Orion Visual Cortical Prosthesis by Cortigent (Vivani Medical subsidiary): status and timeline

Orion Visual Cortical Prosthesis

Wirelessly-powered brain implant with 60 micro-electrodes on visual cortex to restore vision. Glasses capture video and convert it to stimulation patterns that generate light points the patient interprets as vision.

PilotStage 3 of 5

Six-year feasibility study complete; planning pivotal trial for FDA marketing approval.

Updated Mar 2025Checked 10 Oct0 updates this week

Milestones

Next · Cortigent plans pivotal trial with FDA

Argus II retinal prosthesis approved by FDA2013Complete.
Second Sight acquired by Nano Precision Medical, forming Vivani2022Complete.
Orion feasibility study enrollment (6 subjects)2018Complete.
Orion six-year feasibility study concludesMar 2025Complete.
Vivani announces merger of Cortigent with ClearOne for public listingJul 2026Complete.
Cortigent plans pivotal trial with FDATarget 2026Current milestone.

Most important updates

Cortigent Orion Visual Cortical Prosthesis completes six-year feasibility studyMar 2025

Upcoming

2026Cortigent plans pivotal trial with FDA (next)
2027FDA Pre-IND meeting for pivotal trial

Current obstacles

Brain tissue movementBrain shifts with breathing and heartbeat. Electrodes drift off target. Mechanical design improvements needed for electrode contact.
Limited resolution60 electrodes provide coarse vision. Patients detect shapes and movement, but reading and facial recognition remain difficult.

Physics limits

Electrode density limitsPlacing more electrodes requires a larger implant and more surgical trauma. There is a practical limit before insertion becomes infeasible; 60 electrodes balances capability with surgical safety.
Visual cortex mapping variabilityThe visual cortex is highly organized but varies between individuals. The map of which electrodes correspond to which parts of the visual field must be learned for each patient, requiring training time.

How it works

4 parts

Capture

Video camera in glasses

Glasses with small video camera capture the real-world scene.

Processing

Wireless belt unit

Processor converts video to electrical pulse patterns and sends them wirelessly to implanted electrodes.

Stimulation

Visual cortex activation

Each electrode stimulates neurons, creating a phosphene (point of light). 60 electrodes together create a 60-point pattern.

Interpretation

Brain learning

Patient learns to interpret the 60-point pattern as visual scene, like learning braille. With training, they navigate and recognize objects.

Spec sheet

Spec	Orion Visual Cortical Prosthesis
Electrode count in array	60 micro-electrodes^R (reported)
Surgical placement site	Visual cortex surface^R (reported)
Feasibility study enrollment	6 subjects^R (reported)
Feasibility study duration	6 years (2018-2025)^R (reported)
Electrode functionality at end of study	96% (4% loss)^R (reported)

^R reported by the company

Update log

1 update

Mar 2025

Major: Cortigent Orion Visual Cortical Prosthesis completes six-year feasibility studyPressTest

About Cortigent (Vivani Medical subsidiary)

The team behind Orion Visual Cortical Prosthesis

Cortigent (Vivani Medical subsidiary)

Visual cortical prosthesis, brain implant, vision restoration

Cortigent develops Orion, a brain implant to restore vision to blind patients. Orion uses electrodes on visual cortex to generate light points that bypass damaged eyes and optic nerves. A subsidiary of Vivani Medical (NASDAQ: VANI), Cortigent is planned to go public via merger with ClearOne.

Orion uses 60 micro-electrodes implanted on the visual cortex to generate phosphenes (points of light) perceived by blind patients.
Six-year feasibility study (2018-2025) showed all six subjects improved with the system on versus off in visual function tests.
Devices remained operational with fewer than 4% electrode loss; next step is planning pivotal trial for FDA marketing approval.

cortigent.com (opens cortigent.com)Company profile →

Founded: 20224 yrs
Headquarters: United States
Status: Privateof Vivani Medical
Listed: CRGT
Valuation: private
Works in: NeurotechRestoring sight
Coverage: 1 program · 2 updateslatest 1 Jul 2026checked 10 Oct
Acquired by: Vivani Medical

Spec

Orion Visual Cortical Prosthesis

Electrode count in array

60 micro-electrodes^R (reported)

Surgical placement site

Visual cortex surface^R (reported)

Feasibility study enrollment

6 subjects^R (reported)

Feasibility study duration

6 years (2018-2025)^R (reported)

Electrode functionality at end of study

96% (4% loss)^R (reported)