Orthocell partner secures FDA clearance for PearlBone
Key points
- Orthocell partner Marine Biomedical received US FDA 510(k) clearance for PearlBone.
- Orthocell holds a 12% equity stake in Marine Biomedical following an $1.1 million investment.
- The regulatory approval enables PearlBone to enter the US market for bone repair.
Regenerative medicine company Orthocell (ASX:OCC) announced that its partner Marine Biomedical received US FDA 510(k) clearance for PearlBone.
The approval unlocks entry into the United States market for the bone graft substitute derived from sustainably sourced pearl shell.
Orthocell holds a 12% equity interest in Marine Biomedical following its $1.1 million investment and maintains a first right of refusal for global distribution rights.
Orthocell Chair John Van Der Wielen said, "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."
The PearlBone product is developed using pearl shell from Western Australia's Kimberley region to support orthopaedic, trauma, and reconstructive surgery.
Following the announcement, the Orthocell share price was unchanged at $0.56.
Marine Biomedical is advancing commercial readiness activities ahead of the product launch in the United States.
The transaction broadens the company's portfolio across bone, nerve, and tendon repair products.
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