JieCheng Medical Files IPO Prospectus Highlighting J-Valve System for Minimally Invasive Treatment of Aortic Stenosis and Regurgitation

Valvular Heart Disease and Dysfunction: A Leading Cause of Disability, Reduced Quality of Life, and Premature Mortality in Patients with Cardiovascular Disease WorldwideWhen heart valves are affected by cardiac infections, age-related degenerative changes, and calcification, they fail to open or close properly, leading to conditions such as valvular stenosis or regurgitation. This impairs the heart's ability to pump blood to all parts of the body.

In China, rheumatic valvular heart disease was historically the most prevalent form. However, with improvements in living conditions and the advent of an aging society, the incidence of degenerative valvular disease in the elderly has been continuously rising. Among these conditions, aortic stenosis and aortic regurgitation have gradually become the most common valvular heart diseases in the elderly population.

Valvular Heart Disease: Treatment modalities include early pharmacological therapy, surgical intervention for severe cases, and novel minimally invasive interventional procedures. For elderly patients, advanced age, frailty, and severe disease status, often accompanied by multiple comorbidities, typically preclude open-heart surgery. The emergence of Transcatheter Aortic Valve Replacement (TAVR), a minimally invasive interventional technique, has brought hope to this patient population.

Traditional aortic valve replacement surgery requires sternotomy, establishment of cardiopulmonary bypass, and is performed under general anesthesia with cardiac arrest. In this procedure, any improper maneuver at any stage can pose a life-threatening risk to the patient, resulting in high surgical risk, significant trauma, and numerous postoperative complications.

TAVR is performed on a beating heart, where a transcatheter delivery system is used to position a prosthetic valve at the aortic valve site. Once in place, the valve is deployed and rapidly expands under body temperature conditions, thereby replacing the diseased aortic valve. TAVR significantly reduces surgical risks for elderly patients with high-risk aortic valve disease, offering minimal invasiveness and faster postoperative recovery. It not only markedly extends patient survival but also substantially improves quality of life.

Currently, the market share of artificial biological heart valves in China is far lower than that in developed countries, and the domestic TAVR market is still in its early stages of development. Based on current indications, there are at least 500,000 patients in China who qualify for TAVR, with the vast majority not having been hospitalized for treatment.

As TAVR technology gradually becomes widespread in top-tier hospitals, the potential demand for heart valves is also emerging. Data from Huatai Securities shows that by the end of 2018, more than 80 hospitals had experience performing TAVR procedures. As this technology enters more hospitals, the domestic market is expected to exceed RMB 10 billion by 2029.

The TAVR market in China boasts broad prospects, and CAUSPER MEDICAL INC. (hereinafter referred to as “CAUSPER MEDICAL”) is one of the earliest domestic companies to establish a presence in this field. CAUSPER MEDICAL’s J-Valve “Transcatheter Implanted Bioprosthetic Heart Valve” was approved for market launch by the China Food and Drug Administration in 2017 and has received numerous awards and honors, including the “China Medical Device Technological Innovation Award.”

CAUSPER MEDICAL, established in 2009, is a high-tech medical technology company with full independent intellectual property rights. Its flagship project is the research, development, and production of the innovative J-Valve precise positioning transcatheter heart valve implantation system.

What are the features of the J-Valve system? What advantages does CAUSPER MEDICAL hold? To gain deeper insights into CAUSPER MEDICAL, a reporter interviewed Dr. Zhang Ji, founder of CAUSPER MEDICAL.

Valvular Heart Disease: A Global Challenge. According to research data, there are currently 12 million patients with valvular heart disease worldwide, and approximately 1 million people die from this condition each year.

To address this challenge, Dr. Zhang Ji and his team developed the J-Valve transcatheter heart valve, which is indicated for patients with aortic stenosis, aortic regurgitation, or combined aortic stenosis and regurgitation.

It is reported that the J-Valve system is China’s first original transcatheter heart valve with international intellectual property protection, enjoying a leading position both domestically and internationally. Notably, technologies associated with the J-Valve system have been exported in reverse to developed countries in Europe and North America. For instance, following special access approval by Health Canada, the J-Valve system was used at St. Paul’s Hospital in Vancouver to successfully perform minimally invasive transcatheter heart valve replacement in more than ten Canadian patients suffering from severe aortic regurgitation.

Dr. Zhang Ji stated, “Core technological advantages and extensive experience will ensure that this technology maintains a leading position in the market.” Liu Fei, Chinese Consul General in Vancouver, remarked that in the realm of science and technology, China had historically been an importer of high-tech products and technologies from Canada. The J-Valve system represents the first case of a high-end medical device from a developed country fully incorporating Chinese intellectual property rights, opening up broad avenues for China-Canada cooperation and signifying the global emergence of “Created in China” within the medical device sector. National authorities responsible for science and technology consider this invention to be of profound significance for the field of cardiology worldwide.

Dr. Zhang Ji, who led the team in developing the J-Valve, is among the first generation of formally trained cardiac surgeons in China. He became an attending physician at Beijing People’s Hospital at the age of 28. In 1991, he went to Canada for advanced studies, completing postdoctoral fellowships in cardiac surgery at several universities, including those in Toronto. With over 30 years of experience as a frontline cardiac surgeon, Dr. Zhang holds more than ten international invention patents in related fields.

Dr. Zhang Ji also served as an executive at professional cardiac assistance companies, including as President of the Canadian Cardiac Surgical Consulting Company and Chief Executive Officer of JMD Innovation. These experiences have allowed him to accumulate extensive expertise in scientific research and corporate management.

Through his professional work, Dr. Zhang Ji accumulated substantial technical expertise and experience, establishing connections with numerous specialized engineers. In 2009, at the invitation of the Wujiang District government in Suzhou, Dr. Zhang successfully implemented the J-Valve technology in Suzhou. “With favorable timing, geographic advantages, and strong human resources all in place, we founded CAUSPER MEDICAL,” stated Dr. Zhang. The company’s R&D team comprises Dr. Zhang Ji and several senior foreign professionals.

It is understood that the J-Valve system, developed by CAUSPER MEDICAL, is currently the only minimally invasive solution worldwide for treating aortic regurgitation. To date, nearly 1,000 patients have received implants of this product. Dr. Zhang Ji stated, “Over 90% of patients have recovered well and can live like normal individuals.”

Regarding the unique advantages of J-Valve, Dr. Zhang Ji stated, “The J-Valve system is the only heart valve system worldwide featuring intelligent three-dimensional positioning, enabling autonomous alignment. The J-Valve system offers a straightforward operational workflow and can be mastered quickly in terms of technical requirements. Physicians can rely on the system’s positioning mechanism to perform valve replacement procedures, thereby reducing surgical risks.”

Dr. Zhang Ji stated, “Aortic regurgitation is a challenging condition, and the advent of the J-Valve system has filled a gap in the minimally invasive treatment of this disorder.” Currently, aortic valve replacement using this technique takes only 7–10 minutes, allowing patients to ambulate as early as the following day.

Currently, Europe and the United States have already recommended the use of TAVR technology for patients with heart valve disease in their management guidelines. In China, although many technologies are still in the initial application stage, it is foreseeable that transcatheter treatment for heart valve diseases has broad prospects, and an increasing number of patients will benefit from it.

CAUSPER MEDICAL has also implemented multiple initiatives in market promotion. Dr. Zhang Ji introduced, “The hospital organizes patients into clubs for exchange and learning. CAUSPER MEDICAL provides in-depth articles and videos on platforms such as its official website and WeChat public account, enabling patients to gain a deeper understanding. Meanwhile, we hold professional educational lectures to promote the technology and applications of the J-Valve product. Additionally, we establish partnerships with major media outlets, conducting publicity through various channels including newspapers, magazines, and television.”

“We aim to establish our presence in China, expand sales, and benefit more patients,” concluded Dr. Zhang Ji.