Paul Anderson, managing director of Orthocell Ltd (ASX:OCC), provides Proactive with an update on the Remplir™ market authorisation study. The first stage of this crucial study has concluded successfully, with all nerve repair surgeries performed without adverse events, using a rat sciatic nerve injury model to evaluate Remplir’s safety and efficacy.
This milestone is significant for Orthocell's global expansion and pursuit of US market clearance, expected in the early months of 2025. The study, led by Professor Bill Walsh, assessed Remplir's impact on sensory and motor function recovery and nerve regeneration quality. With the surgical phase completed, Orthocell is set to advance to the remaining stages of the study, aiming for completion in the third quarter of this year.
Orthocell is also on schedule to submit its 510K market authorisation application to the US Food and Drug Administration (FDA) in the fourth quarter of 2024, with sales anticipated to commence shortly after approval.
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