Israeli device maker Keystone Heart raised $14 million in a Series B funding round in support of its TriGaurd implant, designed to help protect the brain during transcatheter valve replacement procedures.
The company plans to use the funds to launch clinical trials in the U.S. and Europe to generate data in support of ongoing commercial efforts. Keystone also hired Hank Hauser as its vice president of clinical operation to oversee the trials.
Keystone won CE Mark approval in the European Union for the TriGaurd device, which protects patients from blood clots that may be dislodged during transcatheter procedures.
The device has not yet been cleared in the U.S., where Keystone will have to contend with rivals like Claret Medical, which has a head start with the FDA. Claret earlier this year won FDA investigational device exemption to conduct U.S. clinical studies of its Sentinel cerebral blood clot defense system in patients undergoing transcatheter aortic valve replacement.
Keystone’s latest funding round was led by OrbiMed, the company said.