Hile Bio-Technology subsidiary's bone repair material registration accepted

Shanghai Hile Bio-Technology Co., Ltd. announced that its controlled subsidiary, Shaanxi Ruisheng Bio-Technology Co., Ltd., recently received notification from the National Medical Products Administration (NMPA) regarding the acceptance of its registration application for a Class III medical device. The product, named "Natural Bone Repair Material," is intended for the repair of jawbone defects, with acceptance number CQZ2501670.

This natural bone repair material is categorized as a Class III medical device under "17-08 Oral Implant and Tissue Reconstruction Materials" and "17-08-06 Bone Filling and Repair Materials" in the NMPA's classification. The oral bone defect repair procedure addresses functional and aesthetic issues caused by alveolar bone defects or absorption, commonly arising from periodontitis, trauma, or insufficient bone volume before dental implant surgery.

The company highlighted that the product is currently in the acceptance phase, with subsequent approval processes including review, examination, and certification. While the acceptance is a positive step, Hile Bio-Technology cautioned that the product's registration for market launch and future production involves uncertainties, and the company cannot predict its impact on future financial performance.