News Feature | July 31, 2015

Abbott Reaches Deals With Heart Valve Companies Tendyne, Cephea

By Jof Enriquez,
Follow me on Twitter @jofenriq


In separate transactions, Abbott Laboratories has agreed to buy Tendyne Holdings, Inc. for $250 million, and to provide an undisclosed amount of capital for Cephea Valve Technologies. Both privately-held companies are developing devices that would complement Abbott's own portfolio of mitral valve replacement therapies.

North Chicago, Ill.-based Abbott, which previously held a $25 million minority stake in Roseville, Minn.-based Tendyne, agreed to buy the latter's remaining equity for $225 million up front, plus future regulatory milestone payments, Abbott said in a statement. The transaction is expected to close in the third quarter of 2015.

Separately, Abbott said it provided capital and gained the option to purchase Santa Cruz, Calif.-based Cephea for an undisclosed sum.

"Mitral valve disease is highly complex and requires multiple treatment options in order to tailor the therapy based on each person's anatomy and health situation," said John M. Capek, Ph.D., executive VP of ventures for Abbott, in the statement. "The Tendyne acquisition and our agreement with Cephea broaden our foundation as one of the leaders in treatments for mitral valve disease, with the goal of bringing promising, less invasive valve treatment technologies to people who need them."

Mitral valve disease, caused by leaky mitral valves that allow blood to flow backward into the left atrium of the heart, could develop into life-threatening complications such as abnormal heart rhythms, blood clots, and heart failure.

While other device companies, such as Medtronic and Edwards LifeSciences, are betting big on transcatheter aortic valve replacement (TAVR) devices, Abbott sees a similar multi-billion market potential in treating mitral valve disease — the most common heart valve disease, with an incidence rate three times that of aortic valve disease.

"Given the market opportunity and clinical need, we see this as a significant driver for growth several years from now," said John Capek, head of ventures for Abbott, in an interview with Reuters.

Abbott makes a mitral valve repair device called MitraClip, the world's first transcatheter mitral valve repair device. The product was approved by the United States Food and Drug Administration (FDA) in October 2013 for the treatment of mitral regurgitation, a type of mitral valve disease. Abbott claims that more than 25,000 people have received the MitraClip device, including patients in the U.S., Canada, Europe, and unspecified countries in Asia and Latin America where it is available.

Similar to MitraClip, both Tendyne's and Cephea's devices are mitral heart valve replacements that are placed into the heart via a catheter threaded into the femoral vein.

According to Abbott, Tendyne's Bioprosthetic Mitral Valve System is currently an investigational device with an ongoing U.S. clinical trial for safety and effectiveness, and a planned trial in Europe next year for a CE Mark designation. Cephea is developing a catheter-based mitral valve replacement therapy.

Capek said in the Reuters interview that Tendyne's device has been implanted in 10 people so far with positive outcomes, while Cephea's device is at an earlier stage of development.