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

Shanghai Hile Bio-Technology Co., Ltd. announced that its controlled subsidiary, Shaanxi Ruisheng Bio-Technology Co., Ltd., has received notification that its medical device registration application for "Bone Repair Material" has been accepted by the National Medical Products Administration. The product, classified as a Class III medical device, is intended for the filling and repair of maxillofacial bone defects and alveolar bone defects.

The "Bone Repair Material" addresses functional and aesthetic issues arising from alveolar bone defects or resorption, commonly associated with periodontitis, trauma, or insufficient bone volume before dental implant procedures. The product aims to restore bone structure and provide a stable foundation for teeth or implants through the implantation of bone repair materials combined with guided bone regeneration technology. This new product offers structural designs like blocks and columns, which are expected to enhance stability and improve repair outcomes.

The company stated that the product is currently in the acceptance stage, with subsequent steps including review, approval, and certification. The administrative approval period is 20 working days, with a potential extension of 10 working days for special circumstances. The company emphasized that this stage does not guarantee product registration, future production, or sales, and the project's impact on future performance is uncertain.