Broome built its name on pearls. Now the shell they grow in has been cleared to repair broken bones in America

Broome’s pearl farms have spent generations selling what grows inside the oyster. Now the shell itself has been cleared for use inside the human body.

Marine Biomedical, a Western Australian company formed in 2021 by Willie Creek Pearls and researchers at the University of Western Australia, has received US Food and Drug Administration clearance for PearlBone, a bone graft substitute made from nacre, the hard, iridescent layer better known as mother-of-pearl. The product is designed to help fractured bone repair itself.

Chief executive Rolee Kumar called the clearance the company’s “ticket to the United States”. Its ASX-listed strategic partner, the Perth regenerative medicine company Orthocell, announced the clearance to the market.

What exactly has been approved?

The cleared product is PearlBone Putty 1600. It went through the FDA’s 510(k) process, the route used for most medical devices. Instead of proving a new treatment from scratch, a company shows its device is substantially equivalent to one already on the US market, known as the predicate device.

Ms Kumar said PearlBone was tested against an established bone graft already sold in the US, and the company showed it was as safe and effective. She said the building blocks of nacre are also found in human bone, so it was no surprise that PearlBone supported bone healing in studies.

The company is clear that clearance is a first step. More work is needed before surgeons use it on patients, and it has not yet been sold.

Why pearl shell?

Bone grafts are used when a fracture, injury or operation leaves a gap that bone cannot bridge on its own. Surgeons can take bone from elsewhere in the patient’s body, use donor bone, or use a manufactured substitute that gives new bone a scaffold to grow into.

Nacre is one of nature’s toughest materials: layers of mineral held together by a natural protein glue, built by the oyster to line and repair its own shell. Researchers at UWA have spent years studying whether that structure could do the same job in a human skeleton.

What does it mean for the Kimberley?

Pearling is one of the oldest industries in the north-west, and Broome’s identity is built on it. Willie Creek Pearls chief executive Paul Birch said the partnership showed the industry what “can potentially be done”.

He said there was enough shell for now, but that could change as demand grows, and other parts of the oyster could one day feed into biomedical products too. That matters for a regional industry that has long depended on a single luxury product and the swings of the global jewellery market.

Keeping the processing in Broome also keeps the jobs and the know-how in the Kimberley, rather than shipping raw shell elsewhere to be turned into a medical product.

Why the US before Australia?

Professor Kevin Pfleger, UWA’s director of biomedical and health innovation, said it was common for Australian medical inventions to win US approval first. Australia’s small population makes it more viable to launch locally after a product has been approved overseas.

He said the hard part now was commercial: making sales, reaching patients and persuading surgeons to use it. Regulatory approval was critical, but it was not the finish line.

Ms Kumar said she hoped to bring PearlBone to Australian patients and to expand into dental treatments, where bone grafts are widely used to rebuild the jaw before implants.

How big is the prize?

The US bone grafts and substitutes market is worth about US$1.1 billion a year. Even a small share would be a large business for a company that only formed five years ago, and a rare example of a Western Australian medical invention built from a resource grown in the state’s own waters.