Innovative Approval! The 4th Domestic Edge-to-Edge Mitral Valve Repair Device Launched

Recently, the National Medical Products Administration approved the registration application for the innovative transcatheter mitral valve repair system developed by Kokai (Nantong) Life Sciences Co., Ltd. (hereinafter referred to as: Kokai Life Sciences).

Image Source: NMPA Official Website

Multiple Innovative Products
Focus on Structural Heart Disease

Kokai Life Sciences was founded in September 2018. Since its establishment, it has always focused on the field of structural heart disease, developing systematic solutions for valve diseases targeting different populations, needs, and scenarios. Its team is also very high-profile, with founder Dr. Chen Dakai and the company's technical team having many years of R&D experience in the cardiac medical field, and their technical level is among the leading in China.

Currently, Kokai Life Sciences has completed three rounds of financing, with the funds mainly used for advancing large-scale clinical trial projects of existing heart valve products, continuous investment in valve clinical applications and validation trials, development of subsequent innovative product pipelines, and potential strategic cooperation. Among the three rounds of financing, the highest amount reached 350 million RMB. Additionally, according to Yaozhi Patent Database, Kokai Life Sciences currently holds over 200 authorized patents, most of which are related to valve products.

Source of the image: Yaoke Data - Investment Landscape Database

The transcatheter mitral valve repair system approved for marketing this time is a key product of Kokai Life Sciences. According to the information on the NMPA's official website, the product consists of a clip device and delivery system, as well as a catheter sheath assembly. It is delivered percutaneously and is suitable for patients with degenerative mitral regurgitation (MR≥3+) who are considered by the cardiac team to be at high risk for surgical procedures and whose mitral valve anatomy is appropriate.

According to the PharmCube medical device data query, apart from the recently approved transcatheter mitral valve repair system, Kokai Life Sciences has one other product that has been approved for marketing. In 2024, its balloon inflation device was approved for marketing, and one more product has entered the innovation channel — the transcatheter self-expanding aortic valve system, with the registration progress as follows, which is expected to be approved this year.

Image Source: Yaoke Medical Device Data

It is worth mentioning that its transcatheter self-expanding aortic valve system is also a heavyweight product. This product features the world's first 3D spatial bending adjustment technology. Compared with traditional technologies, this product solves the problem of treating pure aortic regurgitation through the femoral approach and can precisely deliver the valve to the designated position.

Significantly Accelerated Growth
Local Power is on the Rise

Mitral Regurgitation (MR) is one of the most common heart valve diseases, characterized by a high incidence rate, low awareness, and low treatment rate. With the growth of an aging population, the prevalence of MR in China is gradually increasing. Interventional treatments for MR include transcatheter mitral valve repair and transcatheter mitral valve replacement. According to publicly available data, China’s transcatheter mitral valve repair market is expected to reach 4.56 billion yuan by 2025, with an annual compound growth rate of 18.3%. The replacement market is growing even faster and is expected to exceed 10 billion yuan by 2030.

From the international market perspective, the international transcatheter mitral valve repair technology has entered a mature stage, with the core being transcatheter edge-to-edge repair (TEER) technology. Representative products include Abbott's MitraClip system, Edwards' Pascal Precision system, etc.

The MitraClip system is the only TMVr product to have received FDA/CE/NMPA triple certification, obtaining CE approval in 2008, FDA approval in 2013, and NMPA approval in 2020. It is also the first TMVr product approved in China, and has now been iterated to its fourth generation (G4).

The Pascal Precision system was approved by the FDA in September 2022, making it the second FDA-approved mitral valve repair system. Unlike Abbott's product, this device can be used to treat two conditions: mitral and tricuspid regurgitation.

In the Chinese market, although domestic companies started relatively late, in recent years, with strong policy support and continuous breakthroughs in technological innovation, domestically produced products have gradually been launched.

According to the PharmCube Medical Device Database, before the launch of Kokai Life Sciences' transcatheter mitral valve repair system, three domestically produced edge-to-edge repair products had already been approved in China, respectively from HanYu Medical, DeJin Medical, and DuanYou Medical.

Image Source: Yaoke Medical Device Data

Although international transcatheter mitral valve repair systems currently have significant advantages in terms of technical maturity and clinical data accumulation, companies in China are rapidly catching up through differentiated innovation and other approaches. In the future, with further advancements in technology and the integration of intelligent techniques, mitral valve interventional treatment will develop towards more minimally invasive and durable solutions, offering better options for tens of millions of patients worldwide.

Conclusion

At present, the strength of China-produced innovative medical devices is continuously bursting forth. An increasing number of locally innovated devices have been approved, and more and more gaps in the market are being filled by China-produced innovative medical devices. With the further advancement of technology and the continuous realization of results from local innovative device companies, the "value content" of China’s medical device products will become increasingly higher, and the process of China substitution will accelerate.

References:
1. Kokai Life Sciences Official WeChat

Editor: Muyan

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