Home software, which enables the HeartCheck Pen to be connected to a personal computer to upload the heart rhythm recording to CardioComm Solutions’ C4 medical call service telemedicine group for review by a physician. The HeartCheck Pen and GEMS Home solution provide an extension to the HeartCheck ECG Monitor solution, which may be used only under physician direction. Both devices can communicate with CardioComm Solution’s C4 medical call center.

“Through this consumer product,” said Etienne Grima, CardioComm Solutions’ CEO, “we are truly putting people’s heart health into their own hands.” The Pen will display only the heart rate count until an interaction with a physician occurs. Once a C4 physician has provided review and feedback to the customer, the Pen’s screen can be unlocked to display the real-time ECG and heart rate count for subsequent heart rhythm recordings.

“We feel the HeartCheck Pen is a true remote monitoring device because it is compact, easy to use, and takes accurate heart readings in only 30 seconds. The Pen may be used from anywhere, including at home, the office, the gym or in remote areas, which are often inaccessible to common ECG machines,” said Grima. The HeartCheck Pen stores up to 20 ECGs, and the data can be downloaded to GEMS Home, where repeated recordings can be managed in a personal health data record. The GEMS Home software offers a simple software user interface for managing heart rhythm recordings and associated data, the company said.

“What makes this product unique,” explained Grima, “is that after a consumer sends a selected heart rate recording to the C4 medical call center over the Internet using GEMS Home, the actual ECG recording will be reviewed and interpreted by an attending C4 physician. The ECG report will then be made available to the customer, again through

GEMS Home, where they may retrieve the ECG interpretation and use it in communicating with their own health care providers.”

The HeartCheck ECG monitor functions as an arrhythmia as well as a resting ECG monitor, providing a function much like a digital thermometer for the heart. Other such devices may connect via cell phone or over the Internet, and enable individuals to record and store their ECGs, but the critical question often asked is who will review these ECGs and how?

“At CardioComm,” said Grima, “we’ve developed FDA-cleared and CE-approved solutions to answer these two questions. We can transmit these ECGs under a standardized format in such a manner that physicians have rapid access to review them and provide a medical interpretation or recommendation for how patients should proceed.

“Using a handheld ECG device is not new,” added Grima. “What is new is that with our proven C4 technology, patients now have the unique capacity to securely connect over the Internet and within minutes have their ECGs accessed by physicians from anywhere in the world. The significance of this is the existence of a large population of consumers with chronic conditions who own or wish to purchase devices that can assist in monitoring their heart health.”

“Any person interested in monitoring their health for primary or secondary disease reasons would benefit from this solution,” said Michael Baber, business development director for the HeartCheck brand. CardioComm Solutions is now in the process of developing market channels for the distribution of this new device and service. “Our cycle time for bringing this product




to its current market-ready stage has been less than 14 months, and we intend to keep the momentum going,” said Grima.

Grima said a priority for the current year is the global commercialization of the HeartCheck Pen Handheld ECG Monitor and GEMS Home solution. In association with the launch of this new offering, he said the company is preparing for a financing round with an eye toward private placement. “Together with the anticipated completion of our new GEMS 4.0 platform, 2012 indeed promises to be an exciting time for CardioComm Solutions,” Grima said.




Case Medical study uses fMRI to investigate dystoniaBy ROBERT KIMBALLMedical Device Daily Staff Writer

An estimated 300,000 people in North America are afflicted with dystonia, a disorder characterized by a progressive loss of motor control. Patients with generalized dystonia grapple with involuntary muscle spasms that lead to uncontrolled twisting and turning in awkward, sometimes painful postures. Although cognition, intelligence and life span are often normal, the disorder can have a devastating impact on quality of life, as its victims frequently struggle to perform simple activities of daily living.

At University Hospitals (UH) Case Medical Center’s Neurological Institute (Cleveland), a research team is using advanced imaging technology to explore the complex network of brain activity relating to movement in healthy subjects and in patients with dystonia.

“Unlike a typical MRI, functional MRI [fMRI] is not looking specifically at structure of the brain, but rather function. It is looking at what specific parts of the brain are being used, and at what time. These scans are looking at oxygenation of the brain. In other words, what parts of the brain are getting the most oxygen and being used as an activity is taking place. By imaging the blood flow, we can tell which part of the brain is being used,” Benjamin Walter, MD, medical director, deep brain stimulation program, UH Case Medical Center, and assistant professor of Neurology, Case Western Reserve University School of Medicine (also Cleveland) told Medical Device Daily.

Walter’s current research explores two key areas: the nature of brain activity in patients with dystonia, and how that differs from activity in normal subjects; and understanding how deep brain stimulation (DBS), a leading-edge treatment for selected dystonia patients, works to quiet the involuntary spasms. Treating dystonia with DBS involves the placement of electrodes in the internal segment of the globus pallidus, a subcortical structure also targeted in the DBS treatment of Parkinson’s disease, essential tremor and obsessive compulsive disorder. “In disorders such as Parkinson’s and essential tremor, when you turn the stimulator on there’s a pretty quick benefit,” Walter said. “That’s not the case with dystonia – it slowly improves over a long period of time, six months or longer. So there’s more of a neuroplastic effect that’s probably involved in the mechanism of DBS.” The initial stage of Walter’s research involves using fMRI to observe brain activity in healthy subjects and in patients with dystonia who have not received DBS implants.

“This study is looking at primary dystonias that are going in for DBS treatment,” Walter told MDD. “DBS is used for primary general dystonia when the symptoms are severe enough to warrant treatment.” Not all forms of dystonia require DBS, but Walter says that “other forms of dystonia, for example, cervical dystonia, can use botulinum therapy as a treatment, but DBS is recommended for that type as well.”

The research team chose to study their subjects’ proprioception – the sense of how their own limbs are oriented in space – “because that’s very close to movement, and you get direct feedback about joint position when you move a limb.”

Using a small device that vibrates over a wrist tendon, the researchers induce a movement illusion (the false perception that the subject’s wrist is flexing) and examine the resulting fMRI images.

“In our normal patients, we’re seeing that the motor cortex and the motor portion of the basal ganglia and the posterior striatum are involved,” Walter notes. “In our dystonic patients, we’ll look for changes in how the proprioceptive input is being handled. We’re hoping to discover where the signal is becoming abnormal in these patients, whether there are different anatomical structures involved, and whether there’s a different place we could put the DBS wire and get a more robust effect.”

The next stage of the research will include fMRI imaging of patients who have received DBS




treatment. “DBS is not really well understood,” Walter says. “In part you need to know where to look, and this type of neuroimaging can tell us where there are abnormal hot nodes that are involved in our proprioception paradigm and may be worth investigating using other methods. Essentially, we’re defining the differences between dystonia and normal patients, and in the dystonia patients who get DBS, we’ll be looking for changes in their brain activity over time, as the dystonia melts away.”

Walter told MDD that more than 80,000 patients worldwide have received DBS. “It has been used for dystonia [for which it has a Humanitarian Device Exemption], but also for Parkinson’s, and essential tremor.”

University Hospitals Neurological Institute in Cleveland offers the full range of neurological and neurosurgical services at its primary location, UH Case Medical Center. In addition, patients in northern Ohio can be seen close to home at one of the community medical and health centers.




HeartLight EAS lights the way for catheter ablation of AFBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

A company known to use the slogan “see what you ablate, ablate what you see” at tradeshows has made large strides lately towards enabling electrophysiologists to do just that. The company has developed an atrial fibrillation catheter ablation system that incorporates, for the first time, an endoscope for direct visualization of a beating heart in real time without radiation.

CardioFocus (Marlborough, Massachusetts) reported that a study in the Journal of Cardiovascular Electrophysiology demonstrates the high acute and chronic success rates achievable with a single AF ablation procedure using the HeartLight Endoscopic Ablation System (EAS). The study was conducted by Boris Schmidt, MD, and colleagues at Cardioangiologisches Centrum Bethanien (Frankfurt, Germany), and was published online in January 2012.

In addition to the endoscope for direct visualization, the HeartLight EAS also includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the pulmonary vein (PV) ostium (opening) irrespective of the individual patient anatomy, and utilizes laser energy for more efficient, durable and precise ablation treatment.

In the study, “Visually Guided Sequential Pulmonary Vein Isolation: Insights into Techniques and Predictors of Acute Success,” physicians performed ablation with a single HeartLight EAS and single transseptal puncture on 35 patients with drug-refractory paroxysmal or persistent AF. PV isolation was achieved in 70% (96/137) of veins with an initial ablation. After assessment with a circular mapping catheter, continued ablation with the same HeartLight EAS device resulted in an overall 98% single-procedure PV isolation rate.

Stephen Sagon, president/CEO of CardioFocus, told Medical Device Daily the study results were “better than expected.”

Procedures were performed in a mean time of 154 ± 38 minutes with the ablation stage lasting an average of 89 ± 16 minutes and mean fluoroscopy time of 16 ± 6 minutes. Notably, a reduction in procedure time between the first and last 12 cases was observed (175 ± 48 minutes compared to 138 ± 26 minutes). The primary efficacy endpoint of the study was acute PVI, with a secondary endpoint of freedom from AF between 90 and 365 days post-ablation and off antiarrythmic drugs. During a median follow-up of 266 days, 77% of patients (27 out of 35) remained free of any tachyarrhythmia recurrence and off drugs.

“In this study, physicians have demonstrated a high rate of clinical success achievable within a reasonably short procedure time, even among operators still in the midst of the learning curve,” Sagon said. “This reinforces the advantages of HeartLight EAS’ novel, adaptable and user-friendly design, and we look forward to continued positive experiences from this and other medical centers as they begin to standardize and master this ablation approach.”

The company recently received a nod from the FDA to move forward with its investigational device exemption study in the U.S., Sagon said. The device was approved in Europe in 2009.

“Pulmonary vein isolation is a critical indicator of success in catheter ablation procedures for AF. However, this has traditionally been a very challenging and complex endeavor requiring an experienced operator, multiple ablation devices to account for varied patient anatomy, and even multiple transseptal punctures for access,” Schmidt said. “In this study we set out to examine the feasibility of performing a streamlined, visually-guided ablation procedure and record best practices to achieve endpoints of acute and chronic success. Our findings demonstrate that this unique approach to ablation may prove highly effective in treating AF patients.”

With the increasing use of catheter ablation as a treatment option for AF patients, the short learning curve and simplified approach enabled by the HeartLight EAS makes it a “very promising system,” Schmidt said, “especially as the technique continues to be adopted outside




specialized ablation centers. In the paper, Schmidt and his colleagues documented their approach to performing ablation on the center’s first series of patients to undergo treatment with the HeartLight EAS. He added that as the procedure continues to be standardized, additional centers will experience “these impressive, reproducible results.”

CardioFocus secured $5 million in debt financing last year from Silicon Valley Bank to initiate its pivotal trial in the U.S. and expand commercialization in Europe. Previously the company had reported raising a $21.5 million Series C round led by H.I.G. Ventures and KBL Healthcare Ventures with participation from Accuitive Medical Ventures, the Aurora Funds, Oxford Bioscience Partners and SV Life Sciences.

Sagon told MDD that the current take at academic meetings is that ablation results for treating AF are “not as durable as people had hoped.” His company’s approach to visual-guided ablation appears to be offering better durability with a shorter learning curve.

“I think if you’re an electrophysiologist who is used to doing procedures that take many hours with lots of radiation exposure and getting mediocre results, this is a breath of fresh air,” Sagon said.




CerebralRx enters market with vagus nerve stimulation deviceBy AMANDA PEDERSEN Medical Device Daily Senior Staff Writer

CerebralRx, a newly formed spin-off of BioControl Medical (both Yehud, Israel), is hitting the ground running with the launch of its FitNeS vagus nerve stimulation system for epilepsy in Europe.

Not only is the new company’s flagship device already on the market, but it has already been implanted in the first two patients at the Institute for Clinical Neurosciences at the Shalgrenska Academy (Götenberg, Sweden), the company noted. CerebralRx also reported its first order for the FitNeS system from the AMS Group, a distributor of neuromodulation medical devices in Italy.

“We think it’s a unique situation in which the company has just been started but it already has a device in the market,” Ehud Cohen, PhD, CEO of BioControl Medical, told Medical Device Daily. The FitNeS device did, however, have a head start, because it employs platform technology BioControl has already developed for the cardiology space.

In April of last year, BioControl enrolled its first patient in the INOVATE-HF (Increase of Vagal Tone in Heart Failure) study of its CardioFit device, an implantable electrical stimulation device designed to improve heart function in patients with congestive heart failure. Likewise, the FitNeS device is an implantable electrical stimulation device designed to treat epilepsy patients with partial onset seizures who do not achieve full seizure control with available prescription drugs (or those with refractory epilepsy).

“From a technical perspective the two devices are very similar, but from a clinical perspective they are very different,” Cohen said. For starters, CardioFit is the first vagus nerve stimulation device in the U.S. designed to treat heart failure, while FitNeS is not the first vagus nerve stimulation system for epilepsy. “But the market already knows and accepts vagus nerve stimulation as a therapy for epilepsy so therefore the process for entering the market is very different,” he said.

CerebralRx spun out of BioControl Medical to expand the use of this technology outside of cardiology for the treatment of a range of neurological disorders, including epilepsy, Cohen said.

“The formation of CerebralRx and launch of FitNeS are significant milestones that will increase our technology’s penetration in the global neuromodulation market,” Cohen said. “CerebralRx is built on years of development of the CardioFit by BioControl Medical, giving it the scientific and business foundation essential for success as it targets the field of neurology. The first implants and first commercial order of FitNeS are great testaments to the early interest in this new treatment option for patients with refractory epilepsy.”

The FitNeS system consists of an implanted stimulator and stimulation lead, which work together to deliver electrical signals to the left vagus nerve. Designed to deliver targeted, unidirectional nerve stimulation, the system effectively activates nerve fibers toward the brain while minimizing the activation of non-related nerve fibers. This selective approach has the potential to increase stimulation effectiveness while minimizing risk of side effects, according to the company.

Cohen emphasized that while the FitNeS system has CE marking and is available in Europe, the device is not available in the U.S. He said obtaining an investigational device exemption to start a pivotal study of FitNeS in the U.S. should be fairly straightforward though, considering the device is based on the same technology platform as the CardioFit which is already in a pivotal trial.

“The opportunity presented by the FitNeS system is exceptional, thanks to the characteristics and the innovation brought by this device. In my opinion, the FitNeS system will capture a segment of the vagus nerve stimulation market with no competitors among the producers




of active implantable systems and will conquer part of the market that to date has been the stronghold of the pharmaceutical companies,” said Mauro Vendrami, president/CEO of the AMS Group. “For more than 20 years, we have collaborated with companies that produce active implantable systems, but we have seldom experienced the level of synergy, collaboration and enthusiasm that we have found in the CerebralRx team.”

CerebralRx noted that it is launching FitNeS into a therapeutic area with a very large patient population. Epilepsy is a common condition estimated to affect 50 million people worldwide. More than 1% of the population is at risk for developing chronic epilepsy, and onset may occur at any age. The prevalence of active epilepsy in the U.S. is estimated at nearly three million, with 200,000 new cases diagnosed every year; in Europe, these prevalence and annual diagnosis statistics are estimated at 3.5 million and 300,000, respectively. The company also noted that 50% of patients with epilepsy suffer from partial onset seizures, which are typically treated with anti-epileptic prescription drugs. However, 30% of these patients are refractory, or unable to achieve seizure control with available drug therapy.

The FitNeS system was developed to offer a new treatment option for refractory epilepsy patients while delivering improvements over existing vagus nerve stimulation devices. In addition to its potential to increase stimulation efficacy and minimize side effects, the FitNeS system was designed to use lower currents, minimize nerve damage through a unique nerve electrode interface, reduce current leakage through improved cuff isolation, and allow for safe and easy explant of the electrode if required.

CerebralRx said it plans to expand the application of its technology for treating additional disorders, including Alzheimer’s and depression.




CerviLenz offers screening tool for preterm birth riskBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

CerviLenz (Chagrin Falls, Ohio), a woman’s health device company in the Cleveland area, has recently bumped its Series A round of investment up to $8.35 million, thanks to a recent tranche of funding from existing investors.

CEO Dean Koch told Medical Device Daily the company plans to use the funding for general corporate purposes and pre-commercial work for a device it has developed aimed at measuring a pregnant woman’s cervix. A short cervix is the best predictor of preterm birth risk, which Koch said is a leading cause of infant death.

“We’re very blessed with experienced and smart investors, who have a lot of experience in the medical device industry,” Koch said.

The company’s investors include Arboretum Ventures, Chrysalis Ventures, JumpStart, and Northcoast Angel Fund.

The CerviLenz device is already sold in the U.S. and recently received the CE mark for sale in Europe.

CerviLenz said there are an estimated 500,000 preterm births in the U.S. a year. The company was founded in 2008 by Koch, Michael Ross, MD, and Rosalyn Baxter-Jones, MD.

Baxter-Jones, a practicing obstetrician/gynecologist in San Diego, invented the CerviLenz device. The idea was born when she was caring for a pregnant woman who not only dances but teaches dance professionally. One day, the dancer came to the office five months pregnant and contracting. Both Baxter-Jones and her patient were anxious to know if this was really preterm labor or just Braxton Hicks contractions. The dancer wanted to keep dancing, if it was safe for her baby.

In order to answer the question about what was going on with the woman’s cervix, Baxter-Jones needed to measure the patient’s cervical length. From there, she got the idea for CerviLenz, a low-cost tool designed to measure vaginal cervical length, yielding a quantifiable result immediately during a routine office visit.

Koch said preterm births – defined simply as a woman delivering her baby too soon, or before 37 weeks gestation – is a “huge” public health problem, with about 12% of pregnancies ending in pre-term birth.

Until now, there was not a lot of motivation to develop screening tools like the device CerviLenz sells because even if a pregnant woman was identified as being at risk for a preterm birth, there wasn’t a whole lot her doctors could do about it.

“We don’t go looking for diseases we can’t fix,” Koch said.But a new intervention is on the horizon that could change that, adding value to the

CerviLenz device as a screening tool. A gel form of the drug Progesterone is expected to be introduced next year by Edison Pharmaceuticals (Mountain View, California) to reduce the risk of preterm birth in women with a short cervix in their mid-trimester of pregnancy.

The only other way to reliably measure the length of a pregnant woman’s cervix is with a transvaginal ultrasound probe, a more costly method usually reserved for high-risk pregnancies.




ChromaGen’s lenses help aid color blind patientsBy OMAR FORDMedical Device Daily Staff Writer

Life changing is a term that’s often bandied around when it comes to discussing some med-tech company’s products. But in truth, so few manage to live up to the hype the term describes. One small med-tech company in particular is claiming that it definitely has a life changing product and is seeking to more than just live up to the hype.

ChromaGen Vision (Kennett Square, Pennsylvania) unveiled what it calls a “life changing” aid for visual reading disorders often associated with dyslexia and an optical corrective solution for color deficiency, more commonly known as color blindness.

The lenses, which are available as eyeglasses or contacts have been shown to radically improve symptoms of visual reading disorders and color blindness in patients of all ages instantly and without side effects.

“A major cause of the symptoms of dyslexia is lack of synchronicity in the speed of information transmitted from the eyes to the brain,” ChromaGen CEO, Ted Edwards told Medical Device Daily, via email. “The ChromaGen lenses work to selectively change the wavelength of light going into both eyes in a dynamically balanced format. The use of different filters effectively changes the speed of the information in the brain’s neurological pathways, allowing synchronization to take place. Since the 1920s, different variations of optical treatments for dyslexia have existed. ChromaGen’s proprietary 16-filter system is the first to be cleared by the FDA.

The company said that research has shown that nearly one out of two people with dyslexia and 97% of those with color blindness can experience instant relief with ChromaGen lenses.

“When a patient is tested by their eye doctor for ChromaGen lenses, they will know immediately if the lenses can help them,” said Michael Politzer, a ChromaGen Practitioner. “The most poignant cases we have seen are children who struggled with reading, but with the right ChromaGen prescription, have been able to read like never before. The ability to read without words moving on the page or coming in and out of focus gives these kids hope and confidence to pursue dreams they thought might have been out of reach.”

Available only by prescription, the ChromaGen system consists of 16 subtly shaded lenses. An optometrist or ophthalmologist specially trained to test a patient to determine if he or she is a viable candidate for ChromaGen technology tests each eye separately to find the best combination of lenses. Every prescription is tailored to the individual. The company noted that a ChromaGen prescription can be incorporated into an existing prescription for eyeglasses or contact lenses.

ChromaGen Vision was founded when it purchased assets from Cantor & Nissel (Brackley, UK) in 2007. The firm said that as of this time it was solely focused on marketing the ChromaGen glasses and contacts.

“ChromaGen Vision acquired the worldwide rights to distribute the ChromaGen products (excluding Europe) from Cantor & Nissel in 2007,” Edwards said. “This company was founded to bring ChromaGen to the U.S. and other markets, and ChromaGen glasses and contacts remain our sole focus for now.”

He did not go into specifics about funding but he did say that the private company has raised a first round of financing and will raise more capital based on growth.

The ChromaGen products have quite a history and were originally developed by British inventor David Harris.

According to the firm’s website Harris’ journey into developing the ChromaGen products started in 1987.

Harris began his research to develop the ChromaGen filters as far back as the late 1980’s when he began testing patients who were color deficient.




These filters were initially prescribed as contact lenses although a form of spectacles was later developed. It was determined that these lenses also helped dyslexics and in order to confirm this hypothesis a pilot study was carried out at Clatterbridge Hospital, (Wirral, UK).

The results of this study were published in Optometry Today (“Interim report on the use of ChromaGen contact lenses in patients with specific learning difficulties – a comparative study with the Intuitive Colorimeter”).

The benefits they offer people with dyslexia were discovered as part of the product development almost by accident,” Edwards said “Dr. Harris’ lab continues to explore refinements of and new applications for the ChromaGen technology today.”




Clarimedix gains traction despite rough VC landscapeBy OMAR FORDMedical Device Daily Staff Writer

It’s no secret that venture capital is hard to find these days. But one small firm is proving that sound technology along with a raft of angel investors and public grants can be used to solve the problem of how to quickly get an innovative product to the market.

Clarimedix (Boulder, Colorado), a privately held company founded in 2006 that is focused on the development of non-invasive therapeutics for the treatment of disorders associated with vascular dysfunction, is hoping to get its device – which has not yet been given a formal name – to the market within the next 18 months despite a difficult venture funding landscape.

“The company was founded on the notion that it might be possible to develop a true medically validated therapeutic using a non-drug solution like light,” John Dunning, CEO of Clarimedix told Medical Device Daily. “With light you can develop an effective product that actually has a number of potential benefits like that lack of side effects – and is pretty much noninvasive.”

Dunning, who is also the founder of Clarimedix, added, “when we started the company we [wanted to] identify the potential mechanisms that could be involved in using light as a therapeutic treatment, and we identified a potential target.” He said after pairing up with the University of Colorado (Boulder), the company was able to prove it is possible to stimulate a specific novel pathway. The firm’s technology is a nitric oxide (NO) donor therapy that exploits recent developments in the understanding of cellular function and the ability to control it with light. The formulation triggers a powerful drug-like response, while virtually eliminating the side effects associated with conventional NO donor therapies. The device is aimed at treating cerebral vasospasm, Raynaud’s syndrome and Alzheimer’s disease.

“The device is a patch,” Dunning told MDD. “The battery and the light source are built into it. In each of the different conditions the product will be a bit different. For cerebral vasospasm it would be a larger device, since you’re in the critical care setting and for Alzheimer’s it’s usually the shape of a large Band Aid that literally fits on the side of the neck.”

To date, there are other devices out there that use light as a therapy, but none come quite close to what Clarimedix said it is doing. “There are other light devices on the market but none of those technologies are optimized,” he said. “The distinction between what we’re doing and what people have done before in the light area, is that we have discovered a specific receptor and optimized the type of light needed to deliver the response that we want.”

The company said in February 2012 it was commencing with clinical studies and hoped the device for Raynaud’s syndrome will be on the market by mid-2013. But with the initiation of clinical studies, comes the issue of funding and that has proven to be a bit difficult to come by.

“Absolutely there has been difficulty raising money,” he said. “Our funding has come from grants and angel tree investors. The venture capital community has almost been totally absent, and I think the reason for that is a combination of the financial environment we all went through and the dynamic of the venture capital industry – or at least the venture capital industry in medical devices, which is going through changes. So a lot of funds we would have gone to are simply closing up shop and they’re doing something else now. So yes there have been challenges.”

Dunning would not go into specifics on how much the company raised. The company recently secured an investment from the Johnson & Johnson (New Brunswick, New Jersey) Corporate Office of Science and Technology, although financial terms of the deal were not disclosed. Funds secured from this investment will be used to determine the viability of the company’s product for cerebral vasospasm. The study will be completed by the end of the second quarter of 2012, at which point the company hopes to close a further round of investment from an investor syndicate.




Seeking additional funding has been difficult but Dunning told MDD the key to succeeding is persistence. “The solution is to keep hammering away and to have the persistence to get more data and find the money wherever you can find it, to get to the next step,” he said.




CytoPherx gets $34 million in funding for kidney therapyBy ROBERT KIMBALLMedical Device Daily Staff Writer

CytoPherx (Ann Arbor, Michigan) has completed a $34 million round of funding, with a syndicate of investors co-led by Early Stage Partners, ONSET Ventures and Capital.

Midwest Fund, participating in the round. The funds will be used to complete U.S. clinical trials and gain FDA approval to commercialize the CytoPherx anti-inflammatory therapy for acute kidney injury.

“We treat the sickest of the sick,” Jim Danehy, President/CEO of CytoPherx, told Medical Device Daily. “To put that into perspective, there are 160,000 patients who have acute kidney injury requiring dialysis in the ICU every year in the U.S. The mortality rate of these patients is greater than 50%, the average length of stay in the hospital is 32 days, and it costs the healthcare system a little bit more than $100,000 per patient,” he said.

Patients in the ICU with kidney injury often suffer from extreme systemic inflammation, which in turn increases the likelihood of death or long-term illness and low quality of life. The CytoPherx treatment, which is added to the renal replacement circuit, is designed to focus on acute systemic inflammation that is not well addressed with currently available therapies. The treatment removes excessive activated neutrophils – characteristic of systemic inflammatory response syndrome (SIRS) – from the immune system. When a patient is suffering from SIRS, the other organs are also impaired.

CytoPherx’s focus is on kidney impairment is largely because the company co-founder is a nephrologist, David Humes, MD, of the University of Michigan (Ann Arbor). “When your kidneys fail, you’re in trouble because once they go, everything else follows,” Danehy told MDD. “What [Humes] discovered was a way to take the excessive quantity of the hyperactive immune system out of circulation. Literally, out of circulation – with a membrane-based device that selects and removes the overactive component of the immune system that is attacking the patient’s own body. We integrate it into the current standard of care, so you don’t have change the physics of the device to convince the clinical staff to use it.”

CytoPherx has initiated a 344-patient pivotal trial with leading nephrologists and medical institutions across the U.S. The primary trial end point is a clinically and statistically significant reduction in mortality through day 60. In addition, the trial will evaluate the performance of the company’s Selective Cytopheretic Device (SCD) for the reduction of mortality in severe sepsis patients, reduction of Acute Respiratory Distress Syndrome (ARDS), and reduction of patients who need long-term dialysis.

“Mortality rates of patients experiencing acute kidney injury combined with multi-organ failure and/or severe sepsis and requiring Continuous Renal Replacement Therapy (CRRT) are often greater than 50%,” said Danehy. “Our early trials have shown the potential of reducing this by as much as 15%.”

Danehy believes the 15% reduction is sustainable over the course of the trial. “We’ve had around 65 patients exposed to the therapy, and we are confident that our mortality rate will be below 35%.”

In addition to Early Stage Partners, ONSET Ventures and Capital Midwest Fund, joining the financing are new investors Kaiser Permanente Ventures, Emergent Medical

Partners, Charter Oak Equity, Aphelion Capital, and existing investors Lurie Investments, Dow/Union Carbide Employee Pension Plans, Apjohn Ventures and North Coast Technology Investors.




Dune to provide realtime analysis of cancer marginBy AMANDA PEDERSEN Medical Device Daily Senior Staff Writer

When surgical oncologists remove a breast tumor their goal is to get all of the tumor, preferably on the first try. But all too often patients are called back for a second surgery because the surgeon, despite his or her best efforts, just didn’t get it all.

Dune Medical Devices (Caesarea, Israel/Framingham, Massachusetts), has developed a tool to help surgical oncologists analyze the edges of a breast cancer tumor in the operating room and determine in real-time if cancer cells remain.

The goal of the device is to reduce the number of times patients are called back to the OR for a second surgery, CEO Dan Levangie told Medical Device Daily. He said the profound unmet medical need was the driving inspiration behind this device.

“It’s very clear that the status of a lumpectomy margin is an extremely important predictor in outcomes and in the old days mastectomy was the preferred course,” Levangie said. “The importance of margins in this field is well known, documented and pretty dramatic in terms of size.”

He added that breast tumors are being detected at earlier stages – a good thing, of course – but because of this trend the tumors tend to be smaller and non-palpable. That’s where the MarginProbe comes in, to help the surgeon detect the tumor margin in real-time and to prevent the need for a repeat procedure.

The hand-held device is minimally invasive, Dune says, and only adds about three to five minutes to the overall procedure.

Studies have shown the MarginProbe reduces the re-incision rate for these surgical cases by about 50%, Levangie said. The company has submitted the device to the FDA and hopes to have it available in the U.S. in 2013. The device is already available in Europe where the company has won a CE mark for the MarginProbe.

“It’s an adjunctive tool for the surgeon to use at the time of the initial lumpectomy procedure to achieve clear margins,” Levangie said. He said the device itself is “very simple to use” and “fits in very well with the current approach.”

While the initial application of the MarginProbe is for breast cancer surgery, the technology lends itself to a number of potential applications, Levangie told MDD. “Anytime a surgeon is removing a cancer . . . their objective is to remove the tumor, but also to have a margin of normal tissue around the tumor,” he said.

Some of the potential applications of the device include the areas of prostate cancer as well as guiding biopsy for breast lesions. “We think that the MarginProbe technology could add a great deal of benefit in guiding the biopsy,” Levangie said. He added that Dune is in the prototype stage of developing just such a tool based on the MarginProbe technology. “The technology could be applied to a variety of disease states.”

The company recently presented studies at the European Breast Cancer Congress (EBCC) in Vienna that support the substantial reduction in repeat surgeries achieved by using the MarginProbe.

At the EBCC meeting, Dune held a satellite symposium featuring discussions with experts in the field of breast cancer regarding the treatment of women with early stage breast cancer and the importance of margin assessment in breast conserving surgery. The panel conducted a thorough review of clinical experience with the MarginProbe, designed to improve a surgeon’s ability to identify the presence of cancer on the margin of excised tissue during lumpectomy.

“Current data shows that cancer is still present at the margin in over 20% of breast cancer patients after surgery, therefore requiring an additional operation,” said Alberto Costa, MD, editor-in-chief of the journal The Breast, and the symposium moderator. “We have long awaited a technology that could help improve our ability to remove all of a patient’s cancer in one




surgery. The MarginProbe system represents a unique breakthrough for surgeons everywhere. I am excited about the opportunity to be directly involved in the introduction of this product to surgeons in Europe.”

The company presented results from multiple studies investigating the MarginProbe during the symposium.

Mark Gittleman, MD, a principal investigator in the pivotal U.S. trial of the MarginProbe, described the significant increase in the ability of the surgeon to achieve a clear resection margin of the tumor in the breast during the first surgical intervention and to thus reduce the need for repeat surgeries.

Marc Thill, MD, of the Department of Obstetrics and Gynecology, University Hospital of Schleswig-Holstein (Lubeck, Germany) presented results in patients with early stage, in situ lesions in whom clear margin status is a frequent surgical dilemma.

In addition, researchers from the University of California at San Francisco presented cost-effectiveness research that shows opportunity for significant cost-reduction associated with intraoperative use of the MarginProbe during breast conserving surgery.

Dune was founded in 2002 and the privately held company has been financed by Apax Partners since 2004.




Ellipse uses ‘MAGEC’ for treatment of scoliosisBy OMAR FORDMedical Device Daily Staff Writer

For years children suffering with early onset scoliosis had to have multiple surgeries to correct spinal deformities. A small med-tech company is aiming to change that standard of care, with an implant that can be adjusted in the patient after it’s implanted, remotely.

Ellipse Technologies (Irvine, California) spoke with Medical Device Daily and said that its Magnetic Expansion Control (MAGEC) system was truly a “game changer” in the way these young patients are treated.

The device allows a physician to remotely modify the length of the rod and the force applied to the spine throughout the implanted period as the patient responds to therapy. The purpose of the device is to eliminate the amount of repeat surgical procedures, which can in turn reduce the amount of complications and costs associated with this practice.

“It’s the first of its kind technology,” Ellipse chairman/CEO Michael Henson, told Medical Device Daily. “People have been trying to develop this communication from inside the body to outside the body for many years and the engineering team for Ellipse has been able to accomplish this.”

Henson said that often the child has little time to heal in between surgeries which occur every six months and that the physician would rather do the surgeries at an increased frequency since the child’s spine is growing, but can’t because the child needs time to recover.

With MAGEC recovery time is almost nonexistent. “It takes five minutes and instead of taking anesthesia and having a full surgical procedure

the patient is in the doctor’s office with their parents and smiling and talking while their spine is being lengthened,” he said.

Prior to this, he said children and their parents literally had to plan their lives around surgeries.

Anchors are put at the top and bottom of the curve in the spine with a rod placed between them. The physician has an external remote that can control the movement of the spine and make the proper adjustments.

The company unveiled the device and results of 14 patients that had been treated with the system at the 18th International Meeting on Advanced Spine Technologies (IMAST).

“These 14 patients were under 10 and had an average age of about six,” said Principal Investigator Behrooz Akbarnia, MD, who is also a Medical Director at the San Diego Center for Spinal Disorders and is a Clinical Professor of Orthopedics at the University of California at San Diego.

Akbarnia, who also helped develop the device, said that the results were favorable in an interview with MDD prior to his presentation of the data.

“We will show that the device is able to extend non invasively and we will show in this follow up period, that was about a year, that the device is working and is fairly safe. This is the first human study we have done and we’re very encouraged with the results.”

Study results show that seven males and seven females underwent 14 index surgeries and the average time between the first surgery and distraction (or lengthening) was 66 days and thereafter was 43 days. The average distraction achieved was 4.2 mm per patient.

In conclusion preliminary results indicate that MAGEC appears to be safe and provides the distraction comparable with standard growth rod without the need for repeated surgeries and that no major complications have been observed in the short follow up period.”

Ellipse is selling its CE-marked MAGEC System through distribution partners throughout Europe and various countries worldwide. MAGEC is not available for use in the U.S.

Henson added that the unveiling of the results at “[IMAST] is really the kick off for marketing the device. This at first will be in a limited fashion, because we’re still a small company. In the




U.S. we’re still discussing with the FDA, the approval process.”In Europe interest is growing quite rapidly. Henson told MDD that there families flying all

over from Europe to attend some of the clinical sites where the device was implanted.The company, which received its start nearly five years ago is in the middle of closing a

Series C financing. “Now I don’t want to make any conclusions about that because its not totally done, but I

think in the next two to three weeks, we’ll be closing a larger financing which will be used to invest in sales and marketing of the MAGEC and then the [PRECICE] system,” Henson said.

To date, the small med-tech company has raised nearly $22 million.“The next device we will be talking about is the PRECICE, which will be doing the same

thing as [MAGEC] with trauma condition patients in situations where the bone has not healed properly,” Hensen said. “This could occur from the patient having an accident and one leg is shorter than the other. [PRECICE] actually helps the bone to grow so that both legs are the same length. So it’s a use of the technology for a number of different applications.”




Haldor launches ORLocate in U.S., for instrument tracking By AMANDA PEDERSEN Medical Device Daily Senior Staff Writer

When patients undergo surgery they tend to have a number of concerns on their mind, especially if it is their first time in the operating room. Will I wake up missing the wrong body part, such as an arm or a leg when it’s supposed to be a standard gallbladder removal? Or – a more likely scenario – will I leave with more than I came in with, such as a surgical instrument or sponge left behind by mistake?

Fortunately, an Israel-based company, Haldor Advanced Technologies (Tel Aviv), has launched its ORLocate surgical instrument tracking and asset management system in North America. The system has already received FDA 510(k) clearance. According to Haldor, the ORLocate is the first commercially available system that uses radio frequency identification technology to methodically track, manage and analyze usage patterns of surgical instruments, before, during and post-surgical procedure. The system provides hospitals and sterilization centers a return on investment, promotes lean management and enhances patient safety.

“We came across an issue a while ago that really [attracted] our attention,” Rubi Halberthal, president/CEO of Haldor, told Medical Device Daily. That situation is the number of surgical devices and disposable materials, such as gauze or sponges, that gets left behind in patients’ abdomens, a problem commonly referred to as retained surgical items (RTI).

“It happens too often,” Halberthal said. He added that current statistics suggest this happens one in every 1,500 surgical procedures but that “once we looked into it, the statistics are generic and universal, as well as the solution, which is counting.”

The ORLocate system is designed to help hospitals identify when something is missing, what is missing and where it is.

Recently, Haldor was one in a select group of companies exhibiting at an event in Israel hosted by the Ministry of Foreign Affairs of Israel and the Israel Export & International Cooperation Institute. The event was attended by more than 50 CEOs from hospitals throughout the U.S. and Canada, Haldor noted.

“We were honored to have an opportunity to demonstrate how ORLocate can assist hospitals in fulfilling their vision of cost reduction and lean management through the effective management of surgical instruments, one of the most high-cost and non-transparent assets at a hospital,” Halberthal said.

Haldor’s ORLocate system is designed to be highly modular, reliable, scalable and accurate. One of its distinctive traits is the capability to simultaneously read multiple surgical instruments in a split second. It blends seamlessly with the workflow within and between the sterile processing departments and the operating rooms, thus closing the gaps in the lifecycle of surgical instruments. It also provides the capabilities to interact with the hospital’s real-time location system as well as the hospital’s information systems and technologies.

“At the moment, large U.S. academic medical centers manually track more than 35,000 instruments each day (or more than 11 million per year),” Halberthal said. “By using the ORLocate system the hospital can identify when something is missing, what is missing and where it is. This helps hospitals to reduce the loss of surgical instruments, the amount of time required to pack surgical sets, and the training time for newly hired sterile processing technicians. In addition, it increases the accuracy of packed sets to 100% and helps to reduce surgical instrument inventory levels. All of these deliverables help hospitals to save money and save lives.”

He told MDD that Haldor aims to help hospitals reduce cost and achieve “lean management” by enabling effective surgical instrument tracking and asset management.

It wasn’t long after the company received FDA clearance for the system that management realized how much money hospitals can save by using the system to automatically manage and track instruments throughout the hospital. “One of the most expensive assets in the




hospital actually has no transparency,” Halberthal said. So the company converted from a strictly safety-oriented value proposition to a safety and asset management value proposition, he added. “We provide very interesting value to the hospitals and in terms of the complete, integrated system.”

Another important component of the company’s technology, Halberthal explained, is that Haldor worked hard to make sure the system is easy to use and integrates seamlessly into the hospital’s existing workflow process. “We cannot really ask the users to change their methodology,” he said.

Also, the system does not require each surgical instrument to be scanned individually. “You can take 10 instruments, or 20 instruments or more and scan them at once,” Halberthal said.

Haldor is a private company, backed by private individual investors who “have been extremely supportive of the company throughout various investment cycles,” Halberthal said. “We’re now looking at strategic investors to expand the horizon, especially in the near future, we’re calling for strategic partnerships and rapid expansion.”

He also noted the importance of the company’s entrance into the U.S. market. “Our main target market is the U.S. We are very rigorously working in this market to have installation in hospitals within the U.S.,” Halberthal said. “We also have instillations in Europe, starting in Holland and extending to other countries in Europe.”

While the ORLocate system certainly offers an important solution to a critical problem, it is not the only company working in this space. Its closest competitor is ClearCount Medical Solutions (Pittsburgh), a company that developed the SmartSponge System, which also is based on a RFID platform, designed to provide a comprehensive solution that both verifies sponge counts and detects sponges if they remain in the patient. The system is able to provide a double layer of protection, ClearCount notes, because it identifies each sponge used during surgery.




ImageIQ’s partnership with NASA could boost profileBy OMAR FORDMedical Device Daily Staff Writer

A newly launched Cleveland Clinic spin-off is grabbing some attention due to a partnership with National Aeronautics and Space Administration’s (NASA) Ames Research Center, and the Midura Laboratory at the Lerner Research Institute (Cleveland).

ImageIQ (Cleveland) is set to use its imaging software in a study that will look at how space flight-induced vascular alterations occur in the lower leg.

The company will be using its extensive software library and preclinical imaging expertise to develop highly custom-tailored 2-D and 3-D imaging and image analysis techniques to produce objective and quantified data from the imaging work it will perform for the Midura Lab during this study.

The study is a collaborative effort among NASA Ames, BioServe Space Technologies (Boulder, Colorado), and Amgen (Thousand Oaks, California) that will evaluate a novel therapeutic countermeasure to prevent space flight induced bone loss in mice.

“ImageIQ will be taking these imaging samples we get from [the study] and we will scan them on our microscope and then we’ll do image analysis on the number of vessels and the sizes of the vessels, Amit Vasanji, chief technology officer of ImageIQ, told Medical Device Daily.

The Midura Lab at LRI, which will have ImageIQ analyze the images, has a prior history of musculoskeletal research collaboration with NASA Ames. One of the Midura lab’s current research programs is funded by NASA (Hypo-gravity Induces Vascular Atrophy Leading to Bone Loss).

In addition to oversight, NASA Ames will provide the necessary funding to execute Ronald Midura’s PhD, investigation of lower leg vascular alterations resulting from space flight.

The small startup is an Imaging Contract Research Organization that combines software engineering with biomedical and imaging expertise to provide quantitative visual analysis that enhances R&D and product efficacy/safety testing for research, medical device and pharmaceutical organizations.

“What we don’t do is just sell off the shelf software and say here’s the software, good luck,” Timothy Kulbago, CEO ImageIQ told MDD. “We don’t do that because we find that people have the tendency to get into real trouble with that. They get software and try to do an analysis and they don’t get it right. Our philosophy and core business model is that we customize every solution to every customer.”

Since the technology is an algorithm and is used as a measuring tool, the firm did not have to secure FDA approval.

“The complexity of our vascular remodeling research requires a finely-tuned and sophisticated approach to image analysis and visualization. As my lab conducts more and more complex musculoskeletal investigations, the use of custom-tailored imaging and image analysis will continue to be an indispensible tool to produce objective data of high precision and rigor. The only cost-effective and thorough way to analyze large volumes of multi-dimensional image data is through automated and custom-tailored software,” said Midura, PhD Full Staff in the Department of Biomedical Engineering at LRI.

ImageIQ had its beginnings in the Cleveland Clinic nearly 10 years ago. For the better part of a decade, Vasanji ran a core service inside Cleveland Clinic and in the last few years was getting approached by outside firms to provide this service.

Vasanji then worked with Cleveland Clinic Innovations, a segment of the Clinic that helps technologies find a market that is more applicable.

“Some people call us a startup, but I call us a startup with a running start, because we had 10 years of Vasanji’s team doing this already, before we actually became a company,” Kulbago said.

At this point the company is still in the process of making potential customers aware of its




capabilities.“We really feel like we’re in this market making mode,” Kulbago said. “We’re spending a lot

of time educating people on the art and science of what’s possible.” He added that the company’s customers are “split between academic institutions offering

kind of core basic research, and medical device companies who are looking for a faster way to validate their products.”




Ivantis enrolls first patient in Hydrus Microstent studyBy OMAR FORDMedical Device Daily Staff Writer

Ivantis (Irvine, California), a privately held company that designs new technologies to treat eye disease, said the first patient has been enrolled in a study to evaluate its Hydrus Microstent, an intracanalicular scaffold for treatment of primary open angle glaucoma.

The Hydrus IV study will include patients with glaucoma who are undergoing cataract surgery and also taking eye drop medication for their glaucoma. Patients will either receive cataract surgery alone or cataract surgery plus the Hydrus Microstent. The first phase of the study is intended to analyze results from a smaller number of patients.

“We expect two phases of the Hydrus IV study,” Dave Van Meter president/CEO of Ivantis told Medical Device Daily. “The first phase will enroll 75 patients, and early safety data will be submitted to FDA. Contingent upon the approval of FDA, the second phase will expand both the number of centers and number of patients. The second phase will enroll more than 500 patients with primary open angle glaucoma and cataract.”

Ivantis’ Hydrus device, roughly the size of an eyelash, is placed through a micro-invasive procedure and is designed to lower pressure in the eye by reestablishing the patient’s conventional outflow pathway. The majority of glaucoma patients have both a blockage and a collapse of the natural outflow pathway. The Hydrus device relies on a twofold mechanism of action that creates a large opening through the traditional source of flow blockage (known as the trabecular meshwork), and then dilates and scaffolds the conventional pathway through which fluid exits the eye (known as Schlemm’s canal).

The company added that the device is highly flexible and shaped like an eyelash, to match and fit securely into the canal.

Designed to be used sooner in the disease progression than most traditional surgical approaches, the company said the Hydrus device may reduce or eliminate the need for glaucoma medications while effectively controlling intraocular pressure. Ivantis pointed out several studies have indicated that, within six months of diagnosis, as many as 50% of patients are not appropriately following their medication regimen.

The company said it felt encouraged by the pre-IDE process and said that it felt confident about the approval process, but did not specify a time when it hoped to have the device available for the U.S. market.

“We were very pleased with the pre-IDE process and actually received conditional approval to begin the study a few months ahead of our initial projections,” Van Meter said. “Also, as evident at the [American Glaucoma Society Annual Meeting (San Francisco)], where six scientific studies were reported on, we have a rigorous scientific approach that will hopefully support a continued positive process with FDA during all phases of this important study.”

The device already has approval in some markets outside of the U.S. “The Hydrus Microstent has been awarded the CE mark and is being studied in several

controlled trials in Europe,” Van Meter said. “More specifically, surgeons in several European countries, including Germany, Spain, and Italy, have been trained and are treating their patients with the Hydrus procedure as part of ongoing clinical studies. The Hydrus is also being studied in Canada. “

The device comes at a time when there have been significant developments in glaucoma surgery, according to Dr. Kuldev Singh, Professor of Ophthalmology and Director of the Glaucoma Service at the Stanford University School of Medicine, (Stanford, California), and the Medical Monitor for the Hydrus IV study.

“Glaucoma surgery is in the midst of a renaissance and there has been particularly strong interest in the development of a glaucoma surgical procedure that can safely and effectively be performed adjunctively at the time of cataract surgery for patients with both conditions,” Singh




said. “The scientific rigor that Ivantis has demonstrated in the development and investigation of the Hydrus will hopefully have a beneficial impact for glaucoma patients in both developed and developing countries.”

Ivantis was founded in 2007 and since inception it has raised $36 million through two separate financings. Investors include New Enterprise Associates and Delphi Ventures.

The most recent funding round came in June as the company reported it had received $17 million in funding from New Enterprise Associates (NEA) and Delphi Ventures. The company said that the funds would be used to expand clinical activities for the Hydrus.




IVDiagnostics to monitor cancertreatment results with platformBy OMAR FORDMedical Device Daily Staff Writer

Frank Szczepanski has seen the toll that cancer treatments can have on patients. Szczepanski’s wife serves as his personal entry point into the world of cancer survival as she has battled through three bouts of cancer in the last 22 years. In a sense, she has been the inspiration behind his work as CEO of IVDiagnostics (Valparaiso, Indiana), a small start-up that launched in 2008, and has developed a platform to diagnose cancer and monitor the effectiveness of the treatment for the disease.

“About 22 years ago she had gone in for a mammogram and they found a tumor,” Szczepanski told Medical Device Daily. “It turned out to be a tumor that looked like it was pretty significant. The best of care was provided to her by Memorial Sloan-Kettering Cancer Center [New York]. I would go with her to virtually everyone of her oncologists meetings as well as her radiology meetings.”

The firm’s platform, the IVDxTx, which wasn’t developed around the time Szczepanski’s wife first suffered from the disease, is said to provide physicians with the ability to monitor a patient’s circulatory system with minimally invasive techniques. The platform includes the IVD CTC test, which the company said would allow physicians to diagnose cancer, monitor the effectiveness of treatment and predict disease recurrence after treatment has taken place. Specifically it will focus on circulating tumor cells.

The application would have come in handy for the couple, as years later the cancer would resurface, when Szczepanski’s wife began showing symptoms of extreme fatigue and had an extremely low level of hemoglobin.

“We found out that the symptoms were caused by cancer cells that were dominant in apparently the same area that lymph nodes were removed in the very first operation from 22 years ago,” he said. “It was found out by accident really – because no one was actually monitoring circulating tumor cells in her tests.”

He added, “I had already started the company, but this gave me more motivation to work harder and faster to get to this point.”

The test, which has been touted as a liquid biopsy is able to optically scan about 25% of the body’s blood in about 30 minutes. The company said that it is more accurate and sensitive than surgical biopsies.

The entire platform, which includes the test, works a bit like this. There is a biomarker that is basically a membrane protein that’s on the surface of the cancer cells. That’s then bound together with fluorescent dyes in such a way that operators of the technology are able to excite the cells through a custom laser. From there the cells exhibit a signal that’s read by an optical scanner. As the cells are going past the monitored point of where the optical scanner is scanning, software that company has developed charts the data mathematically and graphically in real time.

Plans call for the company to seek approval from the FDA to get the test on the market.“Initially the approach is that this will be used for known cancer patients, be it their first

occurrence, second occurrence or subsequent occurrence,” he said.But getting the test to market will take more than just research. It will take money, and

in an environment where venture capitalists are shying away from med-tech investments, Szczepanski, who has been involved in a total of nine start-ups that span several industries, said he knows that the company has its work cut out for it.

“The way I view it is . . . a number of things have changed and others haven’t,” Szczepanski said in regards to garnering funding in recent years. “What has changed is the financial market. It’s tougher to raise $5 million (which is what we’re doing now). It takes longer. The process is such that maybe the due diligence hasn’t changed, but the ability for the investor to write




a check takes a little bit longer. They want to be absolutely convinced that this is a winning platform and that it really will change the world.”

So far the company has had two private rounds with more than 40 private investors which included Szczepanski and the firm’s other founders, his brother Tom, and Wei He, who serves as the firm’s lead scientist. The company also received $400,000 in federal funding from the National Institutes of Health and the National Cancer Institute and received $244,479 in grants under the Qualifying Therapeutic Discovery Project program.

“So far we’ve raised $1.5 million in the course of three years and now we’re in the process of a bigger raise,” he told MDD.

IVDiagnostics has a core team of seven people, which include scientists, those focused on the regulatory side, and marketing sales. The firm boasts a relatively small burn rate of about $40,000 a month.

“Our burn rates are low because people have been willing to make sacrifices,” he said. “A number of us do not take a salary. [We] basically work for equity. Some folks work for a combination of cash and equity. By keeping our burn rates low it allows us to have a pretty clean balance sheet and as a result it makes it even more attractive for investors.”

Szczepanski said that many companies and investors are interested in the technology and said that there is significant demand for such an application.

“I think it can save a lot of peoples lives,” he told MDD. “I think it can actually track whether or not the therapy is working regardless of whether its chemo, hormonal, radiation or a combination thereof.”




iWalk robotic prosthetics to have ‘profound’ impactBy AMANDA PEDERSEN Medical Device Daily Senior Staff Writer

When the leaders of iWalk (Bedford, Massachusetts), a young bionics company that makes technology to restore natural function and movement for lower-limb amputees, looks back on the company’s legacy 10 years from now, CEO Tim McCarthy says, “it’s going to be a profound social and profound economic impact.”

Founded by Hugh Herr, PhD, a bionics pioneer and bilateral amputee himself whose lifelong quest has been to help amputees move more naturally, iWalk has developed the BioOM, a leg system designed to replace the combined functions of the foot, ankle and calf regions of the human leg. The BioOM is the first in a series of products that will be aimed to emulate or even augment physiological function through electromechanical replacement, according to iWalk.

McCarthy told Medical Device Daily that the limitations of current prosthetic technology lead many amputees to a “morbid fate” of lower back problems, sound side hip and knee problems, and often times obesity – and all the co-morbidities that come with it – because it hurts so much for them to move that they end up sitting on their couch day in and day out becoming depressed and overweight.

And that’s why McCarthy says 10 years from now the company’s legacy will be one of a profound social and economic impact.

“The social impact is that we’re going to drastically improve the quality of life for tens of thousands of people with this platform,” he said, explaining that iWalk’s goal with the platform is to essentially rebuild the limb functions of a human being from the ankle up. “That’s going to translate into enhanced human function and reduce that morbid fate so that amputees are no longer going to complain of lower back problems and sound side hip and knee problems, they’re no longer going to sit on their couch [becoming depressed and obese] . . . and that’s going to save the healthcare system billions of dollars one day.”

The fundamental difference between current prosthetic technology and iWalk’s technology is that the prosthetic legs that amputees today are fitted with give the person using the technology the sensation that the prosthetic leg is stepping in sand while their sound leg is stepping on pavement – and that’s the sensation they will have every step they take for the rest of their life. So there is a shortfall of energy return associated with current prosthetic legs, he explained.

“What the BiOM does, essentially, it’s an intricate electromechanical system,” McCarthy said. The technology is designed to address that stepping-in-sand sensation and it is tuned to the amputee’s height, weight, activity level, and gait to “essentially replace that gross inefficiency associated with today’s technology.”

“The BiOM normalizes step function and returns people back to the quality of life they enjoyed prior to being amputated,” McCarthy said.

And if anybody knows how important that is, it’s Herr, iWalk’s founder. As a teenager, Herr was a “mountain-climbing protégée,” McCarthy said. In the early ‘80s he was caught in a blizzard and trapped on a mountain for days, suffering severe frost bite that resulted in two below-the-knee amputations. “So Hugh, being an 18- or 19-year-old kid, was subjected basically to World War II prosthetic technology and those devices, they just didn’t allow him to return to his active lifestyle,” McCarthy said.

The tragedy was an “academic rebirth” for Herr, who dedicated the next three decades of his life to educational research and entrepreneurial pursuit and today he is “widely considered a thought leader in the human augmentation space,” McCarthy said.

iWalk began its commercial launch of the BiOM in January 2011 and because the company experienced an interest and demand for the BiOM last year that reached unprecedented levels in the prosthetics industry, the company just recently expanded its clinical distribution




network.Lower-limb amputees now have access to the BiOM bionic ankle system through the

addition of 18 new prosthetic providers across 38 regional locations, making the product available at 58 centers across the country.

Clearly the technology being developed at iWalk is innovative and serves a vastly unmet need in the prosthetics industry, so why wasn’t something like this designed years ago? The simple answer, according to McCarthy, is “it’s hard.”

“If solving this human problem were easy, someone would have done it already,” McCarthy said. But it wasn’t easy. “The system has to act and react like your intact anatomy,” he explained. “So that’s the first challenge.”

The second challenge was to make the device durable enough to withstand the wear and tear that comes with using it on a daily basis - much like the wear and tear that automobiles have to endure. Next, this device had to fit in a very compact spot.

So on a micro-level, solving this problem was “really, really, really hard,” McCarthy said, adding that “hard things go unsolved until you have the combination of vision and passion and combine that with expert skills across the boards in term of the engineering function to solve this problem.”

But like any medical device company operating in today’s regulatory and reimbursement environment, bringing an innovative technology like the BiOM to market in the U.S. came with the external challenges of jumping through all the regulatory hoops to get it there.

In iWalk’s case, timing played a key role in making Herr’s vision a reality. As a result of service members returning from Iraq and Afghanistan with limb impairments and amputations, the government invested tens of millions of research dollars to ensure that these wounded soldiers received the best technology available.

Herr received funding from the U.S. Department of Veterans Affairs and the Army’s Telemedicine and Advanced Technology Research Center to support his vision, which ultimately resulted in the development of the BiOM.




Kelyniam switches to med-techindustry, with skull implantsBy OMAR FORDMedical Device Daily Staff Writer

For years, James Ketner manufactured parts for aircraft. That was until about a couple of years ago when Ketner’s company, Kelyniam (New Britain, Connecticut), began supplying Stereolithography models to a device manufacturer. The experience served as a catalyst for Ketner and the company to shift focus to the med-tech industry.

“I saw what [other med-tech companies] were doing and I said, why would you make a mold if you’re only making one piece – a one off item,” Ketner, Kelyniam president/CEO told Medical Device Daily. “You only make a mold if you’re doing 900,000 door handles for Honda, that’s when you make a mold. I thought if we could find a bioimplantable material and machine it, I could do this thing in 24 hours, not four to five weeks.”

As a result, Ketner told MDD that Kelyniam has received FDA approval to begin commercial shipment of its Custom Skull Implants – products that are seen by many in the medical community as game-changers in the world of prosthetics.

“We’ve converted the entire company over to manufacturing this medical device,” he said.Kelyniam Custom Skull Implants are designed and manufactured for each individual patient

to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects. Streamlined CAD/CAM design and manufacturing techniques allow Kelyniam to deliver patient specific implants to surgeons in as little as 24 hours from the receipt of an order.

“I think the thing that’s catching everyone off guard is how fast we can turn this around,” he said. “If you give me the CAD data by 9 a.m. I can have the product on your desk by 9 a.m. the next day.”

The relative quickness in developing the product adds to a better fit for patients, the company said.

“If you take CT scans and it takes you six weeks to get the thing implanted, it’s not going to fit as good, and you can understand why,” he said. The bone is going to move around, it’s going to start healing itself etc. But if you give me a CT scan that’s 24 hours old I can give you a piece that’s going to fit a whole lot better.”

Kelyniam began the development of these new medical devices in 2Q09. In less than two years, the company has perfected a process to quickly and accurately deliver high tolerance, patient specific custom skull implants using PEEK-OPTIMA. The regulatory expertise gained during the submission process will be applied to future Kelyniam products.

According to its website, Kelyniam is capable of producing around 40 units per month and that if the firm can produce 40 units a month with its current pricing and share structure that would result in retained earnings of nearly $.18/share. The firm said it anticipated production of more than 40 units per month by the end of 2012. There are also other products in the pipeline.

Kelyniam was originally founded in 2005 and went public in 2008. Since it switched focus, the firm has made several key investments in more firmly settling into the med-device sector.

In June, the company acquired Cranston Holdings a rapid prototyping business with knowledge and expertise in Stereolithography for the medical industry.

“This acquisition will immediately add additional shareholder value by integrating Cranston’s employees and equipment into our infrastructure”, Ketner said in a release detailing the acquisition of the company “Most importantly, Cranston owns an in house developed proprietary software package that will assist us in our ISO 13485, 21 CFR 820 compliance, and that software package is now IP of Kelyniam.”

And last March, the company signed a supply agreement with Invibio (West Conshohocken, Pennsylvania), the exclusive manufacturer of implantable PEEK-OPTIMA polymer. All of Kelyniam’s Maxillofacial and Custom Cranial Implants will be made with Invibio PEEK-OPTIMA polymer.




Plans call for the company to delve deeper into the med-tech territory. It’s a path that Ketner said he didn’t mind staying on and said that the company probably would never go back to its past roots.

“I’m not going to do anything with airplanes anymore,” he said. “I’ve been there and done that. Sitting there trigging out load pads and fastener locations with your TI55 (calculator) can only last for so long. With [medical devices] it’s fun to work everyday. I’m interested and it’s fun to come into the office.”




Simple device could solve complex problem of acid refluxBy OMAR FORDMedical Device Daily Staff Writer

A simple device solution designed by researchers from the Medical College of Wisconsin (Milwaukee) could help treat patients suffering from the complex problem of acid reflux.

Patients that suffer from acid reflux often have chronic cough, hoarse voices, asthma, throat irritation, difficulty swallowing and postnasal drip. Patients could have these issues significantly reduced if the Reza-Band can get the necessary regulatory approval and become available on the market.

“I’ve been taking care of patients with reflux disease for over 20 years,” Reza Shaker, inventor of the device, and a gastroenterologist with the Medical College of Wisconsin told Medical Device Daily. “Reflux disease has three types. Type one is limited to the esophagus. Type 2 includes the esophagus and areas above the esophagus, and type 3 doesn’t induce injury in the esophagus but when the gastric content reaches the areas above the esophagus it causes damage.”

He added, “for Type 1 we have good medication that takes care of that. Existing medication does not take care of other types above and beyond the esophagus. There are surgical operations that tighten up the sphincter between the stomach and the esophagus and that works for all types, but that’s surgery and it lasts for several years, then it gradually unravels. It has its own problems. We have been scratching our heads on what to do about this.”

That’s where Shaker’s device comes in. The Reza-Band, which is only a prototype at the moment, uses pressure to keep stomach

acid from rising to the throat. To do this, patients wear the device which is an adjustable band around their necks at night. According to Shaker a small pad in front applies a slight amount of pressure just below the Adam’s apple to keep the contents ofthe stomach down.

“The innovation here is the concept of an external assist device that increases the internal pressure and the pressure range that you need,” Shaker said. “It’s like a tight collar when you put your tie on.”

Shaker said that the Reza-Band was evaluated in two small studies held at the college and the device helped 28 patients with a severe type of acid reflux.

With favorable results and growing interest Shaker said that he wanted to look into taking the next step, and possibly get the device into the hands of more patients. To do that would require FDA approval.

Shaker said that he contacted the Medical College’s intellectual property office and from there Somna Therapeutics was formed.

“I went to them and said this is what we have and they took it from there,” he said. “They have filed a patent on this and it’s still under review.”

Nick Maris, who has been working in the medical device sector for more than 15 years, has been tapped to be president/CEO of Somna. He told MDD that the company was aiming to get the device on the market in 2013 pending FDA approval.

“The next three steps that Somna Therapeutics has to go through are product optimization – and that of course is taking the product out of its current prototype form to a more fully commercialized state; the second thing is then to go through the regulatory process with the FDA; and then thirdly we’re going to be conducting a number of clinical trials that add to the clinical work that’s been done by the inventor and Medical College of Wisconsin,” Maris said.

Immediate steps call for the company to raise funding for the product. Although Maris did not directly reveal how much the company raised or get into specifics

about funding, a recent article in the Milwaukee Journal Sentinel reported that Somna said it




expects to announce in the next few weeks that it has raised more than $1 million. If the device can gain approval it could possibly enhance and work well with other therapies

physicians have suggested to treat the disease. Currently physicians recommend everything from diet changes to elevated sleep to keep stomach content from rising.

Maris said that he thinks that patients will gravitate to the device. “The product is designed to be worn at night to prevent the stomach content from coming

up through the esophagus into your throat,” Maris said. “It’s an elegantly simple product that [solves a complex problem],” he said. “It works, it’s easy to use and people get it.”




MindFrame ischemic stroke device successful in human procedureBy OMAR FORDMedical Device Daily Staff Writer

MindFrame (Irvine, California) could be one step closer in its bid to secure FDA approval for its ischemic stroke treatment device. The med-tech firm reported the successful first-in-human procedure related to its MindFrame Capture LP at Katherinen Hospital (Stuttgart, Germany).

The low profile device allows physicians to access tortuous anatomies to remove the thrombus in less than 30 minutes, from time of deployment to clot aspiration. The firm said that restoring blood flow rapidly and removing the clot is key in preventing serious brain damage.

“We’re looking at starting our approval process in the U.S. in 2012,” Ken Charhut, president/CEO of MindFrame told Medical Device Daily. “Probably early next year. We already have CE mark approval for the device.”

The device is actually part of a suite of treatment applications that the company has for treating stroke patients.

“We have a family of products to treat ischemic stroke and they fall under the MindFrame Flow System and the MindFrame Capture system,” he said.

The MindFrame Capture LP has had the CE mark for nearly a year according to the company. Both it and the MindFrame Flow LP are compatible with any microcatheter 10/14 or greater. Charhut said with the MindFrame LP devices, clinicians can expect the additional benefit of increased thrombus aspiration when needed, both locally and proximally, as a result of the reduced microcatheter size.

The company, which was an incubator that was spun out of Intersect Partners (San Clemente, California) in 2007, said that the device offers improved tensile strength and kink resistance for device durability, as well as enhanced trackability for precise placement and control.

One of the true benefits of the device is its small size. “The low profile allows the restoration of flow and retrieval of clots to happen in

microcatheters, which are limited in size to a 10/14,” he said. “What’s out on the market today are products that need to use a 21/27 microcatheter. So the real breatkthrough with [our device], is that since these microcatheters are sent through a guiding catheter, by going smaller you have a lot more open space between the guiding catheter and that allows for greater aspiration.”

Although there is still a ways to go before U.S. patients can be treated by the device, it is already making its mark in Europe.

Hans Henkes, MD, who is helping to lay the groundwork for the clinical use of this advanced technology, touted its use.

“I am extremely pleased with the performance of the MindFrame LP device,” said Professor Henkes, director of the Clinic for Neuroradiology. “The low profile device allowed me to access tortuous anatomies to remove the thrombus within 20 minutes, from time of deployment to clot aspiration. Restoring blood flow rapidly and removing the clot is vital to preventing irreversible brain damage. The new MindFrame LP device is an innovative option in the treatment of acute ischemic stroke.”

Charhut praised Henkes work and said that these first cases prove how effective the device is and the impact it can have on patients and clinicians.

“I am excited about the first cases, which are the result of the ability of our scientists and engineers to rapidly respond to the needs of clinicians,” Charhut said. “This milestone underscores our commitment to delivering truly innovative technologies to clinicians around the world in order to provide outstanding patient care.”

Charhut added that the most recent news solidifies the mission of the company.“The purpose of the company is to provide the clinician with the appropriate tool to




enhance the success rate with the procedure and ultimate clinical outcome,” he said. “So we are a company that’s dedicated to improving the procedure of ischemic stroke therapy. We focus very hard on giving the clinician the appropriate tool to treat the appropriate clot. They aren’t all the same and they’re in different parts of the anatomy of the brain.”




Neuronetics seeks to corner market on treating depressionBy OMAR FORDMedical Device Daily Staff Writer

When it comes to the use of medical devices treating psychiatric disorders, the future is now according to Neuronetics, (Malvern, Pennsylvania), a small med-tech startup that has seen tremendous growth in the past few years. The belief that pharmaceuticals are the only reliable treatment option for mental illness is quickly becoming outdated.

“People tend to think that medical devices to treat brain disorders and psychiatric disorders are off in the future somewhere,” Neuronetics President/CEO Bruce Shook told Medical Device Daily. “They’re not, and we’re here doing it today. That’s probably the most surprising thing to people – when they find out we’re marketing a neuromodulation device that treats brain disorders today.”

The NeuroStar Transcranial Magnetic Stimulation (TMS) therapy system consists of power electronics, a touch-screen control panel, an electromagnetic coil, a single-use treatment link that is placed between the coil and the patient’s scalp, and a treatment chair that looks a lot like a dentist’s chair. During a treatment session the TMS coil is placed over the patient’s left pre-frontal cortex an area of the brain involved in mood regulation and repeatedly energized. Each time the coil is energized an MRI-strength magnetic pulse enters the cortex and briefly introduces an electric current to flow, according to Neuronetics.

The treatment, prescribed by a psychiatrist, is usually administered daily for four to six weeks in a psychiatrist’s office. Each treatment session lasts about 40 minutes, the company noted.

“What this treatment involves is the generation of very powerful MRI strength magnetic pulses that are very brief in duration and very, very focused,” Shook said. “We deliver these pulses to the part of the brain that is known to be dysfunctional in people with depression.”

Shook added, “we respectively pulse that part of the brain and each time we pulse it, we actually induce a small electric current in the cortex, which fires the neurons or brain cells in that region. The act of doing that over and over again many thousands of times actually turns that part of the brain back on and alleviates the symptoms of depression.”

The company first gained FDA approval for the device back in 2008, and since that time the NeuroStar has gone on to treat nearly 5,000 patients.

“I’m sure it would come as a surprise to many people how rapidly it has been adopted and how many clinicians offer it,” Shook told MDD.

But the device, which has had tons of media coverage and publicity, almost didn’t make it to the market. Early in 2007 an FDA advisory panel, without formally voting, gave the device a thumbs-down, questioning among other things the fact that the company filed the application with electro-convulsive therapy (ETC) serving as the predicate device. The panel also recommended to the agency and the company that it dive deeper into its clinical data to determine which subset of patients benefit most from the therapy, which led to the device being indicated for patients with major depressive disorder who have failed to benefit from one prior antidepressant treatment in their current episode.

In a 2008 interview with MDD, the company said that ETC is not an appropriate predicate device for TMS because TMS is so strikingly different.

The firm would eventually resubmit the data to the FDA which is what led to the clearance of the TMS system. While the advisory panel that examined the device in 2007 raised many questions about the therapy, the company noted that there was never any doubt about the safety of it.

In fact one of NeuroStar’s strong selling points, stems from the fact that it doesn’t carry all of the complications or side effects that are seen when taking pharmaceutical therapies. “There




are at least 14 million adults that have a major depressive episode every year,” Shook said. “Only half of those find their way to treatment and of those that get treated the vast majority are getting treated with drug therapy. For at least four million of those the drug therapy doesn’t work.”

He cited frequent changes in medication and harsh side effects as a reason why drug therapy isn’t always the most ideal choice for patients suffering with depression.

While more and more clinicians and patients are giving NeuroStar a chance, so are investors. The firm has completed five rounds of financing and has raised about $128 million.

In May, the company said that it had completed its Series E financing totaling $30million. Two new investors, Polaris Venture Partners and Pfizer Venture Investments, led

the round. Previous investors participating in the round included Investor Growth Capital, New Leaf Venture Partners, Interwest Partners, Three Arch Partners, Quaker BioVentures, and Onset Ventures.

In the future, the company could pursue additional indications for NeuroStar, which include treating depression in pregnant women and chronic pain – but that’s still in the research phase Shook said.

“We like to think we’ve done it right,” Shook said of the growth of the company. “We made some very significant and important investments in technology to make sure that we invest heavily in large scientifically sound clinical trials and we’re investing in a very significant sales and marketing infrastructure to deliver therapy in what is a very large market place.”




NeuroSigma licenses UCLA patents to form NSVascularBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

NeuroSigma (Los Angeles) reported the formation of a majority owned subsidiary, NSVascular, and the signing of an exclusive license with the University of California, Los Angeles (UCLA) covering its medical applications of Thin-Film Nitinol (TFN) technology. Nitinol is a superelastic nickel and titanium alloy with unique properties that allow deformation and subsequent full recovery of the original shape upon exposure to body heat.

NSVascular says it plans to focus on developing and commercializing TFN-covered stents for endovascular applications, with its first two applications being flow-diverting stents for intracranial aneurysms (IA) and stents for treating peripheral artery disease (PAD).

A multidisciplinary team, comprised of researchers from the UCLA Henry Samueli School of Engineering and Applied Science in collaboration with physicians from the David Geffen School of Medicine at UCLA, has been engaged in the development and the in vitro/in vivo testing of TFN-covered IA and PAD stents.

“For the past five years our engineering team has benefited from collaborating with a top-notch UCLA medical team, spearheaded by Dr. Dan Levi and Dr. Fernando Vinuela. I am looking forward to working closely with the experienced management team at NeuroSigma and NSVascular in commercializing this promising technology,” said Greg Carman, PhD, UCLA professor of mechanical and aerospace engineering and a co-founder of NSVascular.

Carman told Medical Device Daily there has been a long history in the neurovascular space of using coils to treat brain aneurysms. “There’s always been a desire for a new method to treat brain aneurysms . . . such as covered stents or things like that,” he said. The problem with covered stents though, is that the coverings on those are fairly thick, making it physically impossible to use the current covered stent technology that’s available, he added.

The current coverings on covered stents range from 100 microns to 200 microns thick, Carman said. The Thin-Film Nitinol that UCLA has developed is only 5 microns which he described as one-tenth the thickness of a human hair, making it “extremely small and flexible.” He also told MDD that because it is so small and flexible, the device is going to be able to deliver a stent to aneurysms in more locations than current devices can.

While the company’s primary focus is on aneurysms and PAD, Carman said the technology may be useful for many more devices in other treatment areas in the future. “I think the outlook for Thin Film Nitinol extend beyond the two devices we’re currently looking at,” he said.

“We are very excited that NSVascular will be moving this technology through translational studies and hopefully ultimately to patients thereby benefitting both society and the economy at large,” said Earl Weinstein, associate director of UCLA’s Office of Intellectual Property.

“We are delighted to have signed our fourth license with UCLA’s Office of Intellectual Property and look forward to working closely with a new team of engineers and physicians from UCLA,” said Lodwrick Cook, chairman of NeuroSigma.

“The successful convergence of engineering and medicine is exemplified by the accomplishments of this team,” said Leon Ekchian, PhD, president/CEO of NeuroSigma.

Intracranial aneurysms result from weaknesses in cerebral blood vessels, which can rupture and lead to stroke and death. It is estimated that up to one in fifteen people in the U.S. develop a brain aneurysm during their lifetime. The traditional method of surgical clipping to treat brain aneurysms is very invasive requiring removal of a section of the skull. Since 1995, endovascular coils, have gained popularity, now accounting for the majority of current procedures.

“Pre-clinical in vivo testing has shown a remarkable 100% aneurysm occlusion rate within minutes of treatment, an achievement unmatched by competing flow-diverting




technologies,” said Fernando Vinuela, MD, director of UCLA’s Division of Interventional Neuroradiology and a co-founder and scientific advisor to NSVascular. “Furthermore, our TFN-covered flow-diverting stent keeps the flexibility of the delivery system allowing safer distal intracranial navigation and stenting of a larger number of aneurysms.”

The company says that flow-diverting stents represent one of the fastest growing segments of the neurovascular market and may supplant intracranial coiling as the preferred treatment for certain aneurysms. Last month, in support of continuing pre-clinical trials at UCLA, NeuroSigma entered into a contract with UCLA to fund the development of prototype TFN-covered stents for use in upcoming human trials.

NeuroSigma noted that 10 million Americans suffer from PAD, a circulatory problem in which narrowing of arteries can lead to a reduction in blood flow to the limbs and a possible precursor to amputation or death from heart attack and stroke.

The license with UCLA also includes the use of TFN-covered stents for the treatment of PAD, the company noted. Since 2009 under an NIH Challenge Grant, UCLA has been conducting in vivo pre-clinical trials to demonstrate that its TFN-covered stents may eventually be used for the treatment of PAD by remaining patent even in vessels as small as 3 millimeters. A unique surface treatment of UCLA’s TFN film provides super-hydrophylic properties, which greatly reduces the adherence of platelets.

NeuroSigma was established to in-license and develop early stage technologies with the potential to transform medical practice. Currently it has a specific focus on neuromodulation and through NSVascular, on Thin-Film Nitinol covered stents for endovascular applications. NeuroSigma employs two therapy platforms: Trigeminal Nerve Stimulation and Deep Brain Stimulation.




OvaScience secures $37M Series B fundingBy OMAR FORDMedical Device Daily Staff Writer

In an environment where venture capital funding is drying up for many healthcare and med-tech companies, OvaScience (Cambridge, Massachusetts), a private company focused on the development of technology to treat infertility, reported a $37 million Series B financing.

The company, which was launched in 2011, is developing a method of capturing mitochondria from a mother’s own ovarian stem cells and injecting them along with sperm into eggs for in vitro fertilization (IVF) procedures.

“What we’re doing is basically adding the mitochondria to the egg at the same time the sperm gets injected into the egg,”Michelle Dipp, OvaScience’s CEO told Medical Device Daily. “So when the patient comes in to have IVF . . . before she starts her IVF cycle, we do a very small ovarian biopsy. We take a piece of tissue the size of a fingernail clipping and then that tissue gets shipped to our lab. We isolate those precursor cells that we have a proprietary way of isolating and identifying, then we isolate the mitochondria. Those mitochondria is then shipped back to the IVF clinic and then the mitochondria is injected along with the sperm.”

She added, “the goal of course is to increase the success rate of IVF. It rejuvenates the egg.”Investors seem to be highly supportive of the company and the therapy – as evidenced by

the amount that was raised in the Series B round.Dipp said that this was because of several factors that include the explosion of the IVF

market and the growing body of evidence that supports the science behind the firm’s therapy. “First and foremost I think it’s really something that resonates personally with people,”

Dipp said. “Almost every single person, with whom I speak with have either gone through IVF or knows someone who has gone through IVF. Some people see that it is very common now in our society and something that’s a growing market.”

She added that recently published studies that were supportive of the science behind the firm’s procedure helped to attract investors.

A study, published in the advanced online publication of the journal Nature Medicine, in February, showcases another therapy the company is working on and demonstrates how OvaScience’s co-founder Jonathan Tilly, PhD, along with colleagues, were able to purify egg precursor cells from ovaries of adult female mice and ovaries from reproductive-age women. Reintroduction of mouse egg precursor cells back into adult mouse ovaries led to the maturation of new eggs that could be ovulated and fertilized to yield healthy embryos.

“This was a huge validation for the science,” Dipp told MDD. “This was a paper that showed that these egg precursor cells not only have the ability to mature into eggs, but in fact these mature eggs can then be fertilized and grow into a healthy embryo.”

The funding will help further develop this egg maturation therapy as well as the procedure that involves the mitochondria, Dipp said.

“Our goal is to launch the product [involving mitochondria] at the end of 2013,” she said. For the financing, existing investors, Bessemer Venture Partners and Longwood Fund,

were joined by new, top-tier investors BBT Capital Management Advisors, Cycad Group, Hunt BioVentures, RA Capital and a large, global institutional investor, among others. In conjunction with this financing, John Simon, managing director of General Catalyst, has joined the OvaScience board of directors. Leerink Swann acted as lead placement agent for the offering.

“Under the leadership of its world-class management and scientific teams, OvaScience has great potential to develop and commercialize new fertility treatment options for women,” Simon said. “OvaScience is rapidly advancing its patented fertility technology aimed at improving fertility outcomes, and we’re pleased to be part of a company that has a unique and differentiated approach in an area with a clear, unmet need.”




PhysioSonics sees nICP device as game-changerBy OMAR FORDMedical Device Daily Staff Writer

Often times in med-tech, the phrase game-changer is tossed around. But a small med-tech firm, PhysioSonics (Bellevue, Washington), says its non-invasive intracranial pressure (nICP) monitoring application more than lives up to the hype surrounding this phrase, and it even has two of the largest players in the med-tech space as investors – Medtronic (Minneapolis) and Johnson & Johnson (J&J; New Brunswick, New Jersey) to prove it.

When asked about how PhysioSonics’ device could be considered a game-changer, Brad Harlow, the firm’s CEO told Medical Device Daily that one had to first consider how intracranial pressure is measured.

“The standard is drilling a hole in the skull, screwing in a bolt and putting a pressure transducer right at the tip of the dura of the brain,” Harlow told MDD. “It’s highly invasive and there’s a risk of infection and death and it’s some what barbaric. But it’s the only way that it’s done today. One of the holy grails of medicine would be to make this procedure (non-invasive).”

Due to the lack of a safe non-invasive technique, ICP monitoring is performed at about only 15% of U.S. hospitals. But PhysioSonics said the device could provide an alternative and give physicians a safer way to monitor ICP.

“Instead of drilling a hole in a patient’s head, you would put a halo on the patient, which would automatically record the blood flow on both sides of the brain in the cerebral arteries,” Harlow said. “We can show the trend as it is both rising and falling.”

Harlow added, “it is a game-changer and it is the reason that Medtronic and J&J invested in the company. They both have product lines that sell into the invasive space.”

The firm raised $8 million in a Series A preferred financing in two tranches led by J&J in 2008 and Medtronic in 2009. In February of this year, the company completed a $4 million Series B preferred equity offering.

The firm plans to secure a PMA for the device sometime in 2013. But it said that it would go for a 510(k) approval of the device, to monitor cerebral blood flow next year.

“We expect to file a 510(k) in December of this year on the CBF,” Harlow said. “And approximately 18 months after that product is approved we would then go into the PMA process with the intracranial process data. You sort of have to get a blood flow monitor out in the market, which has a high value and people can buy it, and then go and get the application approved for intracranial pressure.”

Under the CBF indication the device would use the same hardware as the nICP and could significantly reduce the use of an ultrasound technician to take these measurements.

The company said that it expects $8.6 million in sales of the CBF Monitor in 2012. It said that with the addition of the nICP in 2013, that it anticipated sales growth of 139% in 2013 and 62% in 2014.

The company said that until the filing was made, it had no plans to take the device outside of the U.S. - but did not entirely rule out the idea of pursuing CE mark.

“We would be looking for either a partner because we’re either at that point where a partner for distribution or acquisition would come into play,” he said. “Or concurrently, we would choose to do our own fund raising and our own distribution and look for C.E. mark on the blood flow monitor going forward. Right now though it’s a U.S.-based strategy, but depending on who the strategic partner or distributor is who works with us we could clearly go to Europe concurrently.”

The company has less than 15 employees – almost all engineers. The ideas surrounding the device began nearly a decade ago, Harlow told MDD.

“Really four years ago we started the developmental effort and commercialization efforts if you will,” he said. “So that’s been a very steep hill that we’re about to hit the peak of when we do the 510(k) filing.”




PreviMed thrives while avoiding the traditional VC funding routeBy OMAR FORDMedical Device Daily Staff Writer

At first glance it’s pretty difficult to nail down the concept of PreviMed (San Jose, California). The small firm doesn’t beat to the tune of the same drummer that other companies its size would, by combining the strong ideas and concepts that one would find at a large med-tech company with the savvy and determination of a think tank. With a core staff of four, the San Jose-based company is looking at making a difference in the healthcare landscape by offering practical solutions to patients.

The only real difficulty PreviMed has – and Atul Salgaonkar its founder and CEO agrees – is the lack of venture capital to take some of these ideas and concepts to the next level.

“We’re very good at inventing,” Salgaonkar told Medical Device Daily. “But we’re not very good when it comes to [securing funding from] venture capitalists. At some point we might convert to a nonprofit, but for right now we like the discipline of a for profit company.”

The firm researches innovative solutions for the medical technology domain by harnessing technologies along with a multi-dimensional engineering effort. PreviMed has led technical seminars at research institutions such as NIST (National Institute of Standards and Technology); and contributed detailed concepts to innovation research efforts at National Institutes of Health, the Bill and Melinda Gates Foundation and the FDA’s Orphan Devices program.

Salgaonkar said that at the current time, the company had more concepts than it could fund – but finding financial support for the company’s 23 carefully researched and feasible projects is its next big challenge.

He added that the company had to look for investors; foundations, research organizations, who are co-aligned to become partners and he wants to rule out traditional venture capital if possible.

But a lack of funding hasn’t stopped the company from taking on weighty assignments. One of its 23 projects include a personal airbag system for patients – which at first was deemed impossible by critics – until PreviMed stepped in to apply wireless Body Area Network technology.

“One of journeys has been in this personal air bag program,” he told MDD. “The idea is that if a frail and elderly person falls down it takes about an average 300 or 400 milliseconds for them to fall and it takes 100 milliseconds for the airbag to deploy. So we started with wrist-oriented sensors to detect the fall and we realized that wrist oriented sensors can move very easily. So then we moved to a neck-based sensor. But we found that the battery in the necklace sensor would be too heavy for the patient.”

This team of science-based trendsetters has spent the past two years experimenting with currently available technology for the project. After discarding many designs that did not yield results, PreviMed said that it came up with a vest-like sensor that promises assistance to a wide range of consumers, from the frail and elderly to bicyclists involved in accidents.

The company also is working on software that alerts consumers of prescription medicines and herbal supplements when a combination could prove dangerous, and a Smartphone system that helps manage the behavior of those with impulse control issues.

“We want to do things that are important and may not be ready for commercialization,” Salgaonkar said. “We don’t mind developing the product as much as possible and then documenting it carefully and putting it in the freezer for a while.”

PreviMed has had to do this in one instance regarding its medicine authenticity checker program. The idea was driven by a proposed California regulation that would require an e-pedigree for medicines. The legislation has been repeatedly postponed, causing a temporary halt in development of this product.

“It’s been an interesting journey and we have learned the hard way how to accept setbacks,”




he said.Ultimately, Salgaonkar said that he wants the company to truly become a think tank, and

allied with an organization that shares the firms thoughts and goals.“[In the future] we see ourselves as a research-oriented think tank, that may be part of a

larger foundation,” Salgaonkar said. “Possibly we could be aligned with some other organization that has a similar set of values and our values being shared success and making this possible regardless of commercial benefit.”




Researchers fuse vessels together without suturesBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

Surgeons today reconnect severed blood vessels the same way they did 100 years ago –with a needle and thread. The method earned French surgeon Alexis Carrel a Nobel Prize in 1912, but at last there may be a better way - without using sutures.

Led by microsurgeon Geoffrey Gurtner, MD, a team of researchers at Stanford University School of Medicine (Stanford, California) have used a poloxamer gel and bioadhesive instead of sutures to fuse blood vessels together in animals. Results of their research were published in Nature Medicine.

Gurtner told Medical Device Daily that his team had not presented the research very extensively so not a lot of people in the medical field were aware of it until it was published on Monday. Since then, he said he has received “several hundred emails” from surgeons in a variety of specialities including urology, reproduction, and neurology, who are interested in using this technique for their unique connection problems. He said the reaction has been “surprising.”

“You work on something for four years and you feel like you’re in an echo chamber and nobody is paying attention,” Gurtner said. “It’s nice that this seems to resonate with people who are working out in the trenches.”

The trouble with using sutures is that they are difficult to use on blood vessels less than 1 millimeter wide. Gurtner said he began thinking about alternatives to the needle-and-thread method about 10 years ago when he was chief of microsurgery at Bellevue (New York). “We had an infant – 10 to 12 months old – who had a finger amputated by the spinning wheel of an indoor exercise bike,” said Gurtner, senior author of the study and professor of surgery. “We struggled with reattaching the digit because the blood vessels were so small – maybe half a millimeter. The surgery took more than five hours, and at the end we were only able to get in three sutures. Everything turned out okay in that case, but what struck me was how the whole paradigm of sewing with a needle and thread kind of falls apart at that level of smallness.”

Using sutures also can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot getting stuck and obstructing blood flow. In addition, sutures may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage.

The Stanford researchers say the new method could sidestep these problems. “Ultimately, this has the potential to improve patient care by decreasing amputations, strokes and heart attacks while reducing healthcare costs,” the authors wrote.

Earlier in his career, as Gurtner contemplated a better way of joining together blood vessels, he considered whether ice could be used to fill the lumen, the inner space of the blood vessel, to keep both ends open to their full diameter long enough to glue them together. The idea didn’t pan out so well though. “Water turns to ice quite slowly and you would have to drop the temperature of the surgical site a lot – from 98.6 degrees to 32 degrees Fahrenheit,” he said.

Shortly after arriving at Stanford in 2005, Gurtner approached fellow faculty member Gerald Fuller, PhD, a professor of chemical engineering, about whether he knew of a substance that could be turned easily from a liquid to a solid and back to a liquid again, and that would also be safe to use in vascular surgery. Fuller suggested a FDA-approved thermoreversible poloxamer called Poloxamer 407. It is constructed of polymer blocks whose properties can be reversed by heating.

Fuller teamed up with Jayakumar Rajadas, PhD, director of the Stanford Biomaterials and Advanced Drug Delivery Laboratory, to modify the poloxamer so that it would become solid and elastic when heated above body temperature but dissolve harmlessly into the bloodstream when cooled. The poloxamer then was used to distend both openings of a severed blood vessel,




allowing researchers to glue them together precisely.“This was a collaboration between chemical engineers and clinical surgeons and biologists

so it was really a team effort and a lot of people were involved,” Gurtner said. “Without having the right team I could never get going or get step one done . . . in the five years I’ve been out here we’ve made quantum leaps forward.”

The Stanford team used a simple halogen lamp to heat the gel. In tests on animals, the technique was found to be five times faster than the traditional hand-sewn method, according to the study authors. It also resulted in considerably less inflammation and scarring after two years. The method even worked on extremely slim blood vessels – those only 0.2 mm wide – which would have been too tiny and delicate for sutures. “That’s where it really shines,” Gurtner said.

Dermabond, a surgical sealant made by Johnson & Johnson (New Brunswick, New Jersey), was used to attach the ends of the blood vessels together.

Gurtner told MDD the biggest challenge the team faced – and continues to face – is finding a glue that works and is able to set up quickly enough and be compatible with the blood vessel walls and have sufficient strength to withstand arterial pressure. “We have very demanding specifications for this glue and the glue is really kind of the weak link in this technology,” Gurtner said. He said the Dermabond glue used in the study was okay but not the one the team plans to take to the clinic for a variety of reasons, primarily the fact that it takes too long to dry.

Once the researchers find the right glue, they will be ready to seek permission from the FDA to start a clinical trial. “That’s the last piece in the puzzle. We’ve already thought about what the trial would look like and where we would do it at,” he said.

Poloxamers have been used before as a vehicle for delivering drugs, including chemotherapeutics, vaccines and anti-viral therapies. Researchers have used Poloxamer 407 to occlude blood vessels in experimental animals for the purpose of evaluating the gel’s safety and efficacy in so-called “beating heart surgery,” in which certain vessels need to be temporarily blocked to improve visibility for the surgeons performing a coronary artery bypass.

Although other sutureless methods have been developed, they generally have not produced better outcomes, the authors said. “Often, the use of microclips, staples or magnets is itself traumatic to blood vessels leading to failure rates comparable to or higher than sutured anastomoses,” they wrote.

The study authors say further testing on large animals is needed before human trials can begin, but they note that all of the components used in the technique are already approved by the FDA.

Michael Longaker, MD, the Deane P. and Louise Mitchell Professor in the School of Medicine and a co-author of the study, called the technique a “potential game-changer.”

“When you’re bringing together hollow tubes, whether they’re large structures, like the colon or the aorta, or a small structure, like a vein in the finger of a child, you’re always worried about lining them up directly and effectively sealing them,” Longaker said. “The technique that Dr. Gurtner has pioneered could allow surgeons to perform anastomosis more quickly and with improved precision. Coming up with this solution was the result of the classic Stanford model of bringing together researchers from a variety of disciplines.”




Heart tissue stimulation could lead to light-guided pacemakersBy OMAR FORDMedical Device Daily Staff Writer

A new technique to stimulate heart tissue by low-energy pulses of blue light could lead to light-powered pacemakers in the future according to a study published in Circulation: Arrhythmia & Electrophysiology, a journal of the American Heart Association (Washington).

The research is part of a new field called optogenetics that introduces light-sensitive proteins into “excitable” cells, making it possible to control specific activities within cells. Excitable cells can actively generate electrical signals such as nerve cells and muscle cells.

In the new study, researchers created cells expressing the ChR2 protein and coupled them with heart muscle cells from animals, creating heart tissue stimulated by light. They found light-triggered heart muscle contractions and electrical waves were indistinguishable from electrically-triggered waves.

Rather than directly modifying heart cells, the researchers coupled donor cells optimized for light responsiveness with the heart cells. The new technique uses much lower energy than in prior studies and doesn’t require the use of viruses or the introduction of genes from other organisms into heart cells. Instead, cells from a person’s bone marrow or skin can be cultured and modified to respond to light, reducing the possibility that the immune system will reject the light-sensitive cells.

The main appeal of control by light is the ability to remotely, without contact, turn on/off a single cell or a cell type, not possible by electrical or other means of stimulation.

“We have done this by taking regular non-excitable cells, making them dedicated vehicles for expression of light-sensitve proteins and then using them as donor cells, that couple efficiently to host cardiac myocytes to make heart tissue that can be stimulated/paced by light,” Emilia Entcheva, PhD, senior author of the study and associate professor of biomedical engineering at Stony Brook University (Stony Brook, New York), told Medical Device Daily.

The research has strong implications not only for drug testing for cardiac side effects, but also developing optical pacemakers. The approach may someday improve pacemakers and defibrillators. Instead of metal leads, a light-controlled pacemaker would use biocompatible, flexible plastic optic fibers.

“Finally, the idea of optical cardiac pacemakers may seem a bit futuristic at the moment, but should not be dismissed,” Entcheva said. “The current electronic cardiac pacemakers and cardioverter/defibrillators are well established successful technologies, yet not without problems. Among those are lead failures; compatibility with strong magnetic fields; battery life, price, etc. Efficient optical stimulation with proper solutions for light delivery may overcome some of these problems and may offer a new way of controlling cardiac function.”

In preliminary calculations, a light-based system might require only one-tenth the energy, meaning that a battery could last 50 years rather than five.

But she was quick to note that there were still some hurdles to cross before such devices could be developed.

“Challenges that need to be solved are how would we go about modifying genetically in a safe way, the cells in a patient and how would we go about delivering the light in that location,” she said. “If those questions can be addressed in a reasonable time frame such a device is a possibility.”

Entecheva added that optical pacemakers will be an attractive alternative if proven safe and would be more energy-efficient, but more research still needs to be done.

“I don’t think any application of optogenetics is mature enough to be brought to discussions with the FDA yet,” she said. “So for example the brain research is five years ahead of the cardiovascular research because they started earlier. In that field they are testing primates and it seems as if the application is safe and it doesn’t trigger any adverse affects but as I said I don’t




see the [development of a device] coming out of this in the next few months.”Entecheva touted the findings saying that the results came as a surprise to the team and

the implications could be invaluable. “We were pleasantly surprised because in some ways it exceeded expectations,” she said.

“For example we seemed to require very low energy to stimulate cells with this approach which wasn’t something we would have predicted when we started working on it and this is a relevant finding. I feel this technique will be a valuable research tool for cardiovascular researchers.”




TSI set to launch Phantom MIS hip retractor systemBy OMAR FORDMedical Device Daily Staff Writer

Private company TeDan Surgical Innovations (Houston), which gets its name from combining the first names of its owners (Terry Johnston, Daniel Bass and Danny Fishman) is looking to penetrate the orthopedics market with its Phantom Series MIS Anterior Hip Retractor System. The company reported in February 2012 that it had won FDA approval for the device and planned to launch the application.

According to the company, the hip retractor uses a system of adjustable surgical arms with attachable retractors. With the realization that performing hip replacements through the anterior approach may expedite patient recovery time and reduce post-operative discomfort, surgeons are opting to operate using the anterior technique with increasing frequency. Previously, this technically demanding approach has only been possible using a Judet style fracture table and two surgical assistants. The Phantom MIS Anterior Hip Retractor System allows surgeons to access the surgical site through the anterior approach on a standard operating table without a fracture table or additional personnel.

“Everything in medicine today is MIS and the gold standard up until this point has been coming in the posterior, in hip replacements,” Terry Johnston, who is president of the company, told Medical Device Daily. “This usually requires a larger wound and longer post-op recovery. Due to the fact they remove more anatomy coming from posterior approach than anterior, the hip could become displaced and other complications in poster operative incidents could occur,” he said.

Johnston added, “what we’ve done is developed a self retaining retractor system that allows a surgeon to get the anterior exposure with an MIS type wound and the retractor system itself holds the handheld retractor. So in addition we can eliminate two people from the OR. The other good thing about that is that people get tired but the retractor doesn’t.”

Lawrence Menendez and Daniel Allison, orthopedic surgeons at the University of Southern California Medical Center (Los Angeles), partnered with TeDan Surgical to design and develop this innovative retractor. Allison shared their idea with the TSI team. “We wanted to create a system that could place the anterior approach to hip replacement into the hands of any orthopedic surgeon, minimizing trauma to the patient’s soft tissues and bone, while taking away the need for any surgical assistants,” he said.

The Phantom Series MIS Anterior Hip Retractor System has been used in surgery more than 20 times. Evaluations by surgeons have deemed the system a success, and according to Menendez, initial trials exceeded expectations. “We were nervous before the first surgery that things wouldn’t come together or the surgery would become more complicated, but from the first go-round, the surgery was made much easier. Since then we’ve only been making it better. We set some lofty goals and feel like we’ve accomplished them. We are very excited to start giving this system to other surgeons and patients.”

The private firm, which is also self-funded through its owners said its goal to innovate and address evolving surgical technique in spine surgery. The firm said that it has successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine.

TSI became an ISO certified company in April 2010 and obtained the CE mark in February of 2011, and now distributes in all 50 states and on four continents. The company said that its product offering has grown to more than 750 instruments.

“We make the retractors and products to give companies access to the wound and to the spine or wherever they want to put their implants,” Johnston said. “What we try to do is improve on what’s already out there and we try to make it easy to use for the nurse as well as the surgeon.”




TransEnterix develops laparoscopic vessel sealer, stapler for SpiderBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

Surgeons should be getting a couple new tools to be excited about in the not-too-distant future – a flexible vessel sealer and a flexible stapler from TransEnterix (Research Triangle Park, North Carolina).

The company, which reported raising $15 million toward the end of 2011, told Medical Device Daily in an exclusive first interview that it is using those funds to develop a flexible vessel sealer and a flexible stapler to be used with the TransEnterix Spider system. The system includes access tools and surgical instruments, but the markets for vessel sealers and staplers are dominated by Johnson & Johnson (J&J; New Brunswick, New Jersey) and Covidien (Mansfield, Massachusetts).

“If we really want to compete against J&J and Covidien, we feel like we need to have the entire product category” in laparoscopic surgery, Todd Pope, President/CEO of TransEnterix, told MDD. “Right now we have two, access and instruments.”

Pope said the vessel sealing market is currently estimated to be more than $2 billion, while stapling is a $3 billion-plus market. The TransEnterix Spider (Single Port Instrument Delivery Extended Reach) surgical system gives surgeons 360-degree motion in a device the diameter of a dime. Once inside, the Spider opens like an umbrella, giving surgeons the flexibility and capability to perform a variety of abdominal procedures.

The single incision reduces patient scarring and also means quicker recovery time.The SPIDER became commercially available in the U.S. in early 2010 and later that yearTransEnterix received the CE mark, clearing the way for market entry into Europe. The

company launched a new version of the Spider surgical system in 2011. In addition to the increased strength for dissecting and retracting tissue, TransEnterix says the new Spider system delivers added precision through new endomechanical arms that move and control instruments, but other enhancements include improved ergonomics through a modified surgeon interface and optimized reach for a wide range of patient types and operative tasks.

The ability to vary reach within the abdomen is particularly important in minimally invasive surgeries to treat obesity, like gastric banding and sleeve gastrectomy. The system is designed to address problems surgeons frequently encounter when using other, less sophisticated single-incision systems by opening up and expanding within the patient’s abdomen like an umbrella. According to the company, this allows surgeons to readily triangulate instruments and safely accomplish many tasks from one small incision.

“When we started the company four years ago we wanted to create a new category in surgery … what we hoped to do is take the concept of long flexible instruments and really replace many of the long laparoscopic instruments that were rigid,” Pope told MDD. “Less invasive medicine has driven so much of what is out there in advancements in surgery over the years and we just haven’t had a lot of movement over the last twenty years in laparoscopic surgery.”

Pope said development on both products is already underway and the company hopes to launch one of the new products in 2013 after going through the FDA 510(k) process. TransEnterix’s $15 million financing in 2011 represented the second tranche of the company’s Series B round from 2009 when it raised $55 million, paving the way for the company to manufacture and market the Spider surgical platform. The company’s total venture raised is now about $91 million.

“This investment we just raised was 100% from insiders,” Pope said. “That sends a strong message when you have investors and are totally able to support your latest round. It’s a vote of confidence.”

Pope said more than 1,500 procedures have been performed using the current Spider system in the U.S. and Europe.




UCLA researchers develophologram microscope deviceBy OMAR FORDMedical Device Daily Staff Writer

Researchers at the University of California at Los Angeles (UCLA) have built a compact, light-weight, dual-mode microscope that uses holograms instead of lenses. The device can help physicians and clinicians serve patients in remote areas of the world.

“We’re trying to get some of the conventional aspects of microscope design, that is behind their improved performance in terms of looking at large scale objects with a decent resolution,” Aydogan Ozcan, an associate professor of electrical engineering and bioengineering at UCLA and senior author of the paper told Medical Device Daily. “So one of the reasons why conventional microscope designs are not optimum is because they are composed of many components which make their information gathering capacity limited.”

He added, “our approach is to replace lenses in an optic microscope design.”The prototype weighs about as much as a medium-sized banana and fits in the palm of a

hand. Since it relies in part on mass-produced consumer electronics, all the materials to make it add up to between $50 and $100.

It also has a two-in-one feature: a transmission mode that can be used to probe relatively large volumes of blood or water, and a reflection mode that can image denser, opaque samples. The spatial resolution for both modes is less than two micrometers – comparable to that achieved by bulkier microscopes with low- to medium-power lenses.

Ozcan and his team describe the new device in a paper published in the Optical Society’s (OSA; Washington) open-access journal Biomedical Optics Express.

Part of the device’s success is the weight it shed when researchers got rid of the bulkier, heavier, more expensive pieces that most microscopes rely on for collecting and focusing light: the lenses. Instead of lenses, this microscope uses holograms.

Holograms are formed when light bouncing off (or passing through) a three-dimensional object is made to interfere with a “reference beam,” or light that has not hit the object.

Researchers say to understand how the technology works one must consider this analogy: drop a stone into a still pond and the ripples will move outward in a circle.

Drop two stones and the circular ripples will interfere with each other, making a new pattern of crests and troughs. A person (or computer) analyzing the interference pattern created by those two stones could trace the source back to the stones and recreate what had happened to make the waves.

The UCLA team’s device uses a similar principle to recreate images from interfering light waves.

The inexpensive light source is divided into two beams – one that interacts with microscopic cells or particles in the sample, and the other that does not. The beams then pass to an adjacent sensor chip, where their interference pattern is recorded.

Software then analyzes that pattern and recreates the path taken by the light that passed through or bounced off of the objects being imaged.

Each component of the device is fairly inexpensive according to researchers. The laser light could come from a $5 laser pointer. The sensor chip that collects that light is the same as the ones in the backs of iPhones and Blackberrys and costs less than $15 per chip. Researchers say that the whole image-collecting system runs on two AA batteries.

Where the researchers have reduced weight and expense in doing away with lenses, they have added the power of the cloud.

The microscope captures raw data; but a computer is required to reconstruct the images. Workers in the field could use their laptops to process the information or send it over the Internet or mobile phone networks to a remote server. Mobile phones could also have sufficient processing power to do the analysis on the spot.




The next steps for Ozcan’s team include commercializing the device. Ozcan says he has founded a company that is developing this technology, trying to make a version of the microscopes that can be manufactured and sold to healthcare workers and hobbyists.

The device could be useful in monitoring the immune system of an HIV patient, or looking at the pathology of a patient suffering from malaria.

“It could be used in a variety of different settings depending on the need,” he said. “The main advantage [of the device] is that it’s a platform that can do microscopy analysis.”




Fear of unknown, not money, slows technology adoptionBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

Sometimes it’s difficult to understand why a new technology supported by excellent clinical data experiences slow adoption by physicians who instead continue to use the current gold standard – even if it is more invasive for their patients.

That seems to be the case for AlloMap, a non-invasive genomic-based test from XDx (Brisbane, California) designed to rule out acute cellular rejection in heart transplant patients. While some physicians have been using the tool – a simple blood test – for years to manage heart transplant patients, others continue to rely on the more invasive standard endomyocardial biopsy.

A recent Nature Medicine opinion article written by a professor of internal medicine and pharmacology at the University of Utah School of Medicine (Salt Lake City) suggests that financial incentives promote a continued reliance on biopsies rather than gene-expression profiling to determine cellular rejection in heart transplant patients. But a physician who spoke with Medical Device Daily on Tuesday offered a different perspective on why some physicians may be slow to adopt the newer method.

AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score that tells physicians if the patient is at a high or low risk for cellular rejection.

Andrew Kao, MD, the medical director of heart transplantation at St. Luke’s Mid America Heart and Vascular Institute (Kansas City) has used AlloMap for about five years and speaks highly of the technology. But he says fear of the unknown – rather than financial incentives – is more likely the reason other physicians may hesitate to trust the newer method over the standard.

“From our standpoint we look at what’s best for the patient . . . it’s always unfortunate when people bring money into it . . . in our practice money never even came up,” Kao said. “We’ve been trained for the last 40 years as a group that biopsy is the standard . . . when one generation teaches a second generation who teaches a third and fourth generation it’s hard to break out of that.” He added that even though there is strong clinical data backing the AlloMap method, it is difficult to leap from science to actual practice.

Still, he thinks the majority of his colleagues in the field have their patients’ interest at heart rather than revenue. “I think for a lot of people it’s just a fear of the unknown because no one wants to lose patients, these people have become family, a lot of them, and the last thing you want to do is do something that’s going to cause them demise.”

Kao admits that his practice, a fee-for-service practice, would receive more money if it relied solely on the biopsy approach but his group adopted AlloMap because of the positive impact it has made in their patients lives.

“It’s wonderful. Patients, as you know, really dread having the biopsies. They know it’s a necessary evil, but it’s not something they look forward to,” Kao told MDD. He said that by using AlloMap, most of the time he is able to cancel the patient’s biopsies based on the score.

In the past the patients knew there was no choice but to have a biopsy to check for rejection, but now they know there is an alternative and they are asking for it. Still, there are times when the AlloMap test alone is not enough.

“It’s not meant to replace a biopsy, it just tells us whether the risk of rejection is low or high,” Kao said. “For people who are considered relatively low risk for rejection it’s a very useful tool to tell us when someone does not need a biopsy. It’s an additional layer of protection for the patient when we ask them to get a biopsy . . . there is about a 5% chance or so that they’ll have a rejection (if the AlloMap score is high) . . . it’s a pretty good bet that they don’t have rejection (if score is low). Frankly, it just gives us another data point to follow our patients.”




The IMAGE study, a clinical trial published in April 2010 in the New England Journal of Medicine, demonstrated the comparative effectiveness of the AlloMap test to endomyocardial biopsy. This past April additional analyses of the IMAGE study demonstrated the potential for extended utility of the test. These additional new analyses were presented at the 31st annual meeting and scientific sessions of the International Society for Heart and Lung Transplantation (ISHLT; Addison, Texas) in San Diego in April 2011.

During a phone interview from ISHLT, Pierre Cassigneul, president/CEO of XDx, told MDD that the latest research demonstrated how the AlloMap may help physicians better manage heart transplant recipients with more accurate levels of immunosuppression drugs in order to avoid rejection. “These powerful drugs have severe side effects . . . making patients prone to infection, prone to cancer . . . physicians are over immunosuppressing patients but of course they do that because if the patient is not suppressed enough they could go into rejection . . . so they’re erring always on the side of over immunosuppressing,” he said.

Kao told MDD his patients are very grateful for the AlloMap test. In fact, his practice sometimes offers conferences for other physicians to see a demonstration of the technology and patients are eager to participate as patient testimonials for the method. “Some will drive some distance just to help spread the word,” he said.




InterVapor vows ‘no implant left behind’ in emphysema patientsBy OMAR FORDMedical Device Daily Staff Writer

Uptake Medical (Tustin, California) promises to leave no implant behind in the treatment of emphysema patients all thanks to the power of steam.

The small med-tech firm reported the first commercial use of its InterVapor system for endoscopic lung volume reduction in a patient with severe emphysema. The patient successfully underwent treatment with InterVapor, the first endoscopic lung volume reduction system for the treatment of severe emphysema that uses the body’s natural healing processes without leaving foreign materials in the lung. The patient was treated by the team at Thoraxklinik (Heidelberg, Germany).

Uptake is billing the device as an alternative to far more invasive procedures used in the past.

“There was a surgery called lung volume reduction surgery that was done [and it’s still done – just not that often],” R. King Nelson, president/CEO, Uptake Medical told Medical Device Daily. “In this surgery, [doctors] would treat patients with severe emphysema and they would go in and resect the upper sections or lobes of the lungs. It worked pretty well except the mortality and morbidity rate was unacceptably high.”

He added, “the idea was ‘is there a way to get lung volume reduction without having a very invasive procedure?’ That’s where InterVapor comes in. We use a standard bronchoscope and we insert it through the mouth into the targeted segments of the lung. We go in those areas and the energy source we use is thermal energy or steam. So it’s just sterile water. There’s no drug used or implant left behind. We use that energy source to scar down that very diseased area and basically eliminate it.”

Uptake said InterVapor then triggers the body’s natural healing process, gradually reducing the treated portion of the lungs and increasing the ability to breathe more fully.

The device has been evaluated in the VAPOR study, which was an open label, single-arm trial of InterVapor (Bronchoscopic Thermal Vapor Ablation) in patients with upper lobe predominant emphysema. Primary endpoints measuring lung function improvement and health-related quality of life achieved both statistical and clinical significance. Additionally, 83% of patients met a combined endpoint for clinical improvement.

The trial saw 44 patients completed in Germany, Australia and the U.S. with additional sites in Dublin and Vienna.

The company said that efficacy was consistently demonstrated across all endpoints. Secondary endpoints demonstrated that patients treated with the InterVapor procedure have significant physiologic improvements (including decreased hyperinflation and gas trapping) as well as clinical improvements (reduced breathlessness and improved exercise capacity). All treatments were performed successfully without intra-procedural complications. Adverse events related to treatment included a temporary increase in respiratory symptoms in some patients, which generally resolved with standard medical management. Clinical data supports a favorable risk/benefit profile for the use of InterVapor in the treatment of patients with heterogeneous severe emphysema.

“As investigators in the VAPOR trial, we observed the benefits our patients received from InterVapor and we are pleased to be selected to introduce InterVapor,” said Professor Felix Herth, chief of the department of Pulmonary Medicine, Thoraxklinik Heidelberg. “It is particularly fitting that the first patient case has taken place in November, which marks COPD Awareness month, as InterVapor offers a new treatment option for patients who are looking for relief from their emphysema.”

The company has CE mark approval to begin commercializing the product. The firm expects to gain approval in Australia between now and 1Q12. As for U.S. approval – that answer




is a bit trickier.“In the U.S. we’ve done a stage one pilot trial,” Nelson said. “We have not done a randomized

pivotal trial in the U.S. as of yet. From the day you get approval to start the trial until you get final approval could be at least three years.”

Uptake was founded in 2005 with the specific focus of treating emphysema patients. Since its inception, the firm, with a full time staff of 25, has had about $45 million invested in it primarily by traditional venture capital groups.

“This has been a year of milestones for Uptake Medical,” said Nelson. “This first commercial patient case is the culmination of multiple successes including the completion and subsequent publication of the positive results from the VAPOR trial and receipt of the CE mark for the InterVapor system. The interest in our approach to treating emphysema continues to build and we are enthusiastic as we continue the launch of the InterVapor system.”




VasoStitch set to solve PCI access/closure challengeBy AMANDA PEDERSEN Medical Device Daily Senior Staff Writer

Much has been said over the past several years regarding the development of percutaneous catheter-based cardiac procedures using new technology such as Transcatheter Aortic Valve Implants (TAVI) and Endovascular Aneurysm Repair (EVAR) devices. But the rapid development of these percutaneous procedures has presented a challenge for physicians when it comes to access and closure.

“We have not seen arterial closure systems develop as rapidly and therefore there is a need that has been established” to provide both access and closure for procedures like TAVI and EVAR, David Smith, president/CEO of VasoStitch (Danville, California), told Medical Device Daily.

VasoStitch is an emerging device company that is developing nonsurgical transfemoral and transapical access-and-closure systems designed to facilitate deployment of large-diameter transcatheter therapeutic devices. Smith said that currently physicians have two approaches to chose from when it comes to addressing the access and closure needs associated with procedures like TAVI and EVAR – and neither approach is ideal.

One, the interventional cardiologist has to call in a vascular surgeon to create a surgical cut-down for access. The interventional cardiologist does the procedure and the vascular surgeon has to come back in to provide the closure. This approach creates friction between the two physician specialties as it is a scheduling issue as well as a sharing-of-reimbursement issue and simply not ideal for the interventional cardiologist to have to rely on somebody else to help him complete the procedure.

The other approach is for the interventional cardiologist to use a much larger valve system than they are familiar with using during stent procedures for closure. The problem with this approach is that these existing devices were not designed, nor approved, to close these types of access holes and using them to do so leads to a variety of vascular complications.

Smith says the VasoStitch system is actually designed to provide the access - replicating what the vascular surgeon does by providing a nice cut-down incision into the femoral artery – and then makes the closure part of the procedure much more straight forward. The system is designed to reduce procedural complexity and eliminate the need for an “open” surgical procedure.

The VasoStitch system is a two-step platform, Smith explained.There’s also a time-savings benefit to the VasoStitch system, which of course translates

into cost savings.Smith said that currently, the surgical approach of arterial or cardiac access and closure

for large-diameter, catheter-based interventions adds about 60 minutes to what already is a lengthy and complicated procedure. The VasoStitch system is designed to replicate the current “gold standard” of surgical access and repair in a more rapid and facile fashion – about five minutes – to reduce healthcare costs and enhance adoption of large-diameter cardiovascular and endovascular therapies.

“Physicians not only need to see a time savings, they need to see the clinical efficacy,” Smith said. “By making this device so simple, it’s very easy to deploy, and you’re really doing exactly what the vascular surgeon does - you’re providing a blade access.”

He said VasoStitch anticipates introducing its system to the European market in 2013 and to the U.S. market probably a year later. The company is currently in discussions with several potential strategic partners who have expressed an interest in a relationship with VasoStitch either in a co-development capacity, investment, or other capacity.

“We want to make sure it’s consistent and meets the needs” of the interventional cardiologist.Smith said there are other companies working in this space but VasoStitch is the only




company he is aware of developing both a nonsurgical transfemoral and transapical access-and-closure system to meet this need.

The VasoStitch devices are introduced over the top of a guidewire. The access device looks a bit like a cork-screw, Smith said, and its job is to insert a suture in a cork-screw pattern. The suture stays in place even after the physician withdraws the device. Then, the second device is introduced over the wire that introduces a blade to create the access. Then the physician removes that part of the VasoStitch system and does the catheter-based procedure (TAVI, EVAR, etc.) as he normally would. At the end of the procedure he “simply pulls on the tail of the suture and the suture pulls tight and pulls both sides of the artery together,” Smith said.

VasoStitch, a privately held company, was founded by serial entreprenuer Amir Belson, MD, who previously founded NeoGuide Systems (Los Gatos, California), Emboline (Fremont, California), Modular Surgical, RadGuard Medical (Palo Alto, California), Thermocure (Sunnyvale), Vascular Pathways (Los Altos, California) and ZipLine Medical (also Los Gatos).

Looking into the future, the company says it sees an attractive exit strategy ahead as there are “multiple, well-defined, complimentary, logical acquirers of the VasoStitch technology.”




Velomedix gets IDE to evaluate rapid cooling system for AMIBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

Inducing hypothermia to treat acute events such as cardiac arrest, heart attack, and acute ischemic stroke is nothing new. But one company has developed a system that, if approved, could surpass all existing hypothermia systems in terms of cooling speed. Velomedix (Menlo Park, California), a venture capital-backed, clinical stage device company, said it has received an investigational device exemption (IDE) from the FDA to evaluate the use of rapid therapeutic hypothermia for the treatment of acute myocardial infarction (AMI or heart attack) patients.

The conditional IDE approval allows the company to initiate a clinical trial at select sites in the U.S. Velomedix has developed a system that it says can reach 33ºC in less than 15 minutes, compared to other hypothermia management technologies that take one to two hours to achieve that therapeutic target temperature. The unparalleled cooling speed and procedural efficiency is expected to result in enhanced clinical outcomes and enable more widespread clinical adoption of this therapy, the company noted.

“The fundamental advantage that it brings to the space – AMI, cardiac arrest, and stroke, among other indications, ultimately – is that it has the capability of cooling patients down to 33ºC in less than 15 minutes,” Jeff Gold, president/CEO of Velomedix, told Medical Device Daily. On average, the system reaches that target temperature in about 12 minutes, he added, “which is significantly faster than any other system on the market or in development as far as I know.”

Velomedix has clinical experience in South America and in Europe with several indications, Gold said. It has been used in the cath lab, the ICU, and the ER, with good results, he added. The key to treating heart attack patients with hypothermia is not just to cool the patients’ down, Gold said, but to cool them down before the physician puts a balloon or a stent in. “If you can do that, the results appear to be significant and highly beneficial to these patients,” he said.

The company reported closing a $10.2 million Series B financing early in February 2012, and indicated at the time it had completed an initial human trial in Europe that showed improved survival rates and neurological outcomes for patients suffering a cardiac arrest.

“For AMI patients requiring an intervention to open a blocked artery, the ability to deliver rapid cooling is crucial to optimizing the protective benefits of therapeutic hypothermia while still complying with mandated hospital ‘time-to-treatment’ standards,” said Griff Tully, MD, Velomedix’s VP and chief medical officer.

Velomedix expects to begin enrolling patients in the IDE trial sometime after the first quarter of 2012, Gold said. While there will be some training involved for physicians to use the system, it can be learned in as few as five cases, he said. “The system does most of the work. The physician makes the access to the patient, after that you just plug it in and the machine does all the work,” he said.




World Micro sets sights on medical device marketBy OMAR FORDMedical Device Daily Staff Writer

With an emphasis on stringent quality measures, and steady growth, it was only a matter of time before World Micro (Atlanta) delved into the med-device sector. The electronics distributor, which is a private company and serves the military/aerospace sector, said that it was going to roll out a new business sector to serve the unique requirements of the medical device market.

Todd Ballew, executive VP and general manager at World Micro, spoke with Medical Device Daily about the new rollout and gave insight on why the company, which started nearly 15 years ago, got into the med-tech space.

Ballew said the answer could be summed up in one word, “quality.”“One of the things that’s very critical to our business plan and our business model is quality,”

Ballew told MDD. “Delivering both quality products, with quality processes, from quality people is sort of our tagline. And in that we’ve focused stringently over the last four or five years to find market places where quality is extremely high criteria. Obviously medical devices fall into that category.”

Specifically the company will be distributing components to medical device manufacturers. The road to becoming involved in medical devices was paved when the company recently

earned its ISO-13485 certification.In addition to the certification, the company hired Samtec, product manager, Terry Miller.

He will manage the business development for this market. His duties also include ongoing development of a diverse supplier and customer base, targeting specific OEMs and CMs in the company’s expanded market segment, and working with team members to develop a new line card for the medical device market.

In keeping with its growth strategy, the company also hired an additional six regional sales executives who will support the company’s tactical team-based sales force. The new staff will focus on expanding regional customer bases. In addition, World Micro plans to bring another 10 regional sales executives on board by the end of 2011.

The company said that there has been a great deal of interest from med-tech companies about it delving into the sector.

“We’ve had meetings with about 45 of the major medical device manufacturers and out of those many of them have indicated that they see a real value in what we could bring to the market place,” he said. “There’s definitely a strong fit for what we’re doing.”

Ballew added that advancing into the new sector is part of the company’s continuing strategic growth initiative, which will now enable support of the manufacturing needs of the electro-medical equipment and irradiation apparatus companies, a $30 billion business in the U.S. and a $65 billion industry world-wide.

The company already stretches beyond U.S. borders and soon will have a presence in Europe.

“We do have an Asian facility in Malaysia and we’ll be opening up a location in Europe (Budapest) next year,” Ballew said. “I guess you could say there’s a global foot print but most of our business is domestic.”

With 35% growth last year and an expected 30% this year, the company said that it was a great time to make its move into the med-tech market. Ballew said that the addition of key personnel and the expansion of staff will help the company continue that growth pattern and effectively make an impact on the med-device market.

“World Micro intends to keep up the pace in growing its territorial and customer bases and needs an expanded sales team to support these efforts,” said Ballew, “I’m especially excited about the capabilities Terry is bringing to the company and look forward to bringing customers




the benefits of his industry experience. And, the new market entry and additional staff support will also enable greater coordination with our manufacturer’s representatives program to increase our visibility within the medical device market. We want to help our reps in any way we can to create awareness about World Micro’s values and capabilities and its ability to be a valuable resource in an otherwise underserved market.”



AirXpanders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3American Glaucoma Society Annual Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37American Heart Association . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Amgen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35AMS Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Apollo Endosurgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Arkansas Heart Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Autonomic Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Avinger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Bellevue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57BioControl Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21BioServe Space Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Bluegrass Vascular Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Cantor & Nissel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Cardioangiologisches Centrum Bethanien . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19CardioComm Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15CardioFocus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Case Western Reserve University School of Medicine . . . . . . . . . . . . . . . . . . . . . . . . . 17CerebralRx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21CerviLenz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Chinese University of Hong Kong . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6ChromaGen Vision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Clarimedix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Clatterbridge Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25ClearCount Medical Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Cleveland Clinic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Combat Medical Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Covidien . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62CytoPherx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Dune Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Early Stage Partners, ONSET Ventures and Capital . . . . . . . . . . . . . . . . . . . . . . . . . . 28Edison Pharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Ellipse Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Emboline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Estill Medical Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14German Migraine and Headache Society . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Haldor Advanced Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Idaho Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13ImageIQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35International Headache Society . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8International Society for Heart and Lung Transplantation . . . . . . . . . . . . . . . . . . . . . 66Intersect Partners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Invibio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Ivantis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37IVDiagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Index of companies featured in this publication




iWalk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Johns Hopkins University . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Johnson & Johnson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26, 54, 58, 62Katherinen Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Kelyniam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Lerner Research Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Mayo Clinic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Medical College of Wisconsin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Medical University of South Carolina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Medtronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Memorial Sloan-Kettering Cancer Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Midwest Fund . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28MindFrame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Modular Surgical, RadGuard Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70NeoGuide Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Neuronetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49NeuroSigma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51NSVascular . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Optical Society . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Ospedale di Mirano . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9OvaScience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53PhysioSonics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54PreviMed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Shalgrenska Academy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Stanford University School of Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37, 57St . Luke’s Mid America Heart and Vascular Institute . . . . . . . . . . . . . . . . . . . . . . . . . 65Stony Brook University . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59TeDan Surgical Innovations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Therix Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Thermocure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Thoraxklinik . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67TransEnterix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62University Hospital Hamburg-Eppendorf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8University Hospital of Schleswig-Holstein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30University Hospitals (UH) Case Medical Center’s Neurological Institute . . . . . . . . . . 17University of California at Los Angeles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63University of California at San Diego . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31University of California at San Francisco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30University of California, Los Angeles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51University of Colorado . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26University of Kentucky Albert B . Chandler Hospital . . . . . . . . . . . . . . . . . . . . . . . . . 11University of Liege . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8University of Michigan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28University of Southern California Medical Center . . . . . . . . . . . . . . . . . . . . . . . . . . . 61University of Texas Medical Branch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6




University of Utah . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13University of Utah School of Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Uptake Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Vascular Pathways . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70VasoStitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Velomedix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71World Micro . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72XDx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65ZipLine Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Zoll Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

med -tech innovation in · pdf filecompany news, regulatory activity, legislative actions,...

Documents