SCIENTECH(02291): MemoCarna Oxide Film Single-Rivet Patent Foramen Ovale Occluder Obtains Medical Device Registration Certificate

SCIENTECH(02291) announces that its wholly-owned subsidiary, Shanghai Shape Memory Alloy Material Co., Ltd., has obtained a medical device registration certificate (Registration Certificate No.: Guoxie Zhuzhun 20263132087) issued by China's National Medical Products Administration for the MemoCarna Oxide Film Single-Rivet Patent Foramen Ovale Occluder product. Patent foramen ovale ("PFO") is usually asymptomatic, but severe patent foramen ovale may present with various clinical manifestations, with cryptogenic stroke and migraine being the most common, and it is one of the important causes of cryptogenic stroke. Transcatheter closure is an important treatment method for PFO, but postoperative residual shunt remains a clinical problem. Published studies show that the incidence of residual shunt after PFO closure is approximately 10% to 30%, and it is associated with an increased risk of stroke recurrence. This product is independently developed by the Company, featuring a "M+W" interlocking internal buckle and single-rivet concave disc design, an embedded waist structure, and a three-layer flow-blocking membrane design to enhance closure stability and reduce nickel ion release. It is available in 9 models and specifications to accommodate different anatomical PFO closure needs, effectively reducing residual shunt after closure surgery and improving surgical success rates. Together with the Company's previously registered MemoSorb Biodegradable Patent Foramen Ovale Occluder, the approval and launch of this product further enriches the Company's product portfolio in the field of patent foramen ovale closure treatment, providing clinical options for interventional treatment through different technical approaches. In the future, the Company will continue to deepen its presence in the field of structural heart disease interventional treatment, continuously advancing product research and development and clinical applications, and providing more treatment options for patients.