GNI Group (TYO:2160) subsidiary Berkeley Advanced Biomaterials has obtained 510(k) clearance from the U.S. Food and Drug Administration for the Accelagen Plus Surgical Matrix, its first proprietary brand product, according to a Tokyo bourse filing on Thursday.

Accelagen Plus Surgical Matrix is a biomaterial-based product containing collagen and other materials used for tissue formation and natural wound healing.

The company is looking at a U.S. commercial launch for the product in the first quarter of 2027.

The 510(k) clearance allows the company to market medical devices in the U.S.

With the clearance, the company plans to grow its proprietary product portfolio and transition to this business model amid efforts to improve profitability and reach sustainable growth in the medtech segment.

Berkeley Advanced Biomaterials has historically developed and manufactured biomaterials, mainly bone graft substitutes, as well as supplied products under third party brands.