Orion, under development to deliver meaningful visual perception to blind persons, incorporates advanced neurostimulation technology. It features a wirelessly powered and controlled implantable pulse generator (IPG), connected to an array of 60 micro-electrodes. Cortigent designed the system for implantation on the surface of the brain involved in vision (the visual cortex) in blind patients.
The system features a small processing unit worn on the belt that converts a real-time video stream captured by a camera embedded in special glasses into wireless commands. This precisely stimulates neuron populations and elicits spots of lights called phosphenes, which provide visual perception.
Cortigent presented findings at the North American Neuromodulation Society (NANS) annual meeting in Las Vegas last week. Dr. Nader Pouratian of the University of Texas Southwestern Medical Center served as principal investigator and presented the findings. Cortigent labeled the outcomes, which were observed over six years, as positive.
The subsidiary continues to press forward with its neurotechnology as Vivani looks to complete a separation. In May 2025, the Alameda, California-based company announced plans to spin off Cortigent as it looks to create two focused companies dedicated to driving current and future value in their respective therapeutic areas. Vivani aims to continue advancing its miniature GLP-1 therapeutic implants.
However, the company withdrew its plan in October, still aiming to complete the transaction “as soon as possible.”
More on the findings from Cortigent
Cortigent’s lead neuroscientist, Uday Patel, said: “We are encouraged by the positive clinical study results that demonstrate the Orion cortical stimulation system’s safety and reliability over 6 years and ability to deliver meaningful visual perception. Our next step will be to plan a larger pivotal clinical trial intended to seek marketing approval, subject to discussions with the U.S. Food and Drug Administration.”
Six patients received Orion implants between January 2018 and January 2019, with the study concluding in March 2025. The six-year early feasibility data demonstrated improvement with the system turned on versus off in all subjects in visual function tests. These tests required subjects to detect a small square on a computer screen and detect movement across the visual field.
All subjects had either a positive or mild positive score on the final Functional Low-vision Observer Rated Assessment (FLORA). This tool measures the impact on well-being and functional vision. All devices remained functional throughout the study, with investigators reporting a loss of functionality on fewer than 4% of electrodes.
Three subjects had devices safely explanted after their respective three-year visits. One subject had his device safely explanted at the study’s conclusion. Investigators observed one serious adverse event — a seizure — early in the study. With stimulation patterns adjusted, investigators saw no further seizures or serious adverse events in any subjects.
“We are very grateful to Dr. Pouratian and his fellow investigators and medical institutions that conducted this important clinical trial. We look forward to advancing the Orion cortical stimulation system in 2026 and working with world-leading experts and the FDA to eventually commence a larger pivotal trial,” said Cortigent CEO Jonathan Adams.
