HANGZHOU, China and CAESAREA, Israel and TAMPA, Fla., Dec. 26, 2018 -- Venus Medtech (Hangzhou) Inc., the preeminent Chinese transcatheter heart valve company, today announced it has closed its Merger with Keystone Heart Ltd., a privately-held medical device company and makers of TriGUARD 3™. The Merger provides Venus Medtech with TriGUARD 3, the first Cerebral Embolic Protection Device designed to provide complete coverage to all brain regions for patients undergoing cardiac procedures, as well as an established clinical and commercial organization in both the US and Europe.
"It is of utmost importance to us that our devices improve the quality life of the patients whom receive them," said Eric Zi, co-founder and CEO of Venus Medtech. "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 Europe through which we can introduce our entire portfolio of products. We will be the first to bring the significant and extensive benefits of combining embolic protection devices together with our Venus TAVR products for Chinese's patients"
Keystone Heart is focused on protecting the brain from embolic debris to reduce the risk of brain infarcts during TAVR, 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 enrollment completion in the early part of the first quarter of 2019 and FDA approval in Q3 of 2019. CE mark approval for Europe is anticipated by the end of Q1 2019.
"We are excited to be joining a truly entrepreneurial company like Venus," said Chris Richardson, president and CEO, Keystone Heart, LTD. "Providing brain protection for every TAVR 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 TAVR 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 & Europe."