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ClearPoint Neuro Announces FDA De Novo Marketing Authorization of SmartFlow Cannula for Direct Delivery of Gene Therapy to the Brain
Only Device Approved to Deliver First Disease-Modifying Treatment for AADC Deficiency in the United StatesSOLANA BEACH, CA / ACCESSWIRE / November 13, 2024 /
About this update from Clearpoint Neuro Inc.
[{"type":"text","content":"Only Device Approved to Deliver First Disease-Modifying Treatment for AADC Deficiency in the United StatesSOLANA BEACH, CA / ACCESSWIRE / November 13, 2024 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the \"Company\"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced the U.S. Food and Drug Administration (FDA) 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™ (eladocagene exuparvovec-tneq) for the treatment of aromatic L-amino acid decarboxylase (AADC) 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. \"Today is one of the most important strategic milestones in the history of our company,\" commented Joe Burnett, President and CEO at ClearPoint Neuro. \"FDA's granting of this De Novo classification is the culmination of years of disciplined co-development, creative problem solving, and tireless efforts. We could not be prouder of the PTC and ClearPoint Teams and how we have worked together. Most importantly, we are thrilled and humbled that children with this terrible disease will now be treated with the first-ever neuro gene therapy available commercially in the United States.\"\"I am proud to have served as a PI in the trial supporting today's landmark approvals,\" stated Dr. Daniel Curry, Director, Functional Neurosurgery and Epilepsy Surgery at Texas Children's Hospital and Professor, Neurosurgery and Surgery at Baylor College of Medicine. \"I have witnessed first-hand the positive impact these treatments have had on children with AADC Deficiency. Neurosurgeons are leading the way in this promising field to address the underlying genetic cause, and not just the symptoms, of devastating neurological disorders by delivering gene therapy directly to targets in the brain through dedicated platforms.\"\"Today's De Novo approval will give confidence to all our current and future biopharma partners that ClearPoint has the experience to help their cell and gene therapies cross the finish line,\" commented Jeremy Stigall, Chief Business Officer and Biologics and Drug Delivery Leader at ClearPoint Neuro. \"We offe...