Newsletter summary

Co-development of Xintong Medical treatment-B (02160.HK) and 4C MedicalRoulettegameAltaValve transcatheter mitral valve replacement products have been awarded the title of groundbreaking equipment by FDA, and global confirmatory clinical trials are expected to begin by the end of 2024.

Text of news flash

[Xintong Medical-B has been recognized by FDA breakthrough equipment, AltaValve mitral valve replacement product has attracted attention] Xintong Medical-B (02160.HK) has recently announced that it is similar to 4C Medical Technologies.Roulettegame, Inc. The AltaValve transcatheter mitral valve replacement medical device jointly developed has been awarded the title of breakthrough equipment by the Food and Drug Administration (FDA) of the United States. This honor marks the high recognition of AltaValve's innovation and clinical needs, and adds a touch of light to the future market prospect of the product. The innovation of AltaValve is that it provides an atrial-only transcatheter treatment for patients with mitral regurgitation who cannot undergo conventional surgery or repair through the edge of the catheter. This scheme effectively reduces the complexity and variability associated with anchored mitral annulus while preserving key cardiac structures and reducing the risk of left ventricular outflow tract obstruction or left ventricular injury. FDA's groundbreaking device identification is intended to accelerate the review process to ensure that patients receive this potentially more effective treatment as soon as possible. 4C Medical has previously achieved positive results in the early feasibility study of AltaValve and is expected to launch global clinical trials by the end of 2024 to promote the product to receive EU CE certification and FDA approval. This development will undoubtedly be a positive signal for Xintong Medical-B and its investors. AltaValve's breakthrough equipment identification not only highlights the company's innovative strength in the field of medical devices, but also opens up new possibilities for the company's future development.