Medtech company raises $32M for foam-based LAAO device
Conformal Medical, a New Hampshire-based medical device company, has closed a Series D extension financing round worth $32 million.
The company is expected to use these funds to help advance its CLAAS AcuFORM left atrial appendage occlusion (LAAO) device, which was designed to protect patients with nonvalvular atrial fibrillation from stroke without the use of anticoagulants. The device has a foam-based structure, allowing it to conform to a variety of different patient anatomies. In addition, according to Conformal Medical, the CLAAS technology has shown potential to be safely and effectively implanted without the use of procedural transesophageal echocardiograms, with operators just using intracardiac echocardiography.
Some of this new financing will go toward enrolling additional patients into the ongoing CONFORM pivotal trial, which is comparing the CLAAS technology to other commercially available LAAO devices. The company hopes trial data will then help support approval from the U.S. Food and Drug Administration.
“We are pleased to have treated over 100 patients with the next-generation AcuForm System, with impressive deliverability and safety performance to date,” James Reinstein, president and CEO of Conformal Medical, 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 ICE guidance as it would eliminate the need for general anesthesia and intubation for these procedures.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.