ClearPoint Neuro Announces Canadian Approval for its Navigation System Further Expanding Our Drug Delivery Ecosystem and Global Footprint

Combined clearance of the navigation and drug delivery technologies enables Canadian neurosurgery centers to leverage the Company's flagship image-guidance workflow and advances ClearPoint Neuro's overall global infrastructure in support of its strategy to enable 20,000 cell and gene therapy procedures annually.

SOLANA BEACH, CA / ACCESS Newswire / April 20, 2026 / 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 receipt of a Medical Device License (MDL) from Health Canada for its Neuro Navigation System, further expanding our Drug Delivery ecosystem and global footprint. Covering both ClearPoint MRI-guidance and new iCT-guidance workflows in Canada, the MDL builds on the previously announced therapy delivery product clearance for the SmartFlow Neuro Cannula received in October 2025. This milestone reinforces ClearPoint's role as a global leader in integrated navigation and therapy delivery solutions and will enable the Company's biopharma partners to operate Canadian clinical trial and commercial sites using the same platform and standardized workflow already in use in the United States.

Canada represents a strategically important market for cell and gene therapy development, given its concentration of leading academic medical centers, proximity to U.S. trial infrastructure, and established regulatory framework. With both the navigation and delivery components of ClearPoint's platform now cleared in Canada, biopharma sponsors can design Canadian trial sites with greater consistency in workflow, which may reduce trial complexity, minimize surgical variability, and accelerate the path from clinical development to commercial scale.

"What we announced in October established Canada as part of our 34-country regulatory network for therapy delivery," said Mary McNamara-Cullinane, Senior Vice President of Regulatory Affairs at ClearPoint Neuro. "With today's navigation clearance, Canada is now fully integrated into ClearPoint's global regulatory and clinical infrastructure. Our goal is to continue to demonstrate to our biopharma partners that working with ClearPoint Neuro provides access to a growing global installed base where patients can be enrolled across an expanding number of geographies and, over time, prepare programs for broader commercialization. Expanding regulatory approvals internationally is a core component of our drug delivery ecosystem, and this level of standardization provides a unique asset as partners' therapies advance through clinical development and toward global deployment."