• Exclusive UK distribution agreement with LEDA Orthopaedics
• Regulatory submission to BSI for Remplir approval in UK/EU on track
• Early distributor appointment allows market access preparation ahead of approval

Orthocell Limited (ASX: OCC) has announced the appointment of LEDA Orthopaedics as the exclusive distributor for Remplir in the United Kingdom. The appointment follows Orthocell's recent regulatory submission to the British Standards Institution (BSI) in December 2025, seeking approval to commercially distribute Remplir in the UK/EU market valued at US$750 million. The submission process remains on track, with regulatory approval anticipated in Q3 2026. Appointing an exclusive distributor ahead of regulatory clearance allows Orthocell and LEDA Orthopaedics to commence market development activities in preparation for launch, including surgeon engagement, medical education, hospital procurement pathways, and distribution planning, enabling a rapid commercial launch following approval. LEDA Orthopaedics is a UK-based specialist distributor of orthopaedic implants and surgical technologies with a focus on innovative solutions for upper extremity, trauma, and reconstructive procedures, including peripheral nerve repair. The company maintains established relationships with orthopaedic surgeons nationwide and will support the rollout of Remplir in the UK through its network of over 40 direct sales representatives. Orthocell's Australian-based marketing and medical education teams will also support the UK rollout, leveraging the proven programs and clinical evidence that have underpinned the successful launch of Remplir in Australia and the United States. Remplir is already approved and selling in Australia, New Zealand, Singapore, the US, and Hong Kong, with first sales expected in Canada in the near term. Orthocell remains well funded, with circa $49.4 million cash reserves at 31 December 2025, providing a strong balance sheet to support its global distribution strategy, progress its EU and UK regulatory programs, and drive the ongoing commercial rollout of Remplir in existing and new markets.

Orthocell remains well funded, with circa $49.4 million cash reserves at 31 December 2025, providing a strong balance sheet to support its global distribution strategy, progress its EU and UK regulatory programs, and drive the ongoing commercial rollout of Remplir in existing and new markets.