ORTHOCELL LIMITED — Capital/Financing Update 2025

Aug 12, 2025

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Commercialisation of Remplir™ into US$1.6B[1] US Market Continues to Build Momentum

Perth, Australia; 13 August 2025: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to provide an update on the continuing successful commercialisation of its flagship nerve repair product Remplir™ in the US.

Orthocell confirms the commercialisation of Remplir in the US continues to track in accordance with the Company’s plans and strategy. Ten surgeries have now taken place in the US using the product as familiarity and knowledge continues to build within the surgical community. Experience in existing markets, including Australia and Singapore, has demonstrated the importance of these early surgeries in the path towards more widespread adoption and therefore revenue growth.

In addition, the Company advises it has lodged 36 applications to hospital Value Assessment Committees (VACs) with 3 approvals already received. VACs review requests for use of new products, services, or technologies in their hospital assessing their clinical effectiveness, safety, and cost-effectiveness. VAC approval is an important and necessary step in achieving widespread surgical adoption in the US hospital system.

The hospitals targeted for VAC approval have been sourced from Orthocell’s network of US distributors, which covers 25 states, with specifically identified surgeons operating at the hospital required to recommend and support the application process.

Furthermore, Orthocell has now shipped 4,000 Remplir units to its US logistics provider, Uniphar, for use in US surgical procedures. All units have been manufactured at the Company’s manufacturing facility in Western Australia.

The Company has also hired two further on-the-ground employees in the US to support the US roll out, including a regional sales director with direct experience in the nerve repair product market.

Orthocell CEO, Paul Anderson, said : “We continue to make excellent progress in the US with surgeons building familiarity through early surgical procedures. We’ve seen the strategic importance of these early procedures in our successful market launches of Remplir in Australia and Singapore.

Our network of distributors remains an important avenue to market and they have been instrumental in identifying key hospitals for us to target VAC approvals. This is the next important step for us in order to achieve more widespread adoption of Remplir, which in turn will drive revenue generation for Orthocell.”

Release authorised by: Paul Anderson Orthocell Ltd CEO and MD

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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com

1 Estimated using referenced papers from both US and OUS databases and studies

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For more information, please contact:

General enquiries

Media enquiries Investor enquiries

Paul Anderson Haley Chartres Shaun Duffy Orthocell Limited H^CK Director VECTOR Advisors CEO and MD P: +61 8 9360 2888 P: +61 423 139 163 P: +61 404 094 384 E: paulanderson@orthocell.com.au E: haley@hck.digital E: sduffy@vectoradvisors.au

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 14 US distributors, with first sales expected to follow shortly. The Company’s flagship nerve repair product is also approved in Australia, New Zealand and Singapore and is distributed exclusively by Device Technologies Group. 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

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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.

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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com

1 Estimated using referenced papers from both US and OUS databases and studies