In a six-patient Early Feasibility Study with follow-up extending to six years, Cortigent’s Orion visual cortical prosthesis improved performance on visual function tasks with the device activated versus deactivated in all participants. Final Functional Low-vision Observer Rated Assessment scores were positive or mildly positive across the cohort. Devices remained operational throughout the study with fewer than 4% of electrodes losing functionality. One serious adverse event—a seizure early in the study—was managed by modifying stimulation parameters, with no additional serious events reported. Three devices were explanted around year three and one at study completion without safety issues.
The core development is Cortigent’s disclosure of long-term safety, reliability, and functional signal from Orion, presented at the North American Neuromodulation Society meeting, and its intention to advance into a pivotal trial aimed at U.S. marketing authorization. The investigational system delivers camera-derived visual information via a 60-electrode array placed on the visual cortex and is designated a Breakthrough Device. Enrollment for the feasibility study occurred between 2018 and 2019; the study concluded in March 2025.
Strategically, the data help reposition the company from retinal prosthetics to cortical neurostimulation, expanding its potential population beyond rare inherited retinal diseases to common causes of blindness such as glaucoma and diabetic retinopathy. The six-year durability profile and manageable neurologic risk signal address two frequent objections to implantable BCIs: long-term reliability and safety under chronic stimulation. The small sample size limits generalizability, but the combination of objective task improvements, patient-centered functional assessments, and stable hardware performance provides a credible foundation for a pivotal design discussion with FDA. The legacy of Argus II, previously approved for retinitis pigmentosa, adds regulatory and operational experience in PMA-class neuroprosthetics that few competitors possess.
For sites, a pivotal program would concentrate activity at high-volume academic centers with neurosurgery, neuro-ophthalmology, and vision rehabilitation under one roof. This brings implications for cortical mapping workflows, perioperative protocols to mitigate seizure risk, device programming infrastructure, and sustained post-implant training—each adding staffing and scheduling complexity. CROs supporting the trial will need proficiency in neuromodulation device studies, including device-off comparators, adjudication of visual function endpoints, and long-term device performance monitoring. Regulators are likely to scrutinize the clinical meaningfulness of outcomes beyond lab-based tasks, pushing toward standardized functional mobility or multi-luminance performance measures and consistent use of validated patient-reported tools. Payers will focus on durability, real-world functional gains, and the total cost of care against alternatives such as low-vision aids and assistive technologies, making early health economics planning essential.
The next inflection hinges on pivotal trial design: target population definition, control strategy using device-off periods, endpoint selection balancing functional mobility with patient-reported outcomes, and prespecified thresholds for electrode longevity and neurologic adverse events. Details on software update governance and human factors could influence both FDA review and site adoption. Manufacturing scale-up and quality system readiness will come under equal scrutiny given multi-year implant demands. Watch for whether Cortigent seeks Coverage with Evidence Development to align regulatory and reimbursement timelines, and how it sequences U.S. and OUS site activation to de-risk enrollment. The unresolved questions are typical for first-in-class cortical vision devices: the magnitude and consistency of functional benefit in a larger, etiologically diverse population, the training burden required to translate phosphenes into usable vision, and the sustainability of electrode performance beyond six years. If the pivotal trial clarifies those points, Orion will test whether cortical prostheses can move from engineering accomplishment to routine clinical service.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
