reStoring sIGHt wiTh a neuroprosthEsis for the blinD

Projektinformationen

SIGHTED

ID Finanzhilfevereinbarung: 101212687

DOI

10.3030/101212687

EK-Unterschriftsdatum 29 April 2025

Startdatum 1 Mai 2025

Enddatum 31 Oktober 2027

Finanziert unter

• The European Innovation Council (EIC)

Gesamtkosten

Keine Daten

EU-Beitrag

€ 2 499 749,37

Koordiniert durch

SORBONNE UNIVERSITE
France

Periodic Reporting for period 1 - SIGHTED (reStoring sIGHt wiTh a neuroprosthEsis for the blinD)

Berichtszeitraum: 2025-05-01 bis 2026-04-30

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

Blindness is a highly disabling condition affecting autonomy, mobility, and social participation. Around 40 million people worldwide live with profound blindness, often caused by irreversible damage to the eye or optic nerve, while the brain’s visual pathways remain intact but unused. Existing assistive solutions improve safety but do not restore vision, leaving a major unmet medical need.

The SIGHTED project addresses this challenge by developing a novel visual neuroprosthesis that restores functional vision by directly stimulating the lateral geniculate nucleus (LGN) in the brain. By bypassing damaged ocular structures and interfacing with the central visual pathway, the system aims to generate structured visual percepts that support navigation, spatial awareness, and independent mobility.

The system integrates four key components:
(1) the Fountain Probe neural implant with >1,000 stimulation electrodes,
(2) camera-equipped smart glasses,
(3) an external processing unit translating visual input into stimulation patterns, and
(4) stimulation control electronics.

The overall objective is to advance the technology from TRL3 to TRL5 and prepare it for a First-in-Human study by demonstrating safety, functionality, and regulatory readiness.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

Work so far has focused on building and validating the Fountain Probe implant, generating early scientific evidence, and preparing the pathway toward clinical testing.

A key technical achievement has been the development of a new prototype of the Fountain Probe, together with improved surgical tools that increase implantation precision and reliability. In parallel, a new processing workflow for the flexible polyimide material used in the probe has been established in Europe, supporting more robust and scalable device manufacturing.

Early preclinical studies in non-human primates are providing important proof-of-concept results. The probe was implanted with high precision. Mapping of visual responses shows that the probe can access a wide area of the visual field, and electrical stimulation has been shown to produce localized visual percepts (phosphenes), supporting the underlying scientific approach.

Alongside this technical and scientific progress, the project has established the foundations required for clinical translation. A Quality Management System has been implemented, the Clinical Investigation Plan for First-in-Human testing has been drafted, and preparatory work on biocompatibility assessment is ongoing to ensure regulatory readiness.

In parallel, work on the business and implementation side has continued, including development of a business plan and model, as well as an early health economic assessment to understand potential value in healthcare systems. Together, these activities support preparation for future clinical studies and long-term translation toward patient use.

Overall, the project has moved from early design toward an integrated system with demonstrated preclinical functionality and a clear pathway toward clinical validation.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

The project is expected to have long-term impact across scientific, economic, and societal domains by advancing a novel neurotechnology for restoring functional vision in people with profound blindness.

From a scientific perspective, the project contributes to the emerging field of high-resolution brain–computer interfaces by enabling targeted, high-channel-count stimulation of the lateral geniculate nucleus (LGN), a key relay in the visual pathway. This approach not only supports the generation of visual percepts, but also provides a unique platform to study and better understand how visual information is processed in the brain. More broadly, it establishes a framework for interfacing with deep brain structures, with potential applications beyond vision.

Economically, early health technology assessment suggests that even partial vision restoration leads to meaningful quality-of-life gains, supporting a strong value proposition in line with existing reimbursement benchmarks for implantable neurotechnologies. Full economic impact will depend on future clinical validation.

Societally, the technology targets one of the most disabling sensory impairments, with the potential to improve autonomy, mobility, and social participation for individuals with severe vision loss. By enabling a degree of functional vision, the project aims to reduce dependence on care and support more independent living.