Conformal Medical Raises $32M to Advance Next-Generation Heart Occluder

Conformal Medical has secured $32 million in additional funding to support the development and clinical trials of its innovative left atrial appendage occlusion (LAAO) device. The company's CLAAS AcuFORM system, designed to reduce stroke risk in patients with atrial fibrillation, aims to compete with established players in the billion-dollar LAAO market.

Funding Boost for Pivotal Trial

The recent $32 million investment, an extension of Conformal Medical's series D financing round, will primarily support the ongoing CONFORM trial. This randomized non-inferiority study compares the CLAAS device with Boston Scientific's Watchman and Abbott's Amplatzer Amulet systems. The company reports being approximately one-third of the way toward its enrollment goal of 1,600 participants with non-valvular atrial fibrillation.

James Reinstein, President and CEO of Conformal Medical, stated, "We are pleased to have treated over 100 patients with the next-generation AcuFORM System, with impressive deliverability and safety performance to date." The funding will also aid in preparations for future commercialization efforts.

Innovative Foam-Based Technology

Conformal's CLAAS AcuFORM system distinguishes itself from competitors by employing a foam matrix that conforms to the patient's unique anatomy. This design aims to simplify the implantation procedure, offering easier alignment and requiring only two device sizes: large and regular.

The company suggests that its technology may allow for same-day procedures by eliminating the need for general anesthesia and transesophageal echocardiograms. Instead, clinicians can confirm the implant's seal through angiography and potentially use intracardiac echocardiography (ICE) guidance.

Competitive Landscape and Market Positioning

The LAAO market has seen increased activity in recent years, with major players vying for market share. Boston Scientific's Watchman device recently received FDA approval for use in atrial fibrillation patients following ablation procedures. Johnson & Johnson and Medtronic have also entered the sector through acquisitions, highlighting the growing interest in LAAO technologies.

Conformal Medical's approach seeks to address limitations of current devices by offering a more adaptable and potentially simpler implantation process. The ongoing CONFORM trial and the earlier GLACE study in Europe aim to provide clinical evidence supporting the efficacy and safety of the CLAAS AcuFORM system.

As the company progresses through its clinical trials and prepares for potential market entry, the recent funding injection positions Conformal Medical to continue its pursuit of what it calls "the next generation of left atrial appendage occlusion devices."