Yixin Medical's Transcatheter Mitral Valve System Enters Clinical Trials, Targeting China's Trillion-Yuan Cardiovascular Intervention Market

In May 2021, MitrAssist Lifesciences' MitraFix^®Transcatheter Prosthetic Mitral Valve System (abbreviated as "MitraFix^®”）successfully obtained filing approval from the Human Genetic Resources Administration of the Ministry of Science and Technology, announcing its official entry into the registrational clinical trial phase, and is poised to become China's first approved transcatheter mitral valve replacement (TMVR) product featuring globally leading technology.

Mitral regurgitation is the most common valvular heart disease in an aging society,Patients with severe mitral regurgitation who do not receive effective treatment have a 5-year mortality rate of 50%.

atIn Western countries, the prevalence of mitral regurgitation in the general population is 1.7%., in the United States alone, there are 4.1 million patients with mitral regurgitation, of whom 1.67 million require surgical intervention. In China, amid an increasingly aging population, systematic epidemiological data on the specific incidence of mitral regurgitation remain lacking; by extrapolating from U.S. epidemiological data, it is estimated thatIn China, approximately 7.5 million patients with mitral regurgitation require interventional treatment, of whom approximately 5.5 million have severe mitral regurgitation.

For patients with mitral regurgitation, the current mainstream treatment is throughOpen Surgical Valve Replacement, due to traditionalSignificant surgical trauma, and many patients have a poor baseline condition,Only 2% of patients with moderate-to-severe mitral regurgitation undergo surgical treatment.

With advancements in medical device R&D and clinical research, interventional therapies (such as transcatheter mitral valve replacement, TMVR) have become an emerging treatment modality for mitral regurgitation.Transcatheter mitral valve replacement (TMVR) enables the treatment of mitral valve diseases via a minimally invasive approach under imaging guidance, without requiring cardiac arrest or cardiopulmonary bypass support.

Due to the complexity of the mitral valve structure and high technical barriers, transcatheter mitral valve replacementHigh R&D difficulty, currently absolutelyMost are in the exploratory or early-stage clinical development phase.

MitrAssist LifesciencesFounded in August 2017, isOne of the first companies globally to develop transcatheter mitral valve replacement systems., and is also a globally leading provider of cardiovascular interventional product solutions. As a leading enterprise in the cardiovascular interventional therapy industry, particularly in the field of mitral valve intervention, MitrAssist Lifesciences has, since its inception, upheld the mission of "Dedicated to cardiac care, guided by the heart, harnessing global technology, and healing hearts worldwide," and has strategically deepened its presence in the valvular interventional therapy sector.

Since its establishment, MitrAssist Lifesciences has completed two rounds of financing: In November 2017, MitrAssist Lifesciences secured $25 million in Series A financing, led by Fosun Pharma with participation from Ping An Capital; in December 2020, it closed a $70 million Series B financing round. This round was led by Centurium Capital and co-led by the CICC Qide Fund and affiliated funds under CICC Capital, with CITIC Securities and Tonghe Capital participating as co-investors.

MitrAssist Lifesciences was founded by a seasoned team with an average of over 20 years of experience in the medical device industry and more than a decade of collaborative partnership. Under the leadership of the founding team, MitrAssist Lifesciences possesses comprehensive capabilities in R&D, manufacturing, clinical operations, regulatory affairs, marketing, and strategic integration, achieving highly synergized operations across the entire value chain encompassing R&D technology platforms, supply chain management, clinical and market access, and commercialization.

Driven by clinical needs, MitrAssist Lifesciences has diversified its core product portfolio across multiple fields, coveringStructural Heart, Heart Failure, Coronary, Intraoperative Protectionmultiple series of products in related fields.

Product categories primarily coverInterventional coronary drug-coated balloon products, interventional heart failure treatment products, cerebral thrombus protection devices, and interventional heart valve treatment products all possess global intellectual property rights and feature globally leading technology.MitrAssist Lifesciences currently holds over 50 global patents for its core products, covering multiple countries and regions including China, Europe, the United States, and Japan.

It is worth noting that,MitrAssist Lifesciences' transcatheter mitral valve replacement product is the world's only device that enables the same valve to accommodate both transapical (TA) and transfemoral (TF) delivery approaches., the transapical and transfemoral venous delivery systems feature the world's smallest delivery system radius, and this transcatheter mitral valve replacement product is currently the only one to enable fully ultrasound-guided procedures in patients and be published and introduced in the authoritative academic journal JACC Interventional, filling a gap in China's interventional mitral valve replacement technology.

MitrAssist Lifesciences' core transcatheter mitral valve replacement product, MitraFix^®Consists of a transcatheter artificial mitral valve, a delivery system, and a loading device. MitraFix^®led by the medical device team of Shanghai MitrAssist Lifesciences and Academician Hu Shengshou from Fuwai Hospital, successfully developed over many years, this is aA globally leading innovative product.

MitraFix^®It is also the world's only interventional mitral valve replacement product compatible with both transapical (TA) and transfemoral (TF) approaches., which implants the prosthetic mitral valve at the mitral annulus via a transapical (TA) or transfemoral (TF) delivery system.

In November 2018, Yunnan Fuwai Hospital successfully performed Asia's first transcatheter mitral valve replacement, MitraFix.^®Becoming the first transcatheter mitral valve replacement system in Asia approved for the humanitarian application of new in-hospital technologies. Application results showed a smooth surgical procedure, significant improvement in postoperative valve function, absence of serious complications, complete resolution of valve regurgitation, and satisfactory clinical outcomes during the follow-up period, fully demonstrating MitraFix^®safety and efficacy.

May 2021, MitraFix^®Having successfully secured filing approval from the Human Genetic Resources Administration Office under the Ministry of Science and Technology (HGRAC Filing No. 2021BAL0290), it officially enters the registration clinical trial phase. Poised to become China’s first approved and marketed transcatheter mitral valve replacement (TMVR) product, it will bring new hope to more patients with mitral regurgitation.

In the future, MitrAssist Lifesciences will continue to advance technological innovation and industrialization in cardiovascular interventional medical devices, establishing itself as a leading cardiovascular platform company both in China and globally. Leveraging the vast and continuously growing cardiovascular market in China and worldwide, the company will take independent innovation as its core driving force, integrate and deploy globally leading technologies, and deliver world-class comprehensive solutions for interventional cardiac therapy to physicians and patients, ultimately benefiting a broader patient population.

References:

1. Chinese Circulation Journal, 2021, Vol. 36, No. 4, pp. 407-411.

2. Pan Wenzhi et al., Current Status and Prospects of Transcatheter Interventional Therapy for Mitral Regurgitation, *Chinese Journal of the Frontiers of Medicine (Electronic Edition)*, 2017, Vol. 9, Issue 7.