Conformal Medical’s CLAAS Device Pivotal Trial Supported by Series D Financing

June 5, 2023—Conformal Medical, Inc., which is developing next-generation left atrial appendage occlusion (LAAO) technology, announced the successful completion of its Series D funding round, raising a total of $35 million.

According to the company, the oversubscribed round reflects the progress and achievements made since its last funding round, including the initiation of the CONFORM clinical trial that was announced in June 2022. The pivotal CONFORM trial is evaluating the safety and efficacy of the company’s CLAAS system compared to other commercially available LAAO devices and will support the company’s FDA premarket approval application.

Conformal Medical’s CLAAS system is designed to seal the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation to reduce the risk of stroke without the need for anticoagulants. The CLAAS technology features a foam-based architecture designed to conform to a broad range of LAA anatomies with only two sizes.

The company stated that the CLAAS device aims to simplify the procedure by allowing off-axis positioning while providing a more uniform seal. The CLAAS implant may also be able to eliminate the need for procedural transesophageal echocardiogram so that physicians may perform the procedure without general anesthesia. This has the potential to shift clinical practice to a single operator procedure performed under conscious sedation without general anesthesia, noted Conformal Medical.

The financing round was led by SPRIG Equity with participation from all major Series C investors.

James Reinstein, CEO of Conformal Medical, commented in the company’s press release, “Conformal Medical is committed to bringing the innovative CLAAS system to the large and rapidly growing LAAO market in the United States. The Series D funding provides us the resources to complete enrollment in the CONFORM trial, drive iterative development projects, and broaden the clinical experience of the CLAAS system in expanded geographies. We are thrilled with the ongoing support of our investors and welcome SPRIG Equity in recognizing the significant market opportunity and the potential advantages our system can provide.”