Edwards Lifesciences Acquires Global Rights to J-VALVE® Transcatheter Aortic Valve System from China's Genrui Medical

Recently, Genesis MedTech Group (hereinafter referred to as “Genesis MedTech”) announced that it will transfer the equity interest in its overseas subsidiary, JC Medical, and the J-VALVE held by such subsidiary.^®Transcatheter Aortic Valve System (hereinafter referred to as: J-VALVE^®valve) related intellectual property and commercial rights to Edwards Lifesciences.

Pursuant to the transfer agreement, the consideration for this transaction includes an upfront payment and sales-related milestone payments. Meanwhile, Genesis will retain the rights to develop, manufacture, and market J-VALVE in China.^®Exclusive rights to the valve.

Wang Xin, Chairman and CEO of Genesis Medical Technology Group, stated: “J-VALVE^®“The valve offers unique advantages in the treatment of aortic regurgitation. We aim to maximize the clinical adoption of this innovative product and expand its global impact, thereby benefiting more patients. In the future, Genesis will remain dedicated to developing innovative products and exploring superior medical solutions to benefit more patients both domestically and internationally.”

In 2022, Genesis completed the acquisition of JC Medical. As one of the “pioneers” in the field of transcatheter aortic valve replacement (TAVR) in China, JC Medical is also the only company in the country to have commercialized treatments for both aortic regurgitation and aortic stenosis.

Edwards Lifesciences, the pioneer in the global heart valve field, not only holds nearly 70% of the global valve market share but is also currently the only company worldwide with four product pipelines for interventional valve therapies. After divesting its critical care business this June to secure approximately RMB 30.4 billion, Edwards Lifesciences has been actively making acquisitions, embarking on an aggressive buying spree in the field of interventional heart valve therapy.

For example, Edwards Lifesciences previously completed an equity investment in Genesis Medical, equivalent to approximately RMB 180 million in USD. The funds will be used to support Genesis’s product and market development. This strategic investment by Edwards in Genesis signifies that Genesis’s product R&D capabilities and its development and operational model have gained recognition from international industry giants.

The core of this transfer transaction—J-VALVE^®Valves belong to the TAVR sector, which is not only Edwards Lifesciences’ core business but also the most mature segment in the global field of interventional valve therapy. Currently, multiple domestic companies have emerged to compete in this market.

Leveraging its original and unique “Autonomous Navigation Positioning System,” J-VALVE^®The transfemoral transcatheter aortic valve system has driven source-level technological innovation in China’s TAVR sector, breaking the competitive monopoly held by imported TAVR devices.

August 2023, J-VALVE^®The TF valve has received the “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA). This product features a unique “movable positioning element system,” which allows the native valve leaflets to be clamped between the positioning elements and the stent after deployment. This sandwich-like configuration provides additional support for valve fixation without relying on radial force, enabling effective treatment of severe aortic regurgitation and mixed aortic valve disease predominantly characterized by regurgitation.

According to news previously released by Genesis Medical, J-VALVE had already...^®The TF valve has already been approved for “Humanitarian Device Exemption” use by the U.S. FDA and Health Canada, benefiting more than 30 patients in both countries and receiving high praise from physicians in these two nations.

Additionally, publicly available online data indicate that transcatheter aortic valve replacement (TAVR) is currently performed in more than 700 hospitals across the United States. From late 2011 to 2019, a total of over 276,000 TAVR procedures were conducted in the U.S., yet fewer than 1% of these were for the treatment of pure aortic regurgitation. To date, the U.S. Food and Drug Administration (FDA) has not approved any interventional aortic valve product for the treatment of regurgitation.

In February 2024, JC Medical completed the J-VALVE in the United States.^®Patient enrollment for the TF valve Early Feasibility Study (FDA EFS) was completed, and approval to initiate the pivotal clinical trial (FDA Pivotal Trial) was obtained in the first half of this year.

In July 2023, Genesis completed patient enrollment for the domestic clinical study required for product registration. Currently, the one-year patient follow-up has been concluded. Professor Wang Chunsheng from Zhongshan Hospital Affiliated to Fudan University, the principal investigator of this study, stated, “J-VALVE^®“The TF valve can simultaneously treat aortic regurgitation and stenosis, offering unique advantages and excellent clinical performance, particularly in the treatment of pure non-calcific aortic regurgitation.”

Genesis MedTech’s J-VALVE® TF valve epitomizes the pioneering spirit of Chinese enterprises in the field of heart valves.

As the most mature segment in the valve field, TAVR has entered a phase of accelerated growth. According to Frost & Sullivan, the number of patients with severe aortic stenosis (AS) and pure aortic regurgitation (AR) in China is projected to reach 9.3 million by 2025. The number of TAVR procedures in China is expected to reach 109,500 by 2030, representing a compound annual growth rate (CAGR) of 36.6% from 2021 to 2030. The CAGR for TAVR procedures in China exceeds the global average over the same period.

Meanwhile, the TAVR market has also formed a “2+N” competitive landscape, where “2” refers to Edwards Lifesciences and Medtronic, which continue to hold significant market shares globally, while “N” denotes competitive domestic companies such as Venus Medtech, MicroPort CardioFlow, Peijia Medical, and Jiecheng Medical.

Among them, Venus Medtech has three commercialized TAVR products. VenusA-Valve is the first TAVR product approved by the NMPA for commercialization in China. VenusA-Plus is China’s first approved retrievable TAVR product; it retains the strong radial support force of the first-generation valve while adding retrieval and repositioning capabilities, thereby reducing procedural difficulty and significantly shortening the operator’s learning curve. The Pro version ensures radial support force while delivering precise aortic arch crossing performance, and its capsule tip designed with superelastic materials further enhances intraoperative maneuverability. The approval of this product marks Venus Medtech as the first company in China to offer three TAVR products.

In China’s TAVR market, Peijia Medical is also a significant player. As of the date of its 2023 annual report, Peijia Medical had two commercially launched TAVR systems. In 2023, its market share for transfemoral TAVR exceeded 20%, and the number of covered hospitals increased from nearly 300 to approximately 500. Meanwhile, the terminal implantation volume of Peijia Medical’s TAVR products reached 2,484 units in 2023, more than double the implantation volume in 2022.

The continuous application and development of TAVR technology have further driven market prosperity, but also intensified competition. Some argue that the increasingly fierce competition in the TAVR sector will lead to business “spillover,” i.e., business expansion. The target of such expansion is the sector of transcatheter mitral and tricuspid valve interventions.

Taking mitral valve interventional therapy as an example, in the field of mitral valve interventional repair, the successive approvals of Hanyu Medical and Depu Medical have broken the monopoly held by imported products; meanwhile, in the field of mitral valve interventional replacement, Peijia Medical, Nuomai Medical, Yixin Medical, Qiming Medical, and Zhenyi Medical all have related pipelines under development.

Focusing on the development of the TAVR sector itself, heart valve materials have undergone three generations of technological innovation, evolving from mechanical valves to bioprosthetic valves and then to transcatheter intervention valves. In the future, polymer materials will become the star material for TAVR due to advantages such as superior durability and ease of processing and customization. Reports explicitly state that TAVR companies with the capability to manufacture polymer valves will emerge as industry leaders within the next 3–5 years. Currently, domestic enterprises involved in the research and development of polymer-based TAVR include Peijia Medical and Yixin Medical.

Regarding delivery systems, the development of more refined systems, accompanied by a series of engineering challenges such as valve size compression and loading, remains a hurdle that companies must overcome. With future breakthroughs in these areas, the TAVR market may well usher in its next phase of rapid growth!