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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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 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 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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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 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™.
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Orthocell has submitted a regulatory application to the FDA of Thailand to commence sales of its groundbreaking nerve repair device Remplir™, with clearance expected in Q3 CY2025.
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Orthocell has announced it has submitted an application to Health Canada for a Medical Device Licence (MDL) to sell its leading nerve repair product Remplir™ into the US$75 million Canadian nerve repair market.
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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.
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Orthocell has today announced the achievement of first sales of Remplir™ in Singapore, marking another significant milestone in its global commercialisation strategy.
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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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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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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.
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Orthocell has today announced that it has received firm commitments for a $17 million capital raising via an institutional placement.
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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, Remplir™
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Orthocell has announced that it has successfully completed the first stage of the Remplir™ US 510(k) market authorisation nerve repair study.
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Orthocell has today announced that the Company has submitted a regulatory application to the Health Services Authority of Singapore for approval to market and sell Remplir™ for use in peripheral nerve repair procedures.
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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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Orthocell has appointed Device Technologies as the exclusive distributor of Remplir™ for peripheral nerve repair in Australia.
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Orthocell’s Remplir™ device has gained Australian regulatory (Therapeutics Goods Administration) approval, representing a paradigm shift in product design and application for complex and often life-changing nerve repair procedures.
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