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Medtronic Moves into Mitral Valve Replacement
Company to Acquire Twelve, Inc. for $458 Million
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August 25, 2015 -- This morning, Medtronic plc (NYSE: MDT) announced it has agreed to acquire privately-held device company Twelve, Inc., based in Redwood City, California. If you've never heard of Twelve, that's because the company has been very low key as it has been developing its technology, namely a mitral valve replacement device that can be delivered via catheter. Twelve has opted instead for developing its technology out of the spotlight: for example, the company has opted not to have a website. So far.

What Twelve does have is their transcatheter mitral valve replacement device (TMVR) which is just beginning its first clinical pilot study, "Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation."

The company was initially known simply as "Foundry Newco XII" because it was the twelfth company to emerge from the medical device incubator, The Foundry. In a press release about this new company's initial financing in 2010, The Foundry stated, "Foundry Newco XII is currently not disclosing its product or market plans." Today that has changed. Medtronic "has agreed to pay up to $458 million for Twelve including $408 million at closing and $50 million on achievement of CE Marking."

Mitral valves and Medtronic are no strangers to The Foundry. A previous Foundry graduate was eValve, maker of the MitraClip, and acquired by Abbott in 2009. Another company emerging out of The Foundry was Ardian, maker of the Symplicity® renal denervation device, and acquired by Medtronic in 2011. In fact, Andrew Cleeland, President and CEO of Ardian at the time is currently President and CEO of Twelve, Inc.

The only currently FDA-approved transcatheter device for treating the mitral valve is Abbott's MitraClip, which doesn't replace the valve but performs a repair to reduce regurgitation. While Twelve's device is just beginning its journey to approval (it's not yet approved in any country) this acquisition is yet another sign of the movement from open surgery to minimally invasive catheter-based approaches for treatment of structural heart disease.

This morning's press release from Medtronic, Inc. follows:

Medtronic to Acquire Twelve, Inc., Developer of Transcatheter Mitral Valve Replacement Device

August 25, 2015 -- Dublin -- In support of the company's therapy innovation strategy, Medtronic plc (NYSE: MDT) today announced that it has signed a definitive agreement to acquire Twelve, Inc. ("Twelve"), a privately-held medical device company based in Redwood City, Calif., focused on the development of a transcatheter mitral valve replacement (TMVR) device. Twelve is the twelfth company spun out from the premier medical device incubator The Foundry.

"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, Coronary & Structural Heart, Medtronic. "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 2015. The transaction is expected to meet Medtronic's long-term financial metrics. Medtronic expects the net impact from this transaction to be earnings neutral as the company intends to offset the dilutive impact of the transaction. 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 Sean 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."

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

The Twelve, Inc., TMVR device is not for sale in any country.

About Medtronic
Medtronic plc (, headquartered in Dublin, Ireland, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.

About Twelve
Twelve, Inc. is a privately held medical device company based in Redwood City, Calif., focused on the development of a transcatheter mitral valve replacement (TMVR) device. It is the twelfth company spun out from the premier medical device incubator The Foundry. Twelve is supported by leading healthcare investors Domain Associates, Versant Ventures, Morgenthaler Ventures, Longitude Capital, Emergent Medical Partners, Vertex Venture Management, and Capital Group.

Reported by Burt Cohen, August 25, 2015