Orthocell (ASX:OCC) submitted a 510(k) application with the US Food and Drug Administration to sell its Remplir nerve repair device in the US market, according to a Thursday filing with the Australian bourse.

The submission is based on a regulatory study of Remplir, which met all the endpoints and provided key data to support the application, the filing said.

The 90-calendar day review process is expected to start between March and April 2025, with commercial distribution expected soon after, the filing said.

Shares fell nearly 5% in midday trade Thursday.

Price (AUD): $1.20, Change: $-0.06, Percent Change: -4.78%