Regenerative medicine company Orthocell (ASX:OCC) has appointed its first four US distributors of its nerve repair product Remplir.
Remplir received US FDA 510(k) clearance on 3 April, allowing for its immediate commercial distribution into the US.
It is a collagen wrap used in nerve repair surgery to assist surgeons in improving outcomes in repairing and regenerating damaged nerves. In addition to the US, Remplir is currently approved for sale in Australia, New Zealand, and Singapore, with pending approvals in Canada and Thailand within the next six months. Regulatory applications for the EU and UK will be submitted in the next six to 12 months, said the company.
Orthocell said its first four distributors specialise in nerve repair and have relationships in Michigan, Virginia, Colorado, and Indiana. The distributors will market and distribute Remplir for use in the surgical repair of peripheral nerves across their respective geographic regions, undertaking medical education, targeted promotion activities and initiating sales, as well as expanding the network of referring plastic and orthopaedic surgeons.
The distributors will operate on a commission-based structure typical of US medical product distributor relationships. Orthocell said it is well-positioned to achieve first sales of Remplir, having already undertaken extensive pre-launch activities on the expectation that FDA 510(k) clearance would be successfully received.
Orthocell CEO and managing director, Paul Anderson, said, “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. 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.
“The distributor model is an excellent fit for us in the US. 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. 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.”