Filling gap in market: VenusP-Valve™ approved by China's NMPA

HANGZHOU,China,July 13,2022 -- On July 11,2022,VenusP-ValveTM,Venus Medtech's in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system,was approved by China's National Medical Products Administration (NMPA) for the treatment of severe pulmonary regurgitation (≥3+) in patients after congenital heart defects (CHD) procedure with native right ventricular outflow tract (RVOT). The approval has made VenusP-ValveTM the first TPVR product to be marketed in China,marking another milestone following its CE MDR approval.

As the first self-expanding TPVR product approved for marketing in both China and Europe,VenusP-ValveTM sets itself apart with remarkable clinical value. Uniquely designed with both flared ends,the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery,with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability,VenusP-ValveTM is able to meet the needs of 85% of patients in the case of large RVOT.

For the registration application,the NMPA has accepted the overseas clinical trials data of VenusP-ValveTM as clinical evaluation data,that is,the CE clinical trial data was applied. In April 2022,VenusP-ValveTM received CE marking under the MDR and has been applied to a number of commercial cases. The product was approved by the FDA for compassionate use in two cases in the U.S. in May 2022 and the first compassionate case was completed successfully in June 2022. In addition,the Investigator Meeting for VenusP-ValveTM US Clinical Study was held,and the Japan-US Harmonization By Doing Program was agreed upon by the FDA and PMDA with a plan to conduct clinical trials in the U.S. and Japan simultaneously,which will accelerate its registration and marketing in both countries.

Following its first clinical implantation in 2013,VenusP-ValveTM has been used in nearly 300 cases for humanitarian reasons,spanning more than 20 countries and regions in Asia,Europe,North America,and South America. With clinical data from Europe and China backing up its long-term safety and efficacy,VenusP-ValveTM has received high recognition from the international medical community.

According to three-year follow-up data of the European clinical trial,the success rate for TPVR with VenusP-ValveTM is 100% in 64 patients (some patients have not been included due to the ongoing pandemic). All-cause mortality and surgical re-intervention rates were zero. In addition,no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects. Meanwhile,five-year follow-up data of the Chinese trial reported a 3.64% postoperative five-year all-cause mortality rate.

Noteworthily,Venus Medtech earned First Prize of the Technical Invention Award of the Excellent Achievements in Scientific Research (Science and Technology) of Higher Education in March 2021 for its key materials and technologies of self-expanding Interventional pulmonic valve system project,which was mainly applied to VenusP-ValveTM. Jointly undertaken by the Company and Sichuan University,the project received strategic support from the National Key Research and Development Program under the 13th Five-Year Plan.

Academician Prof. Ge Junbo,Director of Cardiology Department at Zhongshan Hospital Affiliated to Fudan University and Principal Investigator (PI) of the Chinese clinical trial of VenusP-ValveTM,congratulated Venus Medtech on the NMPA approval of the product. "The first clinical application of VenusP-ValveTM dated to May 2013,and we were all impressed by its excellent immediate outcomes. The overall clinical results of the multi-center study testified to effective and steady improvements it brought to patients' cardiac function,making me extremely proud of this Chinese-developed valve product. Moreover,its recent launch in Europe and compassionate use in the U.S. demonstrated the recognition it received from the international medical community. That's how a truly meaningful innovative medical device is defined."

In recent years,the Center for Medical Device Evaluation (CMDE) of NMPA has continuously optimized its procedures by introducing new policies and boosting review quality and efficiency in accordance with the decision of the State Council to reform the review and approval system of drugs and medical device. By doing so,the CMDE has effectively expedited the review and approval of domestic innovative medical devices and contributed to the high-quality growth of the industry. New policy documents including the Special Review Approval Procedure for Innovative Medical Devices and Priority Review and Approval Procedure for Medical Devices have been issued to create a green channel for clinically urgent novel devices and accept overseas clinical trial data. The improvements underlined CMDE's science-based,pro-reform orientation.

"The fast-tracked approval of VenusP-ValveTM would not be possible without CMDE's generous support. Their patient-centric orientation is an important driver in promoting innovative medical devices",commented Eric Zi,Co-Founder,Executive Director,and General Manager of Venus Medtech. "As one of the first companies to work on transcatheter structural heart devices in China,we have always embraced a clinical value-oriented approach to innovation. Aspiring to lead technological advances in our country,we are committed to delivering unprecedented,groundbreaking products in China and beyond. The approval of VenusP-ValveTM in China is another key milestone following its CE MDR approval. Filling a gap in China's TPVR market,the product is expected to benefit more patients across the country."