Recently, " R&D of New Preloaded Interventional Heart Valve System", a Venus Medtech-led R&D program, passed the China National Center for Biotechnology Development with excellent performance. This is another successful closing the Company had after “National Science and Technology Support Program – Development of New Biological Heart Valve”. In addition, Venus Medtech has another national key R&D program in progress titled "Development and Application of Self-expanding Transcatheter Pulmonic Valve Replacement System".

 

The program comprises of four research topics, namely Research and Development of Valve Design, Manufacturing and New Delivery System, Research on Anti-perivalvular Leakage Technology, Research on Anti-calcification Technology, and Research on Preloaded Valve Technology.

According to the National Key R&D Program Comprehensive Performance Assessment Expert Panel, the program has been executed in a successful manner. Studies have been conducted on the anti-calcification and self-flattening functions of bioprosthetic heart valves. Technologies such as retrievable delivery system, retrievable valve frame, and adaptive controllable deformation for anti-perivalvular leakage have been developed and incorporated into novel products such as retrievable TAVR systems and fully-released and retrievable preloaded self-expanding dry-tissue valves.

It is noteworthy that VenusA-Plus retrievable TAVR system was approved for marketing in China in 2020. Venus PowerX, a fully-released and retrievable dry-tissue valve TAVR system launched First-in-Man (FIM) study in December 2021 with ongoing clinical trials.

 

As a leading provider of bioprosthetic heart valve systems, Venus Medtech has set a number of records for Chinese makers in the sphere. For example, VenusA-Valve and VenusA-Plus, the first NMPA-approved TAVR system and its second-generation product, ushered in a new era for TAVR in China. So far, TAVR products by Venus Medtech have reached 9,000 implantations. VenusA-Valve is also the only TAVR product supported by nine-year follow-up data in China.

In addition, Venus Medtech has cemented its leadership in the development of next-generation TAVR products. On December 16, 2021, balloon-expandable dry-tissue valve Venus-Vitae concluded FIM study in two cases in Argentina. Venus-Vitae adopts advanced anti-calcification technologies to improve valve durability. The specifically designed dry-tissue valve can be pre-mounted and contains no residual aldehyde, which enhances safety and boosts ease in clinical application as well as storage and transport. Its patented wire lock technology can also ensure that the valve does not shift on the balloon catheter, effectively assisting the operator in precise positioning.

 

Venus-PowerX, another novel dry-tissue product of the Company, completed FIM clinical trial at West China Hospital, Sichuan University on December 21, 2021. As the world’s first fully-released and retrievable dry-tissue valve, Venus-PowerX features a wire-controlled design that allows for retrieval of the valve after 100% complete release, providing greater safety than traditional delivery.

 

 “We are grateful to the recognition of our R&D efforts from the authorities”, commented Eric Zi, Founder and General Manager of Venus Medtech. “We will redouble efforts to apply the research achievements and help foster a science-based, standardized and systematic R&D and assessment system for domestic innovative products including TAVR products, so as to facilitate the demonstration, promotion and application of such products. Venus Medtech will continue to work on technological issues that are crucial to the core competitiveness and independent innovation capability of the industry as well as national security, thereby supporting Chinese-made innovative medical devices to emerge as global leaders with scientific and technological advances.”