Orthocell proudly congratulates our Co-Founder and Chief Scientific Officer, Professor Minghao Zheng AM, on being appointed a Member of the Order of Australia (AM).
Quarterly Report for period ended 31 December 2025
Orthocell has today released its Quarterly Report for the period ended 31 December 2025 – a quarter marked by continued revenue growth and accelerating U.S. commercialisation.
AFR | The company repairing human bone with Kimberley pearl shells.
The AFR has profiled Orthocell’s increased investment in Marine Biomedical and its novel bone-repair technology, PearlBone™, in this article by Tom Rabe titled ‘The company repairing human bone with Kimberley pearl shells.’
Orthocell Chairman John Van Der Wielen explains that this investment contributes to Orthocell’s broader strategy to support surgeons with a more complete trauma-repair toolkit spanning nerve, tendon and bone, while bringing new Australian-made biomedical innovation to international markets.
Here’s an excerpt:
“It’s the same market in a sense, and all of the surgeons dealing with trauma will tell you that when you’ve got a gunshot injury or a major trauma from a car accident, you need bone, nerve and tendon,” Van Der Wielen said.
With regulatory approvals already secured for Orthocell’s nerve repair device, Remplir™, across Australia, the US, Canada, Singapore and Hong Kong, and PearlBone now progressing toward US approval, Orthocell is executing a long-term strategy to expand across multiple surgical indications and markets.
Ausbiz | Interview with John Van Der Wielen
Orthocell Chairman John Van Der Wielen recently spoke with ausbiz about the Company’s strategic investment in Marine Biomedical and the rationale behind securing global distribution rights to PearlBone™.
Orthocell Finalises Formal Agreement with Marine Biomedical and Secures Strategic Rights to Groundbreaking Bone Regeneration Technology, PearlBone™
Orthocell has entered into a binding Formal Agreement with Marine Biomedical, increasing its equity interest from 1.72% to 11.7% for a total investment of AU$1.05 million.
As part of the transaction, Orthocell has secured a first right of refusal over global distribution rights for PearlBone™, Marine Biomedical’s bone regeneration technology, and any future bone repair and regeneration products.
PearlBone is an innovative, next-generation bone substitute product developed using sustainably sourced pearl shells from the West Australian Kimberley coast. The product has highly promising applications in bone repair and regeneration across the orthopaedic, trauma and reconstructive surgery markets.
Marine Biomedical is progressing toward U.S. regulatory approval and commercialisation of PearlBone, with a pivotal study nearing completion to support a U.S. FDA 510(k) submission by March 2026, positioning the product for potential entry into the US$1.6 billion global bone substitute market.
Orthocell Chair, John Van Der Wielen, said:
“This partnership adds further value to Orthocell’s strategy by introducing a leading bone regeneration product that can be sold alongside Orthocell’s market-leading collagen device. PearlBone strengthens our biologically driven portfolio and positions Orthocell as a multi-product company spanning bone, nerve, and tendon repair.
“This investment is sensibly timed for shareholders, given the impending FDA application, and we believe Marine Biomedical has the potential to become a large and successful biotechnology company in its own right.”
Orthocell Records Seventh Consecutive Quarter of Record Revenue at $3.2m
For the quarter ended 31 December 2025, the Company achieved record quarterly revenue of $3.2 million, representing a 7.0% increase on the prior quarterly record and a 45.2% increase on the prior corresponding period. This outcome reflects a compound quarterly growth rate of 10.4% since Q3 FY24.
Orthocell Submits Regulatory Application for Remplir™ into EU and UK
Orthocell has submitted a regulatory application to the British Standards Institution (BSI) seeking approval to commercially distribute Remplir™ in the European Union and United Kingdom, a combined nerve repair market valued at approximately US$750 million and comprising an estimated 500,000 peripheral nerve repair procedures each year.
Orthocell Strengthens Asian Growth Platform with First Commercial Sales in Hong Kong
Orthocell has announced that it has completed the first commercial sales of Remplir™ in Hong Kong, representing a key milestone in the Company’s Asian growth strategy.
Remplir™ Nerve Sparing Prostate Cancer Surgery Commercial Opportunity Gathers Momentum
Momentum is growing for Remplir™ in nerve-sparing prostate cancer surgery, with around 100 surgeries now performed using the flagship nerve repair device.
Orthocell Appoints Second Canadian Distributor for Remplir™
Orthocell has appointed its second distributor in Canada. The appointment completes national coverage across the US$75 million Canadian market, ensuring access for patients and healthcare providers nationwide.