Conformal Medical Nets $32M in Funding for LAAO Tech

Conformal Medical Inc. is more financially solvent these days, having recently closed a $32 million Series D extension financing.

The money will help support enrollment of Conformal Medical’s ongoing CONFORM Pivotal Trial and fund key pre-commercialization initiatives for the CLAAS AcuFORM LAAO (left atrial appendage occlusion) system. The CONFORM Pivotal Trial is evaluating the safety and efficacy of the CLAAS System compared to other commercially available LAAO devices and will support U.S. Food and Drug Administration (FDA) pre-market approval. The CLAAS AcuFORM System is designed to seal the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AFib) to reduce stroke risk without the need for anticoagulants.

“We are pleased to have treated over 100 patients with the next-generation AcuFORM System, with impressive deliverability and safety performance to date,” Conformal Medical President/CEO James Reinstein said. “We look forward to building upon this robust body of evidence to further validate our one-size strategy, and the promising experience from our GLACE trial, demonstrating successful use of ICE guidance as it would eliminate the need for general anesthesia and intubation for these procedures.”

Conformal Medical’s proprietary CLAAS AcuFORM technology features a foam-based architecture designed to conform to a broad range of LAA anatomies with only two sizes. The AcuFORM device may also accelerate the shift to ICE-guided LAAO closure due to simplified sizing and seal confirmation, thereby potentially eliminating the need for a procedural transesophageal echocardiogram and general anesthesia. This is a significant advancement with the potential to shift clinical practice to a single-operator procedure that is less invasive for patients. The company remains focused on completing the CONFORM and GLACE clinical trials to demonstrate its safety profile and ability to offer solutions that address unmet clinical needs and transform the way Left Atrial Appendage Occlusion is treated.

Piper Sandler acted as exclusive financial advisor and Gunderson Dettmer acted as legal counsel to Conformal Medical in this transaction.

The CONFORM Pivotal Trial plans to randomize approximately 1,600 patients worldwide and is now more than 30% enrolled. It aims to generate pivotal data supporting next-generation stroke prevention therapies for individuals with non-valvular atrial fibrillation (AFib) who want an alternative to long-term oral anticoagulation.

Conformal Medical is a medical device company developing devices to prevent stroke in patients with non-valvular atrial fibrillation. The company’s proprietary technology is intended to make left atrial appendage closure a same-day, single-operator procedure.