Orthocell grows US distributors for nerve repair product to 12

Orthocell’s sales rollout for flagship nerve repair product Remplir has gathered pace with 12 US distributors appointed as it looks to capitalise on regulatory approval.

Orthocell is growing its US distributors for Remplir ahead of schedule. Pic via Getty Images.

• Orthocell grows US distributors of its flagship nerve repair product Remplir to 12

• Product granted US Food & Drug approval in April with signing of distributors ahead of schedule

• Remplir distributors now cover 21 US states with plans to continue growing distribution footprint

 

Special Report:  Perth-based regenerative medicine company Orthocell has taken the number of US distributors appointed for flagship nerve repair product Remplir to 12 as it looks to capitalise on US Food & Drug Administration (FDA) approval in April.

Orthocell (ASX:OCC) has added a further eight US distributors for trademarked Remplir, taking the total number of distributors in the US to 12.

The company said signing of distributors had progressed ahead of expectations after previously advising it was targeting to have 10 distributors in place by June 30.

Orthocell said the rapid signing of new distributors was a testament to the quality of Remplir and the distributor’s belief in being able to generate strong sales for the product in the US.

Remplir is a collagen wrap used in nerve repair surgery to assist surgeons improve outcomes in the repair and regeneration of damaged nerves.

The company announced on April 4 the product had been granted US FDA 510(k) clearance, paving the way for its commercial distribution in the world’s largest nerve repair market, estimated at US$1.6 billion (~A$2.bn).

Following the latest appointments, Orthocell’s distributor group collectively covers 21 US states.

Growing list of US distributors

These distributor relationships are non-exclusive and Orthocell plans to continue to sign additional distributors to expand access to the US.

The company said distributors would operate on a commission-based structure typical of US medical product distributor relationships, which was a cost-effective operating model.

Orthocell said that US distributors generally focused on specialist product lines within a given medical field in local geographic regions where they held trusted relationships with surgeons and hospitals.

Distributors will market and distribute Remplir for use in the surgical repair of peripheral nerves across their respective geographic regions.

They will undertake medical education, targeted promotion activities and initiate sales, as well as expanding the network of referring plastic and orthopaedic surgeons.

The distributor network will be managed by an in-house team of sales directors led by the US vice president of sales with a further four territory managers to support sales activities.

Orthocell said its internal management resources remained focused on the rollout of Remplir in the world’s largest healthcare market.

In addition to expanding its portfolio of distributors, Orthocell said on-the-ground sales and marketing and medical education executives were focused on training sales reps.

They were also submitting proposals to key hospitals to become approved suppliers, expanding a key opinion leader (KOL) panel and undertaking product roadshows in preparation for imminent first product use.

Orthocell said it was well positioned to achieve first sales of Remplir in the lucrative US nerve repair market in the near term.

Growing global footprint

April was a landmark month for Orthocell with Remplir also granted regulatory approval in Thailand and Canada.

Remplir is also approved for sale in Australia and New Zealand with regulatory applications for the EU and UK on track to be submitted in the next 6–12 months.

The company is targeting a large global addressable nerve repair market estimated to be worth more than US$3.5bn.

An estimated two million peripheral nerve repairs are performed annually across Australia/New Zealand, Singapore, USA, EU/UK, Canada, Brazil, Japan and Thailand.

With a strong balance sheet of $31.7m cash at March 31 and no debt, Orthocell is well funded to continue to broaden its commercial footprint and grow revenues in existing and new markets.

‘Well ahead of the targets’

Orthocell CEO and managing director Paul Anderson said it was very pleasing to see such rapid progress on expansion of the US distributor network so soon after receiving US FDA clearance.

“We’re well ahead of the targets we had set ourselves and expect that to translate to first US Remplir sales this quarter,” he said.

“Our US team has been working tirelessly leading up to the product launch and we’re confident we have the right strategy to drive market penetration of the US.

“For us, that means a combination of experienced internal employees complemented by a portfolio of distributors who have active sales channels to reach and engage our customers.”

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Orthocell grows US distributors for nerve repair product to 12