News

Orthocell Receives Regulatory Approval for Remplir™ in Hong Kong

Orthocell has received regulatory approval from the Hong Kong Department of Health's Medical Device Division to commence sales of Remplir™ in the Hong Kong nerve repair market.

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ASX Announcements

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Orthocell US Remplir™ Sales Rollout Gains Pace with 12 Distributors Now Appointed Covering 21 States

Orthocell has appointed 12 US distributors for its nerve repair product Remplir™, well ahead of the expected target of 10 distributors by 30 June.

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Orthocell Secures Health Canada Approval for Remplir™ in US$75 million Canadian Market

Orthocell has secured a Medical Device Licence from Health Canada for Remplir™, opening access to the US$75 million Canadian nerve repair market.

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Orthocell Receives Regulatory Approval to Commence Sales of Remplir™ in US$84 million Thai 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.

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Company news

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Orthocell Appoints its First Four US Remplir™ Distributors

Orthocell has appointed four US distributors for its flagship nerve repair product Remplir™, enabling the commencement of commercial distribution into the US.

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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.

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Meet The Board | Independent Director, Dr. Ravi Thadhani

In this episode of Orthocell’s ‘Meet the Board’ video series, we feature Independent Director, Dr. Ravi Thadhani.

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Evidence

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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.

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Commencement of Nerve Repair Study

Orthocell (ASX:OCC) has announced the commencement of a nerve repair study aimed at supporting product marketing initiatives and international regulatory and reimbursement strategies for its nerve repair device, Remplir.

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Patient stories

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MEDIA | 7 News

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.

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MEDIA | 9 News

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.

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