Orthocell Ltd Expands Ukraine Remplir Programme Ahead of EU UK Clearance
Orthocell expands Remplir humanitarian programme in Ukraine as surgeons validate clinical utility
Orthocell Limited (ASX: OCC) has expanded its global humanitarian programme, shipping additional Remplir nerve repair devices to Ukraine following the success of the initial deployment in April 2025.
The expansion carries a dual significance for investors. It delivers humanitarian impact to victims of war, while generating real-world clinical validation ahead of anticipated regulatory clearance in the European Union and United Kingdom in 2H CY2026. Surgeons treating complex battlefield trauma have reported strong clinical utility.
A coalition of Australian corporate donors agreed to purchase 100 devices at humanitarian pricing, with Orthocell donating a further 100 devices. The Ukraine Crisis Appeal has pledged AUD $10K to support the effort.
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A coordinated philanthropic initiative backed by major Australian donors
The expanded shipment is now in transit to Ukraine, supported by leading Australian corporate donors. The initiative builds on the initial humanitarian shipment delivered in April 2025, which was coordinated through Professor Fiona Wood AO and UK defence surgeons supporting battlefield trauma programmes.
The corporate donor coalition that purchased the additional devices comprises:
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Wyllie Group
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Andrew Forrest’s Minderoo Foundation
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Canaccord Genuity Australia
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Gilbert + Tobin
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Device Technologies Australia
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Bell Potter
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Argonaut Securities
The scale of the need remains substantial. Current estimates indicate that more than 400,000 Ukrainians, including children, have sustained trauma-related injuries during the conflict, creating ongoing demand for advanced reconstructive and nerve repair technologies.
Why Remplir matters: the science of nerve repair
Remplir is a collagen medical device used to repair damaged peripheral nerves, the nerves that carry signals between the brain, spinal cord and the rest of the body. It is made from pure collagen and, in clinical practice, creates a bioactive healing chamber to support new tissue formation and integration.
This differs from the traditional approach. Suturing nerves can place delicate tissue under tension, which may cause scarring, fibrosis and neuroma formation, all of which can compromise recovery.
The device serves three clinical purposes: connecting severed nerves following trauma, protecting repaired or decompressed nerves after injury or surgery, and capping nerve endings following amputations or other procedures to support improved patient outcomes.
| Feature | Patient / Surgical Benefit |
|---|---|
| Bioactive healing chamber | Supports new tissue formation and integration |
| Patented technology | Differentiated approach to nerve repair |
| Reduces or eliminates sutures | Faster, easier surgical procedure |
| Pure collagen construction | Avoids tension-related scarring and fibrosis seen with suturing |
Real-world battlefield use accelerates surgeon education and familiarity with the device ahead of any commercial launch in new markets.
Clinical validation from the battlefield
Remplir devices have been used to treat several severe trauma injuries sustained during the conflict, including peripheral nerve injuries associated with amputations, blast trauma and nerve crush injuries.
The initial April 2025 shipment generated substantive clinical data, with Remplir used in 23 combat surgeries on Ukrainian troops across a range of peripheral nerve injuries, with surgeon feedback described as very positive and remote training delivered via video by Australian orthopaedic surgeon Dr Alex O’Beirne.
Alongside the device shipments, Orthocell is supporting a peer-to-peer surgeon training programme in partnership with The Ukraine Crisis Appeal. This was anchored by a recent Nerve Symposium held in Sydney, Australia, advancing knowledge-sharing in reconstructive surgery, peripheral nerve repair and trauma management.
Paul Anderson, CEO and Managing Director
“Feedback from surgeons about the clinical utility of Remplir in practice has been extremely positive. Remplir devices have already been used in the treatment of several severe trauma injuries sustained during the ongoing conflict in Ukraine, including peripheral nerve injuries associated with amputations, blast trauma, and nerve crush injuries.”
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The commercial pathway: from humanitarian use to global launch
The clinical experience gained through real-world use in Ukraine is expected to support surgeon education and the initial commercial launch following anticipated regulatory clearance in the EU and UK.
Remplir was cleared by the US Food and Drug Administration (FDA) in April 2025, described as the largest healthcare market in the world. The device’s current regulatory footprint and next catalyst are as follows:
Remplir’s US commercial rollout has built early momentum since the April 2025 FDA clearance, with 19 active hospital customers, a repeat usage rate of approximately 70%, and a cash runway of around $50 million supporting multi-market expansion without near-term capital pressure.
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United States (FDA cleared, April 2025)
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Australia, New Zealand and Singapore (distributed by Device Technologies Group)
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Canada, Thailand and Hong Kong
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EU and UK, with clearance expected 2H CY2026 (next catalyst)
The anticipated EU and UK clearance is an anticipated regulatory milestone. By building surgeon familiarity and accumulating real-world clinical evidence through the humanitarian programme, Orthocell is positioned to enter these markets with an established base of clinical experience supporting the launch.
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