Boston Scientific Pumps $200 Million Into MValve Technologies

By Jof Enriquez,
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Boston Scientific has announced the closure of a new round of financing worth $200 million and the right to acquire Israel-based MValve Technologies Ltd., developer of a transcatheter mitral valve replacement (TMVR) system that works in tandem with Boston Scientific's LOTUS transcatheter heart valve for the treatment of mitral regurgitation.

MValve secured a $15 million convertible loan from Boston Scientific in 2013 to develop its valve technology. The new round of financing will fund the first-in-human clinical trial to test how well the LOTUS valve, which is deployed inside the MValve docking system, can help deliver better outcomes for patients with mitral regurgitation, the most common heart condition.

"The TMVR segment represents another significant growth opportunity as we continue to build our Structural Heart portfolio," said Kevin Ballinger, senior VP and president, Interventional Cardiology, Boston Scientific, in a press release. "This round of financing will support the development of the MValve technology in anticipation of a first-in-human clinical trial, and we are pleased to be continuing our collaboration."

MValve successfully implanted its transcatheter docking device, in combination with the Lotus valve, on a 72-year-old male patient in Germany. The patient failed to improve with previous treatments, and his cardiac status and worsening mitral annular calcification deemed his case inoperable. However, MValve claims its transcatheter system improved the patient's condition.

"The MValve transcatheter mitral replacement system is a unique approach to mitral valve replacement therapy. The MValve docking device provides a secure platform within the mitral annulus, enabling the implantation of an approved transcatheter heart valve, such as the Lotus valve, in the native mitral position. This procedure in many ways mimics the "Valve-in-Valve" or "Valve-in-Ring" procedures currently performed in patients with degenerated previously implanted surgical prostheses," said Dr. Maurice Buchbinder, interventional cardiologist, founder and medical director of MValve, who was present during the procedure, in an announcement.

LOTUS is an investigational device in the United States and is CE-marked in the European Union. The MValve docking system is not available for sale.

Medical device companies are betting big on transcatheter mitral valve replacement (TMVR) technologies, following the success of transcatheter aortic valve replacement (TAVR) devices. Medtronic acquired recently mitral valve device developer Twelve, Inc. for $458 million. Edwards Lifesciences bought CardiAQ Valve Technologies in July for $400M. In the same month, Abbott, announced the purchase of Tendyne Holdings, Inc. for $250 million, and an undisclosed amount of investment in Cephea Valve Technologies.