Latest Orthocell (ASX:OCC) News

Orthocell Limited reports an 81.1% overall treatment success rate from its Remplir Real World Evidence study, reinforcing the product’s safety and efficacy as it expands sales in the US and prepares regulatory submissions for the EU and UK.

Orthocell Ltd reported a record $9.23 million revenue for FY25, driven by strong sales of its nerve repair and dental products, alongside securing US FDA clearance for its flagship nerve repair device Remplir. The company is poised for accelerated growth as it expands its global commercial footprint.

Orthocell has achieved a significant milestone by recording its first US sales revenue for Remplir™, its flagship nerve repair product, shortly after FDA clearance and initial surgical use.

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.

Orthocell Limited has posted a record quarterly revenue of A$2.73 million, driven by strong Australian sales of its nerve repair product Remplir™, with US market expansion poised to accelerate in FY26.

Orthocell has marked a pivotal milestone with the first US surgical use of its Remplir™ nerve repair device following FDA clearance, setting the stage for commercial expansion in a $1.6 billion market.

Orthocell’s new study confirms Remplir™ delivers superior nerve regeneration and faster muscle recovery compared to traditional sutures, bolstering its US market rollout plans.

Orthocell has secured regulatory approval to sell its nerve repair product Remplir™ in Hong Kong well ahead of schedule, expanding its footprint across key global markets. This milestone complements recent clearances in the US, Canada, and Asia, positioning the company for significant growth in a multi-billion-dollar market.

Orthocell has rapidly expanded its US distributor network for Remplir™, surpassing its target ahead of schedule and positioning itself for imminent sales in the $1.6 billion nerve repair market.

Orthocell has secured Health Canada approval for its nerve repair product Remplir™, adding the US$75 million Canadian market and expanding its total addressable market to US$1.8 billion. The company plans to appoint local distributors and expects first sales in H2 2025.

Orthocell Limited has reported a third consecutive quarter of record revenue, driven by strong sales growth and strategic market expansions, including a key US FDA submission for its nerve repair product Remplir™.