Proactive’s Tylah Tully breaks down ‘Just the Facts’ of the latest news from Orthocell Ltd (ASX:OCC, OTC:ORHHF).
The company has completed a pivotal US FDA 510(k) regulatory study for its nerve repair device, Remplir™, demonstrating its safety and efficacy in peripheral nerve surgery. This marks a critical step towards gaining US market clearance. The study met all required endpoints using a rat sciatic nerve model, showing that Remplir effectively regenerates nerves with outcomes comparable to an FDA-approved control.
Key findings included restored motor and sensory functions, absence of adverse tissue reactions and high-quality nerve regeneration within 12 weeks post-treatment. Orthocell highlighted the results as a validation of Remplir’s superior clinical outcomes, previously published in a peer-reviewed journal.
The company remains on schedule to submit its 510(k) application this month with FDA clearance anticipated in the first quarter of 2025. Upon approval, Orthocell aims to enter the US$1.6 billion nerve repair market. Remplir is already approved in Australia, New Zealand and Singapore, with increasing adoption by surgeons.
Orthocell has cash reserves of approximately A$33 million, which support its planned US commercial launch and further global expansion. The company has also appointed US sales and medical affairs teams to prepare for market entry and is poised to establish distribution partnerships following FDA clearance.