According to Bairen Medical's announcement, the company received approval from the State Drug Administration not to register medical devices, and the application for registration of biological supplements for ophthalmic surgery was not approved. The product was specially developed for patients with pathological myopia and used for posterior sclera reinforcement surgery. The reason the clinical trial was designed with a single target value, did not use a randomized control design, and did not test separately for minors and adults enrolled at the same time. The available data could not prove the safety and efficacy of the product. Even if this product makes a limited contribution to the company's performance in the short term, it is not a planned sales priority contribution product. The company will actively communicate and seek the product to be launched as soon as possible in accordance with regulations.

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