Claret bags $14M to boost access to brain-protection device

Claret Medical's Sentinel device
Claret Medical's Sentinel TAVR device. (Courtesy of Claret Medical)

Claret Medical has raised $14.5 million. The series C round equips Claret to try to expand access to a device that protects patients from neurological and neurocognitive damage during transcatheter aortic valve replacement (TAVR) procedures.

Santa Rosa, California-based Claret secured FDA approval for the Sentinel device under under the de novo pathway in June. Less than two weeks later, Claret boasted that Cedars-Sinai, Cleveland Clinic, NewYork-Presbyterian and Mount Sinai Heart had already performed TAVR procedures using its device.

Those hospitals and other high-volume TAVR sites were the first targets of Claret’s U.S. commercial strategy. But ultimately Claret wants to reach more patients and a larger number of sites. 

The $14.5 million, Lightstone Ventures-led series C tees Claret up to start that process by setting up market access programs and building out its commercial organization. Existing Claret investors Easton Capital, HealthCor Partners, Incept and Sante Ventures joined Lightstone in the round.

RELATED: FDA clears Claret Medical’s Sentinel TAVR stroke protection device 

Claret attracted the financial support, which comes three years after its $18 million series B, on the strength of data suggesting Sentinel makes TAVR safer. The TAVR procedure can dislodge debris that then makes its way to brain, where it causes strokes. Technological advances and improved patient selection have cut the rate of stroke in patients post-TAVR but it remains a risk.

Sentinel is designed to further mitigate this risk by capturing debris before it reaches the brain. In a recent real-world study, the rate of all-cause mortality and all-stroke among the 280 patients who underwent TAVR protected by Sentinel was 2.1%. The rate in the unprotected arm of the trial was 6.8%, a statistically significant difference that resulted in the study hitting its primary endpoint.

Claret will leverage that data and comparable results from other studies as it tries to demonstrate Sentinel makes a difference to patient outcomes and represents good value to healthcare systems.

That task is the centerpiece of Claret’s post-series C spending plans. The other priority is research and development of next-generation products that cement Claret’s position at the forefront of an untapped market.