Orthocell Achieves Strongest Month of U.S. Remplir™ Sales Since Launch

• Remplir™ is a collagen nerve wrap designed to support the repair and protection of peripheral nerves. Designed and manufactured by Orthocell Ltd in Australia, the FDA-cleared device is emerging as a category leader in key international markets.
• Sales of 92 Remplir™ units in October 2026 generated AU$279,000 in revenue, representing an 84% uplift on average monthly sales of 50 units during Q1 FY27.
• The groundwork laid to launch Remplir in the U.S. is now translating into tangible revenue as Orthocell's commercial strategy gains traction.
• The result reflects growing surgeon adoption, increasing repeat use, a broader base of actively selling distributor representatives and expanded hospital access across key U.S. markets.
• October's performance provides encouraging evidence of strengthening U.S. commercial momentum and supports the outlook for continued Remplir revenue growth.

PERTH, Australia, Nov. 1, 2026 — Orthocell Limited (ASX: OCC) is pleased to provide an update on U.S. commercial performance for its nerve repair product, Remplir™, following the completion of October 2026 trading. The update is being provided ahead of the Company's Annual General Meeting on 6 November 2026, with standard quarterly reporting to continue thereafter.

Orthocell achieved U.S. sales of 92 Remplir units in October, generating AU$279,000 in revenue and representing an 84% uplift on the average monthly sales of 50 units during Q1 FY27.

This represents the strongest month of U.S. sales since launch and reflects growing surgeon adoption, increasing repeat utilisation, an expanding network of actively selling distributor representatives and broader hospital access across key U.S. markets. These results demonstrate progress in converting expanded market access into increased product utilisation and revenue.

Orthocell CEO and MD, Paul Anderson, said: "October represents an important milestone in Orthocell's U.S. commercialisation, with the groundwork laid over the past 12 months now translating into tangible revenue.

"The improvement in key commercial indicators demonstrates that Remplir is gaining traction in the U.S. market. While establishing a new medical technology in a large market takes time and sustained effort, our focus remains on accelerating surgeon adoption, expanding hospital access and increasing product utilisation."

Commercial Growth Accelerating

Orthocell has consistently communicated that commercialisation of innovative medical technologies follows a progressive adoption pathway as surgeons gain familiarity with new treatment options and hospital access expands through Value Assessment Committee (VAC) approvals.

October's performance represents a significant uplift in U.S. sales, reflecting progress in converting expanding market access into commercial utilisation. This U.S. progress, combined with regulatory approvals across seven international jurisdictions and established manufacturing capability, provides a foundation for continued commercial growth.

Orthocell will continue to focus on expanding surgeon adoption, strengthening its active distributor network and growing Remplir utilisation across approved markets to support sustainable revenue growth.

Orthocell Chairman, John Van Der Wielen, commented: "The Board is encouraged by the October sales result and the progress achieved in U.S. commercialisation. Orthocell has invested in the commercial infrastructure required to support Remplir's expansion and is continuing to expand its manufacturing capacity in anticipation of increased demand.

"The Board remains confident in the product's significant U.S. market potential and the Company's strategy to translate growing market adoption into long-term commercial success."

SOURCE Orthocell Limited