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Revolutionize Global Healthcare: Top 10 Israeli medical advances to watch in 2014 @ ISRAEL21c

Top 10 Israeli medical advances to watch in 2014 @ ISRAEL21c

Reporter: Aviva Lev- Ari, PhD, RN

 

Top 10 Israeli medical advances to watch in 2014 | ISRAEL21c 12/29/13, 3:54 PM

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ISRAEL21c compiles a list of the 10 most extraordinary medical devices and pharmaceuticals that promise to revolutionize global healthcare.

 

Top 10 Israeli medical advances to watch in 2014

By Abigail Klein Leichman December 22, 2013, No Comments

Prof. Hossam Haick with the Na-Nose prototype.

In our recent “Top 12 most amazing Israeli medical advances”, we promised a top 10 list of the most exciting Israeli medical-device and

pharmaceutical developments just around the corner.

Like the top 12, this list was also very difficult to narrow down, because Israeli breakthroughs in this field are a near-daily occurrence. Our top 10

is just the tip of the iceberg.

Watch for new health stories on ISRAEL21c every week for a broader picture of how Israeli ingenuity is changing the face of healthcare

worldwide.

1. Na-Nose can detect lung cancer from exhaled breath and will be commercialized in a joint venture with Boston-based Alpha Szenszor – after

a few more years of development and testing by the US Food and Drug Administration (FDA). Invented by Technion Prof. Hossam Haick, Na-

Nose (the “na” is for “nanotechnology”) has been proven in numerous international clinical trials to differentiate between different types and

classifications of cancer with up to 95 percent accuracy.

LLiikkee 2.5k

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2. Hervana non-hormonal, long-acting contraceptive suppository won a $1 million development grant last year from the Bill & Melinda Gates

Foundation. The Gates Foundation is banking on the product’s potential to provide a more accessible, cheaper and socially acceptable family

planning option in developing countries, though it would be marketed in the United States and Europe as well.

Hervana founder Rachel Teitelbaum with Bill Gates.

3. Vecoy Nanomedicines nano-scale virus-traps (“vecoys”) capture and destroy viruses before they can infect cells, offering a huge advance

over antiviral medications and even vaccines. Through the MassChallenge startup accelerator program last November, Vecoy’s platform was

chosen to be tested in zero-gravity conditions on an upcoming NASA space mission.

Treating viruses with vecoys.

4. CartiHeal Agili-C cartilage regeneration solution for knees can regenerate true hyaline cartilage (the most abundant type of cartilage in the

human body) after six months, according to clinical results so far. Based on research at Ben-Gurion University of the Negev, the implant has

earned the European Union’s CE Mark of approval. Further clinical studies could lead to FDA approval in the coming years.

5. Oramed Pharmaceuticals seeks to change Type 2 diabetes treatment from a daily injection to a daily pill. Its oral insulin capsule recently

received patent approval in the EU, and is in Phase 2 clinical trials under an Investigational New Drug application with the FDA. Jerusalem-based

Oramed is also moving forward with clinical trials of a capsule to treat Type 1 diabetes.

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Finally, an oral medication for diabetes?

UPDATED ON 12/4/2015

ORAMED SIGNS UP TO $50 MILLION LICENSING AND INVESTMENT AGREEMENTS FOR ORAL INSULIN CAPSULE IN CHINA

Receiving up to $38,000,000 + royalties for licensing deal and $12,000,000 for equity investment at $10.39 per share

JERUSALEM, Nov. 30, 2015

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has signed definitive licensing and investment agreements valued at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co., Ltd. (“HTIT”) for exclusive rights to market Oramed’s oral insulin capsule, ORMD-0801, in China, Hong Kong and Macau. The agreements were signed at the Israel Knesset (Parliament).

From left to right: Prof. Avram Hershko, Oramed Scientific Advisory Board; Mr. Nadav Kidron, Oramed CEO; Mr. Bin Zhou, Sinopharm Vice General President; Mr. Xiaoming Gao, HTIT Chairman [photo: Maoz Vaystooch. editorial use only/courtesy Oramed.]

[From left to right: Prof. Avram Hershko, Oramed Scientific Advisory Board; Mr. Nadav Kidron, Oramed CEO; Mr. Bin Zhou, Sinopharm Vice General President; Mr. Xiaoming  Gao, HTIT Chairman. Photo: Maoz Vaystooch]

The license agreement payments include a $3 million payment due upon execution of the agreement, $8 million in near-term payments subject to Oramed entering into certain agreements and the balance payable upon achievement of certain milestones. In addition, if all conditions are met, HTIT will pay a 10% royalty on net sales of the related commercialized products.

In addition to the contemplated payments under the license agreement, pursuant to the investment agreement, Oramed will issue to HTIT 1,155,469 restricted shares of Oramed’s common stock at a price per share of approximately $10.39 and $12 million in total, subject to customary closing conditions.

“China recently became the country with the largest number of diabetics in the world. Having signed these definitive license and investment agreements, our oral insulin capsule could help serve the growing population of people in China living with diabetes,” stated Oramed’s CEO Nadav Kidron.  “In addition to the $50 million in milestone payments and investments, we believe the royalties on net sales throughout China will have a very significant impact on Oramed’s future revenues and earnings, upon market approval of ORMD-0801 in China.”

About Hefei

HTIT, which is partially owned by Sinopharm Group Company Limited, has state of the art insulin production facilities in Hefei, China. HTIT has a business focus which includes industrial investment and incubation services; high-tech product R&D; technology transfer and related consulting services.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801).  Having completed separate Phase IIa clinical trials, the company anticipates the initiation of separate Phase IIb clinical trials, in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration.  In addition the company is developing an oral GLP-1 analog capsule (ORMD-0901).

For more information, please visit www.oramed.com, the content of which is not part of this press release.

SOURCE

http://www.oramed.com/oramed-signs-up-to-50-million-licensing-and-investment-agreements-for-oral-insulin-capsule-in-china/

6. Premia Spine developed the TOPS (Total Posterior Solution) System, aiming to revolutionize the spinal implant market with an artificial joint in

the same way that total hip and total knee replacement systems made hip and knee fusions a thing of the past. TOPS is available already in

Austria, Germany, the UK, Turkey and Israel. An FDA study is now in the follow-up phase.

TOPS is revolutionizing the spinal implant market.

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7. Mapi Pharma recently won US patents for two promising slow-release platforms for drugs to treat multiple sclerosis symptoms and pain. “We

believe in two to three years they could be in the final stage of development, and about three years to market,” says Mapi Pharma president and

CEO Ehud Marom. Another slow-release platform for a schizophrenia drug is next in the pipeline.

8. Discover Medical introduced the SomnuSeal mask for CPAP machines – used widely by sufferers of sleep apnea – in Europe. If sales are

successful, the US market will be next. Because SomnuSeal is more comfortable than the current masks used with the machine, compliance

could be much greater. Plus, the device does not put strain on the heart as the current mask does.

A more comfortable, safer mask for treating sleep apnea.

9. Real Imaging is in the midst of European clinical trials of RUTH, its radiation-free, contact-free, inexpensive and advanced imaging system

for early detection of breast cancer. The system, which has won patent approvals in several countries, analyzes 3D and infra-red signals emitted

from cancerous and benign tissue, generating an objective report that needs no interpretation. Founder and CTO Boaz Arnon presented RUTH

at the most recent conference of the Radiological Society of North America. Initial release of the product will likely be in Europe sometime in

2015.

Top 10 Israeli medical advances to watch in 2014 | ISRAEL21c 12/29/13, 3:54 PM

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About Abigail Klein Leichman

Abigail Klein Leichman is a writer and associate editor at ISRAEL21c. Prior to moving to Israel in 2007, she was a specialty writer and copy editor at a daily

newspaper in New Jersey and has freelanced for a variety of newspapers and periodicals since 1984.

View all stories by Abigail Klein Leichman →

RUTH, a hands-off breast cancer detection alternative.

10. NeuroQuest has started clinical testing in the United States, under the auspices of Harvard Clinical Research Institute, for its

groundbreaking blood test to detect early-stage Alzheimer’s disease. Initial trials in Israel showed NeuroQuest’s test – based on research by

Prof. Michal Schwartz of the Weizmann Institute of Science – to be 87 percent accurate with an 85% specificity rate in detecting Alzheimer’s and

ALS, two common neurodegenerative diseases.

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