Biosis Healing officially entered the new field of oral cavity

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After Ligating Clips approved by the China National Medical Products Administration (NMPA) for the registration of Class III medical devices in December 2021, Biosis Healing officially entered the new highland in the field of oral cavity.

On April 6th, one of the "key members" of the SIS series products of Biosis Healing - 博瑞金® Oral Biological Graft, was approved by NMPA for the registration of Class III medical devices [国械注准 20223170457]. After Hernia Graft, Anal Fistula Plug, and Dura Repair Mesh, this certificate is the fourth Class III medical devices certificate for animal-derived products of the SIS series products of Biosis Healing,

What makes us most proud is that this certificate is also the first oral soft tissue repair graft product made of SIS biomaterials in China.

Picture: 博瑞金® Oral Biological Graft

Like other members of SIS series products of Biosis Healing, Oral Biological Graft has attracted much attention from the beginning of the project. It was one of the important products in the "National High-tech Research and Development Program (863 Program) Project" undertaken by Biosis Healing, and was included in the national key research and development plan.

Picture: Animation demonstration of some clinical applications of 博瑞金® Oral Biological Graft

博瑞金® Oral Biological Graft is mainly used for covering and repairing superficial soft tissue defects in the oral cavity. It uses the acellular porcine small intestine submucosa matrix material with independent intellectual property rights of Biosis Healing as raw material, and is produced by non-cross-linking process to form a three-dimensional loose porous structure, retains natural biologically active ingredients.

This product can replace the inert tissue source material dermal matrix products, has high biological induction activity, can induce the regeneration and repair of soft tissue, and promote the rapid crawling of the mucosa to cover the defect area. With anti-infection function, it can isolate and protect the wound surface. The product has good affinity and compliance with tissue, closely adheres to tissue, has good plasticity, and provides high patient comfort. It has good biocompatibility, can be degraded and absorbed, and has no foreign matter residue, which can speed up the recovery process of patients and relieve the pain of patients.

The product is implanted into the oral defect area, which not only ensures the high expected tissue repair ability, but also meets the needs of patients in terms of functional and aesthetic repair. It can be widely used in the repair of defective tissue in pars buccalis, tongue, jaw, lips, gums and other oral cavity. It has been confirmed by a large number of clinical experimental data that the product has a significant effect in the excision and repair of maxillary tumors, periodontal tissue repair, and oral mucosa wound repair.

It is worth noting that, in the conclusion of the joint research of Biosis Healing and Tianjin Medical University School of Stomatology on Biosis Healing SIS biomaterials, it is also indicated that Biosis Healing SIS biomaterials can be used in oral soft tissue repair and guided bone regeneration, and has good application prospects.

Picture: Schematic diagram of SIS-fusion peptides for bone-guided regeneration The research result was included in "Advanced Functional Materials"

Picture: Schematic diagram of SIS-P1P2-EXO membrane preparation for guiding bone regeneration The research result was included in "Composites Part B"

The product will be available soon, and the national investment promotion has been officially launched.

For more product details, please contact us.

Tel.: +86-10-61252660  Oral Products Division