Orthocell has received clearance from the US-based Food and Drug Administration to begin selling its nerve repair product Remplir in the country.
The Murdoch-based regenerative medicine company told the market it was fully funded for its rollout into the US nerve repair market – valued at $US1.6 billion – due to having $32 million in the till as of March 26 2025.
“I’m delighted to announce we have received FDA clearance for our market-leading nerve repair product,” Orthocell chief executive and managing director Paul Anderson said.
“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.”
Friday’s market update follows news earlier this year that John Van Der Wielen-chaired Orthocell had posted its third consecutive quarter of record revenue.
As of 7.58am AWST, Orthocell shares were up 2 per cent to $1.47.
