Marine Biomedical Submits 510(k) Application to the U.S. FDA for PearlBone™

Marine Biomedical today announced the submission of its 510(k) application to the United States Food and Drug Administration (FDA) for PearlBone™, the Company’s first marine-derived bone graft substitute.

This submission marks a significant regulatory milestone as Marine Biomedical advances toward U.S. market clearance.

PearlBone™ is a next-generation biomaterial developed from sustainably sourced pearl shell. Designed to support natural bone regeneration, the material combines its unique structure with advanced biocompatibility and has undergone extensive preclinical validation. PearlBone™ is manufactured under globally recognised quality standards from its state-of-the art GMP facility in Broome, Western Australia- a first of its kind for regional Australia.

The global bone graft substitute market is projected to expand from USD $3.1 billion in 2022 to USD $5.6 billion by 2032 (CAGR 6.2%), driven by applications across orthopaedic trauma, spinal fusion and oncology-related procedures, underscoring sustained clinical demand. Limitations associated with autografts, allografts and some synthetic materials continue to drive the need for safe, scalable and biologically compatible alternatives.

The 510(k) submission follows comprehensive material testing, safety assessment and manufacturing validation aligned with FDA regulatory requirements.

Rolee Kumar, Chief Executive Officer of Marine Biomedical, said:

“Submitting our 510(k) application is a defining milestone for Marine Biomedical. It reflects years of disciplined scientific development, manufacturing testing and regulatory preparation.

PearlBone™ represents the first product in our broader marine biomaterials platform, and this step brings us closer to delivering innovative, sustainably sourced solutions to the global orthopaedic market.”

Marine Biomedical integrates biomaterial science, clinical insight and advanced manufacturing to address unmet needs in bone repair and regeneration. The Company will provide updates as the regulatory review progresses.