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Orthocell’s PearlBone Option Clears a Major US Regulatory Hurdle
10:09am on Tuesday 3rd of November, 2026 AEDT
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Healthcare
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Orthocell’s PearlBone Option Clears a Major US Regulatory Hurdle
10:09am on Tuesday 3rd of November, 2026 AEDT
Key Points
FDA 510(k) clearance for marine-derived PearlBone bone graft substitute
Orthocell owns 12% of Marine Biomedical after investing A$1.05 million
First right of refusal over global distribution rights and future bone repair products
US launch preparation now shifts towards manufacturing and commercial readiness
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