|Boston Scientific's Lotus valve is implanted in the mitral valve using MValve's docking system--Courtesy of Boston Scientific|
Boston Scientific ($BSX) announced that it has obtained an exclusive $200 million option to acquire Israel's MValve Technologies, maker of a transcatheter mitral valve replacement (TMVR) system for mitral regurgitation. Boston Scientific also said it is providing additional financing to the company in anticipation of a first in-human clinical trial. The bigwig has been financing MValve since 2012.
The official announcement of the option came just now, though Israeli newspaper paper Globes broke the news last year. Such a transaction would add to the $1 billion-plus spent by competitors Abbott ($ABT), Medtronic ($MDT) and Edwards ($EW) in recent months, as they place their bets on different companies in the hopes of winning the battle for transcatheter mitral valve dominance. The treatment paradigm is expected to someday become several multiples of the fast-growing market for transcatheter aortic valve replacements, estimated to be $2 billion at present.
MValve is developing a docking system for TMVR that works in conjunction with Boston Scientific's Lotus Valve (currently used for TAVR, at least in Europe). That makes Boston Scientific's approach distinct from those of its competitors, which are acquiring companies that make the actual implants as well as the associated delivery catheters. In general, delivery systems pose fewer clinical risks than the implants that they deliver, so Boston Scientific's strategy could prove clever, assuming its Lotus Valve proves efficacious in the mitral valve too.
"The TMVR segment represents another significant growth opportunity as we continue to build our Structural Heart portfolio," said Kevin Ballinger, senior vice president and president of Boston Scientific's interventional cardiology unit, in a statement. "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."
In fact, MValve just announced the first implantation of the Lotus TAVR using its docking system. The procedure occurred in Bonn, Germany, on a 72-year-old with mitral valve disease and a failing surgical valve. Mitral valve surgery and other transcatheter therapies were not possible due to the patient's challenging anatomy, heavy calcification, and failed prior treatments attempts, according to an MValve release, demonstrating how transcatheter technologies enable treatment in patients who otherwise lack options.
"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," said Dr. Maurice Buchbinder, the founder of MValve, in a statement. "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."
The procedure was conducted using a transapical (between the ribs in the chest) delivery approach. The transfemoral approach (through the arteries in the leg) is generally considered the most desirable for transcatheter devices.
Following the clinical and economic success of TAVRs, investors are supportive of bigwigs' move to enter what promises to be an even more lucrative arena. But left ventricular assist device specialist HeartWare ($HTWR) saw its stock fall 20% when it announced the acquisition of Israel's Valtech Cardio, which is developing transcatheter and surgical devices for mitral valve repair and replacement. Compounding matters, activist investor Engaged Capital just took a 5% stake in the company and is campaigning to block the transaction.
Still, TMVR is a must-(pay-to-)play market for cardiology generalists like Boston Scientific. So far, the bigwigs have focused on mitral valve replacement, but mitral valve repair is showing promise too, as evidenced by the recent $5 million Series A financing round for Germany's coramaze technologies.
The only approved transcatheter devices for the mitral valve are in the repair arena, led by Abbott's FDA-approved Mitraclip, which earns $250 million per year. Cardiac Dimension's Carillon device and Valtech's Cardioband have CE marks.
Expect more data from aspirants like Harpoon Medical at the upcoming Transcatheter Therapies Conference in San Francisco. Due to the surge in dealmaking for mostly unapproved devices, several early-stage companies are exiting stealth mode.
But not MValve. The company doesn't have a website, for it doesn't need suitors due to Boston Scientific's financial backing and $200 million option.
- read the release from Boston Scientific
- here's the release about MValve's first implant