BEIJING, Sept. 1, 2025 /PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company dedicated to interventional treatment for structural heart diseases, achieved key milestones in its product portfolio and just announced its interim results for 2025H1.
Business Highlights: Big Movement in Commercialization, Registration and Clinical
LuX-Valve Series, TTVR system
- In China, the multicenter clinical trial for NMPA approval has entered long-term follow-up phase, demonstrating excellent results. The randomized controlled trial (RCT) of optimized medical therapy (OMT) has completed subject enrollment. The registration application has received acceptance from NMPA, entering registration stage.
- In Europe, LuX-Valve Plus has completed 6-month follow-up of TRINITY study, its clinical trial for CE Marking and is currently under registration review.
- In U.S., the IDE Early Feasibility Study (EFS) of LuX-Valve Plus has completed subject enrollment and has received reimbursement for device and related costs from CMS. The Company is actively advancing the progress to obtain approval for the Pivotal Study.
Ken-Valve, TAVR (AR) system
- Following its approval by NMPA, Ken-Valve has quickly gained market access. The Company has been actively promoting commercialization activities, with smooth progress in hospital adoption. Ken-Valve is designed for aortic regurgitation (or combined with stenosis), which meets unmet clinical needs especially for large annuli.
JensClip, TMVr system
- The registration application to NMPA has been submitted, entering registration stage.
- The globalization process of JensClip is being actively pursued. Pre-commercialization implantations have been performed overseas, demonstrating excellent performance. CE Marking activities are also underway.
Financial Highlights: Great Profitability in Sales Activities
- Total revenue was US$ 3.6 million. Gross profit and sales profit[1] were US$ 1.7 million and US$ 1.1 million respectively, with a gross profit margin close to 90% and sales profit margin[2] close to 60%.
- Adjusted non-IFRS loss[3] was US$ 12.9 million, with a decrease of about 3% compared to 2024H1.
- Net loss per share attributable to ordinary shareholders basic and diluted was US$ 0.06.
- Cash and cash equivalents, term deposits and financial assets was US$ 84.6 million. Net cash used in operating activities was US$ 13 million, with a decrease of around 15% compared to 2024H1.
Note: |
[1] defined as gross profit minus selling and distribution expenses |
[2] defined as sales profit/revenue |
[3] for the purpose of evaluating the Group's operational performance by excluding the impact of share-based compensation expense and foreign exchange differences |
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