JENSCARE-B (09877) Secures NMPA Registration Approval for JensClip and Accelerates Commercial Rollout

Stock News
Sep 22

JENSCARE-B (09877) has announced that its independently developed core product, the JensClip Transcatheter Valve Repair System, has received registration approval from the National Medical Products Administration (NMPA). The company is actively advancing the commercialization and clinical adoption of this product across mainland China and other markets, while also pushing forward its global expansion strategy.

JensClip, an in-house developed transcatheter mitral valve clip and delivery system, is designed to treat patients suffering from severe mitral regurgitation. The device incorporates an innovative self-locking mechanism, which is expected to effectively reduce regurgitation. Its clip linkage design allows for flexible shape adaptation, potentially enhancing procedural safety. Additionally, the clip enables simultaneous capture and control of both mitral leaflets or a single leaflet, improving ease of use during clinical procedures. The integrated release mechanism is anticipated to minimize the risk of operational errors and shorten device manipulation time.

Leveraging its existing resources and platform, the company will continue to drive the commercialization of JensClip in the domestic Chinese market, while also actively pursuing overseas regulatory approvals, including CE MDR certification, and related commercialization efforts. The global expansion of JensClip is also being systematically developed, with compassionate use treatments already underway abroad to aid patients, all procedures progressing smoothly and the product demonstrating strong performance.

As products covering aortic, mitral, and tricuspid valve diseases receive sequential registration approvals across different markets, the company's domestic and international commercialization is expected to generate a synergistic multi-product growth effect. This will help unlock long-term growth potential and build a global growth trajectory. With JensClip now attaining NMPA registration approval, the company's product portfolio covers all three major heart valve areas in structural heart disease intervention. The company will adopt a range of measures to seize market opportunities in the interventional treatment of structural heart disease, continuously broadening its sales network and expanding coverage of target customers.

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