Orthocell Limited (ASX: OCC) has appointed 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) seeking approval to commercially distribute Remplir in the UK/EU. The submission process remains on track, with regulatory approval anticipated in the second half of calendar year 2026.
LEDA Orthopaedics is a UK-based specialist distributor of orthopaedic implants and surgical technologies. Founded in 2013 and headquartered in Huntingdon, the company focuses on innovative solutions for upper extremity, trauma and reconstructive procedures.
Appointing an exclusive distributor ahead of regulatory clearance allows Orthocell and LEDA Orthopaedics to commence market development activities in preparation for launch. These activities include surgeon engagement, medical education, hospital procurement pathways and distribution planning, enabling rapid commercial launch following approval.
Orthocell CEO and MD, Paul Anderson said
“The UK represents an important growth market for Remplir, and we are pleased to partner with LEDA Orthopaedics to support our future commercial rollout.
“LEDA brings deep expertise in orthopaedic distribution and established relationships with surgeons performing complex upper limb and nerve repair procedures. Their network and clinical focus align closely with Remplir’s target surgeon base.
“Appointing LEDA ahead of regulatory approval allows us to prepare the market through surgeon education and engagement, positioning Orthocell for a rapid commercial launch following approval.”