Jenscare, with innovative TTVR, releases 2024H1 interim results
August 27 2024 - 9:00PM
PR Newswire (Canada)
BEIJING, Aug. 27,
2024 /CNW/ -- 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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SOURCE Jenscare Scientific Co., Ltd.
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