Orthocell Partner Gets FDA 510(k) Clearance for PearlBone

Orthocell (ASX:OCC) announced that Marine Biomedical, a company in which it holds a 12% equity interest, has received U.S. FDA 510(k) clearance for its PearlBone bone graft substitute, a product over which Orthocell holds distribution rights of first refusal.

The clearance allows PearlBone, which is developed from pearl shell sourced from Western Australia's Kimberley region, to be marketed in the United States for its cleared indications. Orthocell's 12% interest follows a total investment of A$1.05 million, finalised in January 2026, which also secured a first right of refusal over global distribution rights for PearlBone and future bone repair and regeneration products. Marine Biomedical is progressing manufacturing readiness, market development and engagement with potential partners ahead of a planned U.S. launch. PearlBone is manufactured at Marine Biomedical's facility in Broome. Orthocell says the product could complement its nerve and tendon repair portfolio and that it could draw on its U.S. surgeon relationships and distributor network.

Any Orthocell role in U.S. sales is subject to the exercise of its contractual rights and agreement of definitive commercial arrangements. The release gives no launch date, pricing, revenue expectation or distribution terms.