ReVision Implant (Belgium, EU)

Belgian cortical visual prosthesis company (Leuven) developing “Occular” — a deep, intracortical V1 implant with >1,000 electrodes targeting grayscale vision at >1,000 pixels. The most near-term EU cortical clinical programme (FIH approved, Q3 2026).

Key facts

  • Co-founders: Frederik Ceyssens, PhD (CEO — ex-KU Leuven flexible-electrode researcher, worked with neurosurgeon Bart Nuttin) and Prof. Peter Janssen (KU Leuven neuroscientist; also coordinates EU HyperStim project).
  • Funding: €4M round May 2026 (private investors; existing + new backers); EIC “FlairVision” grant €2.4M; imec.istart and Plug & Play incubators; investing in in-house cleanroom.1
  • Regulatory:
    • FDA Breakthrough Device Designation — awarded March 2026.2 Grants: early feedback on regulatory roadmap, data, clinical trial protocols; access to FDA Total Product Life-Cycle Advisory Program (TAP) Pilot. Note: only ~160 devices globally received Breakthrough status in all of 2025.
    • Also planning EU launch; FDA pre-submission ongoing.
  • Clinical timeline (as of March 2026):
    • October 2026 — first short-term intra-operative clinical test during scheduled brain surgery (epilepsy resection, TTK Budapest).
    • Summer 2027 — early-stage human trials in blind volunteers (subject to regulatory approvals).2
  • Preclinical: >2 years of long-term animal studies completed.
  • Target population: ~650,000 people with untreatable blindness in US + EU combined (company estimate); globally tens of millions with severe vision loss.

Occular (the device)

  • Intracortical electrode arrays targeting primary visual cortex (V1), inserted up to a few cm deep (the human visual cortex is buried up to ~4 cm) — deeper than surface devices like Orion/ICVP, exploiting Martin Bak’s finding that deeper stimulation gives >5x better resolution, in tens of µA vs mA.
  • >1,000 electrodes, ultra-flexible (minimal scarring), patented resorbable-coating insertion method; +15 years lifetime in accelerated aging tests; “virtual electrodes” to boost resolution.
  • Target visual function: grayscale vision >1,000 pixels; success by 2030 = restoring at least 3/20 vision and launching pivotal trials.
  • Strategy (Ceyssens): “performance trumps invasiveness” — universal solution for any blindness cause; brain directly bypasses eye and optic nerve.

Pathway

Long-term monkey preclinical data (Janssen lab, KU Leuven: biocompatibility + eye-tracking efficacy); next: acute intra-operative test during epilepsy resection (TTK Budapest, Hungary — Wittner/Fiáth); longer-term blind-volunteer trial with Prof. Eduardo Fernandez (Spain, UMH Elche); wireless prototype in development.

References

Footnotes

  1. raw/articles/revision-implant-e4m-2026.md

  2. raw/articles/revision-implant-fda-breakthrough-2026.md 2