Milestone Marks Another Dental Product Approval in China’s Fast-Growing Regenerative Sector
Regenity Biosciences, a global leader in regenerative medicine and a portfolio company of Linden Capital Partners, today announced a significant milestone with the regulatory approval from China’s National Medical Products Administration (NMPA) for its MatrixOss™ porcine anorganic bone mineral derived from porcine cancellous bone. Demonstrating its ongoing commitment to the Chinese dental market, the company has achieved another significant milestone with this approval following the September 2024 clearance of its innovative Matrixflex™ crosslinked membrane.
The NMPA approval was supported by robust clinical evidence, including a Level 1 randomized clinical study. This rigorous study directly compared Regenity’s porcine anorganic cancellous bone to Geistlich Bio-Oss®, the current market-leading bone graft offering in China.
This prospective, multicenter, randomized, parallel-controlled trial involved 188 patients and evaluated the effectiveness and safety of Regenity’s MatrixOss™ against Bio-Oss®for bone defect repair following tooth extraction.
“This NMPA approval for our porcine anorganic bone mineral is another significant milestone for Regenity Biosciences, further solidifying our position in China’s rapidly expanding regenerative dental market,” said Shawn McCarthy, CEO of Regenity Biosciences. “Our benchtop studies show that our porcine mineral graft offers demonstrably greater porosity and surface roughness than Bio-Oss® across both small and large particle sizes — key factors in supporting cell infiltration, cell adhesion, vascularization, and bone regeneration. We are proud to offer clinicians in China another proven and reliable option for bone defect repair with robust clinical data supporting its efficacy, reinforcing our commitment to advancing patient care in the dental sector.”
Regenity’s MatrixOss™ features a porous bone mineral matrix composed primarily of calcium phosphate with a carbonate apatite crystal structure, closely resembling natural human bone. The product is offered in both jars and syringe presenting a valuable alternative as a bone graft when the available bone quantity is insufficient for surgicalneeds. Its anorganic bone matrix derived from porcine cancellous bone acts as an osteoconductive scaffold, facilitating the formation and ingrowth of new bone at the implant site. MatrixOss™ bone mineral and the Matrixflex™ membrane can be used together for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) procedures.
The Chinese dental bone graft substitute market presents a significant growth opportunity, valued at $160 million in 2023 and projected to reach $280 million by 2027, representing a Compound Annual Growth Rate (CAGR) of 30%2. This strong growth is fueled by the increasing adoption of dental implants and enhanced affordability driven by volume-based procurement initiatives. Regenity intends to capitalize on these favorable market dynamics through strategic partnerships leveraging its private-label B2B business model for commercialization in China.
Source:
1 Regenity, data on file.
2 iData, China Market for Dental Bone Graft Substitutes – Forecast to 2027