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The clearly established history across global regulatory bodies is expected to de-risk BioPharma partners' pathways towards achieving global scale and standardization.
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 6, 2025 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan. This most recent batch of strategically selected geographical clearances establishes a total of 34 countries worldwide in which BioPharma partners will have a reliable and familiar delivery system for clinical use. Each clearance is intended to serve programs with regional clinical trial needs by simplifying trial design, and longer term should provide partners with expanded pathways for achieving global commercial scale.
The company plans to demonstrate US-cleared products at the 75th Annual Congress of Neurological Surgeons (CNS) in Los Angeles October 13th-15th.
The SmartFlow Neuro Cannula has received 510(k) clearance from the FDA for the aspiration of CSF, injection of the chemotherapy drug Cytarabine into the ventricles, or delivery of the gene therapy KEBILIDI to the brain parenchyma. This device is not intended for implant and is single patient use. Not all products are cleared in all territories.
Posted In: CLPT
