Health · Pharma & Biotech · 1 hr ago
US FDA clears Marine Biomedical’s pearl-shell bone graft
Australian company Marine Biomedical received US FDA clearance for PearlBone, a bone graft substitute made from pearl shell.
The product uses nacre from pearl shell sustainably sourced in Western Australia’s Kimberley region.
PearlBone is made at Marine Biomedical’s facility in Broome, in Western Australia.
Perth-based Orthocell invested A$1.05 million in Marine Biomedical and holds a 12% stake, with a first right of refusal over global distribution rights for PearlBone and future products.
The clearance allows PearlBone to be marketed in the US for its cleared uses, opening a route into a major medical device market.
Marine Biomedical is preparing for a US launch, including manufacturing readiness and discussions with potential commercial and clinical partners.
The US Food and Drug Administration has granted 510(k) clearance to Marine Biomedical’s PearlBone bone graft substitute.
PearlBone is made using pearl shell sourced from Western Australia’s Kimberley region.
The clearance allows PearlBone to be marketed in the United States for its cleared indications.
Marine Biomedical makes the product at a purpose-built facility in Broome.
Orthocell holds a 12% stake in Marine Biomedical after investing $1.05 million.
- Who
- Marine Biomedical received the clearance; Orthocell is its strategic partner.
- What
- The US FDA granted 510(k) clearance for PearlBone, a bone graft substitute.
- When
- The clearance was reported on November 3, 2026; the date it was granted is not stated.
- Where
- The clearance is for the US market. PearlBone is manufactured in Broome, Western Australia.
- Why
- The clearance enables PearlBone to be marketed in the US for its cleared indications.
This story does not have two clearly opposing sides.
Orthocell finalised a strategic investment in Marine Biomedical, bringing its equity interest to 12% for a total investment of $1.05 million.
Stockhead reported that Marine Biomedical had received US FDA 510(k) clearance for PearlBone.
Marine Biomedical began progressing manufacturing readiness, market development and engagement with potential commercial and clinical partners ahead of a planned US launch.
- Product
- PearlBone bone graft substitute
- Regulatory status
- US FDA 510(k) clearance
- Orthocell stake
- 12%
- Orthocell investment
- $1.05 million
- Manufacturing site
- Broome, Western Australia
- Shell source
- Kimberley region, Western Australia
What people are saying
Achieving FDA clearance is a significant step towards unlocking that opportunity.
We believe PearlBone has considerable potential in the global bone repair and regeneration market, and we look forward to working with Marine Biomedical as it progresses towards commercialisation.