Venus Medtech has signed an agreement to acquire Keystone Heart, a privately-held medical device company and makers of TriGUARD 3—a cerebral embolic protection device that is designed to provide complete coverage to all brain regions for patients undergoing cardiac procedures. The acquisition gives Venus Medtech international rights to TriGUARD 3.
Keystone Heart is focused on protecting the brain from emboli to reduce the risk of brain infarcts during transcatheter aortic valve implantation (TAVI), surgical valve replacement, atrial fibrillation ablation and other structural heart procedures. The company is currently enrolling patients in the REFLECT trial in the US to evaluate TriGUARD 3, anticipating enrolment completion in the early part of the first quarter of 2019 and FDA review in the first half of 2019. CE mark approval for Europe is anticipated by the end of this year.
Eric Zi, co-founder and CEO of Venus Medtech, comments: “It is of utmost importance to us that our devices improve the quality life of the patients whom receive them. Our transcatheter heart valve systems offer patients life-saving support—acquiring Keystone Heart allows us the opportunity not only to reduce the risk of brain injury during cardiac procedures but establishes our presence in the US and EMEA through which we can introduce our entire portfolio of products.”
Chris Richardson, president and CEO, Keystone Heart, says: “We are excited to be joining a truly entrepreneurial company like Venus. Providing brain protection for every TAVI patient will differentiate Venus Medtech and position them as a leader in structural heart therapies—underscoring its dedication to excellence, determination to provide a total solution for patients undergoing TAVI procedures and focus on patient safety. 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 US & EMEA.”
The merger is expected to close in the fourth quarter of 2018, subject to customary closing conditions.