Valcare completes first phase of first-in-human Amend trial


Valcare Medical, an Accelmed portfolio company has successfully completed the first phase of its first-in-human (FIH) multicentre clinical trial, taking place in Israel and Europe.

Valcare developed the Amend mitral valve repair annuloplasty ring—a semi-rigid, a ’D’ shaped ring designed to emulate the current gold standard for patients who suffer from mitral valve regurgitation. In a series of cases, the ring was successfully trans apically delivered through a 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”, states Amit Segev, director, Cardiac Catheterization Services at The Heart Center at Sheba Medical Center, Israel and 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 centres 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, and in a compassionate care procedure performed in April 2016 by Gino Gerosa and 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 Shuki Porath as chief executive officer. According to a company release, Shuki Porath has over 20 years of medical device senior managerial experience, including product management, business development, commercialisation and clinical applications. Prior to joining Valcare Medical, Porath served as president & chief executive officer at Keystone Heart, and as senior executive at Biosense Webster. Mr. Porath holds a bachelor of science in electrical engineering, a master of science degree and a master of business administration degree—all from the Technion, Israel Institute of Technology. Sam Shaolian, the founder of Valcare and inventor of the technology, will become the chief technology officer of the company and continue to lead the future products of the company.