-
Orthocell to increase its stake in fellow WA biotech Marine Biomedical from 1.7% to 12% through a $1 million investment
-
A pivotal study on Marine’s Biomedical’s flagship product PearlBone nears completion to support US FDA approval
-
Investment secures Orthocell’s global distribution rights to PearlBone, building on its biologic product portfolio
Special Report: Regenerative medicine company Orthocell has strengthened its biologic portfolio and expanded its commercial reach in the global bone repair market, increasing its investment in fellow WA biotech Marine Biomedical.
Under a Memorandum of Understanding (MoU) executed between the two companies, Orthocell (ASX: OCC)will increase its equity stake in Marine Biomedical from 1.7% to 12% through a $1 million investment.
The investment is contingent upon Orthocell securing the exclusive first right of refusal for global distribution rights to Marine Biomedical’s flagship bone-substitute product PearlBone.
The next-generation biomaterial has promising applications in the orthopaedic, trauma, and reconstructive surgery and is produced from sustainably sourced pearl shells collected off the Kimberley coast in Western Australia.
Marine Biomedical is well advanced in its regulatory pathway, with a pivotal study nearing completion to support a US Food and Drug Administration (FDA) 510(k) marketing submission in Q1 CY2026.
FDA clearance would allow commercial distribution of PearlBone into the US$1.6 billion bone-substitute market.
Expanding regenerative medicine leadership
The agreement marks a strategic expansion of Orthocell’s core regenerative medicine capabilities, adding bone regeneration to its existing focus areas in nerve and tendon repair.
The company’s biologic product portfolio now encompasses solutions for multi-tissue regeneration – addressing the complex needs of surgeons treating traumatic and reconstructive injuries.
Its flagship product Remplir is a collagen wrap used in peripheral nerve repair, which received FDA approval in April. Remplir is also approved in the US, Australia, New Zealand, Singapore, Thailand, Hong Kong and Canada.
Among Orthocell’s other products is Striate+, which is a sterile, resorbable collagen membrane designed for guided bone and tissue regeneration in dental procedures.
Striate+ is approved for sale in Brazil, the US, Europe, the UK, Australia, New Zealand, Canada and Singapore.
The strategic deal enables Orthocell to leverage its established distribution networks, particularly in the US where the company maintains deep relationships with specialist distributors, leading orthopaedic and plastic surgeons.
Orthocell managing director Paul Anderson is also a director of Marine Biomedical. He abstained from board deliberation and voting on Orthocell’s decision to enter the MoU in accordance with best practice corporate governance.
‘Partnership delivers exactly what we look for’
Orthocell and Marine Biomedical plan to complete the formal agreement by end of November.
Marine Biomedical will continue to operate autonomously under its existing leadership team and is not expected to require significant internal resources from Orthocell.
The biotech company’s team comprises world-class researchers and industry leaders focused on developing innovative, marine-derived medical technologies.
Following a $30m placement announced last week the company said it was well funded with more than $50m in cash reserves to advance its product development, regulatory submissions, and commercial expansion strategies across multiple therapeutic areas.
Orthocell Chair John Van Der Wielen noted that, with its strong surgeon relationships and global distribution channels, the company is ideally positioned to bring the first-in-class product to market.
“This partnership delivers exactly what we look for – breakthrough science, a clear regulatory path, and immediate commercial synergy,” he said.
Van Der Wielen said 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.
“Orthocell is committed to its biologically driven portfolio for regenerative repair – bone, nerve, and tendon – and this partnership helps strengthen this strategic direction,” he said.
“It is a purposeful investment, with outstanding potential to enhance patient outcomes, grow revenue and shareholder value.”
Van Der Wielen said it was an ideal time to invest at this pivotal stage of the planned FDA submission for PearlBone, as the Marine Biomedical business was 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,” he said.
This article was developed in collaboration with Orthocell, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
