Successful Mitral Valve Replacement Large Animals Clinical Trial Proves the Accurate Deployment and Long-term Functioning of the Implants in the Heart

Monday, May 25, 2020

Today Israeli based Allium Medical (TASE: ALMD), a device company that specializes in minimally invasive technologies subsidiary, TruLeaf Medical, has successfully tested a novel approach for transcatheter mitral valve replacement in patients suffering from severe mitral valve regurgitation during a long-term trial on large animals.

The trial has proven the implants’ functioning over time and the efficacy and accuracy of the method used to deploy them in the heart.

TruLeaf’s innovative system is based on two steps: A docking implant placed in the left atrium, and a mitral valve which is implanted in the docking implant after the docking implant has healed into place. TruLeaf also developed delivery systems and other equipment required for the full performance of the procedure.

Dr. Amir Halkin, TruLeaf’s Medical Director commented: “TruLeaf approach to trans-femoral mitral valve replacement offers multiple significant potential clinical advantages over competing approaches. TruLeaf now has long-term proof of concept in large animals that their approach may improve left ventricular outflow tract obstruction, reduce para-valvular leaks and improve long term durability of their valve. These remain unsolved problems in the field of trans-femoral mitral valve replacement. We look forward to completing our animal work and moving into initial human clinical testing.”

Globally, approximately 10% of people over the age of 75 suffer from severe mitral valve regurgitation, with approximately 4 million patients in the USA alone. Currently, the principal procedure used to treat patients with severe mitral valve regurgitation is the replacement of the mitral valve in an open-heart surgery with patients being supported by a heart-lung machine. This procedure cannot be used for most patients (older people who suffer from heart diseases or other chronic diseases), due to the significant risk arising from the operation and the lengthy recovery. The approval of the system for clinical use would provide a minimally invasive breakthrough solution that will give hope to those millions of patients.

The mitral valve market is estimated at $ 5 billion in 2020.

Mike Berman, TruLeaf Board Member commented: “We are extremely pleased and excited about our strong clinical results in large animals of our innovative solution for mitral valve replacement.

“This solution which uses a novel minimally invasive technology can potentially provide an effective solution to a huge unmet clinical need of millions of patients worldwide.

“As the field of mitral valve replacement is highly attractive to leading companies as well as investors, we expect the results to significantly elevate and leverage our business development effort.”

Ariel Rubashkin, CEO of Allium group: “The success of this trial is an important milestone for the company. It allows us to continue the development with the aim of treating millions of patients suffering from mitral valve regurgitation. We have recently received a further non-diluting grant from the Israel Innovation Authority, which is another indication of the project’s attractiveness and its potential to provide an effective solution for this massive unmet clinical need.”

It should be noted that approximately 15 years ago a breakthrough was achieved in the field of aortic valve replacement. Until then, the only known method to replace an aortic valve was through open-heart surgery. Since the development of a valve that can be transplanted by means of catheterization, an increasing number of patients are being treated with transcatheter aortic valve replacement. Based on the response to this procedure among healthcare professionals and responses received by TruLeaf over the past several years, cardio-vascular health professionals expect that the field of mitral valve to undergo a similar process.

TruLeaf’s management is of the opinion that reaching the current milestone is an important step in establishing an effective solution for treating patients suffering from mitral valve regurgitation and may be highly attractive for leading companies in the industry searching for innovative solutions for this important medical condition.

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