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

Rhea-AI Summary

Vivani (NASDAQ: VANI) announced that subsidiary Cortigent presented 6-year Early Feasibility Study results for the Orion visual cortical prosthesis at NANS 2026. Six subjects implanted 2018–2019 completed the study in March 2025, showing improved visual test performance with devices functional and <4% electrode loss.

One early seizure occurred; stimulation was adjusted and no further serious adverse events were reported. Cortigent plans to discuss a larger pivotal trial with the FDA in 2026.

Positive

• Safety and reliability demonstrated over 6 years
• All subjects improved on targeted visual function tests
• Devices retained function with <4% electrode loss
• Company planning a larger pivotal trial with FDA interactions

Negative

• Very small sample size: 6 subjects
• Four subjects had devices explanted during or after the study
• One serious adverse event (seizure) occurred early in study

News Market Reaction – VANI

+1.34%

3 alerts

+1.34% News Effect

-10.3% Trough Tracked

+$1M Valuation Impact

$109M Market Cap

0.8x Rel. Volume

On the day this news was published, VANI gained 1.34%, reflecting a mild positive market reaction. Argus tracked a trough of -10.3% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $109M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Study duration: 6 years Implanted subjects: 6 subjects Electrode count: 60 micro-electrodes +5 more

8 metrics

Study duration 6 years Early Feasibility Study of the Orion system

Implanted subjects 6 subjects Implanted between January 2018 and January 2019

Electrode count 60 micro-electrodes Array implanted on the surface of the visual cortex

Electrode functionality loss Fewer than 4% of electrodes Loss of functionality over 6-year study

Serious adverse events 1 seizure Occurred early; no further serious adverse events after adjustment

Subjects explanted at 3 years 3 subjects Devices safely explanted after 3-year visits

Final explant at study end 1 subject Device safely explanted at conclusion of study

NANS 2026 dates January 22–25, 2026 Conference where Orion data were presented

Market Reality Check

Price: $1.12 Vol: Volume 1,372,550 is 3.65x...

high vol

$1.12 Last Close

Volume Volume 1,372,550 is 3.65x the 20-day average of 375,850, indicating elevated interest ahead of this update. high

Technical Shares at $1.49 are trading above the 200-day MA of $1.32, reflecting a pre-existing uptrend into this news.

Peers on Argus

VANI was up about 8% with strong volume, while several biotech peers (e.g., NRXP...

1 Up

VANI was up about 8% with strong volume, while several biotech peers (e.g., NRXP, IGMS, OSTX, XFOR) showed declines of roughly 2–5%. One peer, UNCY, appeared in a momentum scan to the upside but sector moves overall did not track VANI’s strength, pointing to company-specific drivers.

Common Catalyst Select biotech peers had clinical and regulatory updates, but no broad neuromodulation or implant theme matching Cortigent’s Orion data.

Historical Context

5 past events · Latest: Jan 27 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 27	Equity offering close	Neutral	+0.0%	Closed registered direct and concurrent private placements raising about $4.5M.
Jan 25	Equity offering pricing	Negative	-6.8%	Priced common stock offering and private placement at $1.48 per share.
Jan 22	Orion poster preview	Positive	-2.6%	Announced award-winning Orion system poster presentation at NANS 2026.
Nov 13	Q3 2025 results	Neutral	-11.4%	Reported Q3 results, NanoPortal progress, GLP-1 plans, and financing updates.
Oct 28	Large equity raise	Negative	+3.1%	Closed registered offering and private placement totaling about $15.7M gross.

Pattern Detected

Recent news often saw negative or mixed price reactions, especially around offerings, with occasional divergences where dilutive events were bought and positive technology updates were sold.

Recent Company History

Over the past few months, Vivani reported multiple equity offerings and insider-backed financings, including closings on Oct 28, 2025 and Jan 27, 2026. A business update on Nov 13, 2025 highlighted NanoPortal and GLP-1 implant progress, while Cortigent’s Orion system was previewed in a NANS 2026 poster on Jan 22, 2026. Today’s detailed 6-year feasibility results build directly on that Orion poster disclosure, extending the narrative around Cortigent’s cortical visual prosthesis program.

Market Pulse Summary

This announcement highlights 6-year Early Feasibility Study results for Cortigent’s Orion cortical v...

Analysis

This announcement highlights 6-year Early Feasibility Study results for Cortigent’s Orion cortical visual prosthesis, where six implanted subjects retained functional devices with loss on fewer than 4% of electrodes and experienced only a single managed serious adverse event. All participants improved on visual tasks with the system on and had positive or mildly positive FLORA scores. In context of recent financings and prior Orion disclosures, investors may watch for FDA interactions and plans for a larger pivotal trial.

Key Terms

visual cortical prosthesis, neurostimulation, visual cortex, implantable pulse generator, +4 more

8 terms

visual cortical prosthesis medical

"results of a 6-year Early Feasibility Study of the Orion® Visual Cortical Prosthesis System"

A visual cortical prosthesis is an implanted device that aims to restore some sight by directly sending electrical signals to the brain area that processes vision, bypassing damaged eyes or optic nerves. For investors, it represents a high‑risk, high‑reward medical technology: success can open large markets and justify regulatory approval and reimbursement, while failure or safety setbacks can halt development, similar to how a bridge can reconnect a broken road or fail to carry traffic.

neurostimulation medical

"brain implant devices based on precision neurostimulation technology"

Neurostimulation is a medical technique that uses controlled electrical or magnetic pulses to change activity in nerves or the brain, similar to how a pacemaker helps regulate a heartbeat. It matters to investors because devices and therapies using this approach can create new revenue streams or risks depending on clinical results, regulatory approvals, insurance coverage and how widely doctors and patients accept the treatment.

visual cortex medical

"designed for implantation on the surface of the brain involved in vision (the visual cortex)"

The visual cortex is the part of the brain at the back of the head that interprets signals from the eyes, converting light patterns into recognized shapes, motion and color. For investors, it matters because treatments, devices or research that improve or damage visual-cortex function can determine clinical trial results, regulatory approval and commercial potential for vision- or brain-related products—think of it as the brain’s image-processing chip.

implantable pulse generator medical

"wirelessly powered and controlled implantable pulse generator connected to an array"

An implantable pulse generator is a small, battery-powered medical device placed under the skin that sends controlled electrical pulses to nerves or tissues to treat chronic pain, movement disorders, or other conditions. Investors watch these devices because approvals, device longevity, battery or recharge technology, and surgical and replacement demand drive sales, recurring revenue, and clinical adoption — similar to how a reliable power source affects the usefulness of any electronic tool.

phosphenes medical

"stimulate neuron populations and elicit spots of light called phosphenes that provide visual perception"

Phosphenes are brief flashes or spots of light a person sees without actual light entering the eye, often produced by mechanical pressure, electrical stimulation, or nerve activity—think of the stars you see when you rub your eyes. For investors, phosphenes matter because they can be a sign of how a medical device or therapy interacts with the visual system: their presence may indicate intended effect for sight-restoring technologies or signal side effects that affect safety, patient experience, regulatory review, and market acceptance.

functional low-vision observer rated assessment medical

"final Functional Low-vision Observer Rated Assessment (“FLORA”), a tool used to measure"

A functional low-vision observer rated assessment is a standardized test in which a trained observer watches and scores how well a person with impaired vision performs everyday tasks (reading labels, navigating a room, recognizing faces) to gauge real-world visual ability. Investors care because these observer-based measures show whether a treatment or device produces meaningful, practical benefits beyond lab tests—similar to a coach judging game performance rather than practice drills—affecting regulatory decisions, market adoption, and commercial value.

flora medical

"final Functional Low-vision Observer Rated Assessment (“FLORA”), a tool used to measure"

Flora means the collection of living organisms of a particular environment, most commonly plants in ecology or microbes in and on the human body. For investors, flora matters because products, regulations, or research that change these communities can affect market demand, product safety, regulatory approval, or treatment effectiveness — think of it like the health of a garden: if the plants or microbes shift, the whole ecosystem and the businesses depending on it can change value.

adverse event medical

"One serious adverse event, a seizure, occurred early in the study."

An adverse event is any unwanted or harmful medical occurrence experienced by a person during a clinical trial or after using a product, whether or not it is caused by the treatment. Investors watch these reports because they can signal safety problems that delay approvals, trigger additional testing, reduce sales, or harm a company’s reputation — similar to how a series of car breakdowns can cut value and future sales for an automaker.

AI-generated analysis. Not financial advice.

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

FAQ

What were the key 6-year results for Cortigent's Orion system presented at NANS 2026 (VANI)?

The study showed long-term safety, device reliability, and improved visual test performance with Orion on versus off. According to the company, six subjects implanted 2018–2019 completed the study in March 2025 with devices functioning and fewer than 4% electrode loss.

How many patients were in Cortigent's Early Feasibility Study for Orion and when did it conclude?

Six subjects were implanted between January 2018 and January 2019 and the study concluded in March 2025. According to the company, those participants completed device training and demonstrated measurable improvements with the system turned on.

Did any safety issues occur in the Orion 6-year study reported by VANI at NANS 2026?

One serious adverse event—a seizure—occurred early, after which stimulation was adjusted and no further serious events were reported. According to the company, subsequent follow-up observed no additional seizures or serious adverse events.

What functional outcomes did subjects experience using the Orion system in the 6-year VANI study?

All subjects showed improvement on tasks detecting a small square and movement when the system was on versus off. According to the company, final FLORA ratings were positive or mildly positive for all participants, indicating functional vision benefit.

What are Cortigent's next steps for the Orion visual cortical prosthesis after the 6-year results?

Cortigent plans to design and seek FDA discussions about a larger pivotal clinical trial in 2026. According to the company, next steps include planning a pivotal study intended to support marketing approval, subject to FDA feedback.