上海三友医疗器械股份有限公司关于联营公司产品通过创新医疗器械特别审查程序的自愿披露公告

Core Viewpoint - Shanghai Sanyou Medical Instrument Co., Ltd. announced that its joint venture, Chuanfeng Huayu (Suzhou) Intelligent Medical Technology Co., Ltd., has successfully passed the special review procedure for innovative medical devices by the National Medical Products Administration, marking a significant milestone in the company's innovation and development system for 2025 [1][4]. Product Information - The product approved is a spinal surgery navigation and positioning system, classified as a Class III medical device [1]. - The system features a pioneering three-arm surgical robot, enhancing precision and efficiency in spinal surgeries by automating tasks such as drilling, cutting, and screw placement [1][2]. - The integration of high-precision orthopedic digital microscopy technology allows for dynamic positioning accuracy of 0.9mm, significantly surpassing the industry standard of 1-2mm [2]. - The product's design enables rapid registration in just 1-2 seconds, eliminating the need for intraoperative CT scans and further reducing surgery time [2]. Impact on the Company - The approval of this product is expected to positively influence the company's business by enhancing the usage and promotion of innovative products [4]. - The company previously had another product, a porous polyether ether ketone interbody fusion device, enter the innovative channel in April 2025, indicating a strong pipeline of innovative offerings [4]. Shareholder Transfer Plan - QM5 LIMITED plans to transfer 6,669,250 shares, representing 2.00% of the total share capital of Sanyou Medical, through a non-public transfer [7]. - The transfer price will be determined based on the average stock price over the previous 20 trading days, with a minimum price set at 70% of that average [7][10]. - The transfer is aimed at meeting the financial needs of the selling shareholder, and the shares have been released from restrictions [9].