CH-Ventus Makes History as First True Challenger on Global Artificial Heart Stage with BrioVAD® IPO Filing

Recently, BrioHealth Solutions independently developed a new generation of implantable left ventricular assist system (LVAD, commonly known as "artificial heart") BrioVAD.^®The first subject enrollment of the INNOVATE clinical trial has been successfully completed at Emory University Hospital in the United States. This trial will conduct a randomized controlled study directly comparing with Abbott's HeartMate 3, the only fully magnetically levitated artificial heart previously approved by the FDA. This key milestone marks BrioVAD.^®On the highest international stage for artificial hearts, BrioHealth Solutions has officially embarked on a dual journey of technological innovation and clinical application validation, becoming the only medical device innovator currently conducting LVAD clinical trials in the United States.

 BrioHealth Solutions BrioVAD^®Ventricular Assist Device First Implanted at Emory University Hospital in the United States

Global Heart Failure Patients Exceed 60 Million, with About 5% Progressing to End-Stage Heart Failure Annually; Artificial Hearts Hold a Market Potential of Over $300 Billion. In the United States, artificial hearts are categorized as a Class I recommended therapy for end-stage heart failure, with clinical demand steadily increasing. However, the international market in this field is currently entirely monopolized by Abbott's HeartMate 3. Medtronic once introduced the magnetic-levitation artificial heart HVAD, which briefly rivaled HeartMate 3. Nevertheless, due to severe adverse events, the product was withdrawn from the market in June 2021. Abbott’s monopoly has also posed challenges for the global academic community, leaving clinicians with limited product options and sluggish progress in academic research. Despite this, due to the vast patient population and strong clinical demand, Abbott's HeartMate 3 is projected to generate approximately $800 million in annual revenue.

With a group of internationally renowned industry experts' profound accumulation in the artificial heart field, BrioVAD^®BrioVAD, born out of necessity, compared to the industry gold standard Abbott HeartMate 3.^®By adopting a unique discrete magnetic levitation technology, the size of the blood pump is further reduced while maximizing the rotor of the blood pump, achieving lower implant invasiveness and demonstrating superior hemocompatibility and hemodynamic performance. At the same time, through micro-electronic circuit technology, the number of leads is minimized while achieving complete backup, making its transcutaneous cable the thinnest in the world, which helps to minimize the occurrence of transcutaneous cable infections. In addition, through multiple technological innovations, BrioVAD® has achieved portability of external components, and the product has shown comprehensive advantages. Currently, among the clinical data of global artificial heart products that have been published, the clinical results of BrioHealth Solutions are the most outstanding.

 BrioVAD^®Schematic Diagram of Left Ventricular Assist System

 BrioVAD^®Main Components of Left Ventricular Assist System

According to public reports, BrioHealth Solutions' BrioVAD^®In the first half of 2024, it received IDE approval from the U.S. FDA and officially began preparations for the INNOVATE clinical trial, creating a historical precedent as the first active implantable innovative medical device from China to be approved for clinical trials in the United States. INNOVATE is a prospective, randomized controlled, open-label, multi-center, confirmatory clinical trial designed to evaluate BrioVAD.^®In terms of safety and efficacy in treating advanced, refractory heart failure. Participants in the trial were randomly assigned to receive BrioVAD in a 2:1 ratio.^®Or HeartMate 3, the primary endpoint is the survival rate free from disabling stroke and pump replacement in the short term (6 months) and long term (24 months). Other endpoints include the assessment of adverse events, cardiac function, and quality of life in heart failure patients. Notably, the study will also validate the implantation of BrioVAD.^®Whether it can reduce the total number of hospitalization days during the follow-up period to verify BrioVAD^®Whether the technological innovation improves patient outcomes further compared to the current standard of care. The trial is expected to enroll approximately 800 patients at leading medical centers in the United States.

 Francis Pagani, Chairman of the U.S. INTERMACS, Lead Investigator of the INNOVATE Trial, and Otto Gago Endowed Professor of Cardiac Surgery at the University of Michigan Medical School, Introduces BrioVAD at ISHLT^®System and Clinical Trial Protocol

BrioHealth Solutions BrioVAD^®The emergence of BrioVAD has undoubtedly created a huge wave in the American clinical community.^®As the first active implantable medical device in China to receive FDA clinical trial approval, it has garnered positive support from a number of top hospitals in the United States and U.S. health insurance programs. The initial centers participating in the clinical trials are authoritative medical centers in the field of artificial hearts in the U.S., including the University of Michigan Medical Center, Cleveland Clinic, University of Chicago Medical Center, Duke University Medical Center, Emory University Hospital, Montefiore Medical Center, Henry Ford Hospital, and University of Utah Hospital, among others. Meanwhile, according to publicly available information, in the INNOVATE clinical trial, including BrioVAD...^®And its associated routine examination and service fees will be fully covered by Medicare, with an average payment of approximately $220,000. Moreover, according to the relevant rules of Medicare and the pre-market clinical trial practices of VAD, before the completion of IDE clinical trial enrollment and full product approval for marketing, companies can continue to design larger-scale CAP (Continued Access Protocol) trials to continuously verify the safety and efficacy of the product. Taking Abbott's HeartMate3 as an example, before the product was fully approved for marketing in the U.S., it had cumulatively achieved over 3,000 implants, generating hundreds of millions of dollars in clinical trial revenue. This advantage significantly reduces the risks of clinical and pre-commercialization investments during the process of overseas market expansion for enterprises. BrioHealth Solutions is poised to make history, becoming the first Chinese enterprise to lead the global artificial heart technology development and drive transformative changes in the industry.

BrioHealth Solutions Holds First INNOVATE Clinical Investigators Meeting

Previously, BrioHealth Solutions' artificial heart product had already gained widespread recognition in China's clinical and academic circles. Its first commercialized product — CiFu^®VAD (Model: CH-VAD) is the first fully magnetically levitated left ventricular assist device approved for marketing in China, featuring complete independent intellectual property rights and several key breakthrough technologies. With its innovative structural design, CH-VAD demonstrates excellent hemocompatibility and hemodynamic performance, providing a solid guarantee for long-term high-quality life for patients with end-stage heart failure after surgery. Since CH-VAD was launched in China in November 2021, BrioHealth Solutions has gained unanimous recognition from top domestic cardiovascular experts, including those from Fuwai Hospital, Anzhen Hospital, Zhongshan Hospital, Ruijin Hospital, and Wuhan Asia Heart Hospital, thanks to its leading technological advantages, strong global academic resources, and professional industry service capabilities. Among China’s top medical institutions, CH-VAD has consistently ranked first in clinical implantation volume, with a significant market share advantage.

On May 11, 2024, the international top medical journal of cardiothoracic surgery, "The Journal of Heart and Lung Transplantation," published online a research article by the team of Academician Shengshou Hu from Fuwai Hospital, Chinese Academy of Medical Sciences, about CiFu.^®VAD (Model: CH-VAD) Long-Term Single-Center Outcomes at Fuwai Hospital: This marks the first time that research results of a China-originated medical device have been published in this journal. The study shows that patients supported by CH-VAD have high survival rates and low incidence of complications, with long-term support being safe and effective. Compared to international standards, the long-term survival rate of CH-VAD (1-year, 2-year, and 3-year patient survival rates were 93%, 93%, and 89%, respectively) is higher than those reported in large-scale international clinical studies and INTERMACS data. Moreover, the incidence rates of severe adverse events such as stroke, gastrointestinal bleeding, and percutaneous lead infection are lower than those reported in large-scale international clinical studies and INTERMACS data, consistently demonstrating world-leading clinical outcomes.

 Prof. Wang Xianqiang from Academician Hu Shengshou's Team at the Chinese Academy of Medical Sciences Presents Long-Term CH-VAD Results at ISHLT for the First Time

With significant benefits to patients, ventricular assist devices (VADs) have now been included in the reimbursement coverage of basic medical insurance and critical illness insurance in Beijing, Guangdong Province, Shaanxi Province, Xinjiang Autonomous Region, and Hubei Province. As the capital, Beijing's medical insurance policy has an important demonstration effect, and its experience is often referenced by other provinces and cities to formulate or adjust local medical insurance policies. This trend will accelerate the inclusion of LVAD therapy in medical insurance coverage across more regions, bringing good news to a broader patient population.

Regarding this milestone event, Dr. Chen Chen, founder of BrioHealth Solutions, stated: "We are thrilled to launch the INNOVATE clinical trial. After a long journey of continuous innovation, refinement, and quality optimization, we have empowered BrioVAD."^®Life. Despite advancements in the field of ventricular assist devices, there remains an urgent need to enhance device performance and patient outcomes, an area where BrioHealth Solutions is committed to making a difference. The immense enthusiasm displayed by participating centers in advancing late-stage heart failure treatment through this trial is truly gratifying."

BrioHealth Solutions Chooses the U.S. as Its First Stop Overseas, Demonstrating the Company's Firm Confidence in Its Product Technology and Commercialization Capabilities. BrioVAD^®The successful launch of the INNOVATE clinical trial for the left ventricular assist system in the United States marks a significant milestone in the global treatment of advanced heart failure and signifies that BrioHealth Solutions has entered a new era of accelerated development in its globalization strategy.

BrioHealth Solutions was founded in 2008, with its headquarters located in Suzhou, China. The company is dedicated to the research, development, production, and sales of ventricular assist devices with breakthrough technologies. BrioHealth Solutions has successfully completed eight rounds of financing, raising over one billion RMB in cumulative funds, demonstrating high recognition from the capital market. Its strong investment lineup includes well-known industry institutions such as Sequoia Capital China, CICC Qide, PICC Capital, Hony Capital, Baiyang Pharmaceutical, Share Investment, Lake Bleu Capital, Lead Capital, and Guozhu Capital, all jointly supporting BrioHealth Solutions in continuous innovation and breakthroughs in the field of ventricular assistance.