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Exploring the Frontier of Precision Neurostimulation

Cortigent is a leading developer of precision neurostimulation technology, a type of brain-computer interface (BCI) that represents a new frontier in medicine focused on recovering critical bodily functions lost to disease and other causes.

brain platform

One platform.
Two new medical devices in development.

Orion® Visual Cortical Prosthesis System and the Stroke Recovery System apply the same precision neurostimulation technology platform to different areas of unmet critical need.

Development focus

Advancing artificial vision and post-stroke motor recovery

Cortigent applies one precision neurostimulation platform to two distinct programs focused on artificial vision and recovery of hand and arm function following stroke.

Artificial vision program

orion system
Orion® Visual Cortical Prosthesis System

Designed to create useful visual perception through targeted stimulation of the visual cortex

Orion combines a wearable camera, external processor, wireless implant and a 60-electrode array that is placed on the visual cortex. The system recently completed a six-year U.S. Early Feasibility Study and has FDA Breakthrough Device designation.

Explore Orion

Motor recovery program

motor recovery
Stroke Recovery System

Designed to improve recovery of hand and arm function alongside post-stroke rehabilitation

The Stroke Recovery System applies our precision neurostimulation technology to the motor cortex and builds on prior research by Northstar Neuroscience evaluating cortical stimulation to improve post-stroke rehabilitation.

Explore Stroke Recovery

How precision neurostimulation works

By placing the electrode array on the brain’s surface rather than penetrating into brain tissue, Cortigent’s approach delivers more precisely controlled electrical pulses to selected areas of the cortex.

1
Target the relevant cortexVisual cortex stimulation for Orion and motor cortex stimulation for the Stroke Recovery System.
2
Deliver programmed electrical micro-pulsesSoftware dynamically controls the timing, intensity, location and pattern of stimulation across a multi-electrode surface array.
3
Build on a shared system architectureImplantable electronics, wireless communication and external processing support multiple current and future development programs.

orion implant

The shared platform combines implanted electronics, a cortical-surface array, wireless communication and external processing.

A foundation shaped by clinical and commercial experience

Commercial experience with the Argus II and the recently completed six-year Orion Early Feasibility Study inform Cortigent’s device development, clinical strategy and regulatory planning.

Historical foundationArgus II SystemExperience from more than 350 implants.
Current lead programOrion SystemRecently completed a six-year U.S. Early Feasibility Study.
Platform expansionStroke recoveryMotor cortex system in development.

argus ii retinal prosthesis

With more than 350 implants, Argus II was an FDA-approved retinal prosthesis marketed from 2011 to 2019. It is no longer commercially available, and the experience gained through its development helped shape Cortigent’s cortical neurostimulation platform.

Development progress

A clear path from platform development to planned clinical work

Cortigent is advancing device design and manufacturing, regulatory and clinical planning across its development programs.

Near-term next steps

  1. Build the devices (underway)
  2. Secure FDA Investigational Device Exemptions (IDEs)
  3. Commence clinical trials approximately late 2027

Orion

Artificial vision for blindness due to multiple causes

  1. Prototype conversion for clinical trialYear 1–Mid-Year 2
  2. Pivotal clinical trialMid-Year 2–Year 4

Stroke Recovery System

Hand and arm movement in hemiparesis due to stroke

  1. EFS device design and manufacturingYear 1–Mid-Year 2
  2. Early Feasibility StudyMid-Year 2–Year 3
  3. Pivotal clinical trialYear 4

Stroke Recovery System: Key Milestones

  1. First prototype
  2. Validation and qualification
  3. Device production
  4. Verification and validation testing
  5. FDA clearance as an investigational device
  1. Timelines begin after financing is secured and remain subject to funding and development progress.
  2. These steps were successfully completed for the Orion system EFS and are anticipated for the Stroke Recovery System.

Experienced leadership

Medical-device, neuroscience and commercialization experience

Cortigent’s team brings decades of experience developing medical devices, advancing neuroscience and building public companies.

jonathan adams

Jonathan Adams, MBA

Chief Executive Officer

jerry culp

Jerry Culp

Chief Technical Officer

uday patel

Uday Patel, PhD

Lead Neuroscientist

don malackowski

Don Malackowski

Senior Product Development Consultant

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