Jerusalem, Israel, January 12, 2009 – Chiasma, Inc. today made the following announcements:

·        Using the Company’s proprietary Transient Permeability Enhancer (TPE) technology, scientists at Chiasma have delivered drugs orally in animal models that previously had only been available via injection.  The TPE platform has successfully transported proteins, peptides, polysaccharides and non-soluble small molecules into the blood to achieve clinically meaningful bioavailability levels.  The TPE technology is protected by 2 families of patents owned by Chiasma.

·        The investors in the Company’s Series A Preferred Stock --- ARCH Venture Partners, MPM Capital, 7 Health Ventures, Ofer Hi-Tech and F2-ventures --- have invested a total of $9 million and committed an additional $2 million, subject to certain milestones, through the purchase of the Company’s Series B Preferred Stock.  This financing takes into account a recapitalization of the company’s equity structure to reflect that all previous preferred investments are now categorized as part of the Series A Preferred Stock.

·        Chiasma has reorganized its Board of Directors and Management team, which is now led by Fredric Price, Executive Chairman and Acting CEO.  Mr. Price was formerly Chairman of Omrix Biopharmaceuticals and Chairman & CEO of BioMarin Pharmaceutical.  Roni Mamluk, PhD, has been promoted to General Manager and Vice President, R&D.  Scott Minick of ARCH, Todd Foley of MPM, Dalia Megiddo, MD, of 7 Health Ventures and Bard Geesaman, MD, PhD, of GPC-RX and F2 have been elected to the Board; Shay Dubi, MD, PhD, of Ofer HiTech has been named a Board Observer.

·        The Company has moved into state-of the-art facilities in Jerusalem that provide room for expansion of its biology, chemistry and animal laboratories as well as office space to accommodate growth.

Fredric Price said, “Chiasma has undergone a successful transformation recently with the evidence that the TPE system has applicability to a wide range of molecules in multiple animal models.  Our challenge is to achieve results in humans that are as effective as what we have been able to accomplish in animals, and we are focused on entering the clinic later this year.  We are proceeding with drugs that, if approved with the TPE system, will be the first oral delivery for each particular molecule.  Our first-to-market strategy relates to both drugs which we license to third parties as well as drugs for which we initiate development activities on our own and subsequently seek to enter into partnerships in which we retain certain development and commercialization rights.”

“Most macromolecular drugs such as peptides and proteins cannot be taken orally and have to be administered by intravenous, subcutaneous, or intramuscular injection,” noted Roni Mamluk, PhD.  “Bypassing the biological hurdles preventing oral delivery of such drugs may improve a patient’s quality of life through the elimination of injections and, in specific cases, even reduce undesired side effects. 

“We have recently demonstrated that administration of protein drugs formulated with the TPE technology to rats and pigs resulted in blood levels comparable to those achieved after injection of these drugs.  The similarity in outcomes in both rodents and large animals as well as the capability to use the technology with drug molecules of varying sizes and characteristics is encouraging and paves the way for our first trials in humans.”  

Dr. Mamluk continued, “Chiasma has established a well-controlled, simple and cost-effective manufacturing process in which no chemical modification of the drug takes place, and the drug is released in its original form to the blood.  Moreover, the process is designed to ensure the activity and stability of the drug substance.”

7 Health Ventures is proud to introduce the new members of its investment team Limor sandach, Amir Zaidman and Ephraim Heller.Together with the managing partner Dr Dalia Megiddo, this team brings a unique, professional and in-depth experience in developing young companies, Hi-tech management, legal and financial processes, and a direct, friendly and honest way of "doing business".

Limor sandach (formerly a principal in Evergreen fund) is joining as a partner, and brings a large experience in investment in the healthcare field, executive mentoring and business development activities for young start-up companies.

Amir Zaidman (formerly a VP in OHV technology incubator) is joining as a principal, and brings a valuable legal and financial knowledge and an in-depth understanding of business processes and deal structuring.

Ephraim Heller (formerly the co-founder of TheraSense) is joining as a venture partner and brings his extensive executive experience and large network in the health-care industry in the US.

7 Health Ventures is a professional venture capital fund dedicated to investing in Israeli and Israeli-related companies, developing healthcare technologies and products.

AngioSculpt catheter still on a roll with latest FDA 510(k) - Medical Device Daily

By AMANDA PEDERSEN

In September 2004, AngioScore (Fremont, California) received the CE mark to launch its flagship product, the AngioSculpt, in Europe and has been on a regulatory roll with the angioplasty scoring balloon catheter ever since.

"Yes, we're actually doing quite well," President/CEO Thomas Trotter told Medical Device Daily.

On Thursday the company reported its latest achievement: FDA clearance to sell its AngioSculpt Percutaneous Transluminal Angioplasty (PTA) catheter for balloon dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The PTA catheter is not labeled for use in the coronary or neuro vasculature.

Trotter said the latest FDA clearance to market the AngioSculpt PTA catheter opened up opportunities in what he termed the "largest and fastest-growing segments" of the U.S. peripheral artery disease (PAD) market, including the superficial femoral artery (SFA) and stenoses involving hemodialysis of synthetic or native arteriovenous (A/V) fistulae. He noted that in 2007 an estimated 275,000 SFA and 300,000 A/V fistula procedures were performed in the U.S.

The AngioSculpt PTA catheter received initial FDA 510(k) clearance for the treatment of infra-popliteal PAD in September 2005.

In January 2007, AngioScore's companion product, the AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) scoring balloon catheter, received PMA approval from FDA for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion (MDD, Jan. 12, 2007).

Then, this past January, AngioScore reported obtaining import approval for the AngioSculpt in Japan for the interventional treatment of coronary artery disease (CAD). Gaining access to the Japanese market is something very few small device companies achieve, given Japan's high performance standards and stringent quality control requirements.

"You could probably put on one hand the number of small private companies that get it," Trotter said.

Designed to be an improved angioplasty catheter for complex lesions, the AngioSculpt is comprised of a semi-compliant angioplasty balloon surrounded by a scoring element, which is intended to work in tandem with the balloon to deliver a scoring effect to the target lesion upon balloon inflation.

As the balloon inflates, the radial forces are concentrated along the surfaces of the nitinol-scoring element, which results in luminal expansion that is — according to AngioScore — "precise, predictable, and controlled." The catheters represent the "next generation" in angioplasty catheters, Trotter told MDD.

"It's got a lot of advantages in terms of helping the physicians do a better job of placing the stents or opening the arteries and it's a very safe device," Trotter said, adding that the AngioSculpt catheters have been used in more than 15,000 procedures worldwide.

With CE marks in Europe, FDA clearance and PMA approval in the U.S., and import approval in Japan for the CAD indication, Trotter said that completes "pretty much" all the regulatory approvals the company needs for the AngioSculpt catheter. The only thing that remains, he said, is approval for the peripheral indications in Japan, which is expected later this year.

In addition to gaining regulatory ground rather quickly, Trotter said AngioScore also has enjoyed success on the commercial side. Last year the company did just under $10 million in sales, he said, and this year it anticipates "something a little more than $20 million."

The company has doubled in size over the last 12 months in terms of its workforce, Trotter said, and has doubled its sales. AngioScore uses distributors in Europe and Japan and a direct sales force in the U.S., he added.

In October AngioScore reported raising $30 million in private equity financing, which it said helped the company ramp-up its worldwide sales effort (MDD, Oct. 10, 2007).

On the product side, Trotter said the company has "a whole series of longer and larger AngioSculpts that will be released to the market over the next 12 months," for the peripheral indications, including those for which the company just received FDA clearance. Originally designed for smaller, below-the-knee vessels, the longer and larger catheters will be used in procedures involving larger, above-the-knee vessels.

He also mentioned a rapid-exchange version of the catheter for the coronary indications and — looking further into the future — a drug-coated version of the device that is in the works for the PAD market.

Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has received FDA approval to restart patient enrollment in a pivotal IDE trial of its TOPS^{™ System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.}

Impliant voluntarily suspended enrollment in the study in September of last year following one device-related failure. After an extensive investigation conducted by a third-party expert in medical device retrievals and the Impliant Research and Development team, it was determined that device misalignment coupled with excessive shear loading caused the failure. As a result, Impliant has made a few minor design and manufacturing changes to the internal components of the TOPS™ device that allow it to better withstand high shear loads and misalignment while not affecting its range of motion.

Paul McAfee, M.D., Chief of Spine Surgery, St. Joseph’s Medical Center and TOPS™ Principal Investigator, stated, “Impliant should be commended for the responsible way they responded to the one device failure encountered in the study. Excessive shear force has contributed to the failure of several posterior motion devices. I believe the shear testing conducted by Impliant will become the new standard for all posterior motion devices going forward. I am impressed by the level of detail in their investigation in diagnosing and fixing the issue. I look forward to resuming the study and building upon the outstanding clinical results generated thus far in the IDE and under protocol outside the United States.”

“This is a very gratifying day for Impliant,” commented Todd Potokar, President and CEO of Impliant. “The resumption of our TOPS™ clinical study represents the culmination of a lot of hard work and support by individuals both inside and outside the orgainization. We are especially grateful to all of our investigators for their input, dedicaton and support over the past several months. We are all very excited to get started again.”

Impliant has enrolled 74 patients to date in its prospective, randomized IDE study comparing the TOPS™ System to a traditional posterior fusion. The company also currently has 75 TOPS™ patients enrolled under single and multi-level protocols in Brazil, Belgium, Turkey, and Israel.

 Impliant is applying cutting-edge materials and crossbar biomechanical techniques to develop a new class of spine arthroplasty devices that target over 40% of the patients worldwide who undergo fusion surgery and could benefit from a Total Posterior Arthroplasty solution.

Impliant’s TOPS™ System, a mobile posterior device, is designed to stabilize but not fuse the L3-4 or L4-5 vertebral level to alleviate pain stemming from spinal stenosis with or without degenerative facet arthrosis and spondylolisthesis. Following a laminectomy and medial facetectomy, the device is affixed to the spine via four pedicle screws using a standard posterior surgical approach. Impliant believes that the TOPS™ System could benefit over 500,000 patients worldwide undergoing spinal fusion surgery each year. The TOPS™ System is not approved for sale in the United States.

22.6.2008  - The Marker, מאת גיא גרימלנד   הסיפור האישי והמקצועי של אפרים הלר יכול לשמש בסיס לסרט דרמה. הלר הוא ישראלי לשעבר המתגורר בסן פרנסיסקו, ושמשמש כיום שותף עצמאי בקרן הון סיכון 7Health הישראלית, המשקיעה בחברות סטארט-אפ ישראליות המפתחות טכנולוגיות רפואיות. בענף מדעי החיים הישראלי יזכרו את הלר, 46, כמי שעמד מאחורי אחד האקזיטים המרשימים בתחום הביו-טכנולוגיה: מכירת תראסנס (Therasense), שפיתחה טכנולוגיה לבדיקת רמת הסוכר בחולי סוכרת, לאבוט האמריקאית בעבור כ-1.2 מיליארד דולר ב-2003. הלר נולד בישראל. ילדותו עברה בצלה של מחלת כליות קשה שתקפה את אחותו, טלי. כשהיה הלר בן שנה, עברה משפחתו לארה"ב בחיפוש אחר טיפולים רפואיים - שלא היו בנמצא בישראל - שיסייעו לטלי. "בגיל 21 טלי מתה ממחלת כליות", הוא מספר. "הורי תמיד דאגו מה יקרה בעתיד כשהם ימותו, האם היא תהיה בסדר. שאם יקרה להם משהו, אני אהיה אחראי לאחותי". למרות החיים בצל הטרגדיה המשפחתית, עשה הלר חיל בפן המקצועי. הוא למד פיסיקה לתואר ראשון באוניברסיטת הרווארד. לאחר מכן עבד במשך שנתיים בחברה ייעוץ שוודית בשם SIAR שהיה לה סניף בארה"ב. הוא המשיך ללימודי מינהל עסקים באוניברסיטת ייל ולאחר מכן עבד ב-hp במשך ארבע שנים. התפוח לא נופל רחוק בשלב זה לא ניתן שלא להזכיר את אביו של הלר, אדם הלר, שותפו לחברת תראסנס. אדם הלר, 74, הוא ממציא ויזם סדרתי. הוא נחשב לאחד מחלוצי מדעי החומרים לתעשיית האלקטרוניקה, שבנה את הלייזר הנוזלי הראשון. אדם הלר עבד במעבדות בל כחוקר. ב-88' עזב את החברה ועבר לאוניבריסטת טקסס, שם הוא עדיין ממלא תפקידים שונים. "לאבי היה חזון למדוד את רמת החשמליות של אנזימים בגוף", נזכר אפרים הלר בהולדתה של הטכנולוגיה שהובילה לתראסנס. "הרעיון היה לבדוק באופן חשמלי מהי רמת הסוכר בדם מתחת לעור. חולי סוכרת צריכים להזריק 5-8 זריקות ביום כדי לשמור על רמת הסוכר שלהם. כשאתה צריך לדקור את עצמך כל כך הרבה פעמים, זה קשה וכואב". במשך ארבע שנים עבד אדם הלר על הרעיון. ב-92' החליט אפרים להצטרף לאביו והשניים הפכו את הטכנולוגיה שפיתחו למוצר. ואולם קרנות הון סיכון נרתעו מלהשקיע בחברה. "זו היתה תקופה שבה חברות השתלות חזה נתבעו", מספר הלר. "הן פחדו לשים חומרים מלאכותיים בתוך הגוף. מה שתראסנס עשתה היה לקחת חוט דק ולהדביק לו בקצה חומר כימי שמתחבר לסוכר ויוצר זרם חשמלי פורפורציונלי לרמת הסוכר. העובדה שהשתמשנו בחומר כימי הפריעה לקרנות. האנשים שישבו בהן לא הבינו איך אנחנו בכלל מנהלים סטארט-אפ בלי כל ניסיון. האמת היא שהם צדקו. לא היה לנו ניסיון. החלטנו לפתח מכשיר שמאפשר למדוד את רמת הסוכר מחוץ לגוף". השניים פיתחו אבטיפוס המאפשר למדוד את רמת הסוכר בדם באמצעות דגימת דם קטנה פי 30 מהכמות שנדרשה למכשירי המדידה הקיימים. באותה תקופה, חולי סוכרת נהגו לדקור את עצמם באצבע - שם יש כמות רבה של נימי דם. המוצר של משפחת הלר איפשר למדוד דם גם באזורים אחרים בגוף שכללו פחות נימי דם ולהגיע לאותה תוצאה. קרנות הון סיכון התלהבו מהמוצר ותראסנס החלה להתרומם. היא גייסה כ-80 מיליון דולר מקרנות הון-סיכון ואז יצאה להנפקה ציבורית וגייסה עוד כ-40 מיליון דולר. "אחד הדברים הכי חכמים שעשיתי היה לשכור מנכ"ל מקצועי (מארק לורץ מג'ונסון & ג'ונסון)", מודה הלר בכנות מדוע לא ניהל את החברה. "לאחר שפיתחנו את המוצר, המשימה השתנתה והמטרה היתה להגדיל את המכירות שלו. כעת הוא נמכר כחלק ממוצרי אבוט בהיקף של 600 מיליון דולר בשנה. גם המתחרים העתיקו אותו". ב-2002 עזב הלר את החברה וב-2003 היא נמכרה לאבוט בעבור כ-1.2 מיליארד דולר. המשפחה התעשרה, אך "עזבתי כי אני לא מתאים לשמש בתפקיד בתוך חברה גדולה שרק צריכה לצמוח במכירות". בד בבד המשיכו אפרים ואביו לעבוד על פיתוח ההמצאה הישנה שלהם, מכשיר למדידת סוכר מתחת לעור, עד שאושר על ידי ה-FDA (רשות התרופות והמזון האמריקאי) וכיום גם הוא נמכר. הזרוע האמריקאית של הקרן תשעה חודשים לאחר הפרק בתראסנס, נפגש הלר עם קבוצת יזמים ישראלים מחברת אנג'יוסקור, והתלהב מהפיתוח הטכנולוגי. החברה פיתחה בלון צנתור המסוגל לטפל בנגעים בעורקים הכליליים של הלב במצבים של עורקים מפותלים או מפוצלים. הלר שימש מנכ"ל החברה עד 2005. החברה גייסה 15 מיליון דולר ממשקיעי הון סיכון, כשאחד המשקיעים היתה אינומד, קרן מדעי החיים של ג'רוזלם גלובל ונצ'רס, שבראשה עמדה דליה מגידו. "את דליה פגשתי עוד כשהשקיעה בחברת גלוקון, והיא הזמינה אותי לשמש חבר במועצת המנהלים של החברה", מספר הלר. לפני חצי שנה החלה מגידו בניסיונות לשכנע את הלר להצטרף לקרן שהקימה - 7Health, ולפני שלושה חודשים הוא השתכנע והחל לשמש שותף עצמאי בקרן. "הצוות הישראלי בקרן - מגידו, לימור סנדק ואמיר זיידמן - נמצא בקשר עם חברות סטארט-אפ ישראליות. התפקיד שלי הוא להיות הבחור הרע. למצוא חסרונות בחברות שהם מאתרים", צוחק הלר. "מעבר לכך, התפקיד שלי הוא להיות הזרוע האמריקאית של הקרן. הרבה חברות ישראליות עוברות לארה"ב כי שם השוק הגדול, ואני קרוב לשוק הפיננסי ולקהילה הרפואית שם". 7Health מתמקדת בעיקר בחברות ישראליות שמפתחת מכשור רפואי. עד כה השקיעה באנג'יסקור, כיאזמה ואימפליינט. "יוצאת דופן היא כיאזמה שהיא חברה ביו-פארמה. רוב ההשקעות של הקרן הן בתחום המכשור הרפואי". הלר מציין כי אחת המגמות המובילות בענף המכשור הרפואי היא שינוי במיקוד בכל הנוגע לשוק היעד. "במקום לפנות בראש ובראשונה לשוק האמריקאי, מתפתחת תופעה של חברות סטארט-אפ שפונות למזרח הרחוק", הוא מסביר. בדומה ללא מעט משקיעים אמריקאים אחרים, הלר מחמיא ליזם הישראלי על היזמות ורוח החדשנות שלו, אך מציין כי אחת החולשות של חברות סטארט-אפ ישראליות היא שהן אינן מכירות היטב את חוקי הרגולציה והפרקטיקות הרפואיות המקובלות בארה"ב לעומת ישראל, והן אינן יודעות כיצד לתמחר מוצרים בתחום הבריאות האמריקאית. מצד שני, הוא סבור שהחברות הישראליות נעות הרבה יותר מהר לעומת עמיתותיהן האמריקאיות: "היזמים בישראל עובדים קשה יותר ומצליחים לחסוך בזמן הפיתוח ולקצר בשלבים קליניים". זו הסיבה שהלר משקיע בהם ומקווה שהוא יוכל לסייע להם כמה שיותר מנסיונו.

Herzelia, 10 September, 2008 - 7 Health Ventures, a professional venture capital fund dedicated to investing in healthcare technologies and products, announced today it had joined a deferred closing of Tulip Medical's round A of financing. Dr. Dalia Megiddo, founder and managing partner at 7 Health Ventures, will join Tulip's board of directors.

Tulip Medical Ltd. is a medical device company that is developing the next generation solution for the worldwide overweight and obesity epidemic, focusing on the overweight and mild obese markets.

7 Health Ventures is a proud sponsor for the 12th Journey conference.

November 3rd 2008, the David Intercontinental Hotel, Tel Aviv

http://www.journey.co.il/index.html

Jerusalem, Israel, January 19, 2010. Chiasma, Inc., a privately held

biopharma company, announced today that it has granted Novartis an option

to obtain exclusive worldwide rights to develop and commercialize the

Company’s Transient Permeability Enhancer (TPE) technology for use with

certain related small molecule products either in development or currently

marketed by Novartis. In a separate but related agreement, the MPM Bio IV

NVS Strategic Fund L.P. made an equity investment in Chiasma.

The two companies have initiated a feasibility program funded by Novartis.

Should Novartis exercise the option, it would assume the global clinical

development, manufacturing, regulatory submissions and commercialization

of the products containing the TPE technology. Chiasma would receive

payments upon the option exercise and upon successful completion of certain

development and regulatory milestones. In addition, Chiasma would be

eligible to receive a percentage of any incremental profits generated as a

result of the incorporation of the TPE technology into these Novartis

products. Additional terms were not disclosed.

Fredric Price, Chairman and CEO of Chiasma said, “Our strategy is two-fold:

(1) to develop our own proprietary products and seek out partnerships after

demonstrating clinical effectiveness and safety; and (2) to enter into

arrangements with companies whose important drugs could benefit from the

TPE technology.

“Our internally-developed pipeline is focused on developing new therapies by

selecting approved macromolecules that are currently available in injectable

form, changing the route of administration to oral and evaluating them for

2

new indications, thereby creating new drugs that will take advantage of the

505(b)(2) regulatory route in the US and similar regulations in other

countries.

“We are especially pleased that our first collaboration is with an important

marketed product from Novartis, along with certain other products in

development in the same area of therapy.”

Todd Foley, Managing Director at MPM Capital commented, “In preclinical

models, the TPE system has demonstrated encouraging efficacy results as

measured by significant improvements in bioavailability when administered

orally across a wide range of compounds that are currently available only by

injection, and has also established a clean safety profile, which makes this an

attractive investment opportunity.”

7 Health Ventures is a proud sponsor for the 8th NationalLife Science & Technology week, 15-17 June at the David Intercontinental Hotel, Tel Aviv.

http://www2.kenes.com/biomed/Pages/Home.aspx

 ActiViews, founded in 2007, is developing optical guidance systems used in Computer Tomography (CT), fluoroscopy and Magnetic Resonance Imaging (MRI) procedures. ActiViews' first product, ActiSight™, improves minimally invasive oncology diagnosis, with future applications in guiding therapeutic devices to malignant targets. The ActiSight™ is CE approved

The company was founded by Pinchas Gilboa, the founder of SuperDimension. ActiViews CEO, Yuval Zuk,   is the former CEO of Odin Medical Technologies. The company is located in Tirat Hacarmel, Israel and has 10 employees.

The funds will be used to set up a sales network in Europe and for obtaining marketing approval in the USA.

Impliant, Inc., a developer of novel motion-sparing alternatives to traditional spinal fusion surgery, announced today that it conducted the first two implantations of its TOPS VersaLink System, the newest addition to its product portfolio.

The system is comprised of the company's flagship TOPS(TM) Total Posterior Arthroplasty device, a motion-sparing posterior implant designed to treat moderate to severe lumbar stenosis with or without spondylolisthesis and facet arthrosis, attached to the company's recently-developed VersaLink Fixation System(TM). By combining the two devices, the TOPS VersaLink System allows the surgeon to treat different stages of spinal degeneration at two or more adjacent vertebral segments. Surgical treatment of patients with advanced multi-level spinal degeneration has traditionally consisted of a fusion device that spans all of the diseased segments following decompression of the patient's pain generators. However, the TOPS(TM) portion of the TOPS VersaLink System restores near-normal motion to its segment and may thereby reduce the potential for adjacent segment degeneration that may accompany conventional fusion-only constructs.

The first case was conducted by Mr. John Sutcliffe at the London Clinic Medical Center in London, England. "I was impressed with the simplicity of the system. Implantation was very easy and straightforward," commented Mr. Sutcliffe. "VersaLink is a logical next step in the evolution of the TOPS(TM) System. It gives me the ability to address a larger array of patients in my practice, and I fully expect to achieve similar clinical results that I have enjoyed thus far with Impliant's original TOPS(TM) device."

Mr. Sutcliffe's comments were echoed by Dr. Robert Hes and Dr. Bart Conix, who together performed the second surgery at the Middelheim Hospital in Antwerp, Belgium. "It is a very elegant system. We are excited by the flexibility that VersaLink gives us in treating our patients," remarked Dr. Hes.

"We are pleased to add the VersaLink System to our product line," said Todd Potokar, President and CEO of Impliant. "It allows us to expand beyond treating single-level spinal stenosis and opens the door for us to help patients with a much wider range of spinal pathology. The versatility of the system will even allow us to compete in the fusion market as a unique stand-alone fusion device."

About the TOPS(TM) System

Impliant's TOPS(TM) System, a mobile posterior device, is designed to stabilize but not fuse the L3-4 or L4-5 vertebral level to alleviate pain stemming from spinal stenosis with or without degenerative facet arthrosis and spondylolisthesis. Following a laminectomy and medial facetectomy, the device is affixed to the spine via four pedicle screws using a standard posterior surgical approach. Impliant believes that the TOPS(TM) System could benefit over 500,000 patients worldwide undergoing spinal fusion surgery each year. The TOPS(TM) System is currently not approved for sale in the United States.

About the VersaLink Fixation System

The VersaLink Fixation System(TM) is a bilateral titanium lumbar fusion system that is designed to be used in conjunction with a titanium crossbar as a stand-alone fusion device. It is also designed to connect above or below the company's flagship TOPS(TM) device as a hybrid construct. The VersaLink Fixation System(TM) is intended to treat patients with a broad range of spinal pathologies including degenerative disc disease (DDD), disc herniation, lumbar spinal stenosis, and spondylolisthesis. The VersaLink Fixation System(TM) has received CE Mark approval but is currently not approved for sale in the United States.

17 December, 2009, Haifa, Israel, Medic Vision Brain Technologies Ltd (Medic Vision) had announced today the completion of a financing round of approx 1 million USD. The round was led by 7 Health Ventures which was joined by private investors.

Medic Vision was founded in 2006 and is a graduate of the Technion Institute incubator (Technion Seed). The company had developed a unique, patent protected (pending), system for greatly enhancing the signal-to-noise ratio in medical imaging. The first application for the company's proprietary technology is a dramatic reduction in the harmful ionizing radiation which is caused by CT scans.

CT scans have created a frog leap in diagnostics imaging and offer great benefits to patients, physicians and payers, however they also posses risks of mortality and morbidity due to excessive exposure to harmful radiation. It is estimated that 1.5-2% of all cancer cases in the United States may be attributed to radiation from CT studies. The risk is 10 times higher for children. A recent study by the NIH Clinical Center had shown that the level of harmful radiation due to medical imaging to which Americans are exposed had raised 7 folds in 2006, compared to the late 80's.     

Medic Vision's SafeCT technology will enable the medical community to continue to benefit from the advantages of CT images while dramatically reducing the associated risks from harmful radiation. Medic Vision's SafeCT technology is expected to reduce the radiation in CT scans by as much as 80%, while maintaining the image resolution and diagnostics quality. The system is currently being evaluated at the Ramabam medical center in Haifa, Israel.

The new investment will allow the company to obtain FDA and CE regulatory clearance for the SafeCT system. Amir Zaidman, a principal at 7 Health Ventures, will join the company's board of directors.

About Medic Vision –Medic vision was founded in 2006 and had developed a revolutionary system that enables a dramatic reduction of the ionizing radiation caused by CT scanners. It is managed by its founders Ezer Bar-Aviv (CEO), Eliran Dahan (COO) and Zvi Dvir (CTO), and is supported by a reputable Medical Advisory Board. The Chairman of the board of directors is Jonathan Adereth, former CEO and president of Elscint. The company is located in Haifa and has 6 employees.

באירוע ספיד דייטינג שארגנו חברות השירותים הפיננסיים ברוקס-קרת וחברת סיגנל, השתתפו יזמים ומשקיעים פיננסיים, ביניהם קרנות הון סיכון תמיר פישמן DFJ, סקויה, אוורגרין, 7Health Ventures, קומט קפיטל של היזם שמעון אקהויז ועוד.

כ-15 חברות מתחומי המכשור הרפואי והקלינטק השתתפו, כאשר רובן חברות חממה. האירוע החל בסבב קצר בו כל חברה הציגה עצמה בפני כלל המשקיעים, כאשר לאחר מכן החל סבב של פגישות אחד על אחד בין היזם והמשקיע.

כנהוג, בשלב הראשוני חברות מציגות את המוצר שלהם, הפטנטים שיש להם בתחום, ומידע כללי נוסף על השוק בו פועלת החברה. בשלב הבא, השלב האינטמי יותר בין היזם והמשקיע, המשקיעים רוצים ללמוד על העבר של היזמים, להכיר אותם טוב יותר ולקבל תשובות על שאלות ספציפיות, לדוגמא בנושא של רגולציה וניסויים קליניים. בין החברות שהציגו היו חברות המכשור הרפואי אולטראסרג', ג'ווניס וויברנט, ומצד חברות הקלינטק הציגו החברות Seagen CMT, BAS.

בשלב הפגישות הפרטיות משקיעים רוצים ללמוד אודות הסיכונים מולן עומד העסק, לדוגמא חברה למכשור רפואי בה המנהלים אינם בעלי רקע רפואי. הצד השני שמעניין את המשקיעים הוא הסיכון הרגולטורי בהליך הרישוי, והיכולת לשווק את המוצר תחת קוד החזר הוצאות למבטח (Reimbursement), אשר כבר קיים.

אמיר זיידמן, שותף מנהל בקרן הון הסיכון 7Health Ventures, אומר כי האירוע היה מוצלח והיזמים בתחום המכשור הרפואי הציגו טכנולוגיות מאוד יצירתיות, אולם היו חסרים מספר גורמים. "ישנה כמות גדולה של חברות מכשור רפואי בשלבים מוקדמים (Early Stage), שכן זאת תעשיה צעירה מאוד בארץ. פרט לנושאים הברורים כמו גודל השוק, פתרון בעיה קלינית וקניין רוחני, חשוב כי הצוות הצעיר יפתח את המוצר עם אדם המגיע מהתחום הקליני, כבר מהשלבים הראשונים. כמו כן חשוב מאוד לתת דגש על תחום הרגולציה. היתה לי הרגשה שלא כל החברות נותנות לזה את החשיבות הנדרשת, שכן מנקודת ראות המשקיע, הרגולציה הינה מכשול רציני מאוד להצלחת החברה".

נועם גרסל, שותף המטפל בתחום הקלינטק בקרן הון הסיכון גריילוק, אמר כי חברות הקלינטק לא שמות מספיק דגש על תחום השיווק בשלבים המוקדמים של פיתוח המוצר, ולעיתים מתמודדות עם בעיה זו רק לאחר שכבר פיתחה מוצר או אבטיפוס.

Dr. Dalia Megiddo, one of the leaders in the life science industry in Israel, recently founded a new Venture Capital fund - 7Health Ventures. The fund raised 70 million dollars this month from a number of investors headed by Ms. Ruth Wertheimer.

7 Health Ventures will invest in 12 companies, ranging from seed-stage to more advanced stages and will focus on companies that address significant medical needs, such as heart diseases, obesity, neurological diseases, etc

7Health Ventures will collaborate with leading international medical device companies as well as leading international academic research centers. 

“I believe in the Israeli entrepreneur” says Dr. Megiddo, founder of 7Health Ventures, “Israel is one of the leading research & development centers in the field of medical technologies in the world today”.

“We are currently negotiating with a senior partner from the industry to join us” adds Dr. Megiddo. “The 7Health Venture team, with its experience and connections in the medical device industry, will be the most suitable for the Israeli entrepreneur”.

In 2000 Dr. Dalia Megiddo founded Innomed Venture Capital. She has also served in the board of directors in various public companies (Given Imaging-GIVN, Elron-ELRN) as well as private companies

Tmura - The Israeli Public Service Venture Fund, a foundation with a unique business model, was established by leading Israeli venture capital funds to involve the high-tech sector in supporting charitable activities.  The model is simple: early-stage companies give Tmura a warrant, convertible (at exit) into a small portion of their equity. If the company succeeds, Tmura sells its shares and donates the proceeds to charities in Israel; the focus is on education and youth-related activities, and the companies can indicate which organizations they want to support.

7 Health, as well as several other leading venture capital funds, support Tmura's activities and encourage portfolio companies to make an equity donation to Tmura.  For more information, please contact Tmura Executive Director, Baruch Lipner at +972-3-607-4506 or at baruch@tmura.org, or see the Tmura website at www.tmura.org.