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%
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