Conformal Medical Secures $32M Series D Extension to Advance Next-Gen LAAO Technology

Conformal Medical, a developer of advanced left atrial appendage occlusion (LAAO) solutions, has closed a $32 million Series D extension, bringing in a new investor alongside existing backers. The funding will accelerate patient enrollment in the ongoing CONFORM Pivotal Trial and advance pre-commercialization efforts for the CLAAS® AcuFORM™ system.

The AcuFORM device is designed for patients with non-valvular atrial fibrillation (AFib), aiming to reduce stroke risk without the need for long-term anticoagulants. Its foam-based design conforms to a wide range of LAA anatomies using only two device sizes, simplifying sizing decisions. The technology may also support a shift toward intracardiac echocardiography (ICE)-guided procedures, potentially eliminating general anesthesia and transesophageal echocardiography, and enabling a less invasive, single-operator approach.

To date, more than 100 patients have been treated with the AcuFORM system, demonstrating strong deliverability and safety results. ‘These early outcomes reinforce our one-size-fits-most strategy and build on the promising data from our GLACE trial, which demonstrated the success of ICE-guided procedures,’ said James Reinstein, President and CEO of Conformal Medical.

The CONFORM Pivotal Trial is a global, randomised controlled study comparing the CLAAS AcuFORM system with other commercially available LAAO devices. The target is to enrol approximately 1,600 patients at sites worldwide, with over 30% of participants already randomised. The results will support the company’s submission for pre-market approval by the U.S. FDA.