ALAMEDA, Calif. — January 29, 2026 — Leads & Copy — Vivani Medical, Inc. (NASDAQ: VANI) announced that Cortigent, Inc., its wholly-owned subsidiary, presented results from a 6-year Early Feasibility Study of the Orion® Visual Cortical Prosthesis System at the North American Neuromodulation Society (NANS) annual meeting held in Las Vegas, NV, from January 22-25, 2026.
The Orion system, designed to deliver visual perception to blind individuals, incorporates advanced neurostimulation technology. It features a wirelessly powered and controlled implantable pulse generator connected to an array of 60 micro-electrodes. These electrodes are intended for implantation on the surface of the visual cortex in blind patients. A small processing unit worn on the belt converts real-time video captured by a camera in specialized glasses into wireless commands. These commands precisely stimulate neuron populations, eliciting spots of light known as phosphenes, which provide visual perception.
Principal Investigator Nader Pouratian, MD, PhD, from the University of Texas Southwestern Medical Center, presented the study results. Cortigent’s lead neuroscientist, Uday Patel, PhD, noted the encouraging clinical study results, which demonstrate the Orion cortical stimulation system’s safety, reliability, and ability to deliver meaningful visual perception over six years. The next step involves planning a larger pivotal clinical trial to seek marketing approval, pending discussions with the U.S. Food and Drug Administration.
The study involved six subjects implanted between January 2018 and January 2019, concluding in March 2025.
After training and experience using the Orion system, all subjects showed improvement with the system turned on versus off in visual function tests designed to detect a small square on a computer screen and movement across the visual field.
All subjects had either a positive or mild positive score on their final Functional Low-vision Observer Rated Assessment (FLORA), a tool to measure the impact of the Orion system on subjects’ well-being and functional vision.
The devices remained functional throughout the study with a loss of functionality on fewer than 4% of electrodes.
Three subjects had their devices safely explanted after their respective 3-year visits, and one subject had his device safely explanted at the study’s conclusion.
One serious adverse event, a seizure, occurred early in the study. After adjusting stimulation patterns, no further seizures or serious adverse events were observed in any subjects.
Cortigent CEO Jonathan Adams expressed gratitude to Dr. Pouratian and the investigators and medical institutions involved in the clinical trial. He stated that the company looks forward to advancing the Orion cortical stimulation system in 2026 and working with experts and the FDA to commence a pivotal trial.
Cortigent, Inc., a wholly-owned subsidiary of Vivani, develops brain implant devices to help patients recover critical body functions. Its patent-protected precision neurostimulation technology platform leverages neuroscience and microelectronics to create advanced medical devices. Cortigent’s predecessor, Second Sight Medical Products, previously marketed the Argus® II, a medical device that obtained FDA approval to treat retinitis pigmentosa and helped hundreds of profoundly blind patients achieve meaningful visual perception. Cortigent’s next-generation investigational system, the Orion® cortical stimulation system, is designed to treat blindness caused by common conditions including glaucoma and diabetic retinopathy. Orion has an FDA Breakthrough Device designation and completed a 6-year Early Feasibility Study in 2025 with promising safety and efficacy results. Cortigent is also applying its core technology to improve recovery of arm and hand motion in patients with paralysis due to stroke.
Vivani Medical, Inc. develops biopharmaceutical implants using its NanoPortal™ platform. These implants are designed to deliver drug molecules steadily over extended periods, aiming to guarantee adherence and improve patient tolerance. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases, including obesity and type 2 diabetes. The NanoPortal implants are designed to provide patients with the full potential benefit of their medication by avoiding challenges associated with daily or weekly administrations of orals and injectables, including tolerability issues and loss of efficacy.
Source: Vivani Medical, Inc.
