Orthocell Ltd (ASX: OCC), a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of bone and soft tissue injuries, has announced a significant milestone for its strategic partner, Marine Biomedical Pty Ltd. Marine Biomedical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for PearlBone™, an innovative marine-derived bone graft substitute. This regulatory approval enables PearlBone™ to be marketed in the United States for its cleared indications, marking a crucial step in the product’s commercialisation pathway and strengthening Orthocell’s biologically driven product portfolio.
PearlBone™ is a next-generation bone substitute developed from sustainably sourced pearl shell from Western Australia’s Kimberley region. This innovative biomaterial harnesses the natural properties of nacre, the biomineralised structure of pearl shell, to support bone repair and regeneration, with potential applications across orthopaedic, trauma, and reconstructive surgery. Orthocell holds a 12% equity interest in Marine Biomedical, following a strategic investment of A$1.05 million, and has secured a first right of refusal over global distribution rights for PearlBone™ and future bone repair and regeneration products.
The FDA clearance is expected to de-risk the regulatory pathway and advance the commercial opportunity for PearlBone™. It offers Orthocell the potential to expand its product portfolio into the substantial global bone repair and regeneration market, complementing its established nerve and tendon repair technologies. Orthocell may also leverage its existing U.S. surgeon relationships, distributor network, and commercial infrastructure to support PearlBone™’s market introduction, subject to definitive commercial arrangements. Marine Biomedical is currently progressing commercial readiness activities ahead of the planned introduction of PearlBone™ into the U.S. market, with manufacturing based at its purpose-built facility in Broome, Western Australia.
