Clinical Development

Cortigent Clinical Research

Cortigent’s clinical foundation includes a recently completed six-year Early Feasibility Study of the Orion® Visual Cortical Prosthesis System.

Orion Early Feasibility Study

Recently completed six-year U.S. study

Six patients with profound blindness received Orion implants to evaluate the safety and performance of cortical visual stimulation with long-term evaluation and follow-up.

Study designPatients received a 60-electrode array implanted on the visual cortex and completed safety, perception and functional assessments.

PatientsSix patients with various causes of blindness were implanted.

Long-term follow-upThe study recently completed six years of follow-up, with key performance results reported at three years.

Regulatory statusOrion has received FDA Breakthrough Device designation and remains a product in development.

View the ClinicalTrials.gov record ↗

Model wearing an Orion system

Not an actual Orion patient.

Results summary

Performance, function and long-term safety

At the three-year assessment, five of the original six patients completed visual-perception testing and four completed a functional low-vision assessment.

Safety recordSince 2018No serious safety issues since one SAE in 2018 (which resolved safely).
Visual perception5 of 5Significantly better location and motion testing results with Orion on.
Visual acuity2 patientsMeasurable grating visual acuity at the three-year assessment.
Functional assessment4 patientsPositive or mildly positive FLORA results at three years.

The Orion patient journey

1

Screening and consent

Eligibility, informed consent and baseline assessments.

2

Implant procedure

Surgical placement and initial recovery.

3

Fitting and training

System programming and structured visual tasks.

4

Follow-up

Safety, perception and functional assessments over time.

Development roadmap

Planning the next stage of development

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.