Orthocell has appointed its first four distributors in the United States for its nerve repair product, Remplir, in a move that signals the company’s entry into the world’s largest market for nerve repair solutions.
The appointments follow the recent clearance of Remplir by the US Food and Drug Administration (FDA) under the 510(k) process on 3 April 2025, enabling its immediate commercial distribution in the country.
The Perth-based regenerative medicine company expects initial sales in the US to commence in the near term, leveraging the existing relationships its distributors have with surgeons and hospitals in key regions including Michigan, Virginia, Colorado and Indiana.
“We have been working closely with a number of distributors in the United States in advance of our recently received FDA 510(k) clearance and welcome them on board as our first partners in the US,” said Orthocell Managing Director and CEO, Paul Anderson.
“We are looking forward to our distributor network helping us to drive Remplir sales, and as a company, we are primed and ready to deliver Remplir into the US.”
Each of the appointed distributors specialises in nerve repair and will be responsible for marketing Remplir, undertaking medical education, and conducting targeted promotional activities within their designated regions.
They will also play a role in expanding Orthocell’s network of plastic and orthopaedic surgeons. These distribution agreements will operate on a commission-based structure, a model commonly used in the US medical device sector.
According to Orthocell, extensive pre-launch preparations have positioned the company to enter the USD 1.6 billion US nerve repair market swiftly. Manufacturing and logistics systems are in place, and the company has built significant inventory levels to meet anticipated demand.
Anderson noted that the distributor model is a strategic choice for entering the US market, offering scalability and localised expertise without the need for a large in-house salesforce.
“It allows us to partner with distributors that have existing strong relationships and established sales channels with both surgeons and hospitals which means we only need a small, but experienced, on-the-ground team of in-house employees,” he said.
“We are expecting to have ~10 distributors in place by the end of our financial year which would account for representation in approximately 25 states.”
Remplir is a collagen wrap used in peripheral nerve repair surgery to enhance the repair and regeneration of damaged nerves.
The product is already approved for sale in Australia, New Zealand, and Singapore, with regulatory approvals in Canada and Thailand expected within six months.
Orthocell also plans to submit applications for approval in the European Union and United Kingdom within the next 6 to 12 months.
Orthocell is targeting a global nerve repair market estimated to exceed USD 3.5 billion, with approximately 2 million procedures performed annually across key international markets.
As of 31 March 2025, the company reported AUD 31.7 million in cash and no debt.
