ClearPoint Neuro, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for its SmartFlow Neuro Cannula through the De Novo pathway. This authorization is a critical step for the company's biologics and drug delivery segment.
The SmartFlow Neuro Cannula is specifically intended for the intraputaminal administration of PTC Therapeutics' gene therapy KEBILIDI™ (eladocagene exuparvovec-tneq). This therapy is designed for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency, a rare and life-threatening neurological disorder.
This FDA authorization establishes the SmartFlow Neuro Cannula as the only device approved to deliver the first disease-modifying treatment for AADC Deficiency in the United States. This unique positioning underscores ClearPoint Neuro's essential role in enabling advanced neuro-therapies.
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