Source: Medical Device Business Review

Author: Jiang Jiang

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Recently, the Center for Medical Device Evaluation of the National Medical Products Administration announcedKokai (Nantong) Life Sciences Co., Ltd. ("Kokai Life Sciences") independently developed the PIONEER TAVR Transcatheter Self-Expanding Aortic Valve SystemHas passed the review and entered the special review for innovative medical devices."Green Channel"。

This valve system is equipped withGlobally UniqueA new TAVR product featuring 3D spatial bending technology, with patented designs for coronary protection, multi-dimensional anchoring, and unique paravalvular leak prevention.

In recent years, with the intensification of population aging, the number of patients with valvular heart disease has accounted for more than half of adult cardiac surgical diseases, among which aortic valve disease is one of the most common types of valvular disease.

Currently, the treatment methods for aortic valve disease are mainlyMinimally Invasive Interventional Surgery TAVR is dominant, but from a clinical perspective, most TAVR products on the market...Lack of Positioning Device, which requires strong radial tension for fixation, meaning that only the harder calcified tissue of the native diseased valve can ensure a more secure fixation. On the other hand, without calcified tissue as support, the fixation of the valve would be more challenging.

Especially for patients with aortic regurgitation (AR), due to the unique anatomical structure, they often have an enlarged annulus and no calcification. This means that conventional TAVR products must strictly select cases based on valve calcification and annulus size to be successfully applied in the treatment of aortic regurgitation, which greatly limits their use. If this step is ignored,Conventional TAVR products are often prone to displacement, which can lead to complications such as paravalvular leakage and valve thrombosis.

Based on the "hard injuries" of product design, most TAVR products currently (includingEdward, MedtronicSome products) are only applicable for the treatment of aortic stenosis caused by calcification of native diseased valves.

In response to the scarcity of clinically targeted valve systems for aortic regurgitation, Kokai Life Sciences has focused on clinical pain points and begun strategic development.Valve Diseases in Different Populations, Different Needs, and Different ScenariosThe system solution. Nowadays, the PIONEER TAVR aortic regurgitation system that has been developed almost perfectly addresses the issues of valve replacement positioning and fixation.

Over the years, the role of transcatheter aortic valve replacement (TAVR) in treating pure aortic regurgitation (AR) has gained increasing attention. However, previous reports have shown high rates of residual AR and valve displacement, necessitating surgical or secondary interventions.

In this regard, byProfessor Guo Yingqiang from West China Hospital Leads the Valve TeamLast October, Kokai Life Sciences completed the FIM study for PIONEER TAVR, the world's first adjustable transcatheter aortic regurgitation valve.

FIM Study Results Demonstrate Feasibility and Safety of Novel TAVR System Implantation with Promising Short-Term Outcomes: All 10 Patients Successfully Treated Without Conversion to Surgery or MortalityAt 30-day follow-up, the valve hemodynamics were stable, with low transvalvular pressure gradient, no residual AR, and significant clinical outcomes.At the same time, this technological breakthrough has been published in the international authoritative cardiovascular journal, the "Journal of the American College of Cardiology" (JACC).

Source: Kokai Life Sciences Official WeChat

In fact, the international clinical field has long been plagued by the "lack of targeted AR therapeutic devices."

Kokai Life Sciences' PIONEER TAVR Aortic Regurgitation System with 3D Spatial Bending Adjustment is a world-first innovation.Creative SolutionsTransfemoral Approach for the Treatment of Pure Aortic RegurgitationWorldwide technical challenges, overcoming the shortcomings of existing products。

With the completion of the FIM study and the launch of the multi-center confirmatory clinical trial led by West China Hospital of Sichuan University, PIONEER TAVR is expected to promote a new global standard for treating aortic regurgitation. It is foreseeable that the future Kokai Life Sciences product series will have enormous potential in the international market.

Kokai Life Sciences was founded in 2018, and in just six years, as such a young company, it has been able to directly compete with international giants like Edwards and Medtronic in the highly challenging field of heart valves. With an unstoppable wave of innovation, it has successfully transformed intoUnicorn in the industry. This is undoubtedly inseparable from the strong research and development, operation team, and substantial capital support behind it.

Founder of Kokai Life SciencesDr. Chen Dakai, has worked on structural heart disease valve research in Germany and MicroPort, with many years of experience in the cardiovascular field and rich R&D experience in structural heart disease.

The product development team includes several core R&D personnel who have returned from the United States and Germany. With decades of experience in the cardiac medical field, their technical expertise holds an absolutely leading position in China and is on par with the most advanced cardiac medical treatment technologies globally.

At the same time, not only has it put great effort into product innovation, but it has also made choices in clinical applications.The minimally invasive valve team of the Department of Cardiovascular Surgery at West China Hospital of Sichuan University led by Professor Guo Yingqiang, the team led by Professors Guo Huiming and Liu Jian from the Department of Cardiovascular Surgery at Guangdong Provincial People's Hospital, and the multidisciplinary cardiac team led by Professor Pan Xiangbin from Fuwai Hospital, Chinese Academy of Medical Sciences, BeijingTop experts and scholars collaborate to achieve the integration and innovation of medical products through the intersection of medicine and engineering, precisely developing clinical products suitable for Chinese patients.

Since its establishment, Kokai Life Sciences has targeted the field of valvular heart disease, closely following the development trends in interventional cardiology, and filling the gap of clinical needs with innovative products made in China. It has not only achieved technological breakthroughs in aortic valve products but also developedA variety of cardiovascular interventional products with independent intellectual property rights, both have made significant breakthroughs.

For mitral regurgitation, the LIFECLIP® Mitral Valve Repair System developed by Kokai Life Sciences isThe World's FirstSystem for guided repair design using valve tissue,The First Product in ChinaA mitral valve repair system with an integrated sheath delivery design, alsoThe First Product in ChinaA mitral valve repair system that has passed 400 million cycles of fatigue testing across all specifications.

In addition, the company has also focused on developing the KokaClip transcatheter mitral valve repair system, the KokaValve transcatheter aortic valve replacement system, and the KOKA CLAMP™ transcatheter tricuspid valve repair system via femoral vein. These products all possess unique technical advantages and features, have passed ethical review, and are about to enter the clinical stage.

Besides the support from a professional talent team and strong innovative R&D capabilities, the development of Kokai Life Sciences has been even more reliant on substantial capital investment.

According to Aiqicha, Kokai Life Sciences has completed 3 rounds of financing so far.Total financing nearly 700 million yuan.Not only attracted continuous investment from domestic venture capital firms such as Huachuang Capital, but also secured a leading investment from top-tier capital Blue Ocean Capital, and was selected.List of China's Potential Unicorn Companies。

Source: Aiqicha

With the convergence of technology, capital, and clinical drivers, Kokai Life Sciences is undoubtedly well-positioned to expand its product portfolio with more innovative R&D capabilities, delivering products of significant clinical value to more patients.

For research and development-based medical device companies, the resilience of their self-developed products determines how far the company can go in the future.

To expand and refine the valve market, Kokai Life Sciences has established a rich product pipeline extending from preclinical to clinical stages through collaboration and independent research and development, becoming one of the fastest-growing companies with the most comprehensive production lines in the cardiac valve sector.

In order to enhance the company's global competitiveness in commercial development, the company has establishedChina's largest valve machining center developed the first heart valve covering production line in China and established a Class 10,000 bovine pericardium base in Australia.At the same time, Kokai Life Sciences established its R&D center in Germany, enabling its research and development to be in sync with international standards from the very beginning and possess core market competitiveness.

Professional depth determines future height, and product variety determines market breadth.

It can be seen that while the company is conducting research and development, it has already been preparing for industrialization and laying out the entire industrial chain of valves. Currently, Kokai Life Sciences has a relatively mature layout in the field of mitral and tricuspid valve diseases, especially in the mitral valve product line, which basically covers all types of mitral valve diseases.

With the subsequent launch of the PIONEER TAVR Aortic Regurgitation System, it will be able to further improve.Kokai Life Sciences' "Valve Map"。At present, several cardiac centers in developed countries such as Europe and the United States have expressed cooperation intentions to Kokai Life Sciences. It is believed that this product with independent patented design can go abroad soon and benefit patients worldwide, also providing a significant boost for Kokai Life Sciences in its global commercialization process.

Kokai Life Sciences' full-scale efforts both in China and internationally also indirectly demonstrate that currentlyChina-produced TAVR is facing a critical juncture of "breaking through" and "reshaping."

Not so long ago, the heart valve sector was truly the "hottest thing," not only gaining high recognition from investors, with financing amounts and valuations repeatedly breaking records, but also driving the successive IPOs of Qiming Medical, Peijia Medical, and Xintong Medical. According to Frost & Sullivan data, at this rate of popularity, China's TAVR market is expected to reachRMB 5.06 billion, with a compound annual growth rate of 53.1%.

It is precisely based on such grand expectations that, for a period, leading investment institutions presented a prosperous scene of investing in all the well-known heart valve enterprises. But in reality, how is the development of the TAVR market in China?

According to the report by "Outpatient" magazine, the total number of TAVR surgeries in 2022 exceeded 8,500 cases, falling short of industry expectations. By the end of 2022, major Chinese TAVR manufacturers such asVenus Medtech, HeartFlow Medical, Peijia MedicalRevenue and net profit have both increased.Slip Down, with the maximum decline reaching 202.12%. Since 2024, the share prices of these three companies have also been in a continuous slump, falling below the issue price while repeatedly hitting new historical lows, with their market values all dropping below 7 billion Hong Kong dollars.

The reason why the commercialization of this track is not as expected is also easy to understand.

Compared with the 20% penetration rate in developed countries, the penetration rate in China, which is less than 10%, has always left significant room for imagination in this field. However, the commercialization of heart valves has never been a quick-profit business but rather a test of endurance.

First,As an innovative medical device, market education is not something that can be achieved overnight.

TAVR surgery is relatively difficult, with a long learning curve for doctors, which has driven up the investment of medical device companies. TAVR surgery is considered a completely new procedure in China, and doctors require extensive time to learn and refine their skills. This not only demands significant financial investment in doctor training but also entails considerable time costs.

On the other hand,The high price has become a stumbling block for the expansion of TAVR.

Currently, only a few cities in China have included TAVR in medical insurance. Compared with the high cost of TAVR surgery, most patients in China still opt for the more affordable surgical aortic valve replacement (SAVR). Various factors have led to a slow increase in the penetration rate of TAVR in China, and the difficulty for companies to commercialize and monetize has also risen.

In a narrow market with numerous players, there are as many as dozens of products competing on the same stage, and it's not hard to imagine how fierce the competition behind it is. This also makesThe "bubble" phenomenon in China's TAVR sector is becoming increasingly prominent, and adjusting the industrial layout and business model will also become a necessary path for the survival of domestically produced TAVR.

For Kokai Life Sciences, a commercial battle is inevitable after the product launch. Fortunately, a group of domestically innovative companies represented by Kokai Life Sciences has already found a way to break through in commercialization:

Objectively speaking, there indeed exists a significant unmet clinical need in the field of valvular diseases, and the long-term development potential is promising. However, the TAVR sector is evolving too rapidly, still requiring sound commercial logic and sufficient time to mature.

Chinese manufacturers looking to accelerate commercialization and monetization must focus on product innovation and strategic business expansion. This commercial breakthrough battle has already begun, and whoever can be the first to cross the darkness before dawn will lead the way. Time will tell.

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