Venus Medtech and Keystone Heart Complete Merger

December 27, 2018—Venus Medtech announced it has completed its merger with Keystone Heart, Ltd. Venus Medtech is a leading transcatheter heart valve company in China. Keystone Heart is a privately held medical device company and maker of the TriGUARD and TriGUARD 3 cerebral embolic protection device; the company is headquartered in Israel, with operations in the United States.

According to the company’s announcement, the merger adds Keystone Heart’s TriGUARD device, the first cerebral embolic protection device designed to complete coverage to all brain regions for patients undergoing cardiac procedures, to Venus Medtech's portfolio. The acquisition also helps to establish a clinical and commercial organization in both the United States and Europe for Venus Medtech.

"It is of utmost importance to us that our devices improve the quality life of the patients who receive them," said Eric Zi, Cofounder and Chief Executive Officer (CEO) of Venus Medtech in the company’s press release. “Acquiring Keystone Heart allows us the opportunity to reduce the risk of brain injury during cardiac procedures."

In the merger announcement, Keystone Heart notes that it is dedicated to protecting the brain from embolic debris to reduce the risk of brain infarcts during TAVR and other structural heart procedures. Keystone Heart is currently enrolling patients in the REFLECT trial in the United States to evaluate TriGUARD 3 and anticipates completing enrollment in early 2019; FDA approval is anticipated for quarter three of 2019. CE Mark approval in Europe for the device is anticipated by early 2019.

“This partnership provides us the unique opportunity to improve the lives of patients undergoing structural heart procedures with cerebral embolic protection and the ability of bringing new cutting-edge therapies into the [United States] & Europe," commented Chris Richardson, President and CEO of Keystone Heart, in the announcement.