Regenerative medicine company Orthocell Ltd (ASX:OCC, OTC:ORHHF) has wound up the first stage in its pivotal US market authorisation study for its lead asset Remplir™, paving the way to global expansion and US market clearance in the first months of 2025.
The study, a critical step towards securing US market entry, reported that all nerve repair surgeries were performed without any adverse events, setting the stage for subsequent phases of safety and effectiveness evaluation.
Sciatic nerve injury model
The study, led by Professor Bill Walsh of the Surgical and Orthopaedic Research Laboratories at the Prince of Wales Hospital and the University of New South Wales, employed a rat sciatic nerve injury model to assess Remplir’s safety and effectiveness.
With 72 rats divided across three study groups, the research aimed to measure recovery of sensory and motor function and the quality of nerve regeneration.
Completion of the surgical phase allows Orthocell to progress to the final two stages of the study, with the expectation that it will complete the process in the third quarter of this calendar year.
The company remains on track to submit its 510K market authorisation application to the US Food and Drug Administration (FDA) in the fourth quarter of 2024, eyeing first sales shortly after.
Orthocell managing director Paul Anderson said: “Remplir has been shown, in the previous pilot study, to be superior to the existing FDA-approved comparator device for nerve repair, restoring the sciatic nerve to its pre-injured state with no adverse reactions.
US market clearance
“Successful completion of stage one gives us confidence that the final two stages of the US market authorisation study will be consistent with the pilot study results, and the clinical performance of Remplir to date.
“This study is an important next step in our international market access program with the potential to provide data demonstrating the impact and advantages of using Remplir over traditional nerve repair methods.
“We are excited to be at this important stage in the development of this product and remain committed to providing patients access to this life-changing treatment.”
Non-executive director Professor Fiona Wood said: “Results from the first stage of the study are extremely exciting as it de-risks the pathway to US market clearance and is another positive step towards making this life-changing treatment accessible to patients worldwide.”