Jenscare Scientific: Leading the Way in Minimally Invasive Tricuspid Valve Replacement – From Follower to Global Innovator in Transcatheter Heart Valve Technology

In early September, the 2019 China Medical Device Innovation and Entrepreneurship Competition came to a successful conclusion. Ningbo Jenscare Biotechnology Co., Ltd. stood out among hundreds of entries with its internationally leading transcatheter tricuspid valve replacement system, winning the first prize in the national finals.

Following the competition, VCBeat promptly interviewed Dr. Cao Peng, General Manager of Jenscare. In recent years, cardiovascular and cerebrovascular diseases have become a popular focus for entrepreneurs in the high-value medical consumables sector. Dr. Cao shared the distinctive strengths that have enabled Jenscare to stand out amidst intense competition.

China is a country with a high prevalence of valvular heart disease. According to statistics, among the 12 million prevalent cases of valvular heart disease worldwide, more than one-third are Chinese patients. Valvular heart disease refers to pathological changes in the mitral, tricuspid, aortic, or pulmonary valves that impair normal blood flow, cause cardiac dysfunction, and may ultimately lead to heart failure.

Traditionally, the most effective treatment for severe valvular heart disease was open-heart surgery; however, this procedure carries extremely high risks, and most patients cannot tolerate the additional trauma inflicted on the body by such surgery. In 2002, French cardiologist Alain Cribier successfully performed the first transcatheter implantation of a stented aortic valve in a patient, thereby ushering in a new era of Transcatheter Aortic Valve Replacement (TAVR).

Since then, medical device giants such as Medtronic and Edwards Lifesciences have entered this field. To date, over 100,000 TAVR procedures are performed annually in Europe and the United States, and Chinese companies have also developed and launched similar products. After more than a decade of clinical application informed by experience in Europe and the United States, TAVR technology has become relatively mature in both product development and clinical practice.

However, there are still no mature products approved for clinical use in minimally invasive tricuspid valve replacement internationally. With the deepening aging population in China, the demand for minimally invasive tricuspid valve replacement caused by secondary (such as atrial fibrillation, cardiac surgery, etc.) and functional degenerative (such as valvular insufficiency, etc.) heart valve diseases has become an urgent gap to be filled in clinical practice.

Dr. Cao Peng told VCBeat that tricuspid regurgitation is a common type of valvular heart disease. However, due to the unique structure and location of the tricuspid valve, although there have been continuous international efforts to develop transcatheter tricuspid valve replacement (TTVR) technologies, the most advanced products are still in the clinical trial phase.

In September 2018, the world’s first transcatheter tricuspid valve replacement via the right atrium was successfully performed at Changhai Hospital, affiliated with Naval Medical University. The innovative team led by Xu Zhiyun and Lu Fanglin from the Department of Cardiac Surgery at Changhai Hospital successfully treated a patient with severe tricuspid regurgitation who was not a candidate for surgical intervention. This achievement has drawn significant attention from the medical community.

To date, more than thirty patients with severe tricuspid regurgitation who were not candidates for surgical intervention have been successfully treated using Jenscare’s LuX-Valve® transcatheter tricuspid valve prosthesis. This has provided reliable validation for subsequent large-scale clinical trials. “We have submitted the clinical trial application for the first-generation LuX-Valve® and entered the National Medical Products Administration’s priority review pathway for innovative medical devices, enabling the launch of large-scale clinical trials in the near future.”

Jenscare, founded in 2011 and headquartered in Ningbo, Zhejiang Province, is a provider of innovative solutions for minimally invasive interventional therapies for heart valve diseases. The company currently has four flagship products: the Transcatheter Aortic Valve Replacement (TAVR) system, the Transcatheter Tricuspid Valve Replacement (TTVR) system, the Transcatheter Mitral Valve Replacement system, and the Transcatheter Mitral Valve Repair system.

“Among them, LuX-Valve® is the first cardiac valve product in China with fully independent intellectual property rights, and it holds a leading position globally.” Dr. Cao stated that LuX-Valve® has more than ten invention patents and four PCT patents, and clinical trials will be conducted at renowned domestic cardiac surgery hospitals such as Changhai Hospital, Beijing Fuwai Hospital, Anzhen Hospital, Wuhan Union Hospital, and Xijing Hospital.

In fact, the LuX-Valve® was originally a product of medical-engineering collaboration.

In the field of aortic valves, current domestic technologies are characterized by improvements and innovations built upon imitation. However, in the tricuspid valve sector, most Transcatheter Tricuspid Valve Replacement (TTVR) devices currently in clinical trials are designed based on the dimensions of the native tricuspid annulus, with valve fixation relying on annular support and leaflet clamping. Such prosthetic valve devices inevitably lead to complications at the tricuspid position, including injury to adjacent structures, unstable prosthetic valve fixation, and even device migration.

Clinical trial data have shown that complications such as the rate of conversion to conventional open-heart surgery and the incidence of third-degree atrioventricular block during TTVR procedures are relatively high, resulting in suboptimal clinical outcomes. “Although there were no directly referenceable products or experiences, we believed in the ingenuity of our own Chinese team.” Recalling the determination upheld during the early stages of product development, Dr. Cao Peng remains emotional.

In 2015, the R&D team at Jenscare, based on the structural and functional requirements for prosthetic tricuspid valves proposed by clinicians, creatively designed an anchoring device for prosthetic tricuspid valves using a ventricular septal fixation method after repeated trials, thereby breaking through the traditional design paradigm that relies on stent support for valve fixation.

Following extensive validation of efficacy and safety in animal studies, the innovatively designed LuX-Valve® demonstrated excellent performance, featuring ease of implantation and precise positioning, along with favorable experimental outcomes. Subsequently, Jenscare initiated clinical trials in collaboration with Changhai Hospital, affiliated with Naval Medical University. In October 2018, the clinical application results of LuX-Valve® were presented at the Academic Week on Structural Heart Disease, garnering significant interest and encouragement from attending experts, who regarded it as a major original achievement in China’s field of transcatheter valve replacement in recent years.

Dr. Cao shared with VCBeat the story of a patient who left the deepest impression on him during the feasibility study of LuX-Valve®. “When I first met him, this patient, over seventy years old, was already swollen like a ball due to venous regurgitation.” The elderly man told Cao Peng that his daughter’s wedding was scheduled for May 2019, and he hoped to hold on until then so as not to leave any regrets for his entire family.

In late March 2019, the elderly patient underwent LuX-Valve® replacement surgery. By May, he was well enough to stand on the stage at his daughter’s wedding, personally placing her hand into the groom’s—a poignant gesture symbolizing a father’s profound love. His story profoundly demonstrated to Dr. Cao the life-affirming power of the LuX-Valve®, reinforcing his and his team’s resolve to continuously advance the research, development, and iterative improvement of the device.

Dr. Cao Peng pointed out that the second-generation LuX-Valve®, which causes less trauma, has completed animal experiments. As the technology continues to mature, the application scope of LuX-Valve® will extend to heart valve replacement surgeries for younger and lower-risk patients, demonstrating significant application potential.

Currently, Jenscare boasts a R&D team of over 30 members, including several Ph.D. and master’s degree holders who have returned from overseas. These professionals have previously held positions at renowned medical device companies such as GE Healthcare, MicroPort, and Lifetech Scientific, accumulating extensive R&D experience in the design and manufacturing of biological valves and stents, as well as catheter technology. Over eight years of dedicated research and development in artificial heart valves, the company has established a robust and stable technological reserve.

However, Dr. Cao Peng believes that Jenscare’s in-house R&D capabilities alone are insufficient to achieve world-leading technology in transcatheter tricuspid valve replacement. “The integration of medicine and engineering is a crucial component of our product development.” Continuous collaboration with clinicians sparks ideas for product design, which are then realized by the company’s technical team. A advisory board composed of physicians participates throughout the entire R&D process—from fundamental principles and animal studies to clinical trials—engaging in joint discussions. This constitutes Jenscare’s unique R&D model.

In addition, the company has established a 2,600-square-meter production facility, which includes Class 10,000 clean workshops compliant with ISO 13485 and GMP standards, as well as various advanced laboratories, equipped with comprehensive production and inspection equipment.

Dr. Cao told VCBeat that Jenscare’s development goal is to become a platform company dedicated to translating physicians’ unmet clinical needs into solutions, providing the most comprehensive and reliable technologies and products in the field of heart valve disease.

In 2018, Jenscare completed an A-round financing of over RMB 60 million, led by Chende Capital and Proxima Ventures. At that time, Mr. Tan Qing, Partner at Chende Capital, expressed his expectations for Jenscare: “Transcatheter heart valves are the only major medical products that have undergone rigorous validation through basic medical research, clinical trials, and market acceptance. Jenscare’s technical team is a rare asset in China. We hope to develop transcatheter heart valves best suited to China’s specific healthcare needs, providing optimal solutions for Chinese patients with valvular heart disease.”

Heart Valve Fever Reignites: VCBeat to Continuously Monitor the Clinical Progress of Jenscare’s LuX-Valve®