Venus Medtech VenusP-Valve transcatheter pulmonic valve replacement system granted Health Canada approval

HANGZHOU, China, Feb. 5, 2024 /PRNewswire/ -- Venus Medtech (02500. HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that, VenusP-Valve, the company's in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, cleared approval from Health Canada.

As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries 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-Valve is able to meet the needs of 85% of patients in the case of large RVOT.

"VenusP-Valve is able to eliminate pulmonary regurgitation in a wide range of anatomies," said Prof. Lee Benson, Director of Cardiac Diagnostic and Interventional Unit at the Hospital for Sick Children in Toronto, Canada. "Available in different sizes and specifications, the product offers extensive applicability to meet the clinical needs of a larger pulmonary regurgitation patient population."

Clinical data reveals that VenusP-Valve demonstrates safety and efficacy on par with similar products, and excels in aspects such as rates of reintervention and arrhythmia. According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve is 100%. All-cause mortality and reintervention 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. The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients' cardiac function.

As the company's international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022, becoming the first Class III implantable cardiovascular device approved under the new MDR. In 2023, after receiving Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA), VenusP-Valve gained its first ethical approval in the territory, setting the stage for the VenusP-Valve PROTEUS pivotal clinical trial. More recently, the U.S. Centers for Medicare & Medicaid Services (CMS) also granted coverage approval for the PROTEUS study.

"Seeking effective treatments for major diseases that pose a serious threat to human health is what we do at Venus Medtech, which makes us proud to have received this Health Canada approval,'' said Lim Hou-Sen, Chief Executive Officer of Venus Medtech. "The approval of VenusP-Valve represents a meaningful expansion of clinical options for patients in the country."

Following its first clinical implantation in 2013 by Academician Ge Junbo, Director of Cardiology at Zhongshan Hospital, Fudan University, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, and Spain, with its implantation seeing continuous growth in new hospitals and centers.

About Venus Medtech
Venus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertrophic cardiomyopathy and hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.

For more information, please visit https://www.venusmedtech.com

Contacts:
Jill Liu                                              Ophelia Chen
Public Relations                           Investor Relations
liujie@venusmedtech.com       chenwenjuan@venusmedtech.com

Statements
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