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PearlBone gets FDA clearance for world's largest orthopaedic market

Published by ABC Business · Australia 1 h ago
The PearlBone FDA approval follows years of testing, evaluation and development. (Supplied: Willie Creek Pearls)
The PearlBone FDA approval follows years of testing, evaluation and development. (Supplied: Willie Creek Pearls) · ABC Business

Detailed summary

A bone graft substitute made from mother-of-pearl shells sourced off the WA's Kimberley coast receives FDA clearance in the United States. Academics say it is just one example of life-changing medical innovation from WA.

A bone graft substitute made from Kimberley pearl shells has received clearance from the US Food and Drug Adminstration (FDA).

The product is the first of its kind to repair bone fractures using nacre, commonly known as mother-of-pearl.

Marine Biomedical says there is more to be done before the product can treat patients, but regulatory approval is an important first step.

Mother-of-pearl harvested in Western Australia's north could soon be used to fill bone fractures for patients in the United States.

WA biotech company Marine Biomedical has received clearance from the US Food and Drug Administration (FDA) for its bone graft substitute, PearlBone.

The product is the first of its kind to be developed from nacre, commonly known as mother-of-pearl.

The iridescent material has been used for ornamental items, jewellery and even buttons.

But Marine Biomedical chief executive Rolee Kumar said it was also 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.

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