Biotech firm Orthocell is a step closer to its nerve repair device Remplir being approved in the US, following the completion of its US regulatory study.
Biotech firm Orthocell is a step closer to its nerve repair device Remplir being approved in the US, following the completion of its US regulatory study.
The study – which found Remplir to be safe and effective for the surgical repair of nerves in the US – is a key component of the company’s upcoming submission to the Food and Drug Administration this month.
Orthocell told the market it met “all required endpoints and outcomes”, which were consistent to a pre-existing FDA-approved nerve repair control device.
Should the FDA approve Remplir – a collagen-based wrap which augments nerve repair surgery by applying compression – early next year, commercial distribution would likely begin shortly after.
“We are thrilled with the results from our US regulatory study, validating the superior Remplir clinical outcomes, previously published in a highly regarded, peer reviewed journal,” Orthocell managing director and chief executive Paul Anderson said.
“The study results provide key data for the FDA submission to gain market clearance and start selling Remplir in the US.
“We believe Remplir will redefine the nerve repair market and become an important element in the success of nerve repair surgery.”
Orthocell chief scientific officer Professor Minghao Zheng also told the market that the study found that no scarring or induced inflammation occurred following the use of Remplir.
Monday’s update follows news last month that the John Van Der Wielen-chaired company had secured a deal with Device Technologies Asia as its exclusive distributor of Remplir in Singapore, following approval from the Health Sciences Authority in October.
Sales of Remplir will begin in Singapore early next year, along with its existing markets of Australia and New Zealand.
In late-October, Murdoch-based Orthocell tapped investors for $17 million in order to fund its proposed US-based launch. Presently, the company has around $33 million cash in the till with no debt.
Orthocell closed trade up 7 per cent to 87 cents.
