Valcare Medical, an Accelmed Portfolio Company, Announces Successful First-In-Human Procedures of the Amend™ Catheter Delivered Annuloplasty Ring

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 Centerat Sheba Medical Center, Israel and Prof. Ehud Ra'anani, Head of the Cardiothoracic Surgery Departmentwho 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.

Source:  Accelmed