New Money Will Get Claret’s Sentinel™ Stroke Protection Device Through Study

Cerebral protection device developer Claret Medical™, Inc., has been buoyed by the announcement of an agreement to bring in an additional $18 million in Series B financing. The funds will be used primarily to complete the U.S. pivotal trial of the company’s Sentinel™ Cerebral Protection System (CPS) for embolic protection during transcatheter aortic valve replacement (TAVR), which received Investigational Device Exemption (IDE) approval earlier this year.

Background

Stroke can be a devastating consequence and something of an occupational hazard with the current TAVR implant technologies. Claret Medical focuses its energy on development of devices that aim to reduce the amount of debris traveling to the brain after TAVI that may cause a stroke. Its Sentinel CPS is the only filter-based system on the market that both captures and removes embolic debris released during TAVR procedures that could otherwise be a source of peri-procedural stroke. The system has been used in more than 800 procedures worldwide to date.

In addition to the Sentinel pivotal trial, Claret Medical is also embarking upon two other studies of structural heart procedures that could benefit from the use of the Sentinel CPS in reducing cerebrovascular events during complex surgical and transcatheter procedures. The company has also announced that what it calls landmark results from its CLEAN-TAVI trial are set to be presented at TCT as a late breaker on Day 1.

Back to the new financing, according to a company press release, the Series B round was led by Santé Ventures, a prominent healthcare-focused venture capital firm with $260 million in capital under management, with participation from Lightstone Ventures, a leading venture capital firm with $172 million under management. Easton Capital also joined the round. Dr. James Eadie from Santé Ventures and Hank Plain from Lightstone Ventures will be joining the company’s Board of Directors.

Company comments 

“Many consider the stroke rate in TAVR concerning, especially as clinicians look to bring the benefits of TAVR to lower risk and younger patients,” said Azin Parhizgar, PhD, President and Chief Executive Officer of Claret Medical. “The proceeds of this financing round will enable Claret Medical to conduct the SENTINEL pivotal trial, which we expect to confirm the therapeutic importance of embolic debris capture and removal during TAVR. This same approach has long been established in carotid stenting procedures.”

Investigator comments

“The SENTINEL trial will evaluate the role of the Sentinel CPS in reducing the number and size of new ischemic lesions in the brain and their potential impact on patients’ neurocognitive function,” said Martin Leon, MD, Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York and chair of the trial’s Clinical Steering Committee. “By doing so, the trial will help define the field of cerebral protection during TAVR in order to pave the way for safer TAVR procedures.”

Source: Claret Medical, Inc.

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