A patented technology developed at The University of Western Australia has received FDA clearance in the United States for use as a bone graft substitute in the repair of bone fractures.
UWA spin out company Marine Biomedical Ltd has received FDA 510(k) clearance for its PearlBone™ Putty 1600, the first nacre-derived bone graft substitute for repair of bone fractures in patients. The FDA approval follows years of development, testing, evaluation and regulatory work.
Image: Professor Minghao Zheng.
Developed using sustainably sourced pearl shell from Western Australia’s Kimberley region, PearlBone™ harnesses the natural properties of nacre – the biomineralised structure of pearl shell – to support bone repair and regeneration.
The Kimberley region of Western Australia is home to the world’s largest molluscs, Pinctada maxima, known as pearl oysters, which appeared around 13.66 million years ago.
Professor Minghao Zheng AM, from UWA’s School of Biomedical Sciences and Oceans Institute, who is also Marine Biomedical’s Medical Advisor, has led the manufacturing, testing and evaluation of PearlBone™ for safety and quality.
Professor Zheng, also Head of Bone and Brain Axis Research at the Perron Institute, said formation of human bone had evolved from the biomineralisation process of the pearl shell.
“Working with Dr Rui Ruan at UWA, we developed and patented a technology that converts nacre, the mineralised structure of pearl shell, into a bone mineral matrix composite,” he said.
“Essentially, we found a way to accelerate a biomineralisation process that took millions of years in nature, into a process that could be completed in a day.”
The patent was filed in 2018 and was later shortlisted for the WA Innovation of the Year. In 2021, Marine Biomedical Ltd was established in Broome, supported by the local pearl farming industry. Professor Zheng and co-founder Patrick Moase built a manufacturing facility in Broome in 2022.
Professor Zheng said PearlBone was turning a local byproduct into a high-value biomedical innovation and creating a new chapter in Broome’s remarkable pearl industry history.
Broome once supplied an estimated 75-to-80 per cent of the world’s pearl shell for button manufacturing. Today, that same pearl shell has the potential to contribute to the repair of human bone product in the market.
The broader US bone grafts and substitutes market is estimated at US$1.1 billion in 2026, with forecast annual growth of 6.2 per cent through 2033.
Marine Biomedical CEO Rolee Kumar said FDA clearance provided a huge opportunity to enter the US – the world’s largest orthopaedic market – and a major milestone in preparing for US commercialisation.
“It reflects years of scientific research and extraordinary dedication,” Ms Kumar said. “With manufacturing at our purpose-built facility in Broome and our headquarters in Perth, we are proud to advance biomedical manufacturing in regional Western Australia as we prepare for the next chapter.”
