MINNEAPOLIS, March 5, 2025 /PRNewswire/ -- 4C Medical Technologies, Inc. ("4C Medical"), a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, today announced the closing of its Series D financing round resulting in gross proceeds of up to $175 million, led by Boston Scientific Corporation, with participation from certain new and existing shareholders. The financing will be utilized to accelerate the clinical development and commercialization of the AltaValve™ System, the company's next generation transcatheter mitral valve replacement (TMVR) technology.

The proceeds from this financing will primarily be used to support the company's ongoing global pivotal trial ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation), in the U.S. and Europe. 4C Medical commenced enrollment of the ATLAS trial in the U.S. in October 2024. 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. The trial is designed with two separate non-randomized cohorts:

a) Moderate/severe mitral annular calcification (MAC) Cohort, and

b) Primary Cohort that will include patients with no or mild MAC.

"We are excited to welcome Boston Scientific and thank our shareholders for their support with our financing," said Saravana Kumar, PhD, 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."

Dr. Ron Waksman, cardiologist at MedStar Medical Center (Washington DC) is the Chair of the ATLAS Steering Committee.  Dr. Paul Sorajja, cardiologist at Allina Health Minneapolis Heart Institute (Minneapolis, MN) and Dr. Yoshi Kaneko, cardiothoracic surgeon at Barnes-Jewish Hospital (St. Louis, MO), are sharing Principal Investigator responsibilities in the US, while Dr. Vlasis Ninios, cardiologist at Interbalkan Medical Center (Thessaloniki, Greece) and Dr. Lenard Conradi, cardiothoracic surgeon at University Hospital Cologne (Cologne, Germany) are sharing Principal Investigator responsibilities in Europe.

"This financing and participation of Boston Scientific is timely as we continue enrollment in our global ATLAS pivotal trial," said Jeff Chambers, M.D., 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 commercialization."

MR is the most common valvular heart disease affecting nearly 10 percent of Americans aged 75 years and older and occurs when the mitral valve leaflets do not close properly, allowing blood in the left ventricle to leak back into the left atrium. It is a progressive disease and if left untreated, MR can lead to atrial fibrillation, pulmonary hypertension, heart failure and death.

Piper Sandler acted as the exclusive agent and strategic advisor to 4C Medical in connection with the Series D financing.

About 4C Medical Technologies, Inc.

4C Medical is at the forefront of medical device innovation, focusing on developing transformative technologies for structural heart disease, initially targeting MR treatment. The AltaValve System represents a paradigm shift in MR treatment with its atrial fixation as compared to sub-valvular TMVR devices that rely on rigid anchoring mechanisms, potentially affecting hemodynamics and limiting treatment applicability to select MR patients. The AltaValve System aims to minimize design limitations associated with the complexity and variability of the mitral annulus and left ventricle – thus, expanding its applicability to a broad number of MR patients.

For more information about 4C Medical and the AltaValve System, please visit www.4CMed.com.

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SOURCE 4C Medical Technologies, Inc.