A Chinese developer of heart valves, Venus Medtech (Hangzhou) Inc., said Wednesday it has signed an accord to buy Caesarea, Israel-based medical device firm Keystone Heart Ltd. No financial details were disclosed.
Keystone develops and makes medical devices to reduce the risk of brain injuries after cardiovascular procedures, such as transcatheter aortic valve replacement (TAVR), surgical valve replacement or arterial fibrillation ablation.
During these cardiovascular procedures, debris from the aortic valve, ascending the aorta and other sources, can embolize and cause cerebral infarction. Embolic brain lesions resulting from these procedures may lead to potentially devastating outcomes, like stroke, dementia and cognitive decline.
Keystone’s device helps protect the brain from these embolisms.
The acquisition will give Venus Medtech international rights to Keystone’s TriGUARD 3, its first cerebral embolic protection device, which aims to provide complete coverage of all brain regions for patients undergoing cardiac procedures.
The device is inserted via a catheter and is shaped to fit into the aortic arch. A polymeric mesh — a netlike structure — is designed to protect all three major arteries that supply blood to the brain from debris, and is removed after the procedure.
“It is of utmost importance to us that our devices improve the quality of life of the patients who receive them,” said Eric Zi, co-founder and CEO of Venus Medtech in a joint statement published by the companies on Tuesday. “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.”
Keystone is currently enrolling patients for a clinical trial in the US to evaluate TriGUARD 3, and anticipates enrollment completion in the early part of the first quarter of 2019 and a review by the US Food and Drug Administration in the first half of 2019. EU regulatory approval, the CE mark, is expected by the end of this year, the statement said.
“Providing brain protection for every TAVR patient will differentiate Venus Medtech and position them as a leader in structural heart therapies,” said Chris Richardson, president and CEO of Keystone Heart. “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, the companies said.
Founded in 2004, the startup has raised some $14 million to date, according to data compiled by Start-Up Nation Central.