CH-VAD Medical Successfully Enrolls 100 Patients in U.S. Pivotal Trial for BrioVAD, Demonstrating a Viable Path to Autonomous Global Commercialization

At present, almost every innovative pharmaceuticals and medical devices enterprise in China is embracing"The Dream of Going Overseas": Building a team and achieving independent commercialization in the United States is undoubtedly the most "ideal" approach. The overseas market has become a crucial battleground for companies to expand their profit margins, but this path is often considered by most companies as "difficult to navigate" and "unrepeatable."

And a Chinese artificial heart company——BrioHealth Solutions, however, has successfully navigated this path: In 2009, BrioHealth Solutions established a subsidiary in the United States, which officially began operations in 2018. Currently, the company has grown to a team of hundreds, forming a complete operational system that encompasses regulations, research and development, technical support, clinical trials, and commercialization.

BrioHealth SolutionsCEO Lu Chengjie revealed to PharmCube Invest: The U.S. subsidiary is not only the application entity for its core product’s U.S. clinical trials, but will also become the Legal Manufacturer for the European and American markets in the future.

In November 2024, BrioHealth Solutions' independently developed new fully magnetically levitated artificial heart, BrioVAD, began clinical trials in the United States.Becoming the first in China to obtainFDA-Approved and Officially Entered Clinical Trials: Original Active Implantable Medical Device，This YearIn August, it entered the confirmatory study phase, randomly controlled against HeartMate 3, the world's first fully magnetically levitated artificial heart approved for marketing, and as the first domestically produced implantable medical device to be covered by U.S. Medicare.Each clinical case is reimbursable.$220,000。

Obviously, BrioHealth SolutionsThe "going global" story is eye-catching, not only because it has opened the door to the global market with technical strength, but also because its business logic is clear and achievable: the heart failure treatment market behind artificial hearts is as large as the cancer market. The mature clinical diagnosis and treatment system for advanced heart failure in the United States can maximize demand, and the payment system dominated by commercial insurance can leave enough profit space for enterprises.

Lu Chengjie mentioned:"Now, in the U.S. cardiology field, there are three subspecialties that require doctors to undergo specialized training and certification: interventional cardiology, electrophysiology, and advanced heart failure, corresponding to the three areas of greatest clinical demand and highest technical barriers in cardiovascular medicine."Now, heart failure has surpassed cancer to become the biggest burden on public health in the United States, and China is also showing this trend.”

In the field of cardiac intervention and electrophysiology, BrioHealth Solutions has successfully entered overseas markets, becoming a representative of Chinese enterprises."A Benchmark for 'Going Global.' Focusing on the field of heart failure and equipped with the potential 'blockbuster product' of artificial hearts, BrioHealth Solutions seems to aim even higher — relying on the European and American markets to 'grow bigger and stronger' and become a global leader in the heart failure sector."

How Did BrioHealth Solutions Pave Its Way to Independent Overseas Expansion? And What Enables It to Achieve Its Vision? In a Recent Interview with PharmaCubeIn the dialogue with Invest, Lu Chengjie discussed BrioHealth Solutions' unwavering internationalization strategy over the past two decades; its approach to challenging Abbott in overseas markets and its commercialization plans; as well as the long-term goal of further advancing the discipline of end-stage heart failure in China and the commercialization of artificial hearts based on overseas experience.

"Internationalization is localization"

BrioHealth Solutions is a typical"Technology-based" Biotech, founded by Chen Chen, one of the earliest scientists globally to research the full magnetic levitation technology route for artificial hearts (VAD), who previously led the development of the magnetic levitation-based artificial heart Levacor in the United States.

More than a decade of experience in artificial heart research and development has made Chen Chen firmly believe in the absolute advantages of the full magnetic levitation technology route in improving blood compatibility and reducing complications. Meanwhile, to solveThe clinical pain point of Levacor's excessive volume led to his return to China in 2008 to establish BrioHealth Solutions. Through original innovation, he successfully developed China's first ultra-small fully magnetically suspended artificial heart, CiFU.^®VAD (Model: CH-VAD).

It has been proven that Chen Chen chose the right direction.In 2025, the INTERMACS annual report released 5-year follow-up data for fully magnetically levitated and non-fully magnetically levitated artificial hearts, showing that the 5-year survival rate of fully magnetically levitated artificial hearts was 16.2% higher than that of other technical categories of artificial hearts.And currently, BrioHealth Solutions' products and Abbott's acquiredHeartMate3 is one of the only two fully magnetically levitated artificial hearts in the world.

It is precisely this technical originThe innovative capability and potential value allowed BrioHealth Solutions to naturally set an international strategy from the very first day of its establishment.Lu Chengjie's Judgment:"Since our product is based on original technology, it is essentially positioned for internationalization; if it falls short, then it becomes 'a domestic alternative.' Accordingly, the solution to our company's growth lies in internationalization. For a company, whether or not it has an international layout can make a difference of up to 10 times in terms of scale and profit."

With the goal set, BrioHealth Solutions has been practicing a belief on its more than ten years of overseas journey:Globalization is localization.

In Lu Chengjie's view, this first requires companies to adapt to local market rules.——In the United States, whether it is clinical practitioners adopting new therapies or medical insurance and commercial insurance payments, all are based on evidence-based medicine. This means that technical transparency and the extent of clinical data disclosure are crucial.

Under this rule,In 2011, BrioHealth Solutions actively participated in the American Society for Artificial Internal Organs (ASAIO) conference with only the first-generation prototype, publicly disclosing its technology and test performance. In the following years, the company attended the conference consecutively, fully disclosing the performance metrics of its five prototype iterations. Over the years, BrioHealth Solutions has also become the only Chinese artificial heart enterprise to continuously publish and disclose CH-VAD clinical results in top international medical journals and at international academic conferences, enhancing clinical awareness through evidence-based medical evidence.

In November 2024, the single-center long-term results of CH-VAD at Fuwai Hospital were officially published in The Journal of Heart and Lung Transplantation, the top international cardiothoracic surgery journal. This is the largest LVAD single-center study published in China to date and marks the first time that clinical research results on VAD from China have been published in this journal. The study has been recognized by the U.S. Clinical Trials Regulatory Committee, which stated that this Chinese data further supports its U.S. clinical trials.

From the long-term results of clinical applications in China to the clinical trial protocols in the United States, BrioHealth Solutions has solid support from clinical research and data, and has also gained recognition from U.S. heart failure clinicians as a result.

"We have always maintained a very transparent status in terms of R&D, technology, and all kinds of data. Only by doing this over the long term can you gain respect in the industry, build trust and reputation, and more importantly, allow clinicians and patients to fully understand the product. Therefore, when we launched clinical trials in the U.S., almost all American heart failure clinicians wanted to get involved," said Lu Chengjie.

Building local teams in core markets is seen by BrioHealth Solutions as a key step towards internationalization."Required Option."Lu Chengjie said straightforwardly that the characteristic of BrioHealth Solutions is"To truly internationalize in key global markets."

In 2018, after BrioHealth Solutions' CH-VAD China clinical trial was approved, its U.S. subsidiary simultaneously began preparations for the U.S. clinical trial. In recent years, it has continuously attracted local talent, building full-chain capabilities from R&D to commercialization, laying a foundation for its culture and market presence as an international company.At present, BrioHealth Solutions has embarked on the second leg of its international journey.——Establish a local team in Europe.

For the construction of the local team, Lu Chengjie has his own views:"If you want to go global, but you don't build a team in key markets, overseas markets won't see your commitment to development here. How can you attract top talent to join?"

In this sense,Lu Chengjie believes that if Chinese enterprises truly want to internationalize, they must focus on original technology and invest in localization."The traditional overseas expansion model for Chinese companies has been export-oriented, which essentially boils down to 'industry plus trade,' earning profits from ordinary manufacturing rather than true internationalization. On the other hand, multinational corporations we see invest locally, earn local currency, and generate profits driven by technology and services."

Advance to Become a Global Leader in Heart Failure

After six years of localization layout, in the past two years, BrioHealth Solutions has entered a breakthrough period in its overseas expansion:In November 2024, the INNOVATE clinical trial, a "head-to-head" comparison between BvioVAD and HeartMate 3, was officially approved for conduct in the U.S. After entering the confirmatory clinical stage in August this year, it will involve 60 clinical research centers.

This YearIn December, the INNOVATE clinical trial reached its 100th participant enrollment on its first anniversary, marking a key milestone.

As the world's first approved fully magnetically levitated artificial heart,Since its launch in 2017, HeartMate3 has been implanted in over 40,000 cases. After Medtronic's magnetically levitated artificial heart HVAD was withdrawn from the market in 2021 due to safety risks, HeartMate3 became the "monopolist" in the global artificial heart market. In 2023, its sales exceeded $1 billion, making it one of the rare "blockbuster" medical devices.

Comprehensive ChallengeHeartMate3, showcasing BrioHealth Solutions' ambition.

This is first based on BrioHealth Solutions' confidence in its own technical capabilities.——Not "innovating for the sake of innovation," but rather addressing clinical needs more effectively.

Hemocompatibility is the most critical evaluation criterion for artificial hearts.Performance IndexMark,Direct ReflectionThe degree of damage to blood when it flows through the blood pump.Full Magnetic Levitation TechnologyCan achieve rotationImpellerStabilitySuspension,Without relying on blood support,AvoidMechanicalFriction and Blood CompressionCauseBlood Cell Damage, therebySignificantReduced the thrombosis, stroke, and bleeding inside the pumpOccurrence of Adverse Reaction Events。

BrioHealth Solutions Achieves Technological Breakthrough in Fully Magnetic Levitation Technology——The original "discrete magnetic levitation structure," which separates the magnetic levitation and motor in the basic construction of the blood pump, reduces the pump size while enlarging the rotor, thereby lowering the rotational speed. Reportedly, under the same pressure conditions, CH-VAD/BrioVAD only requires about half the rotational speed to achieve the same flow rate as Abbott's HeartMate 3, implying higher stability and less blood damage, with the potential to further reduce clinically high-incidence risks such as stroke and gastrointestinal bleeding.

In addition, BrioHealth Solutions has exclusively designed the global lead with the least number of leads (4 leads), the thinnest diameter (3.3mm) percutaneous cable, has also been clinically proven to significantly reduce the risk of infection compared to existing products.

In fact,The clinical data of CH-VAD in China compared to HeartMate3 has indicated that the long-term survival rate of BrioHealth Solutions' artificial heart is higher, with a lower probability of adverse events.

On the other hand, the diagnosis and treatment system for advanced heart failure in the United States is relatively mature and concentrated in a few dozen leading hospitals, which objectively allows BrioHealth Solutions to adopt a direct sales model. With a small team focusing its efforts, it can directly transform technical strength into commercial capabilities.

Lu Chengjie talked about BrioHealth Solutions' commercialization strategy in the U.S.:"We have advantages in technology and products, plusThe diagnosis and treatment of advanced heart failure in the United States are highly concentrated, and the process of conducting clinical trials actually completes the maintenance of key clients. Currently, we have already exceeded...22 hospitals have completed clinical trial training, with over 4,000 training sessions conducted.”

During the process of in-depth contact with hospitals, Lu Chengjie felt that American clinical experts strongly hoped that more and better artificial heart products would enter the market to address unmet clinical needs in this field, such as percutaneous cable infections, gastrointestinal bleeding, right heart failure, and management of external components."Monopoly and lack of innovation are the biggest problems in the current U.S. artificial heart industry."

Based on this, Lu Chengjie concluded:"The monopoly of Abbott's HeartMate3 is not an absolute monopoly, and the industry still needs better products. AndWe have two key focuses for the U.S. market: one is breaking in, but more importantly,'Make the cake bigger' through competition to drive overall industry growth and innovative development。As a small company entering the competition, we must focus on technological and product innovation as well as service innovation. Our consistent positioning has been to become the true leader in this field through innovation.”

Promote with Global PracticeAdvances in Heart Failure Treatment

Cardiovascular diseases currently rank as the leading cause of death among urban and rural residents in China. However, in stark contrast, the construction of China's heart failure diagnosis and treatment system lags behind. Patients with various types of heart failure are often scattered across multiple disciplines, lacking awareness and access to diagnostic and therapeutic pathways for artificial heart therapies.

The United States was the first country in the world to explore and establish a treatment system for advanced heart failure. Based on its experience, the standardization and streamlining of referral procedures are equally important as the accumulation of clinical treatment expertise.——The establishment and maturation of the concept of advanced heart failure centers have not only significantly improved clinical treatment outcomes for patients with end-stage heart failure but also directly driven the industrialization of artificial hearts in the United States, making it the largest artificial heart market globally.

Currently, in China"The Heart Failure Center" construction has just begun. At this stage, Lu Chengjie believes,"Doing the right thing" means providing the best technology and services, raising awareness, and building systems.。

Therefore, BrioHealth Solutions is not only a participant in the industry but also a collaborative builder of the advanced heart failure diagnosis and treatment system.

As early asIn 2017, BrioHealth Solutions began its collaboration with Fuwai Hospital, completing the first application in China of a domestically developed fully magnetically levitated artificial heart that same year; more importantly, through the clinical application of CH-VAD,BrioHealth Solutions, in collaboration with the team led by Academician Shengshou Hu from Fuwai Hospital, Chinese Academy of Medical Sciences, has established for the first time in ChinaTechnical specifications for VAD surgical implantation, and the VAD treatment and multidisciplinary full-cycle clinical application system in various scenarios，Experts from the departments of cardiac surgery, cardiology, critical care medicine, ultrasound, anesthesiology, and nursing are involved.

When the treatment pathway and market were not yet mature, BrioHealth Solutions took the lead not only by delivering impressive clinical results but also by collaboratively establishing industry standards. Transparent technical pathways, open clinical data, and clear evaluation criteria—these may well become the true competitive barriers for companies when China's artificial heart market matures in the future.

"The artificial heart must serve the patient until the end of their life, which is completely different from other devices. From this perspective, it is problematic that everyone is now concerned about the implantation volume rather than the long-term survival rate," said Lu Chengjie."The true competition lies in who can deliver better clinical benefits."——that is, enabling patients to live longer, experience fewer complications, and enjoy a higher quality of life.。”

It can be seen that, whether it is firmly going global, steadily building a presence in the U.S. market, or strategically cultivating the domestic market in China, BrioHealth Solutions has been implementing a strategy:Adapt to local conditions, system first, evidence-based foundation, innovation paramount.。This seems to be the fundamental narrative of innovative pharmaceuticals and medical devices: high investment in technological innovation and market expansion translates into dual competitive barriers of product strength and commercialization capability, ultimately yielding superlative returns in mature markets. For China's current innovative medical device companies, this is undoubtedly a long-term development model worth paying attention to.

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Zhao Jingyi: sucd0307