VenusP-Valve(TM) obtains CE marking under MDR and debuts in Europe as China's first valve product

HANGZHOU,China,April 12,2022 -- On April 8th,2022,VenusP-ValveTM,Venus Medtech's in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system,received CE marking under the Medical Devices Regulation (MDR) to be marketed in Europe. Designed to treat patients with moderate to severe pulmonary regurgitation with or without right ventricular outflow tract (RVOT) stenosis,VenusP-ValveTM is the first Chinese-made artificial heart valve approved in Europe,marking a new milestone in the global presence of China's innovative medical devices.

As the first self-expanding TPVR product approved for marketing in Europe,VenusP-ValveTM carries remarkable clinical value. Uniquely designed with both flared ends,the product provides stable anchoring and easy delivery,with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability,the product is able to meet the needs of 85% of patients. Following its first clinical implantation in 2013 by Academician Ge Junbo,Director of Cardiology at Zhongshan Hospital,Fudan University,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. In March 2021,VenusP-ValveTM received special use authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in designated medical institutions.

Moderate to severe pulmonary regurgitation is common after surgical correction of congenital heart disease. It leads to right ventricular volume overload and may cause arrhythmia and even sudden death in the long run. The traditional thoracotomy approach to pulmonic valve replacement is difficult and carries high mortality,while existing TPVR products in the European market,due to their balloon-expandable design,apply to patients with particular anatomic structures only and require pre-stenting. Moreover,as these valves come in small diameters,they only work for 15% to 20% of patients. Prior to the certification of VenusP-ValveTM,there was no TPVR product suitable for different anatomical structures and available in such a wide range of specifications.

VenusP-ValveTM has impressive clinical data backing up its long-term safety and efficacy. According to two-year follow-up interim result of the clinical study in Europe,the product demonstrated 100% procedural success,with no reoperation or death observed in two years. In addition,moderate pulmonary regurgitation decreased from 16.88% preoperatively to 0%,and severe pulmonary regurgitation plunged from 83.12% to 1.54%. The data suggest excellent performance,robust safety and reliability,and drastic and steady improvements in patients' cardiac function.

As published on the EU MDR website,VenusP-ValveTM is noteworthily the first Class III implantable cardiovascular device approved under the new MDR. Coming into effect in May 2021,the new regulations set out stricter and more specific standards in technical review and clinical evaluation and require the establishment of expert panels to support such evaluations. After the new rules were adopted,there was no CE MDR certificate issued to any Class III implantable cardiovascular device until VenusP-ValveTM,which is stark evidence of Venus Medtech's world-class clinical trial and quality control systems.

Europe is the bridgehead of Venus Medtech's international strategy. To build a winning commercialization team for VenusP-ValveTM,the Company engaged marketing veterans like Shakeel Osman and David Breant as senior managers. By now,VenusP-ValveTM has received multi-million euro pre-orders.

Apart from the EU,VenusP-ValveTM is undergoing review and approval of registration with the Chinese National Medical Products Administration (NMPA) and is expected to be marketed within 2022. With plans to launch clinical trials in the US in 2023,Venus Medtech is preparing for its investigational device exemption (IDE) application to the FDA. Apparently,the EU approval will give an important impetus to commercialization processes in China,the US,and other markets.

Professor Shakeel Qureshi at Evelina London Children's Hospital,Principal Investigator (PI) of the clinical trial for CE marking of VenusP-ValveTM,congratulated Venus Medtech on the EU approval of the product. "I still remember the first procedure we performed in September 2016 in London and its excellent immediate outcomes",he said. "On that starting point,we continued to recruit additional patients for the trial. The overall clinical results underscored the sustained,effective,and steady improvements the product brings to patients' cardiac function. This is what a truly meaningful innovative medical device looks like."

"For Venus Medtech,the CE marking of VenusP-ValveTM under MDR will open a new chapter of growth in the European market",said Eric Zi,Co-Founder,Executive Director,and General Manager of the Company. "We will leverage this product to scale up our overseas revenue,accelerating our progress to global prosperity. Also,we will continue our clinical trials and commercialization endeavors in global markets for other innovative technologies and products,bringing Chinese innovations to the world."