Orthocell's (ASX:OCC) recently secured FDA clearance for its nerve repair product, Remplir marked a "major milestone" and "de-risking event" for the company, said Euroz Hartley in a Monday note.
The company received regulatory clearance from the US Food and Drug Administration for the product, under the 510(k) pathway, allowing sales in the US market, according to a Friday filing with the Australian bourse.
The research firm noted that the approval enables Remplir to access the $1.6 billion US nerve repair market.
Euroz Hartleys raised its price target from AU$0.97 to AU$1.19 while maintaining a hold rating.
The company's shares fell 4% on market close.
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