medical devices and biopharma delegation to nyc 2013

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Israeli Medical Device and Bio-Pharma CompaniesLife Sciences Roadshow December 2013

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Message for Roadshow of Life Science companies to the USA-December 2013

We are pleased to present to you this roadshow of young Israeli Life Science companies. Many of the participating companies have been nurtured and matured by the national Israel technological incubators program.

Although a small country, Israel has developed an impressive Life Sciences industry with over1,000 companies active in this sector. In 2012 exports reached $8 billion of which the bio-pharma sector was responsible for $6.0 billion and that of medical devices topped $2.0 billion. Israel has proved lucrative for many of the Life Science companies who have significant investments in Israel: GE Medical, J&J, Covidien, Stryker, Boston Scientific, Philips Healthcare, St. Jude, Abbot Laboratories, Bayer Healthcare, Baxter Roche, Merck Serono and more.

We believe the present generation of start-up's will grow and offer investors similar returns as has been the case in the last few years.

This roadshow is a joint effort of Invest in Israel and the Foreign Trade Administration. Israel’s Economic representatives in the USA are responsible for organizing the meeting events between the companies and potential American investors.

Invest in Israel

“Invest in Israel,” serves as the government’s focal point for international companies and individuals interested in investigating direct investment and joint venture opportunities in Israel. It is committed to helping investors locate the right projects, working closely with them throughout the length of the project and serving as a source for investment related information.

Invest in Israel provides the potential and current investor an array of professional services during the pre, present and post stages of the investment process. These include:• Current and accurate information on incentives available to the investor.• Coordination of investor visits and introductions to relevant businesses.• Maintaining a liaison with government and non-government agencies responsible for investment policy.• Providing comparative analysis on services and information on costs of business operations in Israel.• Business reports of Israel’s leading target sectors and implementation of activities to promote these sectors. • Present Israel’s breakthroughs record.

Learn More

To learn more about information or services, you are invited to visit our web site at, www.investinisrael.gov.ilor contact a local Israel economic representative in your area.

5 Bank Israel St. Jerusalem 91036 | Tel: 972-2-6662607, Fax: 972-2-6662938

Email: [email protected]

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For more information please contact:

Gillam KeinanDirector for Foreign InvestmentsLife Sciences SectorInvest in IsraelMinistry of EconomyTel: +972-2-666.2433 | Fax: +972-2-6662938

[email protected]

In the USA

Economic Mission to the East Coast

Ms. Nili Shalev Economic Minister - N. America 800 Second Ave. 16th Floor New York, NY 10017 Tel: 212.499.5610 | Fax: 212.499.5615

[email protected]

Economic Mission to the Midwest

Mr. Yariv Becher Consul - Economic Affairs 111 East Wacker Dr. Suite 1230 Chicago, IL 60601 Tel: 312.332.2160 | Fax: 312.332.2163

[email protected]

Economic Mission to the West Coast

Mr. Gili OvadiaConsul - Economic Affairs456 Montgomery St., Suite 2100,San Francisco, CA 94104Tel: 415.844.7500 | Fax: 415.844.7555

[email protected]

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Companies Index

Medical Devices

AGAM - Biological Products Development ............................ 6

Discover Medical Devices ...................................................... 7

Inovytec Medical .................................................................... 8

Maxillent Ltd ......................................................................... 9

Medispec ............................................................................. 10

PhotoPill Medical ............................................................... 11

Premia Spine Ltd ................................................................. 12

Bio-Pharma

BioGenCell........................................................................... 14

IDD Therapeutics Ltd ........................................................... 15

Medwell Labs ...................................................................... 16

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Medical Devices

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ContactContact person: Dr.Asaf TokerJob Description: CEOE-mail: [email protected]: www.agamgroup.comMobile No.:+972-50-4057353Telephone No.: +972-8-6371017Fax No.: +972-76-5409680Address: Hacharash St. 16, Lab. 207, P.O.B. 2118, Ness-Ziona, 74047, Israel

Company activity in a nutshellAGAM Company provides products based on jellyfish- derived collagen for a wide range of medical, nutritional and cosmetic applications.

Year founded: 2009No. of employees: 5

Product development stage• Successfully completed pre-clinical trials and animal studies• Presently undergoing biocompatibility testing (ISO 10993)• FIM expected Q2/2014Implantable; Therapeutic Devices

Amount of funds raised$2M

Requested investment amount$5.2M

Executive summaryThe Need: Collagen is a platform for various devices utilized in numerous medical fields. Efforts are conducted to develop a safer, effective & cheaper alternative to today's collagen sources (bovine, porcine, equine or recombinant).

Technology: AGAM has knowledge & capabilities to manufacture unique, native, insoluble collagen, utilized by the company in multiple medical, cosmetic, food and beverage products.

Products: • Three dimensional (3D) scaffolds for enhancing various cell lines growth and proliferation. The 3D- scaffolds can be used for cell biology research. Available for sale. • Wound dressing pads which adhere to the wound, without being replaced or supplemented, until they fall off as a scab. Thus, reducing patient's pain and risk of infection during bandage changes, while lowering time & cost of the medical treatment. • Skin substitutes which keep the size and shape of the transplanted area, preventing collapse of the epidermal layer, enhancing healing and improving the esthetic appearance of the transplanted area. • Other collagen products: scaffolds for bone regeneration cartilage, tissue repair, injectable collagen, wrinkle filler, cosmetic creams, food and beverage products.

Agam's Collagen Advantages: • Source: Available & inexpensive, a safe alternative to mammalian derived collagen, eliminating the risk of carrying human-transferred diseases. • Values: Increases proliferation and differentiation of multiple cell types. • Type: native type II collagen, produced without cross-linking materials or modifications.• Cost: high yield production processes resulting in high cost containment.

Intellectual Property: Patent granted in Japan (JP536846). Patent pending in the US and other countries.

Production Facilities: AGAM has signed M.O.U. with a leading Israeli medical devices manufacturer, approved by the CE and the FDA.

Company Name: AGAM - Biological Products DevelopmentSub-Sectors: Therapeutic device, Implantable

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Company activity in a nutshell

Successfully developed the only medical necessity mask for sleep apnea patients (80m patients)

Year founded: 2008No. of employees: 1 + sub-contractors

Product development stage

Finished first generation

Amount of funds raised$1.7M

Requested investment amount$3M

Executive summaryDiscover Medical Devices (DMD) has developed a revolutionary new Continuous Positive Air Pressure (CPAP) mask for Obstructive Sleep Apnea (OSA) – the SomnuSeal. The SomnuSeal successfully addresses the greatest unmet need of compliance in the field of sleep apnea and proves to be the only CPAP mask that is a medical necessity for patients with both sleep apnea and heart failure.SomnuSeal is a game changer since it will double the existing market by adding currently non-compliant patients to the fold (+3m patients) and create devoted customer traction with 23% of the existing patients that have heart failure and must use the SomnuSeal.Sleep apnea treatment market is a substantial market (>$4b/year) with well established distribution routes, sales & reimbursement infrastructure. The market is growing by 15% per year. As more than 50% of diagnosed patients don’t continue with treatment, this means there are more non-compliant patients than the compliant ones. DMD has the only solution for this unmet need. Furthermore, because the SomnuSeal is the only mask that is a medical necessity for patients with cardiac dysfunction then it will create a devoted following in the communities of distributors, physicians and patients with a potential to become first choice for most patients.DMD has two national phase patents, CE mark and AMAR regulatory approvals. We have completed two clinical trials with 70 patients that demonstrate the SomnuSeal value.DMD is looking to raise $3m to enable start of sales, conduct additional clinical trial continue development of the SomnuSeal masks line and sign a strategic agreement with a market leader.

ContactContact person: Eran LaviJob Description: CEOE-mail: [email protected]: www.discovermedical.comMobile No.: +972-52-2649047Address: 84 Yitzhak Rabin Rd. Givatayim, Israel 53483

Company Name: Discover Medical DevicesSub-Sectors: Medical devicesMedical Field: Sleep Apnea

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ContactContact person: Udi Kantor Job Description: CEO & Co -FounderE-mail: [email protected]: www.inovytec.comMobile No.: +972-50-5939132Telephone No.:+972-8-6805441Address: South-Seed Technology bldg. Nahal-Oz Israel


Inovytec specializes in non-invasive life-saving technological solutions that dramatically increase survivability chances of patients suffering cardiac or respiratory emergencies in pre-hospital environments.



First Model Launch with FDA/CE - Q2 2014


Requested investment amount$4-6M

Executive summary

Inovytec Medical Solutions Ltd –Next generation out-of-hospital critical care Inovytec specializes in non-invasive life-saving technological solutions that dramatically increase survivability chances of patients suffering cardiac or respiratory emergencies in out-of-hospital environments.~2.5M people die each year worldwide of pre-hospital medical emergencies such as sudden cardiac arrest (16%), heart attacks, severe asthma attacks, drowning and strokes, just because they are not treated effectively on-site and on-time. A current worldwide problem is the poor ratio between properly equipped paramedics to population; as well as the comprehensiveness of the equipment to meet first responders and non-paramedics abilities to act in emergency cases.The SALI (acronym of Save Life) family of products are the next generation of out-of-hospital medical emergency devices, that are able to address more than 70% of all medical emergencies and enable first responders to provide critical aid to both conscious and unconscious patients having to undergo emergency treatment.SALI is a Self-contained, automated, simple-to-use system, reinforced with full walk-through-instructions, and real-time (cellular-cloud-web) communication with direct link to an off-site professional support center. The SALI in this way meets nearly all requirements for immediate critical care and medical assistance. The huge critical care market ( of $48B) is continuously growing rapidly, driven by both governments legislation and high public awareness and demand.Inovytec has the right combination of unique and innovative solutions that are recognized as the next generation of critical care devices, coupled with a strong team, 6 patent applications, and using only non invasive + off-the-shelf CE and FDA regulatory-approved components. With expectation of less than a year to sales, strong demand from the market and a clear goal to market strategy it is predicted to generate revenues very quickly. In addition, Involytec is in continuous dialogues with strategic alliances to strengthen its marketing platform.SALI demo clip: https://www.youtube.com/watch?v=JbKqQzjJRWY

Company Name: Inovytec Medical Sub-Sectors: Medical devicesMedical Field: Critical care

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Minimally-invasive solution for the sinus lift procedure: solving dental implants' biggest problem.



In the market



Executive summaryMaxillent overcomes the most difficult procedure in dental clinics today: the sinus lift, required for 20% of dental implants, which causes patients major discomfort and requires 3 to 10 rest days. Maxillent’s iRaise™ Sinus Lift System transforms the sinus lift from technically demanding, traumatic surgery into a simple, minimally invasive procedure. It addresses a yearly market of $1.5 billion.In addition to transforming the patient’s experience, iRaise offers ease and simplicity to the dentist – especially the growing demographic of non-specialist dentists performing dental implants, who are reluctant to perform advanced surgery. For dental implant manufacturers, iRaise offers a solution to the problematic tend towards commoditization and price competition.Maxillent’s progress has been rapid: first human implantations were achieved within eleven months from commencement of operations, and sales were achieved within three years. Sales are ongoing in several countries including France, Italy, and Hong Kong. Immediate goals are expanding sales territories and obtaining FDA approval.Management includes CEO Gideon Fostick, a Talpiot graduate with twenty years of high-tech management experience, and CMO Dr. Hadar Better, Past President of the Israeli Association for Oral and Maxillofacial Surgery. Maxillent is a portfolio company of Rainbow Medical.

ContactContact person: Gideon FostickJob Description: CEOE-mail: [email protected]: www.maxillent.comMobile No.: +972-54-4463310Telephone No.:+972-9-9534500Address: POB 4100, Herzliya 4614002, Israel

Company Name: Maxillent Ltd Sub-Sectors: Therapeutic DevicesMedical Field: Dental

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ContactContact person: Julia DivonJob Description: Business Development ManagerE-mail: [email protected]: www.medispec.com Mobile No.: +972-52-8347288Telephone No.:+972-3-6322004Address: 40 Hataasiya st. Yehud, Israel


Medispec as a leader and market opener of innovative shock wave therapy applications targeted to vascular market.



All products are marketed worldwide, the Erectile Dysfunction product is estimated to receive FDA approval by the end of 2014.

Amount of funds raisedSelf financed


Executive summaryFounded in 1992, Medispec has developed a platform shockwave technology which offers non invasive, highly effective therapy for main stream medical conditions in Cardiology, Urology and Orthopedics. Since its establishment, Medispec has become one of the leading suppliers of shock waves non-invasive devices in the world; Company's main future growth engine is expected to be in the vascular market with its innovative treatments for Ischemic Heart Disorder and Erectile Dysfunction, together with continued stable growth in the Lithotripsy and Orthotripsy markets.Medispec's distribution channels include a fully owned subsidiary in USA dedicated to USA market and a network of more than 80 local distributors in most of the countries worldwide, with an install base of over 2000 units.In 2012 Medispec has generated sales of $ 14.6 million USD.ED Market Opportunity:The treatment possibilities of low intensity shockwaves could be utilized in a large number of clinical indications, where, reduced blood flow (ischemia) is present. One of these fields is Erectile Dysfunction (ED). The current available treatment options comprised of surgery (use of implants, reconstruct arteries or block-off veins), vacuum constrictions devices, hormonal therapy and pharmacotherapy. The majority of treatments and management performed today on patients with Erectile Dysfunction is done by modalities that relay mainly on the usage of pharmacotherapy particularly PDE-5 inhibition medication (Viagra / Cialis / Levitra).The marketing positioning for this new treatment option is an alternative to PDE5i. Patients who benefit from these medications, will have the choice to decide on the most suitable treatment option for them. From the Urologist point of view, we plan on direct marketing of this treatment modality to private clinics, as this will bring them back ED patients, which currently receive treatment (PDE5i) from other sources (family doctors, GP's, etc).

Company Name: Medispec Sub-Sectors: Medical EquipmentMedical Field: Urology (Kidney Stones Fragmentation, Erectile Dysfunction) Cardiology, Orthopedics

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ContactContact person: Sharon Ben YehudaJob Description: CEOE-mail: [email protected]: www.photopill-med.comMobile No.: +972-52-8988013Telephone No.:+972-50-5626404Address: 15 Deganiot street, Rehovot Israel 76606


PhotoPill is a medical device Israeli start-up company, which develops a swallow-able miniature self-use disposable capsule that provides light therapy to the gastrointestinal tract, for the purpose of treating Inflammatory Bowel Diseases flare-up in general and Crohn's Disease in particular. The company addresses the 5.5M IBD patients in the Western world with a safer, side-effect free treatment for IBD flare up management.



Pre-clinical

Amount of funds raised$500K

Requested investment amount$500K-$1M

Executive summaryPhotoPill™ is a medical device start-up company, which develops a swallow-able self-use disposable capsule that provides light therapy to the gastrointestinal tract, for the purpose of treating Inflammatory Bowel Diseases flare-up, and Crohn's Disease (CD) in particular. The market - Inflammatory Bowel Disease (IBD) is characterized by intense inflammatory process and ulcerations involving the intestine mucosa. There is an estimation of over 5.5 Million IBD patients in the Western world, of which 2.2 Million are CD patients. There is no cure for IBD, and two-thirds of CD patients go through surgery at some point of their disease. The need - Currently used IBD medications have side effects as they work systematically; Side effects are multiple and at times serious. As most patients (about 90%) are reporting adverse side effects – there is a need for safer treatment with considerably fewer side effects.The solution - PhotoPill™ Medical addresses the CD multi-Billion dollar a year medication market, with a safer, non-chemical solution, by delivering effective local therapy directly to the inflamed intestine tissue without systematic application of chemicals, interference with the body's immune system and no side effects. The PhotoPill™ capsule is a disposable device with a market potential of a medication.Status - The Company has developed a first generation capsule and demonstrated strong efficacy in small animals, completed safety studies in large animals and a first human safety pilot in healthy volunteers. PhotoPill™ is now seeking Round-A funding to develop its 2nd generation capsule and to demonstrate clinical efficacy in CD patients.

Company Name: PhotoPill Medical Sub-Sectors: Therapeutic DevicesMedical Field: Gastroenterology

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ContactContact person: Kali RotemJob Description: VP FinanceE-mail: [email protected]: www.premiaspine.comwww.betterthanspinalfusion.com Mobile No.: +972-54-6886607Telephone No.:+972-72-2281200Address: 7 Giborey Israel St., Netanya, 42502 Israel


Premia Spine has begun commercializing the TOPS System, a superior motion implant which promises to replace traditional spinal fusion surgery for patients suffering from spinal stenosis and other lower back maladies.



FDA study; CE approval with sales in Europe & Israel

Amount of funds raised$7.2M


Executive summaryPremia Spine is commercializing the TOPS™ System, a spine implant for patients suffering from lower back pain. Over 650,000 patients undergo lumbar spinal fusion each year, representing a +$3 billion market. A third of these patients can avoid fusion surgery with the TOPS™ System. Premia’s mobile joint prosthesis recreates stability and motion at the operative level, much like a hip or knee replacement, for the lower back. Premia’s dynamic TOPS™ System offers advantages versus traditional fusion surgery. Patients do not lose any of their motion. Instead, they experience immediate and sustained pain relief and function, as demonstrated by clinical trials since 2005.TOPS was launched commercially in September, 2012. Premia is engaged in a controlled product roll-out in Germany, Austria, Switzerland, UK, and Israel. All centers are supported with direct field personnel. The goal is to expand the Company’s market presence and demonstration the clinical superiority of the device in key accounts. In the US, Premia is engaged in a pilot clinical study, and plans to initiate a pivotal FDA study for US approval.The Company is a reincarnation of Impliant, Ltd $70 million has been invested in developing the TOPS™ System. Premia has 30 worldwide patents.

Company Name: Premia Spine LtdSub-Sectors: Medical DevicesMedical Field: Spine implants

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Bio-Pharma

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ContactContact person: Noam NoyJob Description: CBOE-mail: [email protected]: www.BioGenCell.net Mobile No.: +972-52-2454886Telephone No.:+972-9-8609248Address: Sanz Medical Center Laniado hospital, Netanya, Israel


BioGenCell develops a technology platform for automated production of patient-specific stem-cell-based therapies. The company’s lead product, BGC101, is designed to treat vascular diseases and to enable physicians to treat patients the day after diagnosis.The company is gearing up to start its phase 1/2 clinical trial in ischemic leg patients.



Entering clinical trials


Requested investment amountBioGenCell is currently looking for round A financing of $7M to complete its phase I/II clinical trials. Round B is expected to require $15M in order to receive market approval from the FDA and Medicare reimbursement.

Executive summary

A regenerative medicine biotech company developing a ground breaking technology platform for automated production of patient-specific stem-cell-based therapies. Our mission is to create the safest, fastest and easiest-to use stem-cell therapies, enabling physicians to successfully treat patients the day after diagnosis.

Market Size: Targeting the huge market ($750B) of vascular diseases with Critical Limb Ischemia (CLI) as the initial target - a common complication of diabetes which leads to limb amputations and is considered a “serious condition” due to its irreversible morbidity and mortality (IMM). Medicare’s annual cost of CLI treatments will exceed $8B by 2020.

Lead Product: BGC101 is designed to prevent amputations in “no-option” CLI patients who must undergo amputations, and is expected to save Medicare more than $2B annually, with a total available market of over $5B per year in the US alone.

Regulatory & Reimbursement: Since there is no approved treatment for CLI, new technologies are considered breakthrough therapies by the FDA and can be included in the expedited regulatory programs for serious conditions (FDA CEBER DRAFT GUIDANCE 2013) that significantly shorten time-to-market. Under this program, BioGenCell aims to get FDA approval for treating “no option” CLI patients within 4-6 years.

Trial Status: BioGenCell is entering the clinical trials phase after completing preclinical animal studies, which conclusively proved the concept behind the technology and its superiority in terms of safety, efficacy and production time.

IP Status: Fully owned by the company; protects Product & Methodology; in the national phase.

Company Name: BioGenCellSub-Sectors: Stem Cells TherapyMedical Field: Vascular Diseases

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IDD Therapeutics is an Israeli start-up company committed to designing, developing and commercializing innovative pharmaceuticals for cancer. The company was founded by Dr. Anwar Rayan.



Late Preclinical


Requested investment amount$3M

Executive summaryCompany Technology: IDD Therapeutics is focused on the development of New Therapeutic Entity (NTE) drugs for cancer therapy, using the company's proprietary Intelligent Learning Engine® platform. By screening databases of chemicals targeted towards specific biological targets and indications, this novel discovery platform allows the selection of the best molecules for development, with high probability for possessing outstanding efficacy and toxicology profiles compared to current marketed drugs. The Need and Market size: cancer is the second leading cause of death in the Western World ;~0.6M estimated cancer deaths; ~1.7M newly diagnosed patients in US alone (2013). Billion dollar revenue-generating potential for IDD-1040 ( taxane related cytotoxic drugs) Product (s): IDD’s first lead molecule, IDD-1040, is a prodrug of Paclitaxel consisting of a neuroprotective anti-oxidant moiety, α Lipoic Acid. It is synthesized in a simple one-step chemical procedure. Compared to Paclitaxel, IDD-1040 exhibits a unique PK profile, superior efficacy and excellent safety. Other products in development.IP: 1. Drug discovery platform: system and methods for performing a screening process - WO/2009/090613. 2. Anti-Cancer Drugs: Derivatives of Taxol and Closely Related Compounds - WO/2009/090614 - granted Dec 2013.Regulatory and Business Strategy: IDD-1040 is being developed as a prodrug of Paclitaxel using the 505(b)2 regulatory pathway, as approved at a pre-IND meeting with the FDA, requiring a single toxicology study. IDD has completed seed funding of $1M; seeking $3M to finalize preclinical and Phase I/II studies by the end of 2016.

ContactContact person: Dr. Rachela OppenheimerJob Description: CEO & CTOE-mail: [email protected]: www.idd-therapeutics.comMobile No.: +972-54-2405926Telephone No.:+972-4-6098600Address: Wadi El Haj 13, P.O.Box 1252 Nazareth Elite 17111, Israel

Company Name: IDD Therapeutics LtdSub-Sectors: BiopharmaMedical Field: Cancer Therapeutics

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MedWell is a creative pharmaceutical company that offers a novel approach to managing mild to moderate chronic inflammatory disorders which are mainly treated by non-steroidal anti-inflammatory drugs (NSAIDs).



Clinical trials


Executive summarySteroidal and Non-Steroidal anti inflammatory drugs (NSAIDs) constitute one of the most widely used class of drugs, with more than 70 million prescriptions and more than 30 billion over-the counter tablets sold annually to 15 million patients in the United However, anti-inflammatory NSAIDs are a cause of ulcers and gastrointestinal bleeding (16,000 deaths in the US per year), while selective NSAIDS (COX-2 inhibitors) are related to severe renal side effects and cardiotoxicity. Thus there is a medical need to develop new therapeutics that are, safe and effective anti-inflammatory agents. Medwell’s new chemical entities showed selective inhibition to both COX-2 and 5-LOX enzymes, with a safe and effective anti-inflammatory therapeutic effect. The compounds are based on Docosahexaenoic acid (DHA) and hydroxyproline, which are both natural components that are available in an every day food consumption and participate in the human body's processes, making Medwell’s a new yet safe entity. In clinical pilots done Medwell’s MWL001 showed clear effectiveness in Atopic Dermatitis in children and Eczema in young adults. In its anti aging study, wrinkles were reduced by 20% in the treatment side, compared to 10% in the most effective alternative available today. In preclinical studies in animals the inflammation was shown to decrease while showing superior results to existing drugs, as demonstrated in RA and UC animal models. In addition, the studies demonstrated improved gastrointestinal tolerability and reduced cardio-toxicity. Medwell completed clinical pilots in Pediatric Atopic Dermatitis and Eczema in adults, as well as anti aging applications.Medwell is seeking to complete its US$3M financing round for completing phase II of its dermatology application, and for conducting a phase I/II clinical trial for Fatty Liver (planned for 2014).

ContactContact person:Miki OlshanskyJob Description: CEOE-mail: [email protected] No.: +972-54-4594704Address: Wadi El Haj 13, P.O.Box 1252 Nazareth Elite 17111, Israel

Company Name: Medwell LabsSub-Sectors: Biotechnology Medical Field: pharmacuetics

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