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Venus Medtech and Opus Medical Therapies, LLC Announce Partnership for Transcatheter Mitral Valve Replacement (TMVR) and Transcatheter Tricuspid Valve Replacement (TTVR) in Greater China Market

Venus Medtech and Opus Medical Therapies, LLC Announce Partnership for Transcatheter Mitral Valve Replacement (TMVR) and Transcatheter Tricuspid Valve Replacement (TTVR) in Greater China Market

HANGZHOU, China and ATLANTA, May 2, 2020 /PRNewswire/ -- Venus Medtech (Hangzhou) Inc. ("Venus Medtech" or the "Company", together with its subsidiaries, the "Group", stock code: 2500), the leading Chinese transcatheter heart valve company and Opus Medical Therapies, LLC, a medical device company focused on developing transcatheter mitral and tricuspid valve replacement products for patients undergoing mitral and tricuspid valve disease, today announced a partnership agreement to develop, manufacture and sell these TMVR and TTVR products in Greater China.

This agreement, covering the whole Greater China market, will allow physicians and patients in this region to benefit from transcatheter mitral and tricuspid valve replacement. The combination is unavailable in any other market or from any other company.

"It is utmost importance to us that our devices can save more patients and improve their quality of life. The cooperation with Opus Medical Therapies will enable Venus Medtech to achieve full coverage from functional mitral regurgitation to degenerative regurgitation on the basis of its own product line, and will greatly accelerate the clinical use of tricuspid valve replacement technology. No other company offers this all-valves solution in China and Asia," said Eric Zi, CEO of Venus Medtech.

Mitral Regurgitation (MR) is the most common heart valve disease, which is caused by organic or functional changes to the mitral valve apparatus, including the mitral valve leaflets, valve annulus, papillary muscles and chordae tendinae. In China, the prevalence of MR above the age of 60 is 13.4%, and the number of patients requiring treatment (MR≥ grade 3) is 10 million. At present, for patients with significant mitral regurgitation, cardiac surgery is still the mainstream way of treatment, but the number of mitral valve surgeries in our country is not much more than 40,000 cases per year. In fact, at least 50% of the patients with mitral valve regurgitation are high risk because of advanced age, low ejection fraction, or because of other factors. Sadly, the vast majority of these patients do not receive treatment, and continue to suffer. In recent years, transcatheter mitral therapies have developed rapidly around the world, but due to the complexity of the mitral valve apparatus and the complexity of mitral valve lesions, the current products available in the international market are few and expensive, and they have significant limitations in clinical application. Because the research and development of transcatheter mitral valve therapies is technically challenging and requires large investments, development of mitral valve technology in China is seriously restricted.

Also limited is the development of therapies for tricuspid regurgitation (TR), even though moderate or greater tricuspid regurgitation is not uncommon in the population. Although patients with mild to moderate regurgitation might have few symptoms, patients with severe regurgitation can suffer from debilitating symptoms, and have a higher risk of dying.  Indeed, although the tricuspid valve has long been the "forgotten valve", several long-term registries have shown that tricuspid regurgitation significantly impacts patients' survival and quality of life. Other registries have shown that these risks decrease with treatment, sometimes even in patients who have moderate TR complicated by significant annular dilatation. Despite these benefits, risks of surgery are high; patients undergoing surgical therapy can have an peri-operative mortality rate of up to 10%, with up to 25% mortality rate during follow-up at 32 months after surgery, and even as high as 35% and 56% during follow-up at 3 and 5 years, respectively, after treatment. Therefore, transcatheter therapy is desperately needed as a new option for patients with severe tricuspid regurgitation who are at high risk and not suitable for surgery.

"Venus has established a dominant position in the China TAVR market with its exceptionally safe and effective platform.  Because of my co-founders, Jaime Sarabia and Yen Liao, and the rest of the Opus team, we have extensive pre-clinical and clinical experience in the TMVR and TTVR space. With the depth of our experience and Venus's support, we believe that this partnership will result in furtherance of Venus's pipelines, which have great potential market size globally," said Dr. Vivek Rajagopal, founder and CEO, Opus Medical Therapies.  "This partnership also provides us the opportunity to make an impact in the fast growing structural heart space in an extraordinarily important geographic market.  With Venus as our partner, we also hope to make an impact in the rest of the world."

This impact will greatly ease the burden for the millions of patients with MR and TR who are too sick, too frail, or too old to undergo surgery safely. As physicians and others advance innovative technologies around the world, Venus MedTech will continue to lead the way in China as it continues its extensive basic, translational, and clinical research in transcatheter valvular therapies.  Now, with the successful signing of the cooperation agreement with Opus Medical Therapies, Venus will lead China to the front and center stage of the world's TMVR and TTVR research field. 

About Venus Medtech (Hangzhou) Inc.
Venus Medtech is the leading transcatheter heart valve medical device player in China in terms of implantation volume in 2018. The Company focuses on the design, development and commercialization of transcatheter heart valve products. According to Frost & Sullivan, the Company had a 79.3% market share in China by implantation volume of TAVR products in 2018. The Company's self-developed product, VenusA-Valve, is the first TAVR product approved by the NMPA and commercialized in China. As the pioneer in the transcatheter heart valve industry in China, the Company enjoys first mover advantages. The Company believes that its first mover advantages, together with its comprehensive product pipeline covering all four heart valves, robust intellectual property portfolio with 193 issued patents and 196 patent applications as of November 18, 2019, and visionary management team, will serve as high entry barriers and differentiate the Company from its peers.

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