Marine Biomedical is confident future regulatory approval of its patented bone replacement technology derived from material harvested from pearl farms will lead to a three to four-fold increase in the value of the novel Broome-based business.
From its headquarters across the pristine waters of Broome in Western Australia, the company is seeking regulatory approval on a portfolio of marine-based PearlBoneTM orthopaedic and dental products to bring to market in preparation for an eventual Initial Public Offering if the opportunity arises.
The company has secured a combination of state and federal government support and private investment to advance the development of orthopaedic and dental product applications after identifying significant niche opportunities in trauma medicine and facial and jaw reconstruction.
Marine Biomedical chief executive Patrick Moase, a marine biologist with over 22 years of experience working in regional WA, says promising early-stage discussions have inspired progress on prototype transitioning. He hopes for regulatory approval in the bone substitute market, which is forecast to reach US$4.3 billion in the United States by 2027.
Boase says orthopaedic development is a challenging regulatory pathway to navigate but offers high returns via reimbursement. On the other hand, the dental market approach is slightly less demanding but faces more market competition from multinational consumer products companies.
“Our strategy with dental is to develop a premium orthodontic product specifically recommended to patients by their dentists,” Boase explains.
He says PearlBoneTM – unlike mainstay products typically mined from calcium carbonate – contains similarities to human bone.
“We offer an ocean product which has scientifically demonstrated as having good bio-compatibility traits in a previous non-clinical study and is superfluous to the needs of the Western Australian pearling industry.
“The global market significantly allows us to focus on developing high-end niche products catering to people who are mindful about what they put into their bodies.”
The company is targeting Federal Drug Administration approval to sell its products boosted by a recent $200,000 grant from the Western Australian government for a cleanroom facility in Broome.
It also received Northern Australia Development Program funding from the federal government earlier this month as a further boost.
“We will demonstrate the capability of manufacturing PearlBoneTM in this facility before undertaking pre-submission engagement with the Federal Drug Administration. The cleanroom and product validation process are very complex,” Moase says.
“We intend to demonstrate that PearlBoneTM meets regulatory requirements for reporting and subsequent FDA approval.”
Marine Biomedical is a commercial collaboration agreement with renowned local Broome pearling business Willie Creek Pearls. The University of Western Australia’s Medical School supports the collaboration with medical research expertise.
University of Western Australia Winthrop Professor of Orthopaedic Research and Perron Institute Head of Bone and Brain Research Professor Minghao Zheng is the co-founder of Marine Biomedical and co-inventor of PearlBoneTM.
Orthopaedic surgeon Dr Rui Ruan, a specialist in spinal fusion, is a direct employee of the team. Additionally, the company will be engaging some further expertise from an experienced orthopaedic research PhD candidate to assist with product compatibility testing.
“We will also be trying to attract high-level quality assurance people to work with us regionally, but as you can imagine, you can just find these people by putting an ad in the local paper!” Moase says.
“We are hoping to offer employment opportunities to regional candidates who express interest in the biomedical industry and are keen to be involved in the development of this exciting business.”
Scientific research papers on outcomes are pending.