ClearPoint Neuro Achieves Key Milestones With First U.S. Commercial Gene Therapy Infusions Using SmartFlow Device For AADC Deficiency

Author: Benzinga Newsdesk | August 04, 2025 04:37pm

ClearPoint Neuro, Inc. (NASDAQ:CLPT) ("Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced multiple key milestones demonstrating the progression of the Company's Biologics and Drug Delivery Portfolio including first commercial infusions in the United States, additional partners accepted for expedited review, creation of cell and gene infusion ICD-10 codes, and record clinical trial patients treated globally in the month of July.

The first commercial treatments for KEBILIDI™ (eladocagene exuparvovec-tneq), a gene therapy approved for pediatric and adult patients with aromatic L-amino acid decarboxylase (AADC) deficiency-a rare, life-threatening neurological disorder, have been performed in the United States using the Company's SmartFlow® Neuro Cannula. KEBILIDI is delivered directly to the putamen region of the brain through a stereotactic neurosurgical procedure.

The SmartFlow® Neuro Cannula is the only FDA authorized device indicated for use to administer KEBILIDI.

These groundbreaking treatment procedures were carried out by physician teams separately at hospitals in Texas and Boston, led by neurosurgeons who are part of the IGNITE (Image-Guided Biologic Therapies: Neurosurgeons Innovating Treatment Excellence) working group. The IGNITE consortium, which has been hosted and sponsored by the Company, focuses on driving the field of neuro gene and cell therapy forward, and recently published a peer-reviewed article in the Journal of Neurosurgery: https://thejns.org/view/journals/j-neurosurg/aop/article-10.3171-2025.1.JNS241967/article-10.3171-2025.1.JNS241967.xml

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