Regulators clear Orthocell’s nerve repair product for sale in Canada
Following news last week that it has begun appointing distributors for Remplir in the United States, Orthocell has announced clearance to begin selling the nerve repair product in Canada, a market it estimates to be worth $US 75 million.
In an ASX statement on Wednesday, Orthocell said it has received a Medical Device Licence (MDL) from Health Canada — a federal department responsible for regulating medical products — after an application was lodged in February this year.
Orthocell CEO and MD, Paul Anderson, said: “Each new regulatory approval is an important addition to the overall value of our product portfolio and our Company.
Orthocell added that it now intends to appoint “non-exclusive, local specialist distributors” to drive Canadian sales, with negotiations underway for this.
“Using this strategy, we’re expecting the recently approved jurisdictions for Remplir to start contributing revenue during the second half of calendar year 2025,” said Anderson.
The news follows approval by the United States Food and Drug Administration in April to sell Remplir in a market estimated to be worth $US 1.6 billion. The company’s figures show that the approval takes Remplir’s total addressable market for approved jurisdictions to US$1.8 billion.
It describes Remplir as “a collagen wrap used in nerve repair surgery to assist surgeons to improve outcomes in the repair and regeneration of damaged nerves.”
The product is made in Perth, using Orthocell’s proprietary SMRT technology, which is able to “preserve the natural collagen structure” and the “medical devices’ natural bilayer structure, which features smooth and rough sides, acts to both guide new tissue formation and protect the repair site.”
Picture: credit Orthiocell/Linkedin
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