Venus Medtech National Key R&D Program launched

Recently, Venus Medtech (Hangzhou) Inc. (hereinafter referred to as "Venus Medtech", 2500.HK) successfully held the kick-off meeting of the "Development and Application of Transcatheter Self-expanding Pulmonic Valve Replacement System" project, a National Key R&D Program for the13th Five-Year Plan.

VenusP-Valve, the transcatheter self-expanding pulmonic valve replacement system, is a core product of Venus Medtech, jointly developed by the company and Sichuan University. As the world's first self-expanding transcatheter pulmonic valve to enter clinical trials, it’s able to meet the needs of more than 85% of patients. It is also the only large-sized TPVR product in the world suitable for patients suffering excessive dilation of right ventricular outflow tract.

Held in Hangzhou, China, the meeting brought together Professor Xi Tingfei from Academy for Advanced Interdisciplinary Studies of Peking University, Zhao Jianguo, Researcher from Institute of Zoology, Chinese Academy of Sciences, He Tao, former President and Professor-Level Senior Engineer of Zhejiang Institute of Medical Device Testing and Director of Key Laboratory of Medical Device Safety Evaluation and Research of Zhejiang Province, Tang Zhirong, guiding expert of the project, Eric Zi, Founder, Executive Director and General Manager of Venus Medtech and the project team.

At the meeting, Kuang Dajun, R&D Manager of Venus Medtech, and Professor Wang Yunbing from College of Biomedical Engineering of Sichuan University presented on the development and application of the product and project milestones. Zhao Jianguo and Tang Zhirong, guiding experts of the project, highly affirmed the scientific and clinical value of the product.

Up to now, VenusP-Valve has been in clinical trials in more than 50 medical centers across Asia, Europe, North and South America, with no valve failure observed since the first implantation in 2013. Follow-up data from international multi-center studies also demonstrate its good safety and efficacy.

In April 2019, VenusP-Valve was included by the Chinese National Medical Products Administration (NMPA) in the "Special Review and Approval Procedures for Innovative Medical Devices" and completed a multi-center, single-arm, non-blind critical trial. In March 2021, the product received special use authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in designated medical institutions. In addition, the product is awaiting CE marking approval in the EU.

The National Key R&D Program is one of the highest-level science and technology programs in China targeted at advancing research for social good, with focuses on areas relevant to the economy and livelihood of the population. This project is mainly undertaken by Venus Medtech with participation of Sichuan University, Fudan University Zhongshan Hospital, Fuwai Hospital of Chinese Academy of Medical Sciences and West China Hospital of Sichuan University. It focuses on improving the core competitiveness of the Chinese biomedical materials industry, enhancing the ability of independent innovation, and achieving breakthroughs in major S&T fields pertaining to national security. The project aims to place China in the same league as global leaders in the industry.

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