Conformal Medical has raised $32 million to support the development of its heart implant designed to reduce the lifetime risk of stroke among people with atrial fibrillation.
The company said the proceeds will help bolster enrollment into its pivotal trial, as well as prepare it for future commercialization, as it works to obtain approval for what it describes as the next generation of left atrial appendage occlusion devices.
Conformal’s CLAAS AcuFORM system seals off the small pocket in the wall of the cardiac muscle, where dangerous blood clots are more likely to form with an irregular heartbeat. The company aims to compete in this space with the likes of Boston Scientific’s Watchman implants—which recently obtained a label expansion from the FDA to include afib patients after an ablation procedure—as well as Abbott’s Amplatzer Amulet.
Johnson & Johnson and Medtronic have also set their eyes on this billion-dollar sector, through their respective 2023 acquisitions of Laminar and the surgical Penditure system.
In contrast to other closure systems, Conformal employs a foam matrix that fills the appendage space while matching the shape of the patient’s anatomy. The company said this can simplify the procedure, with easier alignment and only two device sizes to choose from: large and regular.
In addition, with the ability to confirm the implant’s seal through angiography, clinicians may be able to forgo the use of general anesthesia and transesophageal echocardiograms and turn transcatheter LAAO operations into a same-day procedure.
The company has been conducting a randomized non-inferiority study comparing the CLAAS device with the Watchman and Amulet systems, dubbed CONFORM, with plans to follow patients for five years. Conformal said earlier this year it’s about a third of the way toward its enrollment goal of 1,600 participants with non-valvular afib.
“We are pleased to have treated over 100 patients with the next-generation AcuFORM System, with impressive deliverability and safety performance to date,” Conformal President and CEO James Reinstein said in a statement.
“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 [intracardiac echocardiography] guidance as it would eliminate the need for general anesthesia and intubation for these procedures,” Reinstein said.
The GLACE study was a single-arm European study, with early imaging guidance results presented earlier this year at the AF Symposium in Boston.
The $32 million came via an extension to Conformal’s series D venture capital financing, courtesy of an unnamed investor. The round previously collected $35 million in mid-2023, led by SPRIG Equity. Before that, Conformal logged an $85 million series C in 2020.