Orthocell has appointed 12 US distributors for its nerve repair product Remplir™, well ahead of the expected target of 10 distributors by 30 June.
Orthocell has secured a Medical Device Licence from Health Canada for Remplir™, opening access to the US$75 million Canadian nerve repair market.
Orthocell has been granted a licence by the Food and Drug Administration of Thailand to commence sales of Remplir™ into the significant and growing US$84 million Thai nerve repair market.
Orthocell has appointed four US distributors for its flagship nerve repair product Remplir™, enabling the commencement of commercial distribution into the US.
Orthocell Chair John Van Der Wielen spoke with Ausbiz about the Company’s ramp up in the US.
Orthocell has announced that Brazilian Health Regulatory Agency, ANVISA, has granted regulatory approval for the Company’s market-leading dental membrane, Striate+™, allowing the Company to commence sales in the large and important market of Brazil.
Orthocell’s recent FDA clearance made headlines on 7 News this week, with journalist Alice Murray showcasing the human impact of our nerve repair technology.
Orthocell welcomed 9 News journalist Michael Stamp to Orthocell HQ last week to film an in-depth segment about our FDA clearance for the nightly news.
Orthocell has announced that the US Food and Drug Administration has granted regulatory clearance under the 510(k) pathway for the Company’s nerve repair product, Remplir™
Orthocell has today announced that our exclusive global distribution partner BioHorizons has officially completed first sales of Orthocell’s dental product, Striate+™, in Germany, Austria and Switzerland.