PearlBone Gets FDA Clearance for Pearl-Shell Bone Graft
Western Australian biotech Marine Biomedical has received US Food and Drug Administration clearance for PearlBone, a bone graft substitute made from Kimberley pearl shells. The company says more hurdles remain before it can treat patients in the world's largest orthopaedics market.
PearlBone gets FDA clearance, giving Western Australian biotech company Marine Biomedical a bone graft substitute made from Kimberley pearl shells that the US Food and Drug Administration has cleared for the American market. It is the first product of its kind to repair bone fractures using nacre, commonly known as mother-of-pearl.
The United States is the world's largest orthopaedics market. The bone grafts and substitutes sector there is valued at $US1.1 billion ($1.5 billion).
Marine Biomedical says clearance is only a first step. More work is needed before the product can treat patients.
Tested against an existing graft
Chief executive Rolee Kumar said PearlBone was compared against another bone graft already established in the market. "We've been able to demonstrate PearlBone is as safe and efficacious as the predicate device," she said.
Kumar said the materials in mother-of-pearl are also building blocks of human bone. "So in a way, it's not surprising when we do these studies we see PearlBone facilitates bone healing," she said.
The company hopes to bring the product to Australian customers in future. It also wants to expand into other treatments, such as dental work.
Pearl farm supplies the shells
Marine Biomedical was established in 2021. It grew out of a partnership between Broome pearling business Willie Creek Pearls and research expertise from the University of Western Australia (UWA).
Shells farmed by Willie Creek for pearl production are cleaned and prepared. They are then transported to Marine Biomedical's manufacturing facility in Broome.
Willie Creek chief executive Paul Birch said there is plenty of pearl shell at the farm to meet current requirements. That could change as demand for the product grows.
He hopes the wider pearling industry could one day supply Marine Biomedical. "I think it just opens everyone's eyes to what can potentially be done," Birch said. He said more research might find other parts of the oyster useful for biomedical technologies.
Why the US came first
Kevin Pfleger, UWA's biomedical and health innovation director, said it is common for products to win approval in the US before returning to Australia. Australia is a large country geographically but has a relatively small population.
"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," Professor Pfleger said.
He called the clearance an "inspiring" achievement for others in the industry. "The next point is obviously making sales, getting patients and benefiting from that and getting surgeons using it," he said.
"But regulatory approval is critical."
