Orthocell Secures Approval to sell Remplir™ to the U.S. Department of Defence Hospital Network

USA - English

• APAC - English
• APAC - Traditional Chinese

• Orthocell receives approval for Remplir™ to be used across the United States Department of Defence (DoD) and Veterans Affairs (VA) hospital networks, comprising:
  • 51 DoD military hospitals; and
  • 170 Veterans Affairs (VA) medical centres
• For context, Orthocell has already secured 32 Value Analysis Committee (VAC) approvals providing access to over 115 hospitals, with a further 57 VAC applications currently pending approval^[1]
• Orthocell will now leverage its existing U.S. distributor network to target military and VA surgeons operating within these hospital systems. The Company's distributor network currently covers 17 states
• This approval comes at a time when Orthocell is seeing clear evidence of increasing commercialisation and revenue momentum in the U.S. market
• Remplir has already demonstrated its value in conflict-related injuries in Ukraine, with multiple surgical procedures performed, highlighting its suitability for the types of trauma commonly encountered within military healthcare systems

PERTH, Australia, April 16, 2026 /PRNewswire/ -- Regenerative medicine company Orthocell Limited (ASX: OCC, "Orthocell" or the "Company") is pleased to announce it has secured approval for its Remplir™ nerve repair device to be used across the United States Department of Defence (DoD) and Veterans Affairs (VA) hospital networks.

This approval provides access to approximately 51 DoD military hospitals and 170 VA medical centres across the United States, representing a significant milestone in expanding Orthocell's access to the U.S. market.

Orthocell's established U.S. distributor network, which currently covers 17 states, will now target military and VA surgeons operating within these hospital systems. A significant portion of these facilities could be serviced by the Company's existing distribution footprint, supporting efficient market penetration.

This expansion into the defence setting follows the recent clinical use of Remplir in 23 surgical procedures on injured soldiers in Ukraine, across both primary and secondary nerve repair applications.

The Ukraine experience demonstrates the real-world performance of Remplir in a conflict environment and highlights key attributes of the device, including its portability, ease of use, and suitability for treating major traumatic injuries commonly encountered in military settings.

Orthocell believes this validation further supports Remplir's applicability within defence healthcare systems and reinforces its potential to address the needs of military surgeons treating complex nerve injuries.

Orthocell Managing Director Paul Anderson said: "Securing access to the U.S. Department of Defence and Veterans Affairs hospital networks is a significant milestone for Orthocell and a major step forward in our U.S. commercial strategy.

This approval enables us to engage directly with military and VA surgeons treating complex nerve injuries and to leverage our existing distributor network to drive adoption of Remplir across these key institutions.

Importantly, Remplir has already demonstrated its value in conflict-related injuries in Ukraine, highlighting its suitability for the types of trauma commonly encountered within military healthcare systems.

Orthocell is well positioned to capitalise on this expanded access with its existing network of distributors and in-house sales and medical education teams, and will continue to pursue opportunities to increase utilisation of Remplir across key U.S. healthcare segments, including military and veteran care.

^[1] As at 31 March, 2026

Release authorised by:
Paul Anderson
Orthocell Ltd CEO and MD

For more information, please contact:

About Orthocell Limited 
ACN 118 897 135
Registered Office – Building 191 Murdoch University, 90 South Street, Murdoch WA 6150 Australia

Orthocell is a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of bone and soft tissue injuries. Orthocell's portfolio of products include a platform of collagen medical devices which facilitate tissue reconstruction and healing in a variety of dental and orthopaedic reconstructive applications. Striate+™ was the first product approved for dental GBR applications, is cleared for use in the US, Australia, New Zealand, Singapore, UK, Europe, Canada and Brazil and is distributed globally by BioHorizons Implant Systems Inc. Remplir™, for peripheral nerve reconstruction, recently gained clearance for use in the US. The Company has appointed a network of specialist US distributors and recorded initial sales. The Company's flagship nerve repair product is also approved in Australia, New Zealand and Singapore where it is distributed by Device Technologies Group. Other Remplir approvals include Thailand, Canada and Hong Kong. SmrtGraft™, for tendon repair, is available in Australia under Special Access Scheme or participation in a clinical trial. The Company's other major products are autologous cell therapies which aim to regenerate damaged tendon and cartilage tissue.  Orthocell is accelerating the development of its tendon cell therapy in the US with technology transfer and FDA engagement to confirm the path to the US market and prepare for partnering discussions.    

For more information on Orthocell, please visit www.orthocell.com or follow us on Twitter @Orthocellltd and LinkedIn www.linkedin.com/company/orthocell-ltd

Forward Looking Statement

Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, and other statements containing the words "anticipate," "believe," "estimate, "expect," "intend," "may," "plan," "predict," "project," "target, "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company's ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company's ability to obtain marketing approvals for is product candidates. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

SOURCE Orthocell Ltd