First-in-human flexible array implant to restore vision

Project Information

FLAIRVISION

Grant agreement ID: 101214572

DOI

10.3030/101214572

EC signature date 24 April 2025

Start date 1 May 2025

End date 30 April 2028

Funded under

• The European Innovation Council (EIC)

Total cost

No data

EU contribution

€ 2 495 144,15

Coordinated by

KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium

Periodic Reporting for period 1 - FLAIRVISION (First-in-human flexible array implant to restore vision)

Reporting period: 2025-05-01 to 2026-04-30

Summary of the context and overall objectives of the project

Restoring functional vision to individuals with profound blindness remains a critical objective in neuroprosthetics, yet anatomical and other practical constraints have historically limited clinical progress.

While earlier prosthetics focused on implanting micro-electrode arrays in the eye, FlairVision targets the brain's primary visual cortex as in principle a much higher resolution in achievable there. Because the human visual cortex is highly folded and located mostly beneath the surface of the brain, traditional rigid silicon implants cannot safely cover enough tissue to generate a wide, practical field of view. To overcome this fundamental bottleneck, the FLAIRVISION project merges the scientific breakthroughs of two prior European initiatives to develop a highly adaptable cortical visual prosthesis. While our earlier clinical work demonstrated that electrical stimulation via small, rigid arrays enables blind volunteers to perceive simple shapes and object boundaries, our subsequent research yielded ultra-flexible, polymer-based microelectrodes that can physically conform to the brain's complex topography with superior long-term tissue integration.

By combining these proven concepts into a human-scale implantable system, we are preparing a first-in-human clinical study to definitively demonstrate that this flexible array approach can restore a level of artificial vision that is genuinely useful in daily life. Concurrently, to ensure this innovation rapidly reaches the market, the project integrates a robust commercialization strategy driven by our dedicated spin-off company. By establishing medical-grade quality management systems, preparing regulatory pathways, expanding our patent portfolio, and driving toward a Series A funding round, we are actively bridging the gap between pioneering neuroscience and an accessible, life-changing medical device.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Technically, we are making progress towards a first short-term human test in Q3 2026, and a 6 months long test in a blind volunteer starting in 2027.

Activities Performed:

1) Device Design and Scaling: To transition from animal models to human applications, the team redesigned the implant to handle an extended 12 cm distance between the pedestal connector and electrode arrays. We developed a wire-bonding concept utilizing thin, individually insulated gold wires and modified the fabrication process to optimize wire bondability and long-term polymer encapsulation adhesion under physiological conditions.

2) Anatomical Mapping: An anatomical study was conducted using Human Brain Project MRI data from eight subjects to delineate the V1 visual cortex, allowing the team to establish safe insertion trajectories that avoid crossing sulci containing major blood vessels.

3) Surgical Procedure Development: The team constructed mechanical 1024-electrode prototypes, a phantom head, and implant holders for surgical usability testing. They also designed and iteratively refined a specialized tunneling shuttle, testing it on sheep cadavers, a human corpse, and mock skulls to facilitate surgical routing.

4) Precision Insertion Systems: To ensure accurate placement of long, flexible shafts, an insertor device was designed to couple with existing stereotactic frames or robots and integrate directly with camera-based neuronavigation tracking systems.

5) Electronics and Packaging Integration: The team integrated a 256-channel stimulation ASIC onto flexible substrates featuring iridium oxide electrodes. Peripheral electronics were consolidated onto a miniature system PCB controlled via Bluetooth Low Energy (BLE) through a custom mobile application. Additionally, the fabrication process was adapted to support multiple metal interconnect layers and vias to maximize functional channels.


Main Achievements:
1) Fabrication of Human Study Implants: A series of 256-electrode implants—comprising three arrays attached to a single pedestal connector—was successfully fabricated and sent for final assembly.
2)Functional Miniaturized Proof-of-Concept: The team successfully delivered the first functional, and miniaturized standalone prototype system of the future implant.
3)Encapsulation & Biocompatibility Milestones: Long-term encapsulation adhesion was validated via accelerated aging tests in phosphate-buffered saline (PBS). Furthermore, a multilayer thin-film encapsulation strategy (utilizing ALD, Parylene-C, and biocompatible epoxy) demonstrated a proven equivalent lifetime of approximately two years in vivo.
4) Regulatory Progress: Technical and safety files were finalized, securing formal approvals from both the hospital ethical committee and the Hungarian government for acute human insertion tests during brain surgery. Regulatory documentation was also fully prepared for submission to Spanish health authorities as well.
5) Project partner ReVision obtained FDA Breakthrough Device Designation status and was able to close a 4 M€ capital round, thanks to the support by the project.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Once the blind patient will be implanted, this will be the first time a high resolution flexible device is used to interface with the visual cortex directly. This will be instrumental to prove the main thesis of the project, i.e. that it is possible to build a breakthrough visual prosthesis for blind people based on this approach.