Somewhere off the Kimberley coast of Western Australia, the shells once prized for buttons and ornaments have found a new calling: the same iridescent material that makes pearls shine may now help broken bones knit together. The US Food and Drug Administration has cleared PearlBone, a graft made from nacre, which the company says is as safe and effective as a device already trusted by surgeons. The clearance is a threshold rather than an arrival, for the long road from approval to a surgeon's hands is still ahead.
WA's PearlBone, a bone graft made from Kimberley mother-of-pearl, wins FDA clearance for the US market
Building blocks of our bone too
Mark
So what has actually happened here? Is PearlBone on sale in America?
Mimi
Not yet. The FDA has cleared it, which is the first step. Rolee Kumar says there are more hurdles before it can be sold in the US.
Luke
Worth being clear on what the clearance rests on. PearlBone was compared with an existing graft, and the claim that it's as safe and effective comes from the company's account of that process.
Mark
Why mother-of-pearl, of all things?
Mimi
Kumar says the shell's components are also building blocks of bone, so seeing it help healing isn't surprising to her.
Luke
That's her explanation. The report doesn't give study data, so I can't tell you how well it heals compared with alternatives beyond that equivalence finding.
Mark
And the local angle, the Kimberley connection?
Mimi
The shells come from Willie Creek's pearl farm near Broome, are cleaned there, and go to Marine Biomedical's Broome facility. The company began in 2021 with UWA research.
Luke
Supply is fine for now, according to Paul Birch, but he says that could change if demand rises. That's an open question, not a problem yet.
Mark
Why go to the US first?
Mimi
Kevin Pfleger says Australia's population is small, so winning US approval first makes selling at home more viable.
Luke
And the US$1.1 billion figure is the market's size, not a revenue forecast for PearlBone. Sales and surgeon uptake are still unknown.
El Pulso
- A Western Australian biotech has won US regulatory clearance for a bone graft built from pearl shell, opening a door into a market worth US$1.1 billion.
- The clearance rests on a comparison with an established graft, a benchmark the company says PearlBone matches in safety and effectiveness.
- Surgeons, sales and further hurdles now stand between the approval and any real patient use in America.
- The company is looking beyond the US toward Australian customers and dental applications, while the local pearling industry watches to see whether its shells can supply the demand.
Somewhere off the Kimberley coast of Western Australia, the shells once prized for buttons and ornaments have found a new calling: the same iridescent material that makes pearls shine may now help broken bones knit together. The US Food and Drug Administration has cleared PearlBone, a graft made from nacre, which the company says is as safe and effective as a device already trusted by surgeons. The clearance is a threshold rather than an arrival, for the long road from approval to a surgeon's hands is still ahead.
Mother-of-pearl, the iridescent lining of shells long used for buttons, jewellery and ornaments, may soon be packed into fractured bones in American patients. Marine Biomedical, a Western Australian biotech company, has received US Food and Drug Administration clearance for PearlBone, a bone graft substitute made from nacre. It is the first product of its kind built from that material, and the company's chief executive, Rolee Kumar, says the shell's chemistry resembles the building blocks of human bone, which helps explain why its studies show healing.
Clearance came after PearlBone was compared with a graft already established on the market, a benchmark known as a predicate device. Kumar says the company demonstrated that PearlBone is as safe and effective as that device. The reward is large, since the US bone graft sector is valued at about US$1.1 billion, but Kumar calls this an important first step rather than the last. Sales, surgeon adoption and further hurdles still lie ahead, and the company hopes to bring the product home to Australia and expand into dental work.
The venture began in 2021 as a partnership between Willie Creek Pearls in Broome and researchers at the University of Western Australia. Shells farmed for pearls are cleaned and carried to the Broome manufacturing facility. Willie Creek's chief executive, Paul Birch, sees an opportunity for the pearling industry and hopes other parts of the oyster may one day serve biomedicine too. For now the farm has enough shell, though demand could change that.
UWA's Kevin Pfleger calls it an exciting time for the state's medical research, noting that approval in the US often comes before a return to Australia, and that a large country with a small population makes US success the sensible path to a viable home market. The real test, he suggests, will be whether sales materialise and surgeons choose to use it.
Mother-of-pearl harvested off Western Australia's Kimberley coast, the same iridescent material long used for buttons, jewellery and ornaments, could soon be packed into fractured bones in American patients. Marine Biomedical, a WA biotech company, has received clearance from the US Food and Drug Administration for PearlBone, a bone graft substitute.
PearlBone is the first product of its kind made from nacre, the scientific name for mother-of-pearl. Marine Biomedical chief executive Rolee Kumar said the material is well suited to bone repair and regeneration. What the shell is made of, she said, are also building blocks of human bone, so it is not surprising that the company's studies show PearlBone helping bone to heal.
The clearance came after a comparison process. PearlBone was tested against an existing bone graft already established in the market, a benchmark known as a predicate device. Ms Kumar said the company was able to demonstrate that PearlBone is as safe and efficacious as that device.
The prize is considerable. The United States is the world's largest orthopaedics market, and its bone grafts and substitutes sector is valued at US$1.1 billion, about A$1.5 billion. Ms Kumar described the clearance as an important first step into that market, but not the last one: more hurdles remain before PearlBone can be sold there. The company also hopes to bring the product to Australian customers in future and to expand into other uses, including dental work.
Marine Biomedical was founded in 2021 through a partnership between Willie Creek Pearls, a pearling business in Broome, and research expertise from the University of Western Australia. The shells farmed by Willie Creek for pearl production are cleaned and prepared, then transported to Marine Biomedical's manufacturing facility in Broome.
Willie Creek chief executive Paul Birch called the collaboration an exciting opportunity for the pearling industry, and suggested that with more research other parts of the oyster might serve other biomedical technologies. He said the farm currently has plenty of pearl shell to meet the company's needs, though that could change as demand grows. He hopes the wider industry might eventually supply Marine Biomedical.
Kevin Pfleger, UWA's director of biomedical and health innovation, said it is an exciting time for medical research in the state. A professor, he noted that it is common for products to win approval in the US before coming back to Australia. Australia is geographically large but has a relatively small population, he said, so US approval first makes it far more economically viable to market the product at home afterwards.
Professor Pfleger called the clearance an inspiring achievement for others in the industry. The next point, he said, is making sales, getting patients treated and getting surgeons to use the product. But regulatory approval, he said, is critical. Those sales, and the surgeons' response, are what to watch next.
Citas Notables
We've been able to demonstrate PearlBone is as safe and efficacious as the predicate device.— Rolee Kumar, Marine Biomedical chief executive
Regulatory approval is critical.— Professor Kevin Pfleger, UWA
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