Orthocell Ltd (ASX:OCC, OTC:ORHHF) has signed a Memorandum of Understanding (MoU) with WA biotech Marine Biomedical to expand its nerve, tendon and bone portfolio. The company will increase its stake from 1.72% to 11.70% for AU$1.05 million and gain first right of refusal on global distribution of Marine’s products, including the PearlBone™ bone substitute – a market estimated to be worth $US1.6 billion.
The companies will aim to sign a Formal Agreement within 30 business days of the MoU. The Subscription Agreement should then be completed within five business days of that signing.
Developed from sustainably sourced pearl shells collected off Western Australia’s Kimberley coast, PearlBone is designed for bone repair and regeneration across orthopaedic, trauma and reconstructive surgery.
“This partnership delivers exactly what we look for — breakthrough science, a clear regulatory path, and immediate commercial synergy,” Orthocell chair John Van Der Wielen said. “With our strong surgeon relationships and global distribution channels, we are ideally positioned to bring this first-in-class product to market. Marine Biomedical has had significant grant support from the Western Australian Government and has been working for many years on the development of this product.”
US market entry
The product is progressing toward US market entry, and Marine Biomedical is nearing completion of a pivotal study to support a US FDA 510(k) submission targeted for 1Q CY26.
If Orthocell formalises distribution rights as envisaged by the MoU, PearlBone would broaden the company’s offering to surgeons managing complex trauma and reconstructive procedures where multi-tissue regeneration is often required.
The parties will use reasonable endeavours to finalise formal agreements by the end of November 2025. Orthocell notes it remains well funded following its recent placement, with cash reserves of more than AU$50 million, supporting the contemplated investment and potential commercial rollout activities.
Overall, the Marine Biomedical transaction is intended to complement Orthocell’s existing nerve and tendon repair platforms with a biologically advanced bone regeneration option, creating a more comprehensive portfolio across key musculoskeletal indications.
“Orthocell is committed to its biologically driven portfolio for regenerative repair — bone, nerve, and tendon — and this partnership helps strengthen this strategic direction. It is a purposeful investment, with outstanding potential to enhance patient outcomes, grow revenue and shareholder value.
It is an ideal time to invest at this pivotal stage of the planned FDA submission for PearlBone, and Marine Biomedical's business is on a strong growth trajectory. We expect the value of the Marine Biomedical business to increase significantly as its unique bone products achieve regulatory approvals — a pathway well understood by Orthocell,” Van Der Wielen said.
About Marine Biomedical
Marine Biomedical is a Western Australian biotech developing medical products from sustainable marine resources. Its lead product, PearlBone, is a novel bone substitute made from pearl shell with potential applications in bone repair and regeneration across orthopaedic, trauma and reconstructive surgery. The company is led by an experienced team of scientists and executives and operates independently, with no material resourcing expected from Orthocell.
Orthocell managing director Paul Anderson is also a director of Marine Biomedical Pty Ltd. In line with best-practice governance, Anderson abstained from board deliberations and the vote on Orthocell entering the MoU.