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August 6, 2020

Conformal Medical Secures Financing to Support Pivotal Trial of CLAAS Technology

August 6, 2020—Conformal Medical, Inc. announced it has secured $85 million in Series C financing, which will be used to support the company’s United States pivotal trial of its next-generation Conformal left atrial appendage seal (CLAAS) technology in patients with atrial fibrillation (AFib).

Conformal’s randomized pivotal trial is expected to enroll more than 1,300 patients at multiple sites globally beginning in early 2021 to investigate the safety and effectiveness of the CLAAS technology as compared to Watchman devices (Boston Scientific Corporation).

According to the company, the CLAAS system features foam-based architecture designed to accommodate most anatomies with only two sizes and simplified delivery without the need for procedural transesophageal echo, allowing physicians to perform left atrial appendage closure (LAAC) without general anesthesia.

Aaron V. Kaplan, MD, Professor of Medicine at Dartmouth College’s Geisel School of Medicine in Lebanon, New Hampshire, is Conformal’s Co-Founder and Chief Medical Officer. Dr. Kaplan commented in the company’s press release, “[The LAA] is a pouch off the left atrium where clots associated with stroke form in patients with AFib. First-generation technology has demonstrated effectiveness compared to oral anticoagulation and fueled early market growth, despite procedural limitations. The CLAAS technology aims to address these limitations and enable physicians to routinely close the LAA without general anesthesia.”

The financing syndicate included participation from new investors Fidelity Management & Research Company LLC and an undisclosed strategic investor, as well as Catalyst Health Ventures and many returning Series A and B investors.

Andy Levine, President and CEO of Conformal, added, “We are extremely pleased with the strong support of our investment partners, validating the potential of our next-generation technology in the growing LAAC market. With this significant raise, we look forward to initiating our pivotal trial and taking the next step to establish the CLAAS implant as a cornerstone stroke reduction strategy for patients with AFib.”

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