ClearPoint Neuro (CLPT) said late Wednesday the US Food and Drug Administration has granted de novo marketing authorization for its SmartFlow Neuro Cannula for the delivery of PTC Therapeutics' (PTCT) Kebilidi gene therapy to targeted regions within the brain.
Kebilidi is indicated for the treatment of aromatic L-amino acid decarboxylase deficiency, a genetic disorder that typically results in disability, the company said.
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