• First US surgery using Orthocell's Remplir nerve repair device
• Crucial step in the rollout of Remplir in the significant US$1.6 Billion US market
• Surgical case sourced from Orthocell's growing US distributor network

Orthocell Limited (ASX:OCC) has announced the successful completion of the first US surgery using its flagship nerve repair product, Remplir. The procedure was performed at a hospital in Ohio and observed by Orthocell's dedicated Medical Education team. The surgery used Remplir manufactured at Orthocell's facility in Perth, Western Australia. This first US use of Remplir follows the product's US FDA 510(k) clearance in April 2025 and the subsequent appointment of 14 specialist distributors to drive adoption across key regions. The surgical case was sourced directly from Orthocell's established and growing US distributor network, which now includes 14 specialist nerve distributors with mature, direct-to-surgeon, hospital and other customer relationships across 25 US states. Orthocell's in-house Marketing, Medical Affairs and Sales executives are working closely with the distributor network and making significant headway on the Remplir rollout. Remplir is a collagen wrap used in nerve repair surgery to improve regeneration of damaged nerves and patient outcomes, supported by robust clinical evidence.

Orthocell has a strong balance sheet with approximately ~AU$30 million cash at bank and no debt, and is well funded to continue to broaden its commercial footprint and grow revenues in existing and new markets.

Orthocell is targeting a large global addressable nerve repair market estimated to be worth in excess of US$3.5 billion, with an estimated ~2.0M peripheral nerve repairs performed across key regions. The Company is confident its efforts in the US are on track to drive material growth in sales of Remplir during the second half of calendar 2025.