Conformal Medical has raised $32 million to accelerate the development and commercialization of its CLAAS AcuFORM heart implant, designed to lower the lifetime risk of stroke in patients with atrial fibrillation (AFib).
The funding will support enrollment in the company’s pivotal CONFORM trial and preparations for market launch. The CLAAS AcuFORM system is a next-generation left atrial appendage occlusion (LAAO) device that seals the small pocket in the heart muscle wall where blood clots often form in AFib patients.
Unlike traditional devices, the CLAAS system uses a foam matrix that adapts to each patient’s anatomy, requiring only two size options—regular and large—while simplifying alignment. The implant’s seal can be verified via angiography, potentially eliminating the need for general anesthesia or transesophageal echocardiography, and enabling same-day transcatheter procedures.
The CONFORM study compares the CLAAS device to Boston Scientific’s Watchman and Abbott’s Amplatzer Amulet over five years, with about a third of its 1,600-patient enrollment completed. Early data from over 100 treated patients show strong safety and performance.
Conformal’s earlier GLACE trial in Europe demonstrated the feasibility of using intracardiac echocardiography to guide procedures, further reducing patient risk.
The latest funding comes as an extension of the company’s Series D round, adding to the $35 million raised in mid-2023 and following an $85 million Series C in 2020.