BEIJING, Aug. 28, 2024 /PRNewswire/ — Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company dedicated to interventional treatment for structural heart diseases with TTVR breakthroughs, released interim results for 2024H1 ended June 30, 2024.
Financial Highlights
Net Loss attributable to common shareholders was RMB 102 million[1] (US$ 14 million), narrowed down by 41.8% compared to the same period of last year. Cash and cash equivalents, term deposits and financial assets was RMB 922 million (US$ 129 million), which is sufficient for the future development of the Company to achieve its business strategy by advancing the global application of its Core Products, including carrying forward the clinical trial, the registration process, and market launch of the products.
[1] Conversions from RMB to US$ is made at an exchange rate of RMB7.1644 to US$1.00, set forth in the H.10 statistical release of the Federal Reserve Board on Aug 19, 2024.
Business Highlights and Future Expectations
LuX-Valve Series Products, the TTVR system
The six-month follow-up results of confirmatory clinical trial of LuX-Valve Plus has been published. The average device operation time was 35.56 minutes. The efficacy and safety results showed encouraging trends with respect to improvement in tricuspid regurgitation (97.62% of patients had no moderate or above TR), NYHA cardiac function (91.86% improved to post-procedure class I/II), and quality of life (KCCQ score averagely increased by 20 points), with low incidences of composite adverse events (8.33%). Innovative design concept allows wide applicability to large anatomies. In Europe, the subject enrollment for LuX-Valve Plus clinical trial aiming for obtaining CE Certificate is expected to complete in 2024Q3. In the U.S., the IDE for EFS of LuX-Valve Plus has been approved by the FDA, and the EFS has been initiated. It is expected subject enrollment for the EFS clinical trial to complete in 2024Q4. In mainland China, the one-year follow-up for registration clinical trial of LuX-Valve Plus has been completed. It is expected the application for the NMPA approval to be submitted in 2024Q3, and to be approved in 2025H2.
Other Products
Ken-Valve, the TAVR system designed for treatment of severe aortic regurgitation or combined with aortic stenosis, is under registration review process by the NMPA. JensClip, the TMVr system, has completed the subject enrollment for the registration clinical trial and the one-month follow-up with encouraging clinical results.
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