Orthocell (ASX: OCC) has appointed medical device distribution company LEDA Orthopaedics as the exclusive distributor for collagen nerve wrap Remplir in the United Kingdom.
LEDA has more than 40 direct sales representatives across the UK and a dedicated biologics business development manager to support the product launch.
The company maintains relationships with orthopaedic surgeons across the nation and distributes a portfolio of premium technologies from global medical device partners supporting complex upper limb and nerve-related procedures.
LEDA’s appointment follows Orthocell’s regulatory submission to the British Standards Institution in December seeking approval to commercially distribute Remplir to the US$750 million UK and European Union markets, where an estimated 500,000 surgical repairs of peripheral nerves are completed each year.
The submission process remains on track, with regulatory approval anticipated before year end, which will allow Orthocell to commence market access preparation ahead of approval including surgeon engagement, medical education, hospital procurement, and distribution planning, enabling Remplir’s rapid commercial launch.
Important Growth Market
Orthocell chief executive officer Paul Anderson said the company was pleased to partner with LEDA to support Remplir’s rollout in an important growth market.
“LEDA brings deep expertise in orthopaedic distribution and established relationships with surgeons performing complex upper limb and nerve repair procedures and its clinical focus aligns closely with Remplir’s target surgeon base,” he said.
LEDA has extensive experience in orthopaedic technologies across upper extremity, trauma and reconstructive procedures, as well as peripheral nerve repair.
“Appointing LEDA ahead of regulatory approval allows us to prepare the market through surgeon education and engagement and positions us for a rapid commercial launch following approval.”
‘Commitment to Excellence’
“From the first minute we were introduced to Orthocell, we were blown away by their passion, professionalism and commitment to excellence,” LEDA co-founder David Plane said.
“We can’t wait to launch Remplir to the UK’s orthoplastics and nerve repair specialists.”
Remplir is already being distributed in Australia, New Zealand, Singapore, the US, and Hong Kong, while first sales are expected in Canada later this year.
The UK rollout will be supported by Orthocell’s Australian-based marketing and medical education teams, leveraging established surgeon training programs and clinical evidence which have supported launches in Australia and the US.
At end December, Orthocell had $49.4 million in cash reserves to support its global distribution strategy, advance its regulatory programs in the UK and Europe, and drive the continued commercial rollout of Remplir across new and existing markets.
