Promising Six-Year Early Feasibility Study Results Released for the Orion System

Vivani Medical Inc. subsidiary Cortigent Inc. is sharing encouraging six-year Early Feasibility Study results showing the Orion Visual Cortical Prosthesis System improved visual perception for blind patients.

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 that are implanted 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.

“We are encouraged by the positive clinical study results that demonstrate the Orion cortical stimulation system’s safety and reliability over six years and ability to deliver meaningful visual perception,” Cortigent lead neuroscientist Uday Patel, Ph.D., stated. “Our next step will be to plan a larger pivotal clinical trial to seek marketing approval, subject to discussions with the U.S. Food and Drug Administration.”

Results Summary

• Six patients received the Orion system 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 patients had their devices safely explanted after their respective three-year visits and one patient had his device safely explanted at the study’s conclusion.
• 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.

“We are very grateful to Dr. Pouratian and his fellow investigators and medical institutions that conducted this important clinical trial,” Cortigent CEO Jonathan Adams said. “We look forward to advancing the Orion cortical stimulation system in 2026 and working with experts and the FDA to eventually commence a larger pivotal trial.”

Cortigent Inc., a wholly-owned subsidiary of Vivani, is developing brain implant devices to help patients recover critical body functions. Its patent-protected precision neurostimulation technology platform leverages neuroscience and proprietary microelectronics to create advanced medical devices. The firm’s predecessor, Second Sight Medical Products, previously marketed the Argus II, the first and only medical device to obtain FDA approval to treat a rare form of blindness called retinitis pigmentosa. This device helped hundreds of blind patients to 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, completed a six-year Early Feasibility Study in 2025 with promising safety and efficacy results, and is covered by an extensive intellectual property estate. Cortigent is also applying its core technology to improving recovery of arm and hand motion in patients with stroke-induced paralysis.

Leveraging its proprietary NanoPortal platform, Vivani develops biopharmaceutical implants that deliver drug molecules steadily over extended periods of time to help guarantee adherence and improve patient tolerance to medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and type 2 diabetes.