BEIJING, March 25, 2025 /PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company with TTVR breakthroughs and is entering commercialization stage for its TAVR (AR) product, released its annual results for year ended December 31, 2024.
Financial Highlights: Net Loss Narrowed Greatly with Sufficient Cash Balance for the Upcoming Commercialization
- Net loss attributable to common shareholders was RMB 178 million [1] (US$ 25 million), narrowed down greatly by 52.2% compared to 2023.
- Cash and cash equivalents, term deposits and financial assets was RMB 708 million (US$ 98 million), which remained robust and sufficient, safeguarding the commercialization of its core products and R&D efforts.
[1] Conversions from RMB to US$ is made at an exchange rate of RMB7.2377 to US$1.00, set forth in the H.10 statistical release of the Federal Reserve Board on March 17, 2025. |
Business Overviews: The Global Influence of TTVR System Continues to Expand, and TAVR (AR) System has Entered Commercialization Phase
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 the U.S., Europe and China. 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.
TTVR (TR): The influence of LuX-Valve Plus continued to expand, laying a solid foundation for the future global commercialization.
The one-year follow-up results of TRVEL II study, the multicenter clinical trial of LuX-Valve Plus, were released at the Transcatheter Cardiovascular Therapeutics 2024 (TCT 2024) conference in the U.S.. The one-year follow-up results demonstrated the outstanding clinical performance of LuX-Valve Plus in the mid-to long term, with low incidence of safety events and improved efficacy after entering into a longer clinical observation period, and is expected to bring ongoing clinical benefits.
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 low level of 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. More 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, APCASH 2024, China Valve (Hangzhou) 2024, Beijing Valves 2024, PCRCCV 2024 and so on.
As to the registration process of LuX-Valve Plus, it has completed the one-year follow-up of the registration clinical trial in Mainland China and is actively submitting 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.. In Europe, it has completed enrollments for the clinical trial carried out 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, the Company will continue to advance the application of the product globally. More than 50 independent physicians and teaching experts in Mainland China have received training, and footprint to over 220 hospitals with influence in both academia and the industry has been expanded covering more than 30 provinces, municipalities, and autonomous regions in Mainland China. In countries and regions other than Mainland China, the Company 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 its 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.
TAVR (AR): The commercialization of Ken-Valve progressed in full swing, enabling the Company to capture the exact market opportunities available as well as optimize the operational efficiency in order to achieve revenue growth.
The registration application of Ken-Valve has recently been approved by the NMPA. The Company is actively preparing for its commercialization. The Company will continue to expand the sales and marketing team and distribution network to cover more hospitals and scale up the regional penetration. Ken-Valve is a relatively rare TAVR product for the treatment of aortic regurgitation (AR) 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 products and surgical trainings. For Ken-Valve, the Company have trained more than 30 independent physicians and teaching experts. In addition, surgical training and promotion have covered more than 100 multidisciplinary team experts and nearly 100 hospitals.
TMVr (MR): The registration of JensClip has been accelerated, so as to enrich the Company's commercial pipeline in the near future.
JensClip has completed full enrollment in confirmatory clinical trials and one-year follow-up with outstanding clinical results. The Company is expected to submit an application for registration to NMPA in as soon as 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.
Future Expectations: Year 2025 Marks the Company's First Year of Commercialization, with Core Products Set to Enter the Market Successively
The Company keeps enhancing its comprehensive strength so as to achieve globalization strategy. The Company have established an international standard management system for production and manufacturing, which has significantly increased its 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.
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.
With regard to Ken-Valve, the Company 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.
SOURCE Jenscare Scientific Co., Ltd.
