Jean Boulle Group: European Union Approval for Tendyne Transcatheter Mitral Valve

LUXEMBOURG - EQS Newswire - 3 February 2020 - Jean Boulle Medtech Ltd. (the "Company"), founder  of Tendyne Holdings, Inc. ("Tendyne") and a Jean Boulle Group (the "Group") company developing medical technologies that save lives, is pleased to announce that the Tendyne transcatheter mitral heart valve implant which it developed has received CE Mark approval from the European Union.

 

This heart valve implant will now be available throughout the European Economic Area to patients with mitral regurgitation ("MR"). MR is the most common disease affecting heart valves[1] and is a debilitating, progressive and life-threatening condition in which the heart's mitral valve does not close completely, causing blood to flow backward and leak into the left atrium of the heart. Left untreated, MR can lead to heart failure and death.

 

Implanted in a beating heart, the Tendyne valve enables a significantly less invasive procedure for mitral valve treatment than open heart surgery. Traditional open-heart valve surgery is highly invasive, requiring the surgeon to make a 6 to 8 inch incision along the middle of the chest, cutting through the breastbone and stopping the heart in an operation lasting approximately 8 hours, with significant intensive care required during recovery in hospital and subsequent weeks at home. By comparison the Tendyne valve procedure lasts around 1.5 hours with patients expected to be discharged from hospital within 3 days. Current trial results have shown a high level of procedural safety with 98.9% of Tendyne patients in this very ill patient group experiencing elimination of MR at discharge and through one-year after discharge.

 

Commenting on today's announcement, Mr Jean-Raymond Boulle, Chairman and CEO of the Group said:

 

"I am delighted that the Tendyne team behind the breakthrough mitral valve can today reflect on the thousands of lives which will be transformed for the better. Patients with MR in Europe can now avoid open-heart surgery and receive treatment for what otherwise would be an inoperable condition."

 

"Our mitral valve invention will lead to massive associated reductions in the treatment and costs of care borne by patients, healthcare providers and insurers in this billion-dollar healthcare segment."

"Tendyne's success story illustrates the foresight, skills, determination and investment commitment of the Jean Boulle Medtech team. We continue to innovate and to support world class physicians and engineers at research and development facilities in Minnesota and New York U.S.A. as well as in Austria and Holland."

 

Details of Jean Boulle Group's Tendyne Acquisition by Abbott Laboratories

 

In September 2015 the Jean Boulle Group announced that an agreement had been reached for Abbott Laboratories (NYSE: ABT) ("Abbott") to acquire Tendyne from Jean Boulle Medtech Ltd and other Tendyne shareholders for a total consideration of US$400million excluding Abbott's existing 10% of the company.

 

Abbott paid an initial US$250 million under the terms of the acquisition and agreed to two future payments totaling US$150million contingent upon meeting certain regulatory requirements, as well as completing a designated number of successful transcatheter mitral valve replacements in patients.

 

Jean Boulle Medtech's range of medical technologies

Tendyne's global success underlines Jean Boulle Medtech's strategy and its technical and commercial expertise. CE Mark approval for Tendyne confirms the Company's ability to invent or discover breakthrough technologies, accelerate their development and to achieve a successful exit once their potential is proven. Jean Boulle Medtech continues to explore and develop new technologies in a range of life saving areas of medicine.

 

VDYNE

Jean Boulle Medtech founded VDYNE, a medical device company focused on the development of a transcatheter replacement valve to treat patients suffering from tricuspid regurgitation ("TR"). VDYNE is currently undertaking late stage pre-clinical testing, including the completion of good laboratory practice compliance and a range of mandatory pre-clinical testing steps.

VDYNE is targeting first-in-man chronic feasibility studies in the first quarter of 2021.

 

Trained Therapeutix Discovery

Jean Boulle Medtech founded Trained Therapeutix Discovery ("TTxD"). Under an exclusive license from the Ichan School of Medicine at Mount Sinai TTxD is developing nanobiologics that regulate the innate immune system to effectively treat cancer and other major diseases.

Notes to Editors:

 

The Tendyne™ TMVI is a fully retrievable and repositionable, apically tethered tri-leaflet porcine pericardial valve sewn onto a nickel-titanium frame specifically designed to address the complex mitral anatomy of functional, degenerative and mixed etiology mitral regurgitation. The Tendyne™ TMVI system can adapt to a range of patient anatomies thanks to its innovative and unique design. The self-expanding valve is delivered through a small incision in the chest and up through the heart where it is implanted in a beating heart, replacing the person's native mitral valve. Left untreated, mitral regurgitation can lead to heart failure and death. Implanted in a beating heart in a hybrid operating room, the Tendyne™ valve permits a significantly less invasive procedure to mitral valve treatment than open heart surgery.

 

Nearly one in ten people aged over 75[2] have moderate to severe mitral regurgitation and the condition can raise the risk of irregular heartbeats, stroke and heart failure. Patient outcomes have been positive with the Tendyne™ system successfully implanted in 97 of the first 100 patients[3].

 

Global trial results to date have demonstrated excellent procedural safety and have shown 98.9% of Tendyne™ patients experienced MR elimination at discharge which was sustained through one-year in this very sick patient group.[4]

 

Structural heart conditions affect millions of adults and thousands of newborns each year[5],[6]. The structural heart medical device market represents the largest, fastest-growing cardiovascular device market opportunity today[7] and forecasted to be $10+ billion by 2025. The transcatheter mitral repair and replacement market alone is projected to become a multi-billion dollar opportunity by 2025[8].