We are delighted to announce that PearlBone™ Putty 1600, our nacre-derived bone graft substitute, has received U.S. FDA 510(k) clearance.
Developed using sustainably sourced pearl shell from Western Australia’s Kimberley region, PearlBone™ harnesses the natural properties of nacre - the biomineralised structure of pearl shell - to support bone repair and regeneration.
From mother-of-pearl to medical innovation, this milestone follows years of scientific development, preclinical evaluation, manufacturing validation and regulatory preparation. Clearance enables PearlBone™ to be marketed in the United States for its cleared indications.
The broader U.S. bone grafts and substitutes market is estimated at US$1.1 billion in 2026, with forecast annual growth of 6.2% through 2033.
Marine Biomedical CEO Rolee Kumar said:
“FDA clearance is our ticket to the United States - the world’s largest orthopaedic market - and a major milestone as we prepare for U.S. commercialisation. It reflects years of scientific research and extraordinary dedication.”
To our Marine Biomedical team - your incredible teamwork, dedication and sheer determination made this possible. Thank you also to our research and clinical collaborators, advisers, investors and partners for your expertise, persistence and belief in PearlBone™.
With manufacturing at our purpose-built facility in Broome and our headquarters in Perth, we are proud to advance biomedical manufacturing in regional Western Australia as we prepare for the next chapter.