Orthocell’s partner Marine Biomedical has received FDA clearance for PearlBone
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Orthocell Limited (ASX: OCC) announced on 3 November 2026 that its strategic partner Marine Biomedical had received US Food and Drug Administration clearance for PearlBone which is a new bone graft substitute made from marine materials.
The approval will allow PearlBone to be marketed in the United States for its approved uses and is an important step towards its commercial launch in one of the world's largest medical device markets.
PearlBone is made from sustainably sourced pearl shell from Western Australia's Kimberley region and uses the natural properties of nacre which is the mineralised structure of pearl shell, to support bone repair and regeneration.
The product has potential uses in orthopaedic along with trauma and reconstructive surgery and could help to address global demand for advanced bone repair solutions.
Orthocell has a 12% equity interest in Marine Biomedical after it completed a strategic investment of $1.05 million in January 2026.
The agreement also gave Orthocell the first right of refusal over global distribution rights for PearlBone and any future bone repair and regeneration products developed by Marine Biomedical.
The FDA clearance has reduced regulatory uncertainty and gives Orthocell an opportunity to use its established relationships with US surgeons along with its distributor network and commercial infrastructure to support PearlBone's market launch.
Marine Biomedical is now preparing for the US launch through work on manufacturing readiness and market development as well as discussions with potential commercial and clinical partners.
The company manufactures PearlBone at its facility in Broome, Western Australia, which will also support the growth of advanced biomedical manufacturing capabilities in regional Australia.
(Source: Company Announcements)
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