4C Medical Technologies Secures $175 Million Series D Preferred Equity Financing to Advance AltaValve™ TMVR System
4C Medical Technologies
Cardiovascular Consumables Developer
The proceeds from this round of financing will be used to accelerate the clinical development and commercialization of 4C Medical's next-generation TMVR device, the AltaValve™ system. As the world’s only fully retrievable, low-profile, trans-septal transcatheter mitral valve system, the AltaValve™ system is expected to provide the world’s first mitral regurgitation treatment solution that requires only atrial fixation upon market release.
Previously, HeartFlow Medical has made multiple rounds of investments in 4C Medical Technologies, Inc. and owns the exclusive commercial rights to AltaValve™ in mainland China, Hong Kong, Macao, and Taiwan.
China, Shanghai — Recently, 4C Medical Technologies, Inc. (hereinafter referred to as "4C Medical"), an associate company of MicroPort CardioFlow Medtech Corporation (02160.HK, hereinafter referred to as "CardioFlow Medtech"), announced the successful completion of its Series D financing round, raising a total of US$175 million. This round was led by Boston Scientific Corporation, with active participation from both new and existing shareholders. The proceeds will be used to accelerate the clinical development and commercialization of 4C Medical's next-generation transcatheter mitral valve replacement (TMVR) device, the AltaValve™ system.
4C Medical is a medical device company focused on developing innovative therapies for structural heart disease, with business covering the interventional treatment fields of mitral regurgitation and tricuspid regurgitation. Previously, MicroPort CardioFlow Medtech Corporation has made multiple rounds of investments in 4C Medical and holds the exclusive commercial rights to AltaValve™ in mainland China, Hong Kong, Macao, and Taiwan.
Mitral Regurgitation (MR) is a common cardiac valve disease that, if left untreated, can lead to heart failure, arrhythmia, or even death. Current treatment options include medication management, open-heart surgery for repair or replacement, and transcatheter edge-to-edge repair (TEER), among others. However, for patients at high surgical risk, with severe mitral annular calcification, or complex anatomical structures, traditional treatment methods may not offer effective and long-term solutions.
The AltaValve™ system is currently the world's only fully retrievable, low-profile, trans-septal transcatheter mitral valve system. Upon its market release, it is expected to provide the world’s first treatment solution for mitral regurgitation that requires only atrial fixation. The system's innovative design effectively addresses the known challenges of mitral annulus anchoring associated with existing TMVR technologies, protects the patient's cardiac structure during the procedure, reduces the risk of left ventricular outflow tract obstruction or damage, and enhances clinical outcomes.
▲AltaValve™ System
Currently, 4C Medical has launched the global pivotal clinical trial ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) in the United States and Europe. This pivotal trial aims to evaluate the safety and efficacy of AltaValve™ 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 includes two independent non-randomized cohorts: a moderate/severe mitral annulus calcification (MAC) cohort; and a primary cohort comprising patients without MAC or with mild MAC. The success of this trial is not only crucial for the future regulatory approval and market promotion of AltaValve™ but also has significant implications for the technological development of the entire transcatheter mitral valve replacement (TMVR) field.
4C Medical Successfully Completes Series D Financing with Boston Scientific Joining In, Marking Significant Recognition of 4C Medical's Technological Innovation and Clinical Value. As a long-term supporter of 4C Medical, HeartFlow values most the transformation of innovative technology into hope for patients' lives. The groundbreaking significance of this financing lies not only in the affirmation from the capital market but also in the potential of the AltaValve™ system to provide safer and more accessible treatment options for patients with moderate to severe mitral regurgitation — particularly those excluded from traditional therapies due to mitral annular calcification (MAC) or complex anatomical structures. With the acceleration of the ATLAS global pivotal clinical trial, we look forward to further breakthroughs in the clinical safety and efficacy of this product, leading to its successful commercialization and benefiting more patients worldwide.
——President of Xintong Medical
Mr. Jeff Lindstrom
As the largest shareholder of 4C Medical before this round of financing, Heartflow Medical has witnessed the growth journey of 4C Medical from an innovative concept to becoming a leader in the global cardiovascular medical market. This financing not only marks an important milestone in the development of 4C Medical but also brings new hope to patients with mitral regurgitation worldwide. At the same time, it validates the strategic vision of Heartflow Medical's long-term investment in 4C Medical—firmly supporting disruptive innovation enterprises and promoting continuous innovation in treatment solutions for structural heart disease.
The global market's demand for safe, efficient, and minimally invasive innovative mitral regurgitation treatment solutions continues to grow. In the coming years, with the maturation of technology and the accumulation of clinical data, TMVR is expected to become a treatment option for an increasing number of patients. Relying on its unique technological innovation capabilities, as well as the support and empowerment from global strategic partners, 4C Medical Technologies is poised to have strong market competitiveness in this field and is expected to drive the broader application of TMVR technology.
HeartFlow Medical will continue to fully support the development of 4C Medical Technologies, Inc., and looks forward to collaborating with partners in the global medical industry. Prioritizing saving patients' lives and improving their quality of life, HeartFlow Medical aims to provide accessible, truly effective, and comprehensive solutions for treating structural heart disease.
——Chairman of HeartFlow Medical
Mr. Guoming Chen
