American medical device giant Edwards Lifesciences is set to acquire Israeli technology company Innovalve Bio Medical for $300 million.
Innovalve, a startup originating from Sheba Medical Center, was founded in 2018 by Prof. Ehud Ra'anani, Head of the Heart Center, and Dr. Boris Orlov, Head of the Mitral Valve Insufficiency Service.
Innovalve's innovative solution aims to assist countless heart patients suffering from mitral regurgitation, the most common heart valve disease. The company has developed a system for implanting and replacing the diseased mitral valve through catheterization, a minimally invasive procedure, instead of the complex open-heart surgeries that are standard today.
In 2021, Innovalve completed the development of its system. After securing the required approvals from the U.S. FDA, the company began initial clinical trials. To date, more than 40 implantations have been performed, primarily in leading hospitals across the U.S.
In an exclusive interview with Ynet, Innovalve's founder and chief scientist, Prof. Ra'anani, detailed the decade-long journey that led to this acquisition.
He explains that the method developed with his colleagues provides a solution to the prevalent issue of mitral valve leakage. "This valve separates the left atrium from the left ventricle. Currently, the only effective solution for patients with this issue is open-heart surgery. Another catheter-based solution, called MitraClip, works for some patients, but its effectiveness is not complete."
"Many patients suffer from mitral valve leakage and can't undergo open-heart surgery. As a result, they enter heart failure, which severely impacts their quality of life and life expectancy, and many die," he elaborates.
"We're talking about millions of such individuals in the Western world, in the U.S., and Europe, who lack a viable solution for this valve. Due to the significant medical need, all the major companies in this field have invested heavily to develop a catheter-implantable valve but have failed because it is extremely challenging to anchor and reach this valve, which is located in a very complex area of the heart."
Edwards Lifesciences' acquisition of Innovalve marks a significant step in addressing these challenges and providing a much-needed solution for patients worldwide.
So, what makes the Israeli invention so special?
"Our technology allows us to reach this difficult spot in the heart, and more importantly, to securely anchor the valve while the heart is beating, as the entire procedure is performed on a beating heart. We enter through the groin and guide the valve to its location."
Prof. Ehud Ra'ananiPhoto: Sheba Medical CenterWhat are the plans? This is a substantial sum. Will you continue developing the company here in Israel or pursue something else with the exit?
"Fortunately, in this unique model, we established the company together with Sheba Medical Center, under the significant leadership of Prof. Shlomo Noy, Vice President of Research and Development. This allows the hospital to receive a very respectable amount from this sale, which will return to the hospital, benefit the patients, and be used for patient care and the development of additional technologies.
"Fortunately, Edwards plans at this stage to continue operating Innovalve, which is located within the Heart Center at Sheba, with all its employees, production, and development. It seems that it will remain this way for the near future until Edwards decides to move operations to the U.S. The company has an amazing team, and I am pleased that this team will be able to continue operating from Sheba, at least for the foreseeable future."