Orthocell partner receives US FDA clearance for marine-derived bone graft

• Orthocell partner Marine Biomedical has opened the door to the US market after receiving FDA clearance for its PearlBone bone graft substitute
• Company holds 12% equity interest in Marine Biomedical following a $1.05 million investment
• PearlBone is manufactured at Marine Biomedical’s purpose-built facility in Broome with pearl shell from the Kimberley region.

Special Report: Orthocell’s strategic partner Marine Biomedical has received US Food and Drug Administration (FDA) 510(k) clearance for PearlBone, a next-generation bone substitute developed using pearl shell from Western Australia’s Kimberley region.

Perth-based Orthocell (ASX:OCC) finalised a strategic investment in Marine Biomedical in January 2026, increasing its equity interest to 12% for a total investment of $1.05 million.

The deal also secured OCC a first right of refusal over global distribution rights for PearlBone and future bone repair and regeneration products.

Regulatory clearance enables PearlBone to be marketed in the US for its cleared indications, marking a significant step towards commercialisation in one of the world’s largest medical device markets.

OCC said the biomaterial harnessed the natural properties of nacre, the biomineralised structure of pearl shell, which has been sustainably sourced from the Kimberley region, to support bone repair and regeneration.

PearlBone is manufactured at Marine Biomedical’s purpose-built Broome facility in WA, supporting the development of advanced biomedical manufacturing capability in regional Australia.

‘Considerable potential’ in bone repair and regeneration

OCC said the FDA clearance created the potential to leverage its established US surgeon relationships, distributor network and commercial infrastructure to support PearlBone’s market introduction.

PearlBone has potential applications across orthopaedic, trauma and reconstructive surgery.

Marine Biomedical is now progressing activities ahead of the planned US launch, including manufacturing readiness, market development and engagement with potential commercial and clinical partners.

OChair John Van Der Wielen said FDA clearance for PearlBone was an exciting milestone for Marine Biomedical and an important development for OCC.

“Our investment in Marine Biomedical was made with a clear strategic objective to secure exposure to an innovative bone regeneration technology with the potential to complement Orthocell’s established nerve and tendon repair portfolio,” he said.

“Achieving FDA clearance is a significant step towards unlocking that opportunity.

“We believe PearlBone has considerable potential in the global bone repair and regeneration market, and we look forward to working with Marine Biomedical as it progresses towards commercialisation.”

This article was developed in collaboration with Orthocell, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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