Grand Pharmaceutical Secures Exclusive Rights to InnovHeart's Saturn TMVR System, Targeting the Multi-Billion-Dollar Transcatheter Mitral Valve Market

On November 28, Grand Pharma (512.HK) announced that it had entered into a strategic cooperation agreement with InnovHeart S.r.l. for equity investment and product licensing. Grand Pharma will acquire approximately 17.8% equity stake in InnovHeart for about €43.8 million, as well as the exclusive rights to develop, manufacture, and commercialize Saturn, an innovative global medical device for mitral valve replacement, in the Greater China region (Mainland China, Hong Kong, Macau, and Taiwan).

Saturn represents another globally innovative product achieved by Grand Pharma in the field of precision interventional medicine, marking a significant strategic move in the company’s effort to build an internationally leading platform for precise diagnosis and treatment of cardiovascular and cerebrovascular diseases through interventional approaches. Grand Pharma stated that the acquisition of Saturn, a mitral valve replacement product, will enhance the company’s portfolio in structural heart disease, enrich its pipeline of investigational products in vascular intervention, and further advance the comprehensive establishment of its “passive + active” innovative medical device platform. With this development, Grand Pharma has completed a comprehensive layout of innovative products across six key areas: coronary vascular intervention, peripheral vascular intervention, neurointervention, structural heart disease, electrophysiology, and heart failure. This positions the company as one of the most extensively diversified and comprehensively disease-covering players in the field of precision interventional diagnosis and treatment for cardiovascular and cerebrovascular conditions.

The announcement stated that InnovHeart is an Italian medical device company focused on the development of innovative transcatheter mitral valve intervention (TMV) medical systems, dedicated to providing innovative treatment options for patients with valvular heart disease. The company’s founding team has been deeply engaged in the field of valvular heart disease for over a decade and possesses extensive experience in product development.

InnovHeart’s flagship product, Saturn, is implanted via a transseptal interventional approach, minimizing surgical trauma and shortening postoperative recovery time. It innovatively combines annuloplasty with valve replacement technology to enhance device adaptability, making it suitable for various common mitral valve anatomies.

According to Frost & Sullivan, there were approximately 210 million patients with valvular heart disease worldwide in 2019, resulting in about 2.6 million deaths. Among these conditions, mitral regurgitation is the most common type of valvular heart disease. For patients with severe mitral regurgitation who do not receive effective treatment, the five-year mortality rate can reach approximately 50%.

Due to the complex anatomy of the mitral valve, currently marketed repair techniques such as edge-to-edge repair can only temporarily address certain issues, whereas transcatheter mitral valve replacement (TMVR) holds promise as a standardized, universal treatment for various types of mitral valve diseases. Frost & Sullivan projects that the global market size for mitral valve interventions will reach $17.4 billion by 2030; according to Huatai Securities’ research on the TMV market, China’s market capacity is expected to be approximately RMB 11.8 billion by 2030.

Due to the significant technical challenges in research and development, there are currently no commercially available products for transcatheter mitral valve replacement (TMVR) via a transseptal approach worldwide. The introduction of the Saturn device is expected to enable patients with mitral regurgitation in China to have simultaneous access to the most advanced TMVR therapies available globally.

Precision interventional diagnosis and treatment of cardiovascular and cerebrovascular diseases is one of Grand Pharma’s core strategic sectors. Adhering to the therapeutic philosophy of “intervention without implantation,” the company has successively deployed a portfolio of globally innovative products. Since the beginning of this year, Grand Pharma has strategically accelerated the expansion of its high-end medical device pipeline, with cumulative investments exceeding USD 160 million. Upon completion of this transaction, the company will have a reserve of 10 innovative products in this field, two of which have already received marketing approval in China, while the remaining eight are actively advancing through clinical registration processes in China. The company aims to achieve phased and tiered market launches of these innovative products in the coming years, thereby driving leapfrog growth in this business segment.

Currently, Grand Pharma has established multiple R&D and production bases both domestically and internationally in the field of precision interventional diagnosis and treatment for cardiovascular and cerebrovascular diseases. The company has a reserve of 50 R&D personnel, with nearly 40% holding master’s or doctoral degrees. It holds over 30 patent families, including granted patents, domestic patent applications, and PCT international patent applications. With a solid industrial foundation and robust R&D capabilities, Grand Pharma is well-positioned to secure its leadership across various sub-sectors of precision interventional cardiovascular and cerebrovascular care, while supporting the development of a distinctive portfolio of high-end innovative medical devices characterized by “implant-free intervention,” “concurrent heart-brain treatment,” and “passive + active” technologies.

Grand Pharma stated that the company will continue to focus on innovative business development in six key areas: coronary intervention, peripheral vascular intervention, neurointervention, structural heart disease, electrophysiology, and heart failure. By adopting a combined approach of internal and external R&D, the company aims to accelerate its research and development pace. Leveraging the Group’s robust global R&D capabilities and sustained capital investment, it will continuously explore cutting-edge global technologies to provide enduring momentum for the Group’s long-term growth, with the goal of establishing this segment as a leading “precision interventional diagnosis and treatment platform for cardiovascular and cerebrovascular diseases” in China and globally.