SANTA ROSA, Calif.--(BUSINESS WIRE)--Claret Medical®, developer of the Sentinel® Cerebral Protection System, the first FDA-cleared cerebral protection device for transcatheter aortic valve replacement (TAVR), today announced that it has closed on a Series C financing of $14.5 million led by Lightstone Ventures, with participation from existing investors Easton Capital, HealthCor Partners, Incept LLC and Sante Ventures.
As the leader in cerebral protection for TAVR, the company will use the proceeds to support market access programs, research and development for next generation products, and expansion of the commercial organization to build upon the successful controlled commercial release of the company’s Sentinel Cerebral Protection System in the U.S.
Since the company’s Series B round in 2014, Claret Medical has pursued a structured study program of the Sentinel device involving three randomized studies and more than 2,300 patients, including its U.S. SENTINEL pivotal trial and a large-scale, real-world trial. It has also gained FDA clearance and successfully commercialized Sentinel in leading TAVR centers across Europe, selected Asia Pacific countries and, most recently, the U.S. To date, more than 5,000 patients have benefited from the use of Claret Medical’s cerebral protection technology during their cardiovascular procedures.
“We appreciate our investors’ continued confidence in the large market opportunity presented by our technology,” said Claret Medical CEO Azin Parhizgar, PhD. “Our ongoing investment in a broad clinical program has shown that Sentinel is safe, easy to use and highly effective in reducing periprocedural TAVR stroke by 70 percent.1 We look forward to continuing to work with leading TAVR centers around the country to integrate Protected TAVR using the Sentinel into their programs to enhance patient safety.”
Sentinel is the first and only FDA-cleared device that captures and removes debris that is dislodged ubiquitously during TAVR, regardless of the TAVR system used or a patient’s risk profile, before it can travel to the brain and potentially cause neurological and neurocognitive damage.
About Claret Medical
A privately-held company, Claret Medical develops innovative solutions for cerebral protection during structural heart and vascular interventions. Believing that not all cerebral protection devices are created equal, the company developed the Sentinel dual-filter system as the only system to capture and remove debris from the patient. It has been the leader in the field of cerebral protection since 2011 and is currently the only commercialized cerebral protection device available in Europe. It is also the first and only commercially available cerebral protection in the U.S for Protected TAVR. For more information on Sentinel or the Company, please visit www.claretmedical.com.
|1.||Seeger J, Gonska B, Otto M, Rottbauer W, Wöhrle J. Cerebral embolic protection during transfemoral aortic valve replacement significantly reduces death and stroke compared with unprotected procedures. JACC Cardiovasc Interv. 2017 Sep 7. pii: S1936-8798(17)31313-4. doi: 10.1016/j.jcin.2017.06.037. [Epub ahead of print]|