Medtronic to Buy Transcatheter Mitral Valve Replacement Startup

Medtronic plc has agreed to acquire Twelve Inc., a privately held medical device company based in Redwood City, Calif., focused on the development of a transcatheter mitral valve replacement (TMVR) device, which is not yet for sale in any country. Twelve—appropriately and succinctly named—is the twelfth company spun out from The Foundry medical device incubator.

“Upon close, this acquisition will strategically augment our existing capabilities in the transcatheter mitral space, which represents an important growth opportunity for Medtronic,” said Sean Salmon, senior vice president and president, Medtronic’s Coronary & Structural Heart division. “We have followed the transcatheter mitral valve space closely and firmly believe that Twelve has the most novel technology along with a strong, proven team. The combined strengths of our organizations will significantly accelerate our ability to deliver an exciting and differentiated therapy to patients, physicians and healthcare systems around the world.”

Mitral regurgitation occurs when the heart’s mitral valve fails to close normally, allowing blood to flow backward when the heart contracts. Over time, this will lead to declining heart function and heart failure. The TMVR device under development is being designed to treat patients with mitral valve regurgitation in whom standard restorative surgery is not recommended. The majority of these patients are largely underserved with limited treatment options.

“Twelve’s technology is a truly creative solution that brings together valve technology with a unique and highly differentiated dual-stent fixation design,” said Andrew Cleeland, president and CEO, Twelve. “Our acquisition by Medtronic will create a tremendous opportunity to leverage Medtronic’s expertise and proven success in the structural heart space to advance the treatment of mitral regurgitation.”

Medtronic has agreed to pay up to $458 million for Twelve including $408 million at closing and $50 million on achievement of CE marking. The cash- and debt-free transaction remains subject to customary closing conditions, and is expected to close in October.

Medtronic will manage the Twelve product line as part of the Coronary & Structural Heart division within the Cardiac and Vascular Group.

“We are keenly focused on improving patient outcomes and expanding access to care for those who need it most,” added Salmon. “We believe this acquisition will help deliver on this commitment by enabling Medtronic to bring forward a best-in-class transcatheter mitral valve replacement device with the potential to transform patient care.”

Medtronic is based in Dublin, Ireland.