Valcare Medical, which develops medical devices for minimally invasive treatment of Mitral Valve Regurgitation, has announced the successful completion of first phase of its First-In-Human (FIH) multi-center clinical trial, taking place in Israel and Europe. Valcare Medical is an Accelmed portfolio company.
Valcare developed the Amend Mitral Valve Repair Annuloplasty ring, a semi-rigid, ‘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."
Additionally, Valcare's Amend system was implanted successfully by the heart team at Shaare Zedek Medical Center Interventional Cardiology laboratories in Jerusalem (Dr. Almagor and 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.
The company has also announced the expansion of its management team and the appointment of Shuki Porath as CEO. Porath has over 20 years of medical device senior managerial experience, including product management, business development, commercialization and clinical applications. Sam Shaolian, who founded Petah Tikva-based Valcare in 2012, and is the inventor of its technology, will become CTO.
Accelmed managing partner Uri Geiger, who is chairman of Valcare’s board of directors, said, “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 Amend system is expected to address the $5 billion market for medical devices geared towards minimally invasive treatment of Mitral Valve disease.
Since it was founded in 2009 by Mori Arkin, the chairman of the investment committee, and Dr. Uri Geiger, 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 devices, 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.
Published by Globes [online], Israel business news - www.globes-online.com - on June 20, 2016
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