ClearPoint Neuro announces SmartFlow Neuro Cannula FDA authorization

ClearPoint Neuro (CLPT) “announced the U.S. Food and Drug Administration has granted marketing authorization for the SmartFlow Neuro Cannula using the De Novo pathway. The SmartFlow Neuro Cannula is intended for intraputaminal administration of PTC Therapeutics’ gene therapy KEBILIDI for the treatment of aromatic L-amino acid decarboxylase deficiency. This signifies the first-ever FDA marketing authorization of a device used to deliver gene therapy directly to regions of interest within the brain. AADC deficiency is a fatal, rare genetic disorder that typically causes severe disability and suffering from the first months of life, affecting every aspect of life-physical, mental and behavioral. The suffering of children with AADC deficiency may be exacerbated by episodes of distressing seizure-like oculogyric crises causing the eyes to roll up in the head, frequent vomiting, behavioral problems, and difficulty sleeping. The lives of affected children are severely impacted and shortened. Ongoing physical, occupational and speech therapy, and interventions, including surgery, also are often required to manage potentially life-threatening complications such as infections, severe feeding and breathing problems.”