ClearPoint Neuro, Inc.

We are a commercial-stage medical device company, incorporated in 1998 as a Delaware corporation, that develops and commercializes integrated systems used in minimally invasive neurosurgical procedures in the brain. Since 1998, we have focused on developing capabilities for magnetic resonance imaging ("MRI") guided interventions, building an intellectual property portfolio, and identifying commercial applications for our technologies. In 2021, our efforts expanded to include the development and commercialization of neurosurgical device products for the operating room setting, as well as consulting services for pharmaceutical companies. In 2025, through our acquisition of IRRAS Holdings, Inc. ("IRRAS"), we expanded our portfolio into neurocritical care. IRRAS is a commercial-stage medical technology company focused on treatments for intracerebral hemorrhage, intraventricular hemorrhage, and other conditions requiring intracranial fluid management. The IRRAS products complement our existing neurosurgical technologies and broaden our reach into acute care settings, enabling us to offer an expanded set of solutions spanning functional neurosurgery, neurocritical care, and intracranial drug delivery. Our business consists of two integrated components: (i) a business providing medical devices for neurosurgical applications, and (ii) a business focused on partnerships in the biologics and drug delivery space. Our primary medical device product is the ClearPoint system, an integrated system comprising hardware components, disposable components, and intuitive, menu-driven software. The ClearPoint system's primary applications are to target and guide: (a) the insertion of deep brain stimulation electrodes, biopsy needles, and laser catheters; and (b) the infusion of pharmaceuticals into the brain. The ClearPoint system was originally designed for use in an MRI setting. In 2021, we launched the SmartFrame Array Neuro Navigation System and Software, which allows for operating room placement of the ClearPoint system and completion of the procedure in the MRI suite.