Marine Biomedical, a Western Australian biotechnology company, has secured clearance from the US Food and Drug Administration for PearlBone, a bone graft substitute made from mother-of-pearl harvested off the Kimberley coast. The product is the first of its kind to be developed from nacre, the iridescent material used for jewellery and buttons.
Marine Biomedical was established in 2021 through a partnership with local pearl producer Willie Creek Pearls and research expertise from the University of Western Australia. A manufacturing facility for PearlBone was built in Broome in 2022. Chief executive Rolee Kumar said the material was effective for bone repair and regeneration. "The material of what the mother-of-pearl is made out of, all of these are actually building blocks of our bone too," she said. "So in a way, it's not surprising when we do these studies we see PearlBone facilitates bone healing."
Kumar said FDA clearance was an important first step, but more hurdles remained before the product could be sold in the United States, the world's largest orthopaedics market with the bone grafts and substitutes sector valued at $US1.1 billion ($1.5 billion). "We've gone through a process where PearlBone was compared against another existing bone graft that's established itself in the market," she said. "We've been able to demonstrate PearlBone is as safe and efficacious as the predicate device."
The company hopes to bring PearlBone to Australian customers in future and expand into applications such as dental work.
Willie Creek Pearls chief executive Paul Birch said the collaboration was an exciting opportunity for the pearling industry. "I think it just opens everyone's eyes to what can potentially be done," he said. "And with more research, there might be other parts of the oyster that can be used for other biomedical technologies."
UWA biomedical and health innovation director Kevin Pfleger said it was common for medical products to gain US approval before returning to Australia due to the country's small population. "If we get approval in the US first, it means it's much more economically viable for us to then come back and market in Australia," he said.
Professor Pfleger called the clearance "inspiring" for others in the industry, adding that the next steps included making sales, getting patients to benefit and getting surgeons to use the product.
Analysis
Why This Matters
- PearlBone offers a new option for bone repair using a renewable natural material, potentially reducing reliance on synthetic grafts.
- The FDA clearance opens the $1.5 billion US orthopaedics market to a WA-grown innovation, boosting the local biotech sector.
- For the pearling industry, it creates a new revenue stream from shell byproduct, with potential for further biomedical applications.
Background
Marine Biomedical was founded in 2021 as a partnership between Willie Creek Pearls and UWA. The company built a manufacturing facility in Broome in 2022 to process pearl shell into PearlBone. Mother-of-pearl, or nacre, is a naturally occurring composite that shares chemical components with human bone, making it suitable for grafts.
Key Perspectives
Rolee Kumar, Marine Biomedical CEO: Says PearlBone facilitates bone healing because its composition mirrors the building blocks of bone, and the product has been shown as safe and effective as an existing market comparator.
Paul Birch, Willie Creek Pearls CEO: Says the collaboration could inspire further research into using other oyster parts for biomedical technologies, and the entire pearling industry may eventually supply shell to Marine Biomedical.
Kevin Pfleger, UWA biomedical director: Notes that regulatory approval is critical but the real work begins with sales and surgeon adoption, and that US-first approval is a common economic strategy for Australian medical innovators.
What to Watch
- Additional regulatory and commercial hurdles Marine Biomedical must clear before PearlBone sales begin in the US.
- The company's plans to seek Australian regulatory approval and timeline for domestic availability.
- Whether shell supply from Willie Creek can scale with demand, potentially involving the broader pearling industry.
Checked
12 claims in this story checked against 1 source: 12 supported.
Show each claim
- SupportedMarine Biomedical has received FDA clearance for PearlBone.Latest Science news: “WA biotech company Marine Biomedical has received clearance from the US Food and Drug Administration (FDA) for its bone graft substitute, PearlBone.”
- SupportedPearlBone is the first bone graft substitute developed from nacre.Latest Science news: “The product is the first of its kind to be developed from nacre, commonly known as mother-of-pearl.”
- SupportedThe US is the world’s largest orthopaedics market, and its bone grafts and substitutes sector is valued at US$1.1 billion (A$1.5 billion).Latest Science news: “The United States is the world's largest orthopaedics market, with the bone grafts and substitutes sector valued at $US1.1 billion ($1.5 billion).”
- SupportedPearlBone is made from mother-of-pearl harvested off the Kimberley coast.Latest Science news: “The shell is harvested at Willie Creek Pearls, off the Kimberley coast.”
- SupportedKumar said the material’s components are building blocks of bone.Latest Science news: “The material of what the mother-of-pearl is made out of, all of these are actually building blocks of our bone too,”
- SupportedKumar said PearlBone facilitates bone healing.Latest Science news: “So in a way, it's not surprising when we do these studies we see PearlBone facilitates bone healing.”
- SupportedKumar said PearlBone was demonstrated to be as safe and efficacious as the predicate device.Latest Science news: “We've been able to demonstrate PearlBone is as safe and efficacious as the predicate device .”
- SupportedBirch said the collaboration opens people’s eyes to what can potentially be done.Latest Science news: “I think it just opens everyone's eyes to what can potentially be done,”
- SupportedBirch said further research might identify other oyster parts for biomedical technologies.Latest Science news: “And with more research, there might be other parts of the oyster that can be used for other biomedical technologies.”
- SupportedPfleger said US approval first can make it more economically viable to later market a product in Australia.Latest Science news: “So if we get approval in the US first, it means it's much more economically viable for us to then come back and market in Australia.”
- SupportedThe company was established in 2021 through a partnership with Willie Creek Pearls and UWA research expertise.Latest Science news: “Marine Biomedical was established in 2021 through a partnership with local Broome pearling business Willie Creek Pearls and research expertise from the University of Western Australia (UWA).”
- SupportedA PearlBone manufacturing facility was built in Broome in 2022.Latest Science news: “A manufacturing facility for PearlBone was built in Broome in 2022.”
