Venus Medtech Acquires Cardiovalve to Optimize its Innovative Products Pipeline of Mitral and Tricuspid Valve Replacement

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HANGZHOU, China, Dec. 7, 2021 /CNW/ -- Venus Medtech (Hangzhou) Inc. (Venus MedTech, 2500.HK), a leading, innovative Chinese structural heart disease treatment company, announced its acquisition of Cardiovalve Ltd. (Cardiovalve), a pioneering transcatheter mitral and tricuspid valve treatment company on December 7th, 2021. Venus Medtech will acquire 100% equity interest and corresponding equity at a consideration of $300 million, and will pay the consideration conditionally in installments subject to the completion of certain milestone events as agreed. The Acquisition is intended to expand the innovative product layout of mitral valve replacement and tricuspid valve replacement, further enhance the company's product pipeline in the field of cardiac valve disease treatment, and accelerate its internationalization.

Cardiovalve Ltd. (previously Mitraltech Ltd.) was headquartered in Israel in 2010. Amir Gross, CEO of Cardiovalve, is a serial entrepreneur. He founded and led Valtech Cardio until its acquisition in 2017 by Edwards Lifesciences, a global cardiovascular device giant, at a total deal size of $700 million.

Its independently-developed Cardiovalve System is a transcatheter interventional replacement product for patients suffering from mitral or tricuspid regurgitation. Compared with products of the same kind, its transfemoral approach significantly improves the safety of treatment and its 55mm annuli is suitable for about 95% of the patient population. Its unique short frame design lowers the risk of LVOT obstruction. Cardiovalve has applied for over 215 patents, of which 83 have been granted.

Its treatment of mitral regurgitation has entered clinical trials in Europe and is currently in an early feasibility study in the U.S.. Well-noted international cardiovascular centers such as the Piedmont Heart Institute (US), IRCCS Policlinico San Donato (Italy), Universitaet Mainz (Germany), Heart-Center University Clinic Bonn (UKB) (Germany), University Heart Center Lübeck Medical Clinic II (Germany), etc. were involved in its clinical trials. Furthermore, its device for the treatment of tricuspid regurgitation received 'Breakthrough Device Designation' by the FDA in January 2020 and entered an early feasibility study. It is worth mentioning that Cardiovalve is also the first privately held company to receive FDA's early feasibility study (EFS) approval for both TR and MR indications.

Interventional treatments of mitral and tricuspid regurgitation have been regarded as technically difficult globally. However, the patient population grows with each passing day. The number of people suffering from mitral regurgitation and tricuspid regurgitation is expected to exceed 22 million by 2025 in China alone, while the patient populations in Europe and the U.S. will reach 14 million and 9.2 million respectively in 2025. In this context, the total potential market value of mitral valve replacement and tricuspid valve replacement in China, Europe, and the U.S. is expected to exceed $4.7 billion in 2030.

As a pioneer in the field of heart valve disease treatment in China, Venus Medtech is committed to continuous innovation and building a complete product system to fully serve doctors and patients. After the acquisition of Cardiovalve, the company will continue to advance its clinical research in Europe and the U.S., while accelerating its clinical development and registration in the Chinese market. In May this year, Venus Medtech announced its investment in Valgen Holding Corporation in order to consolidate its mitral valve repair product and tricuspid valve repair product pipelines. The acquirement of Cardiovalve will make Venus Medtech one of the most complete platform companies in the field of mitral regurgitation and tricuspid regurgitation treatment in China, and it will also bring new opportunities for Venus Medtech's innovation and internationalization.

"First of all, Cardiovalve is a best in class device," said Prof. Francesco Maisano, Chief of Cardiac Surgery and Director of the Valve Clinic at the IRCCS San Raffaele University Hospital and fellow of the European Society of Cardiology (ESC). "Behind this device there is a great team, and the original concept goes back almost ten years. From the very beginning, we knew that the future of TMVR and TTVR would require a transfemoral implant, simple and repeatable, minimizing the many challenges of valve replacement. After ten years of intense work, the valve is ready to become the best solution for TMVR and TTVR." Prof. Maisano is known as one of the world's top experts in mitral and tricuspid valve treatment, as well as the principle investigator of Cardiovalve.

Prof. Scott Lim, Medical Director of the UVA Advanced Cardiac Valve Center, pointed out that "Increasingly, it has become evident that there will be a role for a transcatheter mitral valve, particularly for functional mitral regurgitation. Additionally, there has been a surge of excitement in the cardiovascular community about transcatheter tricuspid valve replacement, even over repair technologies. The Cardiovalve core technology, a transvenous transcatheter mitral and tricuspid valve, delivers the impressive potential of a less invasive valve replacement technology along with an evolved delivery system. We look forward to the continued clinical research trial investigations of this valve in the international cardiovascular community for both mitral and tricuspid valve disease."

"The acquisition of Cardiovalve will create synergy with the company's existing product layout," says Venus MedTech's CEO, Eric Zi, "and will further consolidate

the company's leading position in the field of structural heart disease in China and globally. This is in line with the long-term vision of Venus Medtech to innovate and commercialize globally. We believe that the Cardiovalve system will promote innovation in Venus and provide more innovative treatments for doctors and patients worldwide."

"We are honored to be backed by Venus, the leading player in China. We believe that cooperation with Venus Medtech will accelerate our development in the global market, especially the Chinese market, and achieve more breakthrough innovations," said Amir Gross, CEO of Cardiovalve. "We believe that this agreement is only a first step to a fruitful, long-term relationship in which we will continue to bring multiple innovations to market jointly."

About Venus MedTech

Venus Medtech, is the leader in transcatheter structural heart valvular therapies in China. It was established in 2009, and listed on the Main Board of the Hong Kong Stock Exchange on Dec 10th, 2019. A strong track record of innovative R&D has gained Venus Medtech significant first-mover advantages. VenusA-Valve and VenusA-Plus, self-developed 1st and 2nd generations of TAVR products, are the world's first products approved by the NMPA and commercialized in China. In terms of R & D layout, the company has built a number of technical platforms in order to move into the fields of hypertrophic cardiomyopathy, hypertension interventional therapy, and even heart failure treatment, besides heart valve disease, and is committed to providing a complete integrated solution for structural heart disease.

About Cardiovalve

Cardiovalve Ltd. was headquartered in Israel in 2010. With 40 employees, Cardiovalve operates from 1,700 sq. ft. facilities with inhouse manufacturing and clean rooms, and is the holder of over 200 patents and patent applications. The Cardiovalve System offers a self-developed mitral and tricuspid replacement valve delivered via a transcatheter approach, intended to reduce the mortality and morbidity associated with surgical treatment options for both mitral and tricuspid valve regurgitation indications. The Cardiovalve system is currently enrolling patients in several multi-center studies for both mitral valve replacement and tricuspid valve replacement in the US and in Europe. Initial clinical results are promising.

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SOURCE Venus Medtech (Hangzhou) Inc.

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