• Orthocell records first US sales revenue from Remplir nerve repair product
• Follows first surgical use of Remplir on June 26 and subsequent early cases
• Transition from US FDA 510(k) clearance to first sales revenue in just over 3 months

Orthocell Limited (ASX:OCC) has recorded its first sales revenue from its flagship Remplir nerve repair product in the US$1.6 Billion US market. This critical milestone in the commercialization of Remplir follows the first surgical use of the product on June 26, 2025 and subsequent early surgical cases. The achievement marks a transition from US FDA 510(k) clearance for Remplir to first sales revenue in just over three months. The early surgical cases have been an important real-world validation of the order fulfillment process and associated customer invoicing requirements. Orthocell CEO Paul Anderson said the rapid transition from regulatory clearance to first sales revenue is a testament to the company's US roll out plan, including key internal hires, appointing specialist distributors, manufacturing ramp up, and working with a US logistics partner. The early-stage day surgery cases are an ideal starting point to build familiarity and knowledge, leading to widespread adoption and revenue growth, similar to the successful approach taken in Australia.

Orthocell has a strong balance sheet with approximately $28.6 million cash at bank (as at 30 June 2025) and no debt, and is well funded to continue broadening its commercial footprint and grow revenues in existing and new markets.

Orthocell expects to follow a similar path to widespread adoption and revenue growth for Remplir in the US as it has successfully undertaken in Australia, albeit on a far larger scale. The company is confident its efforts in the US are on track to drive growth in Remplir sales during the second half of calendar 2025.