One platform supporting two programs in development
Orion and the Stroke Recovery System are distinct programs built on Cortigent’s shared precision neurostimulation technology platform.
Program portfolio
One platform supporting two medical device programs
Precision neurostimulation platform
Implantable electronics, a cortical surface array, wireless communication, external processing and stimulation software.
Orion® Visual Cortical Prosthesis System
Recently completed six-year U.S. Early Feasibility Study and received FDA Breakthrough Device designation.
StrokeRecoverySystem
Exploring device and regulatory planning for investigation alongside post-stroke rehabilitation.
Development roadmap
Development milestones across both programs
This timeline summarizes device, regulatory and planned clinical milestones for Orion and the Stroke Recovery System.
Near-term next steps
- Build the devices (underway)
- Secure FDA Investigational Device Exemptions (IDEs)
- Commence clinical trials approximately late 2027
Orion
Artificial vision for blindness due to multiple causes
- Prototype conversion for clinical trialYear 1–Mid-Year 2
- Pivotal clinical trialMid-Year 2–Year 4
Stroke Recovery System
Hand and arm movement in hemiparesis due to stroke
- EFS device design and manufacturingYear 1–Mid-Year 2
- Early Feasibility StudyMid-Year 2–Year 3
- Pivotal clinical trialYear 4
Stroke Recovery System: Key Milestones
- First prototype
- Validation and qualification
- Device production
- Verification and validation testing
- FDA clearance as an investigational device
- Timelines begin after financing is secured and remain subject to funding and development progress.
- These steps were successfully completed for the Orion system EFS and are anticipated for the Stroke Recovery System.
Orion
Camera-based visual input, external processing and targeted stimulation of the visual cortex.
- Recently completed six-year Early Feasibility Study
- FDA Breakthrough Device designation
- Array of sixty, independently controlled electrodes
- Targeted visual cortex stimulation
Stroke Recovery System
Targeted stimulation of the motor cortex being developed for investigation alongside rehabilitation.
- Designed to improve hand and arm recovery
- Used alongside structured rehabilitation
- Array of sixty, independently controlled electrodes
- Clinical initiation targeted for late 2027
A platform with potential beyond today’s programs
Cortigent’s immediate focus is Orion and the Stroke Recovery System. Our shared platform is expected to support the development of additional precision-neurostimulation and brain-computer interface (BCI) research applications addressing critical unmet needs.
Cortigent may evaluate additional applications of precision neurostimulation as its platform and current development programs advance.
