ClearPoint Neuro Announces Expanded International Clearances for Key Therapy Delivery Product; Now Totaling 34 Countries Worldwide

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 importance of these international regulatory clearances is well established and continually discussed with each partner within our portfolio of 60+ BioPharma sponsors," commented Mary McNamara-Cullinane, VP of Regulatory Affairs at ClearPoint Neuro. "The extensive regulatory support we provide partners evolves with each new therapy development program. After we support the early pre-clinical work and INDs, these expanded international clearances can play a role in localized trials and simplify pathways to commercialization from one country to the next. We leverage our team's expertise to anticipate what each regulatory body will need to reduce complexity for our partners."

"Each clearance is expected to provide a decisive advantage for all sponsors trusting us to support their new therapy development as our products have extensive testing, credible history, and technical dossiers on-file across various geographies," added Megan Falkenberry, VP of Quality at ClearPoint Neuro. "We believe that this is essential for speeding up the cell and gene therapy clinical trial process, reducing technical risks, and reducing surgical risks. The ClearPoint Neuro team is incredibly motivated to do our part in ensuring more patients can be treated by these first-of-kind, breakthrough restorative gene and cell therapies being developed by our partners. By standardizing and simplifying every possible aspect of the surgical workflow, ClearPoint Neuro hopes to reduce barriers to adoption and allow partners' therapies improved chances to succeed."