Orthocell Ltd (ASX:OCC, OTC:ORHHF) has appointed UK medical device distributor LEDA Orthopaedics as the exclusive in-country distributor for Remplir™, marking an early commercial step ahead of the company’s planned entry into the UK and broader European nerve repair market.
The appointment follows Orthocell’s December 2025 submission to the British Standards Institution seeking approval to sell Remplir in the UK and EU, a combined market the company values at US$750 million and estimates accounts for around 500,000 peripheral nerve repair procedures each year. Approval remains on track for a decision in Q3 FY26.
By locking in a distributor ahead of regulatory clearance, Orthocell is aiming to accelerate launch preparations, including surgeon engagement, medical education, hospital procurement pathways and distribution planning, so it can move quickly once approval is granted.
“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," Orthocell CEO and MD, Paul Anderson said. "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.”
UK launch groundwork begins before approval
LEDA Orthopaedics was founded in 2013 and is based in Huntingdon. It specialises in orthopaedic implants and surgical technologies for upper extremity, trauma and reconstructive procedures. The company has more than 40 direct sales representatives across the UK, along with a dedicated biologics business development manager to support the Remplir launch.
LEDA Orthopaedics Co-Founder and Director, Jonathan Bloy said, “We are delighted to partner with Orthocell to introduce Remplir to the UK market. LEDA Orthopaedics has a strong track record in bringing innovative orthopaedic and surgical technologies to surgeons across the UK, and we believe Remplir represents an important advancement in peripheral nerve repair. We look forward to working closely with the Orthocell team to build awareness and adoption of this technology throughout the UK surgical community.”
LEDA’s existing relationships with orthopaedic surgeons and its experience in peripheral nerve repair made it a strong fit for the product. The distributor also supplies technologies from partners including Skeletal Dynamics, Checkpoint Surgical, Groupe Lépine and Integrum, and supports surgeon training through cadaveric and hands-on education programs.
The UK rollout will also be supported by Orthocell’s Australian-based commercial, marketing and medical education teams, drawing on training programs and clinical data used in launches in Australia and the United States.
LEDA Orthopaedics Co-Founder and Director, David Plane said, “As a company, LEDA’s focus is on partnering with the world’s leading medical device manufacturers, to bring game-changing technology to UK surgeons and their patients. From the first minute we were introduced to Orthocell, we were blown away by their passion, professionalism and commitment to excellence. We can’t wait to launch Remplir to the UK’s orthoplastics and nerve repair specialists.”
Remplir is already approved and generating sales in Australia, New Zealand, Singapore, the US and Hong Kong. Orthocell expects first sales in Canada in the second half of FY26 as it continues to expand its international footprint.
The company has cash reserves of about $49.4 million at December 31, 2025, leaving it funded to support global distribution, progress regulatory programs in the UK and Europe, and continue the commercial rollout of Remplir in existing and new markets.