Orthocell completes all nerve repair surgeries in Remplir US market authorisation study

Australian regenerative medicine company Orthocell (ASX:OCC) has announced it has completed the first stage of the Remplir US 510(k) market authorisation nerve repair study.

The company said all surgical repairs of severed nerves were performed with no adverse events reported. Completing the first stage enables Orthocell to progress with the final two stages of the study.

The company said it is on track to submit an application to the FDA in the fourth quarter of calendar year 2024 for clearance to sell Remplir to surgeons in the US for use in peripheral nerve repair surgeries.

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. 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.”

Professor Bill Walsh, the director of surgical and orthopaedic research laboratories at the Prince of Wales Hospital in Sydney and the University of New South Wales, is conducting the nerve repair study. The study is evaluating the safety and effectiveness of Remplir when used as a nerve wrap in peripheral nerve repair, compared to traditional repair methods.

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