Orthocell has announced the submission of its U.S. FDA 510(k) regulatory application for clearance to commercially distribute Remplir™ into the US$1.6 billion 1 U.S. nerve repair market.
Podcast | Frazis Capital Podcast
Orthocell CEO & MD, Paul Anderson, recently joined Micahel Frazis on the Frazis Capital Podcast.
Orthocell Achieves Major Milestone with First Sales of Remplir™ in Singapore
Orthocell has today announced the achievement of first sales of Remplir™ in Singapore, marking another significant milestone in its global commercialisation strategy.
The Australian Financial Review | Perth’s billionaires pile into medtech Orthocell
Orthocell has been featured in The Australian Financial Review in an article by Health Editor Michael Smith titled “Perth’s billionaires pile into medtech Orthocell”.
Orthocell successfully completes US FDA 510(k) regulatory study for Remplir™
Orthocell has today reached another significant milestone with the successful completion of its Remplir™ 510(k) nerve repair regulatory study, validating Remplir as a safe and effective biological medical device for use in the surgical repair of peripheral nerves.
The Australian Business Review | Orthocell leaps closer to FDA approval after pivotal nerve-repair product study success
Orthocell has been featured in The Australian Business Review, following today’s announcement that the US FDA 510(k) regulatory study of peripheral nerve-repair product Remplir meets all endpoints.
Orthocell Appoints Exclusive Distributor to Commence Sales of Remplir™ in Singapore
Orthocell has announced that it has appointed Device Technologies Asia as the exclusive distributor of market leading peripheral nerve repair device Remplir™ in Singapore.
Stockhead Long Shortz | No nerves as company enters US market
Orthocell Chairman John Van Der Wielen spoke with Stockhead to discuss the Company’s strategic positioning ahead of its US market entry, sharing insights on why Remplir represents a compelling investment opportunity.
Meet The Board | Independent Director, Dr. Ravi Thadhani
The fourth episode of Orthocell’s ‘Meet the Board’ video series is now live – featuring Independent Director, Dr. Ravi Thadhani.
Appointment of Key US Executives to Lead Remplir™ Launch
Orthocell has appointed two experienced US-based executives to drive the market launch and sales of Remplir™ following the expected US FDA approval in the first quarter of 2025.