Valtech Cardio wins CE Mark for Cardioband mitral repair device

Valtech Cardio, which agreed to be acquired by HeartWare International (NSDQ:HTWR) earlier this month, today said it won CE Mark approval in the European Union for its Cardioband mitral valve repair device.

Or Yehuda, Israel-based Valtech said it plans to unveil the Cardioband device at the PCR London Valves meeting in Berlin next week.

“We are pleased to be able to introduce Cardioband to the European markets,” founder & CEO Amir Gross said in prepared remarks. “Receipt of the CE Mark is the culmination of concerted and concentrated efforts by many individuals, and it is the result of productive collaboration with the medical community. We are confident that Cardioband will prove to be a meaningful addition to physician’s available treatment options in addressing [mitral regurgitation], providing a first-line mitral valve repair option that preserves the ability to perform future percutaneous or surgical valve repair and replacement.”

HeartWare’s stock plunged nearly 21% after the Framingham, Mass.-based company announced the buyout of Valtech, which calls for an up-front payment of 4.4 million shares of HeartWare stock, plus milestones of 800,000 shares when Valtech’s Cardioband annuloplasty device wins CE Mark approval in the European Union and another 700,000 shares on the earlier of 1st-in-human implants for either the Cardioband tricuspid or CardioValve device.

HeartWare is also slated to put up warrants for 850,000 shares at $83.73 apiece once Valtech’s annual sales reach $75 million, and a cash-or-stock earnout of $375 million once revenues reach $450 million. The merger is expected to close late this year.

HeartWare 1st invested in Valtech in 2013. The 2 largest players in the aortic valve space, Medtronic and Edwards, are also pursuing the hot mitral valve space; Medtronic last month agreed to pony up as much as $458 million for Twelve Inc. and its transcatheter mitral valve implant, a day before Edwards closed its $400 million deal for TMVI maker CardiAQ Valve Technologies.