MicroPort CardioFlow Increases Investment in US Structural Heart Disease Innovator 4C Medical

Shanghai, China, 5 November 2021 — MicroPort CardioFlow Medtech Corporation (02160.HK, MicroPort CardioFlow) is set to become the largest shareholder of 4C Medical Technologies, Inc. (4C Medical) following the recent completion of a series C preferred shares subscription agreement. As the lead investor of the round, MicroPort CardioFlow will make a strategic investment up to USD 25 million in 4C Medical, and will be granted the exclusive commercial rights to the investigational tricuspid products in China.

4C Medical is a US-based innovative medical device company focused on developing transcatheter treatment technologies for structural heart diseases, including mitral and tricuspid regurgitation. AltaValve™, an investigational transcatheter mitral valve implantation device developed by 4C Medical, is the first mitral regurgitation solution featuring supra-annular placement and atrial-only fixation. It is designed to preserve the patient’s native mitral valve and left ventricle, eliminating all known issues with conventional transcatheter mitral valve replacement techniques, and is therefore applicable for patients with different mechanisms of mitral regurgitation.

4C Medical is currently conducting its Early Feasibility Study (EFS) clinical trial to demonstrate the safety of AltaValve™, the mitral valve product, to treat mitral regurgitation. Recently, a fully recapturable transseptal delivery system designed for ease-of-use and deliverability was introduced into the clinical study. Using this delivery system, 4C Medical successfully completed its first US clinical study patient with good results. In addition, early preclinical studies were completed to show the feasibility of applying the technology for the treatment of tricuspid valve regurgitation. The proceeds of the fundraise are intended to be used to support the completion of the EFS clinical trial for the mitral valve product and initiate a first in human study for the tricuspid valve product.

VitaFlow® Transcatheter Aortic Valve and Delivery System, the first generation transcatheter aortic valve developed by MicroPort CardioFlow, has been marketed in China since July 2019 as the first product in the country that uses bovine pericardium as valve tissue. Its second-generation product VitaFlow Liberty™ was launched in China in August 2021 and is undergoing clinical trials in Europe, with CE Mark application expected to be submitted by the end of 2021.

Mr. Guoming Chen, President of MicroPort CardioFlow, commented, “MicroPort CardioFlow has previously invested in 4C Medical and became a shareholder back in 2018, and with this round of strategic investment, we will further strengthen our cooperation and be granted exclusive commercial rights of the investigational tricuspid products in China. The move will further enrich MicroPort CardioFlow's product pipeline in mitral and tricuspid valve interventions, which will complement our diversified product portfolio, enhance our market competitiveness and provide a comprehensive structural heart diseases treatment solutions for patients worldwide.”