Orthocell Ltd has cleared the regulatory bar with the Food and Drug Administration (FDA), giving it the green light to start sales of nerve repair product Remplir in the US market.
World’s largest nerve repair market
The company is calling this a ‘landmark development’ that paves the way for commercial distribution of Remplir into the world’s largest nerve repair market, which has an estimated total addressable market value of US$1.6 billion (around A$2.5 billion).
Remplir is a collagen wrap used in nerve repair surgery to assist surgeons to improve outcomes in the repair and regeneration of damaged nerves.
The product will be manufactured at the company’s own factory in Perth and distributed in the US.
Orthocell says the logistics and sales pathway for entering the market are straightforward because of the product’s light weight and shelf-life of three years, which make it easily transported by air freight.
Better still, the company owns and controls the manufacturing process without debt or royalty liabilities, so it will retain all margins associated with the product.
Orthocell CEO and MD Paul Anderson said: “I’m delighted to announce we have received FDA clearance for our market-leading nerve repair product.
“We have been preparing in advance for this pivotal milestone, ramping up production from our facility in Perth and we have significant levels of inventory in place to deliver on early sales orders.
“Our sales, marketing and education team have made great progress identifying key opinion leaders, reputable reference sites and, most importantly, the distributors that we will work with to get Remplir into surgeons’ hands.
“We expect strong product adoption in the US, having experienced rapid sales traction in existing markets driven by the excellent feedback from surgeons in Australia, New Zealand and Singapore.”
Manufacture and distribution
Remplir product destined for the US will be manufactured at the company’s certified Good Manufacturing Practice facility in Perth, using its proprietary SMRT™ manufacturing technology developed in conjunction with Professor Minghao Zheng and the University of Western Australia.
The facility has the capacity to produce 100,000 collagen medical devices per annum without any material capital expenditure from Orthocell to support the initial US roll out.
No real competitors
Orthocell says competitor device penetration into the nerve reconstruction surgical market in the US is estimated at 10%, so Remplir will not be replacing an existing dominant incumbent product to gain meaningful market share.
A recently appointed team of experienced US-based marketing, sales and medical education executives will spearhead the launch.
Orthocell is prepared for the expected step change in revenue from the US, with annual medical device manufacturing capacity for 100,000 units in place, and capability for further modularised low capital manufacturing expansion.
Global domination
Orthocell boasts existing cash reserves of close to $32 million and says it is fully funded not just for the US roll out, but for the continued broadening of its commercial footprint and growth of revenues in existing and new markets.
Remplir is currently approved for sale in Australia, New Zealand and Singapore, with pending approvals in Canada and Thailand in the next six months.
Regulatory applications for the EU and UK are on track to be submitted in the next six to 12 months.
Orthocell is targeting a large global addressable nerve repair market estimated to be worth in excess of US$3.5 billion with around two million peripheral nerve repairs already performed across Australia/New Zealand, Singapore, USA, EU/UK, Canada, Brazil, Japan and Thailand.