{"id":963779,"date":"2026-11-14T04:28:16","date_gmt":"2026-11-14T04:28:16","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/963779\/"},"modified":"2026-11-14T04:28:16","modified_gmt":"2026-11-14T04:28:16","slug":"pearlbone-from-wa-wins-fda-approval-for-us-orthopaedic-market","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/963779\/","title":{"rendered":"PearlBone from WA wins FDA approval for US orthopaedic market"},"content":{"rendered":"

Mother-of-pearl harvested in Western Australia’s north could soon be used to fill bone fractures for patients in the United States.<\/p>\n

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

\"Inside<\/p>\n

A manufacturing facility for PearlBone was built in Broome in 2022. (Supplied: Rolee Kumar)<\/p>\n

The product is the first of its kind to be developed from nacre, commonly known as mother-of-pearl.<\/p>\n

The iridescent material has been used for ornamental items, jewellery and even buttons.<\/p>\n

But Marine Biomedical chief executive Rolee Kumar said it was also effective for bone repair and regeneration.<\/p>\n

\"The<\/p>\n

PearlBone will be used to repair bone fractures for patients in the United States. (Supplied: Rolee Kumar)<\/p>\n

“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.<\/p>\n

“So in a way, it’s not surprising when we do these studies we see PearlBone facilitates bone healing.”<\/p>\n

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).<\/p>\n

Ms Kumar said FDA clearance was an important first step in entering the US market, but there were more hurdles to be overcome before it could be sold.<\/p>\n

\"Rolee<\/p>\n

Rolee Kumar says PearlBone is as safe and effective as existing bone repair materials. (Supplied: Rolee Kumar)<\/p>\n

“We’ve gone through a process where PearlBone was compared against another existing bone graft that’s established itself in the market,” she said.<\/p>\n

“We’ve been able to demonstrate PearlBone is as safe and efficacious as the predicate device<\/a>.”<\/p>\n

She said the company also hoped to bring the product to Australian customers in future and expand into other treatments like dental work.<\/p>\n

‘Exciting’ opportunity for pearl industry<\/p>\n

Marine Biomedical was established in 2021<\/a> through a partnership with local Broome pearling business Willie Creek Pearls and research expertise from the University of Western Australia (UWA).<\/p>\n

\"Paul<\/p>\n

Paul Birch says shells are prepped at the farm before being transported to the manufacturing facility in Broome. (Supplied: Willie Creek Pearls)<\/p>\n

Willie Creek chief executive Paul Birch said the collaboration was an exciting opportunity for the pearling industry.<\/p>\n

“I think it just opens everyone’s eyes to what can potentially be done,” he said.<\/p>\n

“And with more research, there might be other parts of the oyster that can be used for other biomedical technologies.”<\/p>\n

The shells farmed by Willie Creek for pearl production undergo cleaning and preparations before being transported to the Marine Biomedical manufacturing facility in Broome.<\/p>\n

Mr Birch said there was an abundance of pearl shell available at the farm to meet current requirements, but this could change as the product demand increased.<\/p>\n

“So hopefully at one point in time, it might be something the entire industry is able to be involved in and supply to Marine Biomedical,” he said.<\/p>\n

\"An<\/p>\n

The shell is harvested at Willie Creek Pearls, off the Kimberley coast. (Supplied: Willie Creek Pearls)<\/p>\n

UWA biomedical and health innovation director Kevin Pfleger said it was an exciting time for medical research in WA.<\/p>\n

“Often people don’t realise we have some amazing innovations which are changing the world,” he said.<\/p>\n

The professor said it was common for products to gain approval in the United States market before returning to Australia.<\/p>\n

“One of the big reasons is because even though we’re a very large country geographically, we’ve got a relatively small population,” Professor Pfleger said.<\/p>\n

“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.”<\/p>\n

\"A<\/p>\n

Willie Creek Pearls, based on the outskirts of Broome in WA’s north, will provide the product for PearlBone. (ABC Kimberley: Ben Collins)<\/p>\n

Professor Pfleger said the clearance was an “inspiring” achievement for others in the industry.<\/p>\n

“The next point is obviously making sales, getting patients and benefiting from that and getting surgeons using it,” he said.<\/p>\n

“But regulatory approval is critical.”<\/p>\n","protected":false},"excerpt":{"rendered":"Mother-of-pearl harvested in Western Australia’s north could soon be used to fill bone fractures for patients in the…\n","protected":false},"author":2,"featured_media":963780,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[64,63,24513,99,2156,11425,531295,531297,531296,1055,2489,25962,531298],"class_list":["post-963779","post","type-post","status-publish","format-standard","has-post-thumbnail","category-business","tag-au","tag-australia","tag-broome","tag-business","tag-fda","tag-fda-approval","tag-marine-biomedical","tag-pearl-shell","tag-pearlbone","tag-united-states","tag-us","tag-wa","tag-willie-creek-pearls"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/963779","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=963779"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/963779\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/963780"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=963779"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=963779"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=963779"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}