4C Medical Secures $175 Million in Series D Financing to Advance Heart Valve Technology

4C Medical Secures Significant Funding to Enhance Heart Valve Therapy

Introduction
On March 5, 2025, 4C Medical Technologies, Inc., a pioneering company in the medical device sector, announced the completion of its Series D financing round, securing a substantial $175 million in funding. This investment, predominantly led by Boston Scientific Corporation alongside participation from both new and existing shareholders, is set to propel the further development and commercialization of the AltaValve™ System, a next-generation transcatheter mitral valve replacement (TMVR) technology.

Funding Purpose
The funds acquired through this financing will be primarily channelled into advancing the clinical development of the AltaValve System. Specifically, this includes supporting the ongoing global pivotal trial known as ATLAS, which aims to assess the efficacy and safety of the system in addressing mitral regurgitation (MR) in patients unsuitable for surgery or other interventions. 4C Medical commenced participant enrollment for the ATLAS trial in the United States in October 2024, highlighting a major step forward in its clinical journey.

Trial Details
The ATLAS trial is designed to examine both the safety and effectiveness of the AltaValve System in patients suffering from moderate-to-severe mitral regurgitation. The trial is structured into two distinct non-randomized cohorts: one focusing on patients with moderate/severe mitral annular calcification (MAC) and the other including individuals with no or mild MAC. This comprehensive approach will provide critical data regarding the system's performance across diverse patient profiles.

Leadership Insights
Saravana Kumar, PhD, who serves as the CEO and President of 4C Medical, expressed his enthusiasm about the collaboration with Boston Scientific and appreciated the ongoing support from shareholders. Kumar stated, “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, a cardiologist at MedStar Medical Center in Washington, D.C., has taken the helm as the Chair of the ATLAS Steering Committee, thus ensuring a robust oversight for the study. The principal investigator roles in the U.S. are jointly held by notable cardiologists Dr. Paul Sorajja and Dr. Yoshi Kaneko, while their European counterparts include Dr. Vlasis Ninios and Dr. Lenard Conradi.

The Impact of Mitral Regurgitation
Mitral regurgitation is recognized as the most prevalent valvular heart disease affecting approximately 10% of Americans aged 75 and over. It occurs when the leaflets of the mitral valve do not effectively seal, allowing blood to flow backward into the left atrium, thus complicating the heart’s function. Untreated MR can lead to severe complications, including atrial fibrillation, pulmonary hypertension, heart failure, and ultimately, death. This underscores the critical need for effective therapeutic interventions like the AltaValve System.

The Future of 4C Medical
According to Jeff Chambers, M.D., the chairman of the board at 4C Medical, the timing of this financing alongside Boston Scientific’s involvement comes at a pivotal moment as the company continues recruitment for its global trial. Chambers emphasized that having a strong management team and capable clinical leadership positions the company favorably as it moves toward commercialization.

About 4C Medical Technologies
4C Medical is at the cutting edge of medical device innovation, targeting the treatment of structural heart diseases. The AltaValve System offers a transformative approach to MR treatment by utilizing atrial fixation, setting it apart from traditional sub-valvular TMVR devices, which often suffer from design limitations related to anchoring mechanisms. This innovative design is expected to broaden the scope of MR patients that can be effectively treated.

For more information on 4C Medical and its innovative AltaValve System, please visit their website at www.4CMed.com.

Conclusion
With this substantial investment and strategic partnerships, 4C Medical is poised to make significant strides in the field of heart valve therapies, potentially improving outcomes for countless patients suffering from mitral regurgitation.