4C Medical Technologies has successfully wrapped up its Series D funding round, raising up to $175 million. This funding is primarily led by Boston Scientific and will help speed up the clinical development and market introduction of 4C Medical’s transcatheter mitral valve replacement technology, known as the AltaValve System.
Piper Sandler acted as the strategic advisor and exclusive agent for 4C Medical during this funding process. The money raised will focus on supporting the global ATLAS trial, which is currently taking place in Europe and the United States.
Launched in the U.S. in October, the ATLAS trial is designed to assess the safety and effectiveness of the AltaValve System for patients suffering from moderate-to-severe mitral regurgitation (MR). These patients are often unable to undergo traditional surgical options or the transcatheter edge-to-edge repair technique.
Saravana Kumar, the CEO and president of 4C Medical Technologies, expressed excitement about partnering with Boston Scientific and appreciated the support from their shareholders. He noted, “The interest in our ATLAS trial is growing, and with the substantial funds from Boston Scientific, we are eager to prove the safety and effectiveness of the AltaValve System for MR patients.”
The ATLAS trial is organized into two separate, non-randomized groups. One group includes patients with moderate to severe mitral annular calcification (MAC), while the other focuses on patients with no or mild MAC.
Dr. Paul Sorajja, a cardiologist from Allina Health Minneapolis Heart Institute, and Dr. Yoshi Kaneko, a cardiothoracic surgeon from Barnes-Jewish Hospital, will oversee the U.S. portion of the trial. In Europe, Dr. Vlasis Ninios from Interbalkan Medical Center and Dr. Lenard Conradi from University Hospital Cologne will manage the European segment of the trial.
Mitral regurgitation is a common heart valve disorder that occurs when the mitral valve does not close properly. It impacts about one in ten Americans over the age of 75 and can lead to severe health issues if untreated. In May 2024, the AltaValve System received dual breakthrough device designations from the U.S. Food and Drug Administration (FDA), marking a significant milestone in its development.
