Company Announcements

BEIJING , Sept. 1, 2025/PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company with TTVR breakthroughs, achieved milestones in its product portfolio globally, and just released its interim results for 2025H1 ended June 30, 2025.

Business Overviews:

In 2025H1, significant progress was achieved across its product pipeline in the interventional treatment for tricuspid, aortic and mitral valve diseases, establishing a diversified and high-potential product portfolio. More importantly, the Company continued to expand its global business layout, enhancing product influence and clinical application scale, thereby laying a solid foundation for sustainable high-speed growth.

The global registration and clinical progress of LuX-Valve Plus TTVR system achieves key milestones in China, Europe, and U.S.

In China, the multicenter registration clinical trial of LuX-Valve Plus is in the long-term follow-up phase and shows excellent clinical results. Randomized controlled trial (RCT) of optimized medical therapy (OMT) conducted in China has completed subject enrollment. The application for NMPA registration has been submitted and accepted, entering registration review stage. The Company is actively advancing the NMPA registration process of LuX-Valve Plus and strives to obtain the NMPA registration certificate soon.

In Europe, LuX-Valve Plus has completed 6-month follow-up of the global multicenter clinical trial TRINITY Study for CE Marking and is currently under registration review. The 30-day clinical follow-up results of TRINITY Study were officially released at EuroPCR 2025, indicating favorable clinical results. The 30-day clinical follow-up results in large annulus patients in the TRNITY Study were released at New York Valves 2025. The results showed that both groups of patients (large annulus patients and small annulus patients) demonstrated outstanding outcomes. The wide range of application of LuX-Valve Plus provides an excellent treatment option, particularly for patients of annular dilation with severe TR. The 6-month follow-up outcome of TRINITY Study is expected to be released at TCT 2025.

In the United States, LuX-Valve Plus was selected to participate in the FDA's Total Product Life Cycle Advisory Program (TAP) pilot. Its FDA IDE early feasibility study (EFS) 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.

The commercialization of Ken-Valve TAVR system is advancing rapidly, with continuous growth in both hospital coverage and implantations

Ken-Valve has quickly gained market access after its approval by NMPA in 2025H1. The Company has been actively promoting the commercialization activities with smooth progress in hospital adoption. Commercial implantations are being actively conducted across the country.

Ken-Valve has received plenty of positive feedbacks regards its innovative design, operational performance, and clinical efficacy. It is a rare product that is indicated for severe AR (or combined with AS) to meet large underpenetrated clinical needs. Its innovative design accommodates a wide range of complex anatomies, significantly improving procedural safety and flexibility while reducing device operation time. The large-size valves of 29mm, 31mm, and 33mm have been widely recognized by physicians and the market, addressing the unmet clinical need for large-annulus patients. It is also suitable for patients with challenging anatomies, such as severe horizonal heart. The average device operation time was less than 10 minutes, with the shortest being around 4 minutes during the commercialization phase.

We will continue to advance the commercialization of Ken-Valve, leveraging its differentiated competitive advantages, supply chain strengths, and flexible marketing strategies to provide the Company with stable revenue and profits.

JensClip TMVr system has submitted its NMPA registration application

JensClip has submitted its NMPA registration application, entering the registration stage. The one-year clinical follow-up results were released at EuroPCR 2025, showing encouraging efficacy and safety indicators.

The globalization process is being actively pursued. Pre-commercialization implantations have been successfully conducted overseas, with all procedures progressing smoothly and the product demonstrating excellent performance. CE Marking activities are also underway

Global commercialization strategy

• Differentiated Positioning of competitive product portfolio

Our product portfolio leverages diversified, innovative designs to address vast, under-penetrated, and rapidly growing markets. Through differentiated product positioning, we quickly build brand recognition; stable, user-friendly operation of the products rapidly establishes physician habits. Leveraging global KOLs and proctors with extensive experience and academic influence, we disseminate procedural skills and technical expertise via diverse academic conferences, live/recorded cases, and case discussions—radiating from leaders to regional centers to expand product awareness and hospital coverage at speed.

• Global Sales Network

In China, we have established a comprehensive regional distributor network for Ken-Valve, supported by flexible pricing and sales strategies that allow agile, timely responses to market dynamics to accelerate commercialization and expand market share. Overseas, commercial preparations for LuX-Valve Plus are ongoing, with in-depth market research laying the groundwork for imminent market launch.

• Professional Procedural Promotion

A dedicated, high-efficiency commercial team drives market entry, procedural education, and marketing for our products. Through high-standard on-site clinical support and feedback, we ensure consistently high-quality procedures worldwide, enhance customer satisfaction, and establish global procedural standards. Active participation in premier structural-heart conferences, associations, and annual conferences across the globe further elevates brand influence and academic standing.

• Comprehensive Training System

We have built robust internal and external training programs that deliver thorough, professional instruction on product features, procedural techniques, imaging applications, perioperative management, and complex-case handling—accelerating procedural adoption both inside and outside the organization and driving rapid product penetration and market-share expansion.

Future Expectations

The Company will continue to advance the clinical and commercial development of multiple products, striving to become a high-potential medical device enterprise with a global vision and l business layout.

We will accelerate the worldwide rollout of the LuX-Valve series, aiming to set the leading benchmark in transcatheter tricuspid-valve intervention. Leveraging its global partnerships, clinical application experience, and brand reputation, the Company will extend overseas opportunities across its entire product portfolio.

To achieve sustainable rapid growth, we aim to further expand and optimize our product portfolio to address the substantial and urgent unmet clinical needs in structural heart disease treatment.

By further enhancing operational efficiency, rapidly capturing high-growth revenue and profit, and sustaining innovation, the Company will secure long-term success for its globalization strategy.

Financial Highlights: Steady Operation with High Quality of Growth

• Total revenue was RMB 26 million (US$ 3.6 million)^[1], marking a great start for commercialization. Gross profit and sales profit^[2] was RMB 12 million (US$ 1.7 million) and RMB 8 million (US$ 1.1 million) respectively, with a gross profit margin close to 90% and sales profit margin^[3] close to 60%. Sales profitability for product has been achieved.
• Adjusted non-IFRS loss^[4] for the period was RMB 92 million (US$ 12.9 million), with a decrease of about 3% compared to2024H1.
• Net loss per share attributable to ordinary shareholders basic and diluted was RMB 0.41.
• Cash and cash equivalents, term deposits and financial assets was RMB 603 million (US$ 84.6 million). Net cash used in operating activities was RMB 93 million (US$ 13 million), with a decrease of around 15% compared to 2024H1. Going forward, as commercialization progresses, the net operating cash outflow is expected to continue improving, enabling the Company to steadily transition into a virtuous cycle and rapid growth.

 

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SOURCE Jenscare Scientific Co., Ltd.