Highline Capital and Primavera Capital Lead Hundreds of Millions of Dollars in New Financing for Jenscare Scientific to Accelerate Building a Comprehensive Structural Heart Disease Platform

VCBeat has learned that Jenscare, an innovative company specializing in interventional heart valve therapies, recently completed a new round of financing amounting to hundreds of millions of US dollars, led by Hillhouse Investment and Primavera Capital.

It is reported that the institutional shareholders of Jenscare include not only Hillhouse Venture Capital and Primavera Capital, but also large institutions such as CICC Pucheng, China Life Health Industry Fund, PICC Health and Elderly Care Industry Investment Fund, China Asset Management, and ABC International. In addition, there are numerous professional investment firms both domestically and internationally that focus on or have significant holdings in the healthcare sector, including Cormorant, Chende Capital, Proxima Ventures, Jinpu Health Fund, Guangyuan Capital, and Tianji Capital.

Founded in 2011, Jenscare is a representative innovative medical device company in China specializing in structural heart disease. Its independently developed transcatheter tricuspid valve replacement system (LuX-Valve) is currently the only product in China approved to enter registered clinical trials, with market approval expected around 2023. Furthermore, Jenscare has established a reserve of innovative medical device technologies covering the field of structural heart disease; among these, its aortic valve product has entered formal clinical trials, while products such as its mitral valve have entered preclinical research.

Yi Nuoqing, Co-Chief Investment Officer at Hillhouse Capital and Head of Biopharmaceuticals and Medical Devices at Hillhouse Venture Capital, stated: “Jenscare possesses robust capabilities in R&D innovation and the integration of medicine and engineering. Its proprietary transcatheter tricuspid valve replacement system is a global first-in-class product, with clinical trials and regulatory approval progress leading the field. Jenscare has an extensive product portfolio in structural heart disease and heart failure, positioning it to become a comprehensive solutions platform for structural heart disease. Hillhouse will support Jenscare in launching and commercializing more original cardiovascular intervention products in China and globally, addressing the substantial unmet needs in the cardiovascular intervention sector.”

Zheng Jiaqi, Managing Director at Primavera Capital Group, stated, “Minimally invasive interventional technologies for structural heart disease hold immense development potential and represent a prime growth avenue in the cardiovascular field. As a leading platform company in China offering comprehensive solutions for valve intervention therapies, Jenscare boasts multiple internationally pioneering technologies and has made smooth clinical progress. Mr. Lv Shiwen, founder of Jenscare, possesses forward-looking strategic vision and profound technical expertise. The company’s rich product portfolio fills numerous gaps both domestically and internationally through first-in-class products and differentiated technological approaches. Primavera Capital is highly optimistic about Jenscare’s development prospects and will continue to focus on healthcare enterprises with outstanding innovation capabilities and significant clinical value.”

In the field of structural heart disease, the tricuspid valve is known as the “forgotten valve.”

With the extension of life expectancy and the trend of population aging, the incidence of valvular heart disease has been increasing year by year, becoming one of the common and frequently occurring cardiac diseases in China. As understanding of the tricuspid valve domain deepens, tricuspid valve disease is receiving growing attention. The tricuspid valve is the largest cardiac valve; its three-dimensional structure is complex, consisting of three leaflets—the anterior, posterior, and septal leaflets—and exhibits an irregular “saddle” shape. Tricuspid regurgitation is relatively common. Its pathogenesis is associated with left-sided valvular lesions, such as those involving the mitral and aortic valves. Chronic atrial fibrillation (AF), congenital tricuspid valve abnormalities, rheumatic disease, tricuspid valve prolapse, carcinoid syndrome, and iatrogenic injuries such as pacemaker implantation can all lead to the development of tricuspid regurgitation.

According to statistical data from third-party institutions, the number of patients with tricuspid regurgitation in China increased from 8.6 million in 2016 to 9.2 million in 2020, and is projected to reach 10.6 million by 2030. Due to the lack of easily screenable clinical manifestations in the early stages, patients with tricuspid insufficiency are typically diagnosed only in the middle to late stages of the disease, suggesting that the total patient population may be underestimated. Furthermore, the growing number of patients undergoing left-sided heart valve surgery and pacemaker implantation in China, coupled with an increased incidence of atrial fibrillation driven by population aging, has contributed to a year-on-year rise in the number of patients.

Clinically, a significant proportion of patients with tricuspid regurgitation present to hospitals after the critical window for intervention has passed. These patients often exhibit heart failure accompanied by complex comorbidities such as cardiogenic cirrhosis, hepatic and renal insufficiency, and gastrointestinal bleeding, resulting in extremely high surgical risks and substantial challenges in perioperative management. Consequently, under current medical conditions, these patients are limited to conservative treatment, which merely sustains life for a short period with very poor quality of life.

“Even in the most extreme scenarios, if a new product emerges that can save the lives of the most critically ill patients, such innovation holds immense value.” This is the conviction upheld by Jenscare. From Jenscare’s perspective, patients with moderate-to-severe tricuspid valve disease are not untreatable once suitable medical devices become available. In contrast to the continuous launch of new products for transcatheter aortic and mitral valve interventions, the development of transcatheter tricuspid valve implantation (TTVI) devices has progressed slowly. To date, no such products have been approved for market entry in either the United States or China.

In September 2018, after repeated design iterations and animal experiments, Jenscare’s LuX-Valve was used for the first time in a patient with severe tricuspid regurgitation who was no longer a candidate for surgical intervention. This minimally invasive procedure, performed by the cardiac surgery team led by experts Xu Zhiyun and Lu Fanglin from Changhai Hospital Affiliated to Naval Medical University, marked the first trans-right-atrial transcatheter tricuspid valve replacement. Since then, similar treatment approaches have been validated by an increasing number of clinical cardiology teams both domestically and internationally.

In early 2020, Jenscare’s LuX-Valve received approval to initiate clinical trials. This marked a significant milestone in the regulatory approval process for transcatheter tricuspid valve products, representing a groundbreaking “zero-to-one” exploration for Chinese regulatory authorities. According to industry insiders, this endeavor was highly challenging, involving numerous metrics and paradigm innovations. Throughout 2019, Jenscare maintained close collaboration and interaction with regulators, conducting extensive simulation tests and animal studies to validate the product.

It is understood that, due to the extensive innovations in the external design and material selection of the LuX-Valve, the Jenscare team was required to submit hundreds of pages of application materials to demonstrate the scientific rationale behind the novel design concept, and to comprehensively document all procedures and data related to product safety validation. During the registration and approval process, the National Medical Products Administration (NMPA) organized a joint review by eleven experts specializing in structural heart disease. After addressing nearly 70 questions raised by the expert panel, the safety and functionality of the LuX-Valve gained broader recognition.

As of press time, Jenscare’s LuX-Valve has been sequentially enrolling patients at eight clinical trial centers across China. It is reported that, based on the data generated so far, progress has exceeded expectations.

During the extended period when Jenscare was deeply engaged in the development of LuX-Valve, capital markets and the clinical community were not particularly optimistic about transcatheter tricuspid valve intervention (TTVI) due to factors such as high technical barriers, complex manufacturing processes, and relatively low awareness among physicians and patients. This afforded the Jenscare team ample time to refine the product’s details.

In fact, it is not only cardiac surgery experts in China who have actively embraced this new product. It is reported that by the end of 2019, experts at medical institutions in Canada, Europe, and other regions had begun to apply the LuX-Valve in clinical studies. Before the global outbreak of the COVID-19 pandemic, Jenscare had planned to complete 30 LuX-Valve interventional procedures worldwide within one year. Although the pandemic has delayed these efforts, with operations expected to resume in the second half of this year, the device has already gained significant recognition among international peers.

Regarding the future commercialization of LuX-Valve, it is a natural progression for Jenscare to follow the path of “from clinical practice, back to clinical practice.” As the number of cases in LuX-Valve clinical studies continues to grow, the accumulating clinical dataset will guide physicians and patients to pay attention to tricuspid valve disease at earlier stages. The clinical adoption of LuX-Valve will proceed gradually, starting from critical and severe cases and extending to relatively mild cases. If the registration-related clinical studies progress smoothly, LuX-Valve is expected to receive regulatory approval and be launched in 2023.

Given the LuX-Valve’s excellent clinical performance and the rapid pace of product iteration, many assume that Jenscare’s innovative capabilities are focused solely on transcatheter tricuspid valve intervention (TTVI). In reality, over the past few years, the Jenscare team has uncovered a wealth of patented innovative technologies through frequent and in-depth clinical discussions. As the team expanded and integrated, these patented technologies were gradually developed into a platform-based technological reserve. With ongoing R&D efforts, this reserve will translate into a powerful new driver for robust growth.

It is reported that, in addition to LuX-Valve, Ken-Valve, a transcatheter aortic valve replacement system independently developed by Jenscare as the second domestic product specifically designed for aortic regurgitation (with or without stenosis), has currently entered the pre-market registration clinical trial phase.

In the field of minimally invasive transcatheter mitral valve therapy, Jenscare’s product portfolio has entered a phase of intensive output. Its independently innovated transcatheter edge-to-edge repair (TEER) system, JensClip, features a globally pioneering core transmission and locking mechanism design. It addresses the treatment needs for both mitral and tricuspid regurgitation and has completed long-term animal implantation studies, preliminarily validating the product’s safety, efficacy, and operability. Another transcatheter mitral valve repair system, MitraPatch, is poised to become the world’s first product utilizing “leaflet patch” technology for mitral valve repair and is currently preparing to initiate feasibility clinical trials.

It is evident that Jenscare is continuously expanding its structural heart disease product pipeline, building on its high-barrier transcatheter tricuspid valve intervention (TTVI) portfolio, differentiated aortic and mitral valve products, and an innovative heart failure pipeline, thereby platformically delivering innovative solutions that address unmet clinical needs.

It is understood that as the commercialization pathway for minimally invasive heart valve therapies becomes increasingly clear, Jenscare has begun to expand its existing business portfolio. At the end of 2020, Jenscare integrated its previously independently developed heart failure product pipeline. Currently, the MicroFlux atrial septal stent system is preparing to initiate feasibility clinical trials, while the investigational myocardial-filling hydrogel and its delivery devices, AlginSys and EndoInjex, have already been strategically positioned.

Jenscare’s product portfolio demonstrates its robust innovation capability across a diverse range of high-quality medical devices, potentially extending beyond the treatment of cardiac diseases. As turning the “impossible” into reality becomes second nature, Jenscare is transforming more “impossibilities” into “possibilities.”