Venus MedTech Completes $300M Acquisition of Cardiovalve to Expand Global Presence in Transcatheter Mitral and Tricuspid Valve Therapies

VCBeat (WeChat ID: vcbeat) learned that on January 26, 2022, Hangzhou Venus Medtech Co., Ltd. (“Venus Medtech,” 2500.HK), a leading integrated platform enterprise for innovative devices in structural heart disease in China, announced the completion of its 100% equity acquisition of Cardiovalve Ltd. (“Cardiovalve”), an innovator in transcatheter mitral and tricuspid valve therapies. This means that Cardiovalve has officially become part of Venus Medtech’s global operations team as of this date, accelerating the internationalization of its innovative products.

Cardiovalve, founded in 2010 and headquartered in Israel, has independently developed the Cardiovalve system, an innovative transcatheter heart valve replacement solution that simultaneously treats both mitral regurgitation and tricuspid regurgitation. Compared with similar products, its transfemoral venous access approach significantly enhances procedural safety. Additionally, its large 55mm annular design is suitable for approximately 95% of patients, while its unique short stent frame design effectively reduces the risk of left ventricular outflow tract obstruction. Cardiovalve has filed over 215 patents, 83 of which have been granted.

Due to the lack of effective innovative therapies, the number of patients with mitral regurgitation and tricuspid regurgitation is increasing day by day. In China, the patient population is expected to exceed 22 million in 2025, while the patient populations in Europe and the United States will reach 14 million and 9.2 million, respectively, in the same year. The large patient population corresponds to a vast market space. According to forecasts by Edwards Lifesciences, the global leader in valve therapy devices, the total value of interventional therapies for mitral and tricuspid regurgitation will reach $5 billion by 2028, representing a five-fold increase compared to 2021.

Interventional therapies for mitral regurgitation and tricuspid regurgitation have long been recognized internationally as technical challenges. Currently, the U.S. FDA has not approved any products for mitral or tricuspid valve replacement. Cardiovalve occupies a unique position and holds a leading pace among products in clinical development, and it is the first company to receive U.S. FDA approval to conduct early feasibility studies for both mitral regurgitation and tricuspid regurgitation indications.

For the indication of mitral regurgitation, Cardiovalve has entered the clinical trial stage in Europe and the Early Feasibility Study (EFS) stage in the United States. For the indication of tricuspid regurgitation, Cardiovalve was granted “Breakthrough Device” designation by the U.S. FDA in January 2020 and has also entered the Early Feasibility Study (EFS) stage.

As a pioneer in the field of valvular heart disease treatment in China, Venus Medtech is committed to continuous innovation and comprehensive service to physicians and patients by building a robust product portfolio. Through this acquisition of Cardiovalve, the Company will further advance its clinical studies in Europe and the United States, while accelerating clinical development and regulatory approval for market launch in China. With the acquisition of Cardiovalve, Venus Medtech will become one of the most comprehensive platform companies in the field of mitral regurgitation and tricuspid regurgitation treatment in China, while also creating new opportunities for the internationalization of its innovations.

Zi Zhenjun, Founder and General Manager of Venus Medtech, stated, “The successful completion of this cross-border acquisition will have a crucial impact on the company’s further internationalization strategy. We will take this opportunity to reinforce our long-term vision of international innovation and global expansion. Venus Medtech will continue to strengthen and enhance its overall valve product portfolio, providing innovative products and services to patients and healthcare professionals worldwide.”

Amir Gross, CEO of Cardiovalve, stated: “Partnering with Venus MedTech is crucial for Cardiovalve to accelerate the development and commercialization of its products in key global markets. Over the past period, both parties have established a solid relationship of mutual trust and are committed to pioneering a new ecosystem for innovation collaboration in the medical device industry between China and Israel. Looking ahead, we remain dedicated to the continuous development of innovative, high-quality R&D products.”