Report: TMVR at least 4 years from U.S. market

Transcatheter mitral valve replacements are at least 4 years out from hitting the U.S. market, despite the $2 billion recently dropped on companies developing the technology by some of the top names in medtech.

Medtronic (NYSE:MDT), Abbott (NYSE:ABT), Edwards Lifesciences (NYSE:EW) and HeartWare International (NSDQ:HTWR) in recent months have spent a total of $2 billion to buy young companies developing versions of the technology:

• Medtronic paid $458 million for Twelve Inc. in October
• Abbott spent $250 million acquiring Tendyne and took out an unspecified stake in Cephea
• Edwards put up $400 million for CardiAQ Valve Technologies
• HeartWare expanded its footprint outside the cardiac assist device market with its buyout of Valtech Cardio

And Boston Scientific (NYSE:BSX) has an option to buy stealthy Israeli medical device company MValve.

“All these things are still several years away, especially from the U.S. market,” Gabelli & Co. portfolio manager Jeff Jonas told Reuters (Gabelli has a position in Medtronic). Mitral disease is “something that very gradually develops. A ton of people may have it, but a smaller number have it at a life-threatening stage,” Jonas said.

The potential market for TMVI could be 2 or 3 times larger than its older cousin, transcatheter aortic valve replacement, because more patients have mitral valve problems than aortic valve problems, Morgan Stanley analyst David Lewis told the news service.

“What you’ve got is this huge market opportunity. But the challenges are huge, and it’s going to take some time,” said Michael Mussallem, the CEO of Edwards, which has the lead in race for the U.S. TMVI market.

“It is a very interesting space, and there is a need for mitral valve replacement,” said Dr. Saibal Kar of Los Angeles’ Cedars-Sinai Medical Center, noting that it’s early days yet and too soon to accurately predict the size of the market.

“It is unbridled enthusiasm,” Kar said.

“If we have a way where we can replace the valve without surgery, that is where all the excitement is,” added Dr. Mathew Williams of New York University’s Langone Medical Center.

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