Founded December 2016; joined incubator: December 2018
Stage Technology development
Investor The Trendlines Group
CEO Nir Golan
Vvital’s Mitral Valve Posterior Leaflet Repair System (VLR)
Vvital is developing a unique transcatheter mitral valve repair solution to treat and prevent recurrence of mitral regurgitation. Current solutions repair the valve leaflets but lack the ability to provide a long-term solution which may lead to recurrent MR.
Vvital’s solution is based on the gold standard open-heart surgical principle known as the posterior leaflet repair. During the procedure Vvital’s unique flexible implant is deployed on top of the mitral valve and attached to the valve leaflets. The implant covers the posterior leaflet, repairs the valve, and stops the leakage.
Over time, the implant will be surrounded by tissue ingrowth and become an inherent part of the native mitral valve. The implant maintains the valve’s dimensions and prevents future valve dilation and recurrent MR (annuloplasty effect).
Vvital’s combination approach, posterior leaflet repair with the annuloplasty effect, is the first transcatheter repair solution with an effective short- and long-term MR treatment.
Vvital’s novel transcatheter solution—
• Treats mitral regurgitation
• Prevents future valve dilation and recurrent MR, unlike other repair solutions
• Applicable for 95% of MR patients (primary and secondary MR)
• Minimal trauma to the native valve
• Procedure performed with fully beating heart (versus other approaches that require momentary heart arrest during implantation)
25 years’ experience in executive business management in leading global public high-tech companies and start-ups; extensive experience in business development, M&A, start-up establishment, technology, global sales, and marketing; B.A., economics, Tel Aviv University; Executive MBA, The Hebrew University of Jerusalem
35 years’ clinical and academic experience as cardiac surgeon and researcher; former director of Open-Heart Surgery Department, Sheba Medical Center; performed >7,000 open-heart procedures; leader in mitral valve repair operations in Israel; M.D. and Associate Professor of Surgery, Sackler School of Medicine, Tel Aviv University
10 years’ R&D experience in medical device industry including cardiovascular, gastrointestinal and gynecology; expertise in bio-materials, manufacturing processes, and shape memory alloys for medical applications; B.Sc., M.Sc., material engineering, Ben-Gurion University of the Negev
Mitral Regurgitation (MR) is a disorder in which the heart’s mitral valve (comprised of two leaflets) does not close properly, causing blood to flow back into the left atrium. MR may lead to complications including lung congestion and heart failure.
Open-heart surgery (replacing or repairing the mitral valve) is the gold standard for treating patients with moderate to severe MR. Yet, nearly 50% of these patients are not surgical candidates due to age, frailty, and comorbidities.
To treat this underserved population, the market is moving towards less invasive, closed-heart, transcatheter procedures, preferring valve repair over replacement. Minimizing invasiveness of MR repair will allow high-risk patients to be treated more safely.
Unfortunately, a major drawback of current transcatheter repair solutions is postoperative recurrence of MR. Existing techniques focus on “fixing” the mitral valve leaflets and ignore the valve annulus, a ring-like structure surrounding the valve that assists in maintaining the valve’s shape. It is well known in open-heart surgery that supporting the annulus, and maintaining the valve’s dimensions, may prevent recurrent MR.
In the U.S. and EU alone, there are over four million people who suffer from moderate to severe MR, with the severe MR growing at a CAGR of 5-7% (Source: GlobalData). The transcatheter mitral valve repair and replacement market is estimated to reach $1 billion by 2021, with the majority ($700 million) comprised of repair procedures (MedDevice Tracker, 2018).