On March 21, 2025, Jenscare (9877.HK) released its annual result for the year ended December 31, 2024. The company's losses continued to narrow, and its cash position remained robust and sufficient, safeguarding the commercialization of its core products and R&D efforts. As of December 31, 2024, the company's cash was 708 million RMB. By strictly controlling costs and strategically allocating resources, the company ensured the achievement of its commercialization and globalization strategy. In 2024, the company recorded a loss of 178 million RMB, a significant reduction of 52.2% compared to 2023.

The company is committed to becoming a globally leading innovative medical device company, dedicated to meeting the huge and urgent treatment needs worldwide. In 2024, the company further advanced the commercialization preparations for its core product, LuX-Valve Plus, on a global scale. It released significant clinical data at multiple important international academic conferences and successfully progressed the registration clinical trials in overseas regions, including Europe and the U.S.. Another core product of the company, Ken-Valve, obtained approval for registration from the NMPA at the beginning of 2025. The company is actively promoting its commercialization at this moment.

Later, the one-year clinical follow-up results for large anatomy patients (LAP) in the TRAVEL II study were published at the PCR London Valves 2024. The outcomes showed that LuX-Valve Plus maintains similar operating time and success rate in LAP, which not only effectively reduced tricuspid regurgitation and significantly improved patients' cardiac function one month after the procedure, but also maintains a very low new pacemaker onset rate at one year. The design and clinical performance of LuX-Valve Plus make it an ideal option for the treatment of LAP and provide remarkable efficacy and safety.

The global experiences and study outcomes of treating TR with LuX-Valve Plus were shared at EuroPCR 2024, New York Valves 2024, AVAM 2024, 11th Mainz Heart Valves Symposium, Hong Kong Valves 2024, and APCASH 2024, which have captured great attention and received favorable comments from professionals and potential business partners around the globe. We have also shared clinical experiences and live cases at China Valve (Hangzhou) 2024, Beijing Valves 2024, and PCRCCV 2024, demonstrating the outstanding post-procedural results and wide range of applicability of LuX-Valve Plus.

LuX-Valve Plus has completed the one-year follow-up of the registration clinical trial in China and actively submitted the data in accordance with the registration and approval requirements of the NMPA. 

LuX-Valve Plus has entered the clinical trial stage and is actively advancing its clinical trial progress in the U.S..

LuX-Valve Plus has completed all the subject enrollments for the clinical trial carried out in Europe with the aim of obtaining the CE Certificate. Clinical institutions from multiple countries around the world have actively participated in the clinical trial and LuX-Valve Plus won unanimous acclaim from those participating clinical institutions.

LuX-Valve Plus has completed a large number of pre-commercial activities worldwide. In order to meet the substantial and urgent demand from tricuspid regurgitation patients around the world, we will continue to advance the application of the product globally, in order to further enhance the product’s academic position and influence, and lay a solid foundation for the Company’s globalization strategy.

With regard to the LuX-Valve series products, we have trained more than 50 independent physicians and teaching experts in China, and expanded our footprint to over 220 hospitals with influence in both academia and the industry, covering more than 30 provinces, municipalities, and autonomous regions in China. In countries and regions other than China, we have provided training to more than 40 independent physicians and teaching experts, and have successfully completed implantation procedures or treatment promotions in nearly 100 influential hospitals, which has further enhanced our global influence. 

As the date of the year end of 2024, over 600 cases of implantation of the LuX-Valve series products have been completed worldwide, with a record of the longest follow-up of over 6 years. 

The registration application of Ken-Valve has recently been approved by the NMPA. The Company is actively preparing for its commercialization. We will continue to expand our sales and marketing team and our distribution network to cover more hospitals and scale up our regional penetration. Ken-Valve is a relatively rare TAVR product for the treatment of aortic regurgitation in the market. The Company will take the advantage of this market opportunity to gain market shares in the possible soonest time. 

Ken-Valve features a multi-size design with advantage on allowing for a larger anchoring area, which is expected to accommodate a broad range of patients with aortic regurgitation (or combined with stenosis). Its integrated positioning anchor design ensures stable anchoring, and the design of sealing skirt is expected to reduce the incidence of paravalvular leakage post-procedure. The design of delivery system is expected to shorten the learning curve for physicians and reduce procedural time, which will contribute to the commercialization of the product.

Innovative product design and easy device operation have supported the promotion of our products and surgical trainings. For Ken-Valve, we have trained more than 30 independent physicians and teaching experts. In addition, surgical training and promotion have covered more than 100 MDT experts and nearly 100 hospitals. 

JensClip has completed full enrollment in confirmatory clinical trials and one-year follow-up with outstanding clinical results. It is expected to submit an application for registration to NMPA as soon as possible in 2025.

JensClip features an innovative self-locking design, which is expected to effectively improve mitral regurgitation and reduce leaflet tension. The valve clip allows for flexible shape adjustments, which is expected to enhance procedural safety and improve intraoperative maneuverability. Furthermore, its one-piece release mechanism is designed to minimize potential misoperation risks associated with staged attachment, effectively reducing device operation time.

In order to support the development goal of commercialization of our products globally in the future, the Company have established an international standard management system for production and manufacturing, which has significantly increased our production capacity and production yield. In addition, the Company has also adopted a number of cost saving and consumption control measures to ensure its production efficiency. Meanwhile, the Company have constructed and optimized its global supply chain system, improving the efficient supply of the Company's products in the globe in order to meet the increasing overseas demand.  

With our experience in product registration and understanding of regulatory requirements of the major countries/regions such as China, the U.S. and Europe, we are able to keep improving our research and development technology and production process to align with the management vision and research and development capabilities in the world, which ensures not only the safety and effectiveness of our products, but also the stability of the mass production quality of our products. Moreover, we have further improved the global layout of our intellectual property rights to strengthen the protection to the Company's intellectual property rights.

The Company is committed to the independent research and development of interventional medical devices focused on the treatment of structural heart diseases. We intend to strengthen our efforts in research and development of new products, and cooperate with reputed domestic and foreign industry experts, scientific research institutions or technical consulting companies to optimize our product pipeline and improve our existing product candidates.

The year 2025 marks the company's first year of commercialization, signifying a step closer to the company's profitability goal. Multiple products are entering or are about to enter the commercialization stage.

Regarding the LuX-Valve series products, the Company will establish the global technological advantage of this series through a diversified approach, including conducting registration clinical trials and obtaining approvals in multiple national regions globally, continuously expanding business development areas, and establishing international strategic cooperation. This strategy will also provide support for the subsequent development and commercialization of other core products.

With regard to Ken-Valve, for which the approval for registration by the NMPA has been obtained, we have obtained relevant permits for the manufacture and sale of such products, initiated the online registration for such products in multiple provinces, municipalities and autonomous regions, and conducted surgical training and product promotion for the physicians and medical teams in a number of hospitals. The Company is actively promoting its commercialization and expects to achieve commercial implantation in the first half of 2025.

The Company is currently expanding its resources on a large global scale to rapidly advance the commercialization of multiple products in different regions.