Primarily the funding will support the company’s ongoing global pivotal trial, ATLAS, in the USA and Europe, with enrolment of the trial having begun in the USA in October 2024.
“We are excited to welcome Boston Scientific and thank our shareholders for their support with our financing,” said Saravana Kumar, chief executive officer and president at 4C Medical. “The enthusiasm for participation in our ATLAS pivotal trial is palpable, and with this strong capital raise and the backing of Boston Scientific, we look forward to clinically demonstrating the safety and effectiveness of the AltaValve system in treating patients with MR.”
The ATLAS pivotal trial is designed to assess the safety and effectiveness of the AltaValve system in treating patients with moderate-to-severe or severe mitral regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair (TEER). The trial is designed with two separate non-randomised cohorts: a moderate/severe mitral annular calcification (MAC) cohort, and a primary cohort that will include patients with no or mild MAC.
Ron Waksman (MedStar Medical Center, Washington, DC, USA) is the chair of the ATLAS steering committee, with cardiologist Paul Sorajja (Allina Health Minneapolis Heart Institute, Minneapolis, USA) and cardiothoracic surgeon Yoshi Kaneko (Barnes-Jewish Hospital, St Louis, USA), are sharing principal investigator responsibilities in the USA, while cardiologist Vlasis Ninios (Interbalkan Medical Center, Thessaloniki, Greece) and cardiothoracic surgeon Lenard Conradi (University Hospital Cologne, Cologne, Germany) are sharing these responsibilities in Europe.
“This financing and participation of Boston Scientific is timely as we continue enrolment in our global ATLAS pivotal trial,” said Jeff Chambers, chairman of the board at 4C Medical. “With a strong management team and the trial leadership, this financing strategically positions us to accelerate our progress towards device commercialisation.”
Piper Sandler acted as the exclusive agent and strategic advisor to 4C Medical in connection with the series D financing.
