Cortigent is a leading developer of brain implant devices based on precision neurostimulation technology

Cortigent is the only company to have obtained FDA approval of a device providing artificial vision for the profoundly blind

The Company is also developing a new medical device aimed at improving recovery of arm and hand motion in patients with paralysis due to stroke

ALAMEDA, Calif., Jan. 29, 2026 (GLOBE NEWSWIRE) -- 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.

"We are very grateful to Dr. Pouratian and his fellow investigators and medical institutions that conducted this important clinical trial," commented Cortigent CEO Jonathan Adams. "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."

About Cortigent, Inc.

Cortigent, Inc., a wholly-owned subsidiary of Vivani, is developing brain implant devices to help patients recover critical body functions. Our patent-protected precision neurostimulation technology platform leverages neuroscience and proprietary microelectronics to create advanced medical devices. Our 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 innovative device helped hundreds of profoundly blind patients to achieve meaningful visual perception. Cortigent's next generation investigational system, the Orion^® cortical stimulation system, has been designed to treat blindness caused by common conditions including glaucoma and diabetic retinopathy. Orion has an FDA Breakthrough Device designation, completed a 6-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 paralysis due to stroke. For more information and patient videos, please visit: www.cortigent.com.

About Vivani Medical, Inc.

Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. For more information, please visit: www.vivani.com.

Forward-Looking Statements

This press release contains certain "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "target," "believe," "expect," "will," "may," "anticipate," "estimate," "would," "positioned," "future," and other similar expressions that are used in this press release, including statements regarding Vivani's business, products in development, including the therapeutic potential thereof, the planned development thereof, Vivani's plans with respect to Cortigent and its technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani's current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani's control. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, risks of unexpected costs or delays; and risks and uncertainties associated with the development and commercialization of products and product candidates that may impact or alter anticipated business plans, strategies and objectives. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to Cortigent's history of losses and its ability to access additional capital or otherwise fund its business and advance its product candidates and pre-clinical programs. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. There may be additional risks that the Company or Cortigent consider immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by the Company's subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law.

Company Contact:

Donald Dwyer

Chief Business Officer

info@vivani.com

(415) 506-8462

Investor Relations Contact:

Jami Taylor

Investor Relations Advisor

investors@vivani.com

(415) 506-8462

Media Contact:

Sean Leous

ICR Healthcare

Sean.Leous@ICRHealthcare.com

(646) 866-4012

Vivani Subsidiary Cortigent Presents Promising 6-Year Early Feasibility Study Results for the Orion System at NANS 2026