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 Narrowed Significantly with Solid Cash Balance
[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: Remarkable Clinical Results of LuX-Valve Plus were Published, Which Gained Worldwide Recognition and High Attention
LuX-Valve Plus, the proprietary TTVR system, is designed for patients with severe tricuspid regurgitation (TR) and high surgical risk. LuX-Valve Plus breaks through multiple technical difficulties in tricuspid valve interventional therapy. With the design of innovative "interventricular septum anchoring" and "leakproof self-adaptive braided ring", which avoid traditional radial-force fixation and tend to effectively prevent AV Block. LuX-Valve series product is designated by the FDA as a breakthrough device, is enrolled in the Total Product Life Cycle Advisory Program (TAP) pilot of the FDA and was selected for the Expert Panel Scientific Advice Pilot by the EMA.
The six-month clinical follow-up results of multicenter clinical trial TRAVEL II study of the LuX-Valve Plus were officially published at New York Valves 2024. According to the results, the device success rate was about 97%, and the average device operation time was around 35.56 minutes. The efficacy results showed that all patients had their TR grade improved and 97.62% of the patients had no moderate or above TR. In terms of New York Heart Association (NYHA) cardiac function improvement, 91.86% of patients improved from pre-procedure class III/IV to class I/II. In terms of quality of life, patients increased their Kansas City Cardiomyopathy Questionnaire (KCCQ) averaging score by 20 points. The safety results showed that the incidence of composite events is 8.33%. The TRAVEL II study results indicated that LuX-Valve Plus demonstrated promising mid-term clinical performance with no noticeable increase in safety events and continued improvement in efficacy over a longer clinical observation period, enabling the patients to further improve their cardiac function and quality of life, and sustained clinical benefits.
The global compassionate use outcomes of LuX-Valve Plus were released at EuroPCR 2024. In-hospital outcomes indicated that TR grade reduced instantly and 92.2% of patients recovered to moderate and below. The percentage of incidence of new pacemaker implantation was only 3.9%. Subsequently, 30-day outcomes showed TR grade reduced significantly, 95% of patients recovered to moderate and below. NYHA cardiac function improved continuously, 85.4% of patients improved to post-operative class I/II. The echocardiographic findings showed that the right heart/ventricle benefits as well. The study outcomes demonstrate that the LuX-Valve Plus system for TTVR is safe and results in an efficacious TR reduction, and it is applicable to patients with advanced tricuspid disease characterized by large right ventricle dimensions.
The compassionate use experience outcomes of LuX-Valve Plus in Hong Kong were shared at CHINA VALVE (HANGZHOU) 2024. According to the published data, the procedure success rate was 100%. The procedural and 30-day outcomes showed that the incidence rates of all-cause mortality, cardiovascular mortality, malposition/migration, emergency surgery/reintervention, vascular access complication, cerebrovascular accident and myocardial infarction were all 0%, and 100% of the patients had their TR grade improved to none/trace. The study concluded that LuX-Valve Plus is a promising TTVR device, which can cover a wide range of tricuspid annulus dimensions with low pacemaker rate, and demonstrated good procedural and post-procedural results.
Future Expectations: Positive Progress of Clinical Trial and Business Operations Has Made Worldwide, Important Milestones Will be Achieved Started from 2024H2
LuX-Valve Series Products, the TTVR system
In Europe, the subject enrollment for LuX-Valve Plus clinical trial aiming for obtaining CE Certificate is expected to complete in 2024Q3. Various clinical institutions from seven countries worldwide are actively participating in the clinical trial. LuX-Valve Plus has won unanimous acclaim from those participating clinical institutions.
In the U.S., the IDE for EFS of LuX-Valve Plus has been approved by FDA, and the EFS has already been initiated. It is expected the 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 registration to the NMPA for approval to be submitted in 2024Q3, and is expected to be approved in 2025H2.
LuX-Valve Plus has completed a number of pre-commercial activities in multi-regions worldwide. In order to meet the substantial and urgent demand from tricuspid regurgitation patients around the world, the Company will continue to promote the application of the products around the world, which helps to lay a solid foundation for the Company's globalization strategy.
Other Products
Ken-Valve, the proprietary TAVR system designed for the treatment of aortic regurgitation or combined with aortic stenosis, is under registration review process by the NMPA. The application was admitted to enter the priority approval process of the NMPA (the "Priority Approval Process") for medical devices, making Ken-Valve the first valve product to enter this process.
JensClip, the proprietary clip-based TMVr system designed for treatment of severe mitral regurgitation, has completed the subject enrollment for the confirmatory clinical trial and the one-month follow-up with encouraging clinical results. The one-year follow-up results is expected to be submitted for the NMPA approval in 2025H1.
