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Devices Interventional Cardiology Regulatory

 News Release - April 28, 2017

Venus Medtech's TAVR Device Is Approved By CFDA, Creating A New Era Of Interventional Cardiology In China

HANGZHOU, China, April 28, 2017 -- (Healthcare Sales & Marketing Network) -- Venus Medtech (Hangzhou) Inc., announced on April 25th that its transcatheter aortic valve system - Venus A-valve - has been approved by China Food and Drug Administration("CFDA") (registration no.: 20173460680) for sale in China. This marks the first-ever CFDA approved Transcatheter Aortic Valve Implantation ("TAVR, TAVI") device in China, and the official commercialization of the Venus A-valve in China.

CFDA also released the news about Venus A-valve's regulatory approval on its official website recently. Please refer to the following link for detailed information:

Together with a growing economy and an aging population, heart diseases such as aortic stenosis are becoming more prevalent amongst the elderly population. Over the past decades, surgical aortic valve replacement (SAVR) procedures have been used to treat such diseases. However, the effectiveness of SAVR operations is limited due to complications and significant mortality risks, especially for older and higher risk patients.

Venus Medtech's transcatheter aortic valve system, Venus A-valve, offers a less invasive treatment solution for inoperable and high-risk patients, who now can be treated through a minimally invasive procedure as opposed to the traditional open-heart surgery while on cardiopulmonary bypass. Given TAVR's minimally invasive nature, patients also make faster progress in post-operation recovery.

The population over 75 years old in China is approximately 44 million, of which approximately 1.5 million suffer from severe aortic stenosis, and have not had effective treatment. The launch of the Venus A-valve brings about much improved prospects for these patients.

China's first home-made TAVR valve Venus A-valve was successfully implanted in Fuwai Hospital on Sept. 10th, 2012. Professor Gao Ruilin spearheaded the clinical research efforts. As part of the 12th National Five-Year Plan for technological growth, the Venus A-valve registered study included 101 operative cases across leading institutions in China, including Fuwai Hospital, West China Hospital, The Second Affiliated Hospital Zhejiang University School of Medicine, Jiangsu Province Hospital and Rui Jin Hospital. In the study, implantation success rate was 95% and 30-day all-cause mortality was 5%. In the full analysis set, the incidence of composite events (all-cause mortality or severe stroke) at 12 months was 7.1%, on par with international trial results.

Professor Gao Ruilin commented: "The Venus A-valve is better suited for the Chinese population and physiological characteristics, with a higher implant success rate, similar complication rates and lower 2-year mortality rate compared to earlier generation TAVR products. The approval of the Venus A-valve by the CDFA is a true blessing for Chinese patients, and a breakthrough in the cardiovascular medical device sector given this product has been approved in China earlier than any comparable imported devices. This makes history."

When asked about the clinical performance of the Venus A-valve, Dr. Horst Sievert, Director of Frankfurt Cardiovascular Center, commented: "the product design is highly focused on precision, and the results are satisfactory. Overall, based on available data, the Venus A-valve is superior to global competing products, when applied on Chinese patients."

Professor Xingdong Zhang, Scientist of biomaterials at National engineering Research Center for Biomaterials, gave praise to the tissue treatment technology of the Venus A-valve: "Venus-A valve's anti-calcification technology represents a significant development in the application of biological materials in the cardiovascular space, it greatly enhances the valve's durability, prolongs the valve's working life, and significantly improves the patient's experience."

Ms. Nisa Leung, Managing Partner of Qiming Venture Partners, commented on Venus Medtech's recent achievements: "We really value the experience and professionalism of the team under the leadership of Mr. Eric Zi. With the launch of Venus A, we believe Venus Medtech will become a leading cardiovascular company in China, and will also open the door to compete in international markets!"

Mrs. Stephanie Hui, Managing Director of Goldman Sachs (Asia) L.L.C., commented: "Being a first-to-market and innovative cardiovascular device, approved under CFDA's fast-track system, Venus A-valve is a pioneer in the space of interventional cardiology, and has set a good example for future innovation in treating cardiovascular diseases."

When asked about his future strategy, Mr. Eric Zi, CEO of Venus Medtech said, "We have worked hard to get here, and at Venus Medtech, we believe in innovation through solid science. We will continue to help save lives and treat critical cardiovascular diseases at home and abroad. My vision for Venus Medtech goes beyond TAVR, as we aim to become a leader in the structured heart space. Our CE mark study for the Venus Pulmonary valve has already started as of September 2016. Our global trial for the third generation TAVR device, which embodies pre-packaged, retrievable and embolic protection features, will begin around the end of 2017. Its success should help Venus Medtech further strengthen our position in the market, and gain traction on a more global scale."

Source: Venus Medtech

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