Orthocell appoints first four distributors for Remplir nerve repair technology in the US

Regenerative medicine company Orthocell (ASX: OCC) has appointed the first four US distributors for the company’s flagship nerve repair product Remplir.

The move follows regulatory clearance from the US Food and Drug Administration earlier this month, which allowed for immediate distribution into the nation’s US$1.6 billion nerve repair market.

The four appointees are experienced nerve specialists operating in the states of Michigan, Virginia, Colorado and Indiana.

Network expansion

The new distributors will market and sell Remplir across their respective geographic regions, undertaking medical education, targeted promotional activities and initiating sales, as well as expanding the network of referring plastic and orthopaedic surgeons.

They will operate on a commission-based structure, supported by a significant Remplir inventory base that Orthocell has built up to meet projected US sales.

Orthocell expects the sales to drive a significant step change in revenue and provide the company with a pathway to breakeven and profitability.

Pre-launch activities

Managing director Paul Anderson said the new appointments were the result of extensive pre-launch activities the company’s sales, marketing and medical affairs teams conducted in the US.

“We have been working closely with a number of distributors in advance of the FDA clearance and we welcome them on board as our first partners in the US,” he said.

“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 region.”

Efficient path to market

Orthocell believes the distributor model represents Remplir’s most efficient path to market in the US while also providing a cost-effective operating structure for the company.

“This model is an excellent fit for us in the US, as it allows us to partner with distributors that have existing relationships and established sales channels with surgeons and hospitals,” Mr Anderson said.

“This means we only need a small, experienced logistics team on the ground.”

Orthocell is targeting an additional six US distributors by end-June, which would give the company representation in approximately 25 states.

Collagen wrap

Remplir – a collagen wrap used during surgery to improve outcomes in the repair and regeneration of damaged nerves – is currently approved for sale in the US, Australia, New Zealand and Singapore.

Orthocell is expecting additional approvals in Canada and Thailand within the next six months and is on track to submit regulatory applications for the European Union and the UK over the coming year.

The company is targeting a global addressable nerve repair market worth more than US$3.5b, with an estimated 2 million peripheral nerve repairs performed each year globally.

Manufacturing facility

Orthocell manufactures Remplir at its certified facility in Western Australia using the company’s proprietary SMRT technology, developed to preserve the collagen structure for optimal tissue integration.

The facility has the capacity to produce 100,000 collagen medical devices per annum and will not need Orthocell to provide any material capital expenditure in support of the initial US rollout.

An on-the-ground logistics partner will support the US distributors, using a central warehouse facility to co-ordinate order fulfilment and customer service.

Mr Anderson said logistics into the market would be straightforward, as Remplir is lightweight, has a shelf life of three years and can be easily transported by air.