Mitral regurgitation is the most common form of valvular heart disease and affects around 10% of Americans over 75. It occurs when the mitral valve, which is located between the left atrium and the left ventricle, doesn’t close properly. This causes blood to leak backward from the left ventricle into the left atrium, rather than flowing forward into the aorta and the rest of the body, which can lead to serious complications like atrial fibrillation, heart failure, and death if untreated. MR can be addressed with open heart surgery or transcatheter edge-to-edge repair (TEER), a minimally invasive procedure where a catheter is used to place a device that clips the leaflets of the mitral valve together.
However, a company recently received funding for a potentially favorable alternative.
4C Medical Technologies is a Minnesota company focused on minimally invasive therapies for structural heart disease. AltaValve™ System, the company’s transcatheter mitral valve replacement (TMVR) technology, received dual breakthrough designations from the FDA in 2024. The AltaValve™ System is designed for treating patients with moderate or severe mitral regurgitation (MR). AltaValve treats MR by implanting a prosthetic valve via a catheter which regulates blood flow out of the left atrium.
For patients who either have high surgical risk or unfavorable anatomy for TEER, the AltaValve™ implant may provide a favorable treatment alternative to the other options discussed above.
According to a recent press release, 4C Medical announced the completion of its Series D financing round, raising up to $175 million to accelerate the development and commercialization of AltaValve. The round was led by Boston Scientific. The funding will primarily support the global ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) pivotal trial, which is assessing the safety and effectiveness of the AltaValve™ System for treating patients with moderate or severe mitral regurgitation. The ATLAS trial launched in the U.S. in October 2024 and is set to run for seven years. It includes 450 patients determined to be unsuitable for open heart surgery or transcatheter edge-to-edge repair, divided into two non-randomized cohorts: one for patients with moderate/severe mitral annular calcification (MAC), and another for those with no or mild MAC.
This Series D funding positions 4C Medical to advance the clinical and commercial development of the AltaValve System, aimed at addressing this critical health issue.
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