Orthocell has announced that it has successfully completed the first stage of the Remplir™ US 510(k) market authorisation nerve repair study.
All surgical repairs of severed nerves were performed with no adverse events reported. This provides us with confidence that the final two stages, in which safety and effectiveness will be evaluated, will be consistent with the pilot study and positions the Company for US approval in 1Q CY25.
Top-line results from this study are expected in Q3 CY24, and Orthocell remains on schedule to submit its US 510(K) market authorisation application by the end of the year – with progression into sales soon thereafter.
Orthocell Managing Director, Paul Anderson, said:
“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.”
The US addressable market in peripheral nerve repair is estimated to be worth more than US$1.1 billion annually, with an estimated 700,000 procedures where Remplir could be used, completed each year.