Venus MedTech Acquires Cardiovalve to Expand Innovative TMVR and TTVR Portfolio

Hangzhou, December 8, 2021 /PRNewswire/ -- On December 7, 2021, Venus Medtech (Hangzhou) Inc. ("Venus Medtech", 2500.HK), a leading comprehensive platform enterprise for innovative devices in structural heart disease in China, announced that it had signed an agreement with Cardiovalve Ltd. ("Cardiovalve"), a company specializing in transcatheter mitral and tricuspid valve innovative therapies. Under the agreement, Venus Medtech will acquire 100% of Cardiovalve's equity and corresponding rights for a consideration of $300 million. The payment will be made in installments based on the achievement of agreed-upon milestone events. This acquisition aims to expand Venus Medtech's portfolio in transcatheter mitral valve replacement (TMVR) and transcatheter tricuspid valve replacement (TTVR) innovations, further strengthen its product pipeline in the field of valvular disease treatment, and accelerate international expansion.

Cardiovalve (formerly Mitraltech Ltd.), established in 2010, has its headquarters located in Israel. The CEO of the company, Amir Gross, is a serial entrepreneur. Valtech Cardio, a company he founded, was acquired by Edwards Lifesciences, a global cardiovascular device giant, for an upfront payment plus milestones totaling $700 million in 2017.

Cardiovalve, a transcatheter intervention and replacement product independently developed by the company, is capable of treating both mitral regurgitation and tricuspid regurgitation. Compared with similar products, the femoral vein access approach of Cardiovalve significantly enhances treatment safety. Additionally, its large annulus design of 55mm is suitable for approximately 95% of the patient population, and its unique short stent design effectively reduces the risk of left ventricular outflow tract obstruction. Cardiovalve has applied for more than 215 patents, of which 83 have been granted.

Currently, in the treatment of mitral regurgitation indications, Cardiovalve has entered the clinical research stage in Europe and the early feasibility study stage in the United States. The clinical trials are being conducted by internationally renowned cardiovascular centers, including the Piedmont Heart Institute in the United States, IRCCS Policlinico San Donato in Italy, Universitaet Mainz in Germany, Heart-Center University Clinic Bonn in Germany, and the University Heart Center Lübeck Medical Clinic II in Germany, among others. Additionally, for the treatment of tricuspid regurgitation indications, Cardiovalve received the "Breakthrough Device Designation" from the U.S. FDA in January 2020 and has entered the Early Feasibility Study (EFS) phase. Cardiovalve is also the first company to receive simultaneous approval from the U.S. FDA for early feasibility studies on both mitral regurgitation and tricuspid regurgitation indications.

The interventional treatment of mitral regurgitation and tricuspid regurgitation has long been considered a technical challenge internationally. Meanwhile, the population of such patients continues to grow rapidly. In China alone, the number of people suffering from mitral regurgitation and tricuspid regurgitation is expected to exceed 22 million by 2025, while in Europe and the United States, the patient populations will reach 14 million and 9.2 million respectively by the same year. Against this backdrop, the combined potential market value of mitral and tricuspid valve replacement systems in China, Europe, and the United States is projected to surpass $4.7 billion by 2030.

As a pioneer in the field of valvular disease treatment in China, Venus Medtech is committed to continuous innovation and building a complete product system to comprehensively serve doctors and patients. After acquiring Cardiovalve, the company will continue to advance its clinical research in Europe and the United States, while accelerating its clinical development and registration in the Chinese market. As early as May this year, Venus Medtech invested in Demin Medical to strengthen its mitral valve repair and tricuspid valve repair product lines. The acquisition of Cardiovalve will make Venus Medtech one of the most comprehensive platform companies in the field of mitral regurgitation and tricuspid regurgitation treatment in China, while also bringing new opportunities for its international innovation.

Professor Francesco Maisano from the IRCCS San Raffaele University Hospital in Italy and the ESC Valve Center stated that Cardiovalve stands out as a leader among its peers. "Behind this innovative product is an exceptionally talented and robust team with a decade-long dedication to TMVR and TTVR. We firmly believe that the transfemoral venous approach represents the future of TMVR and TTVR due to its simplicity, stability, and safety, which will significantly reduce the challenges associated with valve replacement surgeries. After ten years of relentless progress, Cardiovalve is now poised to become the optimal solution for TMVR and TTVR." Professor Maisano is a world-renowned expert in mitral and tricuspid valve treatments and also one of the principal investigators of Cardiovalve.

Professor Scott Lim, Director of the Advanced Cardiac Valve Center at the University of Virginia, believes that treating mitral valve disease, especially Functional Mitral Regurgitation (FMR), through transcatheter interventions is already a prevailing trend. Moreover, the cardiovascular academic community is even more excited about the emergence of transcatheter tricuspid valve replacement, which has surpassed repair techniques in enthusiasm. Cardiovalve, a replacement product for treating mitral regurgitation and tricuspid regurgitation via the femoral vein, combines ingenious minimally invasive technology with an advanced delivery system, showing great potential. The ongoing clinical trial results of Cardiovalve in treating mitral and tricuspid valve diseases are highly anticipated.

Zi Zhenjun, founder and general manager of Venus Medtech, stated: "This acquisition will create a synergistic effect with the company's existing product portfolio, further advancing Venus Medtech’s leadership and accelerating growth in the structural heart field both in China and globally. It aligns with Venus Medtech’s long-term vision of building a comprehensive platform for structural heart disease, firmly committing to international innovation and global expansion. We believe Cardiovalve will inject innovative energy into Venus Medtech and provide innovative therapies to patients and doctors worldwide."

Cardiovalve CEO Amir Gross noted: "It is a great honor for Cardiovalve to receive support from Venus Medtech, China's leading comprehensive platform for innovative devices in structural heart disease. We believe that our collaboration with Venus Medtech will accelerate our development in the global market, especially in the Chinese market, and lead to more breakthrough achievements. We believe this agreement is only the first step toward long-term win-win cooperation, and we will work together to bring more innovative achievements to the market."