4C Medical Secures $175 Million Series D Financing Led by Boston Scientific and HHF Farun to Advance Pioneering TMVR Technology

On March 5, 2025, U.S. time, 4C Medical Technologies, Inc. ("4C Medical") announced the successful completion of a $175 million Series D financing round. This round was co-invested by Boston Scientific (NYSE: BSX) and HHF Fuyuan Investment as the only two new investors, with existing shareholders also increasing their investments. The completion of this financing will further accelerate 4C Medical's technology development, clinical progress, and market expansion in the field of heart valve disease treatment. Following multiple rounds of strategic investment support from HeartFlow Medical (02160.HK), 4C Medical has once again successfully gained support from new industry players and professional investment institutions, demonstrating the market's high attention and emphasis on the significant potential within the heart valve sector.

4C Medical Focuses on the Development of Transcatheter Mitral Valve Replacement (TMVR) Technology to Address Challenges in the Clinical Treatment of Mitral Regurgitation. Its Flagship Product, the AltaValve™ System, is the World's Only Fully Retrievable Low-Profile TMVR System, Featuring a Unique Atrial Fixation Design that Effectively Reduces Impact on Mitral Valve Anatomy and Lowers the Incidence of Postoperative Left Ventricular Outflow Tract Obstruction. In May 2024, the AltaValve™ System Received Two Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA) for the Treatment Indications of "Moderate to Severe or Severe Mitral Regurgitation (MR)" and "Moderate to Severe or Severe MR with Moderate/Severe Mitral Annular Calcification (MAC)." Currently, 4C Medical Has Initiated Global Pivotal Clinical Trials in the United States and Europe to Further Validate the Safety and Efficacy of the AltaValve™ System.

Currently, there are over 3.4 million new cases of mitral regurgitation globally each year, with an extremely high mortality rate. Existing interventional mitral valve repair technologies, such as MitraClip and PASCAL, have been widely used in clinical practice, generating annual sales exceeding $1 billion. However, due to factors like patient anatomical adaptability, a significant number of patients still cannot benefit from these technologies. In comparison, mitral valve replacement offers more comprehensive treatment and broader adaptability, showing tremendous development potential. The estimated global potential market size for interventional mitral valve replacement is projected to reach several billion dollars. Historically, many well-known companies faced limitations in clinical or commercial progress when developing interventional mitral valve replacement products due to issues such as limited patient suitability and poor surgical safety. AltaValve™ by 4C Medical Technologies solves the patient selection problem caused by fixation methods through innovative design and has advantages in surgical convenience and safety compared to other products under development. It is expected to become a mainstream clinical solution for mitral valve replacement in the future.

Dr. Saravana Kumar, President and CEO of 4C Medical Technologies"We are very grateful for the recognition and support from Boston Scientific, HHF Fuyuan Investment, and other existing professional investors. Transcatheter mitral valve replacement therapy for treating mitral regurgitation presents a significant market opportunity. Our product has already demonstrated its ease of use and long-term device performance through early clinical results. We will utilize this funding from both new and existing investors to advance clinical trials and product commercialization, benefiting more patients and contributing to the global healthcare industry."

Mr. Gu Zheyi, Partner of HHF Fuyuan InvestmentStated: "HHF Fuyuan Investment consistently supports the development of innovative medical devices, committed to bringing optimal solutions to patients worldwide. Fuyuan has been deeply engaged in the cardiac valve field for many years, building profound insights through industrial resources. 4C Medical is precisely a target we have been tracking for years within this sector; its products are globally pioneering and capable of addressing inherent issues with existing therapies. They have the potential to significantly expand the patient applicability range and become a mainstream clinical solution for mitral valve replacement. It turns out that this assessment has also been fully recognized by industry giants such as Boston Scientific. Investing in 4C Medical undoubtedly serves as another testament to HHF Fuyuan Investment's practice of capturing high-quality assets alongside industry leaders and resolutely conducting industrial investments using complex transaction capabilities. We believe that under the efforts of 4C Medical’s management team, with the support of industry giants and the companionship of professional institutional investors, the Altavalve product will be brought to market more quickly and effectively, benefiting patients worldwide."