Conformal Medical, a U.S.-based medical device innovator, has secured $32 million in a Series D extension round to accelerate its next-generation Left Atrial Appendage Occlusion (LAAO) technology. The investment, which includes a new strategic partner alongside existing backers, will fund enrollment in the company’s ongoing CONFORM Pivotal Trial and support pre-commercialization efforts for its CLAAS® AcuFORM™ system. This breakthrough device aims to protect patients with non-valvular atrial fibrillation (AFib) from stroke without the need for long-term anticoagulants.
The CLAAS AcuFORM System is designed with a foam-based architecture that adapts to diverse LAA anatomies using just two sizes, simplifying implantation. Notably, the device has shown promising performance in more than 100 treated patients, offering enhanced deliverability and safety. Early results from the GLACE trial highlight its potential to be guided using intracardiac echocardiography (ICE), avoiding the need for general anesthesia and transesophageal echocardiography, and allowing for less invasive, single-operator procedures.
CEO James Reinstein expressed confidence in the system’s future, citing both clinical trial progress and strong patient outcomes. By simplifying sizing and seal confirmation, the CLAAS AcuFORM could significantly change how LAAO procedures are performed, potentially setting a new standard for stroke prevention in AFib patients. The company remains committed to completing its pivotal studies and advancing toward FDA approval.
Conformal Medical secures $32M Series D extension to advance its CLAAS® AcuFORM™ LAAO system.
Device designed for stroke prevention in AFib patients without long-term anticoagulants.
Early trial results show less invasive procedure potential with ICE guidance and simplified sizing.
