Vivani's Brain Implant Helps Blind Patients See Light And Movement In 6-Year Study
Benzinga Newsdesk 9 months ago
News
Vivani Medical, Inc. (NASDAQ:VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced today that Cortigent, Inc. ("Cortigent"), its
Vivani Medical, Inc. (NASDAQ:VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced today that Cortigent, Inc. ("Cortigent"), its wholly-owned subsidiary developing brain implant devices, presented the results of a 6-year Early Feasibility Study of the Orion® Visual Cortical Prosthesis System under development to deliver meaningful visual perception to blind persons at the North American Neuromodulation Society ("NANS") annual meeting. NANS took place in Las Vegas, NV on January 22-25, 2026.
The Orion system incorporates advanced neurostimulation technology and features a wirelessly powered and controlled implantable pulse generator connected to an array of 60 micro-electrodes designed 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 specialized glasses into wireless commands to precisely stimulate neuron populations and elicit spots of light called phosphenes that provide visual perception.
The study results were presented by Principal Investigator Nader Pouratian, MD, PhD from the University of Texas Southwestern Medical Center. Cortigent's lead neuroscientist, Uday Patel, PhD, commented: "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."
Results Summary
- Six subjects were implanted between January 2018 and January 2019. The study concluded in March 2025.
- After training and experience using the Orion system, all subjects demonstrated improvement with the system turned on versus off in visual function tests 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 their final Functional Low-vision Observer Rated Assessment ("FLORA"), a tool used to measure the impact of the Orion system on subjects' well-being and functional vision.
- All 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 1 subject had his device safely explanted at the conclusion of the study.
- One serious adverse event, a seizure, occurred early in the study. With stimulation patterns adjusted, no further seizures or serious adverse events were observed in any subjects.