Marine Biomedical Achieves FDA Clearance

• Marine Biomedical received FDA 510(k) clearance for PearlBone
• PearlBone is a marine-derived bone graft substitute
• Orthocell holds 12% equity in Marine Biomedical
• FDA clearance unlocks U.S. market for PearlBone
• PearlBone complements Orthocell's regenerative medicine products

Orthocell Limited, a regenerative medicine company, announced that its strategic partner Marine Biomedical has received U.S. FDA 510(k) clearance for PearlBone, its innovative marine-derived bone graft substitute. This clearance unlocks the U.S. market for PearlBone, a product developed from sustainably sourced pearl shell. 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 products. The clearance represents a significant milestone for Marine Biomedical and an important development for Orthocell, enabling PearlBone to be marketed in the United States for its cleared indications.

Orthocell believes PearlBone has considerable potential in the global bone repair and regeneration market and looks forward to working with Marine Biomedical as it progresses towards commercialization.