Claret Medical is a privately held medtech company that developed the Sentinel dual-filter cerebral protection system, the first FDA-cleared device for transcatheter aortic valve replacement (TAVR). The company has commercialized Sentinel across Europe, selected Asia Pacific countries and recently in the U.S., where it completed a controlled commercial release. Claret has conducted a structured clinical program including three randomized studies and more than 2,300 patients, and reports that over 5,000 patients have benefited from its technology. The company highlights data showing Sentinel reduces periprocedural TAVR stroke by 70 percent. Claret plans to use new financing to support market access programs, research and development of next-generation products, and expansion of its commercial organization to build on U.S. commercialization. Claret Medical develops the Sentinel Cerebral Protection System (CPS), a filter-based device that captures and removes embolic debris released during transcatheter aortic valve replacement (TAVR) and other procedures. The company is focused on addressing stroke risk during TAVR through product development and clinical research. Sentinel CPS received Investigational Device Exemption (IDE) approval earlier this year and has been used in more than 800 procedures worldwide to date. Claret is embarking on the SENTINEL pivotal U.S. trial to evaluate reductions in number and size of new ischemic brain lesions and potential neurocognitive benefits, and plans two additional studies of structural heart procedures. The company is privately held and headquartered in Santa Rosa, California. Claret Medical is a California-based medical device company that makes the Montage Dual Filter embolic protection system, designed to capture embolic debris during transcatheter aortic valve implantation (TAVI) procedures. The device won CE Mark approval in the European Union earlier in the year. Published research enrolled 40 TAVI patients and reported the filter captured debris traveling toward the brain in 75% of patients, with captured particles ranging from 0.55 mm to 1.8 mm and consisting largely of fibrin likely from native aortic valve leaflets or the aortic wall. Financially, Claret has raised $3.6 million so far through a private offering of convertible promissory notes participated in by 28 unnamed investors. The company launched the financing in July 2012 and said it aims to raise a total of $4 million, needing another $375,000 before the offering expires in August 2015. Claret Medical is a Santa Rosa, Calif.-based medical device maker focused on embolic protection during vascular procedures. The company landed a CE Mark for its Montage system to protect against brain embolism in vascular surgery. Montage is described as the first filtration system to protect both carotid arteries simultaneously and is delivered during intravascular procedures such as transcatheter aortic valve intervention (TAVI). The catheter can remove potentially stroke-causing embolic material from the body. Claret recently raised $3.38 million in a Series A private equity offering, according to an SEC report. Clinicians quoted in the article said the CE Mark approval is an important step that could potentially reduce stroke rates in TAVI and other vascular procedures.

Total raised

$39M

Funding rounds

4

Latest round

Series C

Latest activity

Oct 2017