Keystone Heart has completed a Series B financing of $14m in a financing round, which is led by OrbiMed.
The Israel-based medical device company will use the proceeds for conducting randomised clinical studies and further commercialization of its cerebral protection device.
The TriGuard Cerebral Protection Device will reduce the risk of cerebral damage during TAVR (Transcatheter Aortic Valve Replacement) and other cardiovascular procedures by protecting all brain territories.
The cerebral protection device will provide full coverage to all aortic arch takeoffs, according to the company.
Conducted as part of financing, a European multi-center, randomized clinical trial during TAVR procedures and a planned FDA IDE study will further assess the efficacy and performance of the TriGuard.
The studies are expected to produce additional clinical data to support the TriGuard commercialization worldwide.
Keystone Heart said it is planning additional studies to leverage the TriGuard product pipeline in TAVR and other cardiovascular indications.
The multi-center, randomized clinical trial DEFELCT I showed a significant reduction of over 60% of new brain lesion volume during protected TAVR procedures, using TriGuard, compared with data on unprotected TAVR procedures.
Conducted in up to 12 centers across Europe and Israel, DEFLECT III is currently recruiting patients undergoing TAVR procedures, to assess this critical effect further.
The TriGuard Cerebral Protection Device is not yet commercially available in the US.
OrbiMed is an investment firm dedicated to the healthcare sector, managing approximately $11bn across public and private company investments.
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Image: TriGuard Cerebral Protection Device. Photo: Keystone Heart/ PR Newswire.