Orthocell has today reached another significant milestone with the successful completion of its Remplirâ„¢ 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 Remplirâ„¢ in Singapore
Orthocell has announced that it has appointed Device Technologies Asia as the exclusive distributor of market leading peripheral nerve repair device Remplirâ„¢ 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 Remplirâ„¢ Launch
Orthocell has appointed two experienced US-based executives to drive the market launch and sales of Remplirâ„¢ following the expected US FDA approval in the first quarter of 2025.
Equity Mates Podcast
Orthocell has been named as a biotech stock to watch on a recent episode the Equity Mates Investing Podcast.
Meet The Board | Chairman, John Van Der Wielen
The third episode of Orthocell’s ‘Meet the Board’ video series is now online – featuring Chairman, John Van Der Wielen.
Executive Series | Meet The Board | Professor Fiona Wood AM
In the second instalment of the ‘Meet The Board’ video series, we meet Professor Fiona Wood, a world-renowned plastic and reconstructive surgeon, and valued member of the Orthocell Board.
Orthocell Receives Regulatory Approval for Remplirâ„¢ in SingaporeÂ
Orthocell has received regulatory approval from the Health Sciences Authority (HSA) in Singapore, allowing the Company to commence sales of its market leading nerve repair product, Remplirâ„¢