HERZLIYA, Israel, June 20, 2016 /PRNewswire/ --
Novel semi-rigid, 'D' shaped ring provides a minimally invasive solution for Mitral Valve Regurgitation - a market of over $3 billion in the US alone
Expands Management Team with Appointment of Mr. Shuki Porath as CEO to lead clinical development and commercialization to current and new markets
Valcare Medical, an Accelmed portfolio company, the developer of novel medical devices for minimally invasive treatment of Mitral Valve Regurgitation, announced today the successful completion of first phase of the its First-In-Human (FIH) multi-center clinical trial, taking place in Israel and Europe.
Valcare developed The Amend™ Mitral Valve Repair Annuloplasty ring, a semi-rigid, a 'D' shaped ring that emulates the current gold standard for patients who suffer from Mitral Valve Regurgitation (the valve that controls blood flow between the left atrium and left ventricle). In a series of cases, the ring was successfully Trans apically delivered through an advanced, catheter-based delivery system, and was secured to the annulus by a series of novel integral anchors.
"The procedure was performed on a high surgical risk patient, in a minimally-invasive transapical approach and in a relatively short time", stated Prof. Amit Segev, Director, Cardiac Catheterization Services at The Heart Center at Sheba Medical Center, Israel and Prof. Ehud Ra'anani, Head of the Cardiothoracic Surgery Department who performed one of the procedures. "Using the Valcare system we were able to repair the patient's mitral valve and significantly reduce valvular incompetence, reducing MR from sever (4+) to trace (1). We are excited to be one the first centers in the world to use this novel technology to help our patients."
Additionally, Valcare's Amend™ system was implanted successfully by the heart team at Shaare Zedek Medical Center Interventional Cardiology laboratories in Jerusalem (Dr. Almagor & Dr. Mirkeen) and in a compassionate care procedure performed in April by Professor Gino Gerosa and Dr. Andrea Colli, Cardiac Surgeons from the Padova University Hospital in Italy.
Alongside the clinical progress, the company announced the expansion of its management team and the appointment of Mr. Shuki Porath as CEO. Mr. Shuki Porath has over 20 years of medical device senior managerial experience, including product management, business development, commercialization and clinical applications. Prior to joining Valcare Medical, Mr. Porath served as President & CEO at Keystone Heart, and as Senior Executive at Biosense Webster, a Johnson & Johnson Company. Mr. Porath holds a B.Sc in Electrical Engineering, M.Sc. and MBA - all from the Technion, Israel Institute of Technology. Sam Shaolian, the founder of Valcare and inventor of the technology, will become the CTO of the company and continue to lead the future products of the company.
Uri Geiger, Managing Partner of Accelmed and Valcare's Chairman of the Board commented, "We are excited with the successful completion of the first implantations of the Amend™ system and thrilled to welcome Shuki Porath to Valcare, leading its clinical development and commercialization to current and new markets. Valcare's novel technology is a pioneering breakthrough for the treatment of Mitral valve regurgitation and could be a base for additional modalities for treatment of other valve disorders. The team is currently focusing on adapting the delivery technique to a transeptal approach allowing for deployment of the system through a puncture in the groin, as well as using the system to treat tricuspid incompetence, another extremely common problem. In addition, we have explored this novel technology, using the ring as a landing zone to support a mitral valve prosthesis in pre-clinical studies, generating interest from a number of other companies active in this arena, as this provides another opportunity to treat patients with conditions that may be more suitable for heart valve replacement than repair."
The Amend™ system is expected to address the $5 Billion market ($3 Billion in the US alone) for medical devices geared towards minimally invasive treatment of Mitral Valve disease. A recently granted US patent on the Valve in Ring enables Valcare to use the Amend™ device also for the replacement of the mitral valve and for tricuspid vale repair.
About Valcare Medical:
Valcare Medical, based in Herzliya Pituach, Israel, develops advanced medical implants and delivery systems for the treatment of Heart Valve regurgitation in a minimally invasive manner. The Valcare Amend™ System is the first device, aimed for treatment of Mitral Valve Regurgitation, and currently under clinical study by the company.
ValCare Medical was founded in 2012 by Accelmed Fund, as part of its 'Targeted Innovation' model. Accelmed, and ValCare Medical's Founder and CTO, Samuel Shaolian, established the company based on technology spanned off Micardia Corporation to leverage the expertise and experience of the leading technical and clinical experts in the field of heart surgery and Cardiology to develop break though technologies for patients suffering from heart disease.
For more information, refer to: http://www.valcaremedical.com
Accelmed is the largest pure play medical device fund in Israel. Accelmed focuses on global investments in mature companies that might serve as a platform to Israeli companies and also builds companies that develop innovative medical device solutions for major markets - such as diabetes, obesity and heart diseases - in which there is currently no medical solution. Since it was founded in 2009 by Mori Arkin, the chairman of the investment committee, and Dr. Uri Geiger, the managing partner, Accelmed has made 18 investments in medical device companies, including M&A and IPO of five of them.
Accelmed manages over $250 million invested in medical device, and has announced initial closing for its third fund: Accelmed Growth Partners - AGP. Existing companies in the portfolio include Corvia, Valcare, EndoSpan, SoniVie, CartiHeal, Nitiloop, Digma, Memic and NitiNotes.
Accelmed has a large and experienced investment management team in the medical device field which, other than Dr Uri Geiger and Mori Arkin, includes four additional partners (Dr. Irit Yaniv, Ilan Ben Oren, Lior Shav, and Amir Blatt) together with a team of analysts and well-known advisors.
More information can be found on Accelmed's website: http://www.accelmed.com