FDA announcements or ClearPoint Neuro press releases

ClearPoint Neuro ($CLPT) Gains FDA Approval for SmartFlow Cannula, First Direct Gene Therapy Delivery to Brain, Shares Up 10.9%

Nov 14, 2024, 01:20 PM

ClearPoint Neuro, trading under the ticker symbol $CLPT, has received FDA De Novo marketing authorization for its SmartFlow Cannula, marking a significant advancement in the delivery of gene therapy directly to the brain. This approval is particularly notable as it represents the first direct local delivery of neurological gene therapy in the United States, aimed at treating severe diseases, primarily affecting young children. The stock has seen a positive response, with a pre-market increase of 10.9%. The authorization is expected to open up new opportunities in the field of gene therapy, potentially transforming treatment options for patients suffering from debilitating conditions.