Vagus nerve stimulation is used for patients whose epilepsy does not respond to drugs, and Synergia Medical, founded in 2015 near Brussels, built a version with optical fibres instead of metal wires. Its NAO.VNS implant is meant to allow MRI scans without restriction and to adapt therapy to each patient, according to its EIC project, which targeted the 8 million patients with drug-resistant epilepsy who are not candidates for brain surgery.
The European Innovation Council granted €2,499,000 towards a €4.5 million project from March 2023 to August 2025 whose objective was: "We will complete a clinical pilot trial & a pivotal study in the EU/US to initiate market approvals." It projected €89 million in revenue by 2028. The final report describes five patients implanted in a first-in-human study with no serious adverse events and a 40% responder rate at six months; it adds that manufacturing "is postponed to 2026". No pivotal study has started. According to Companyweb, staff fell from 21.7 full-time equivalents in 2023 to 11.7 in 2025, when the company lost €8.0 million.
Company file
- Legal entity
- Synergia Medical SA, 0540.563.776, Mont-Saint-Guibert, Belgium
- Founded
- 2015
- CEO
- Charles Nolet, since February 2025 (replaced co-founder Attila Borbath)
- Product
- NAO.VNS optoelectronic vagus nerve stimulator
- Investors
- Newton Biocapital, SFPI, SRIW Life Sciences, Investsud, Invest BW, TheClubDeal, Berrebi family
- EIC project
- NAO.VNS, 1 Mar 2023 to 31 Aug 2025
- EIC funding
- Grant first
Where Synergia Stands Now
In February 2025 the company announced the early results of its AURORA study at UZ Gent and Cliniques universitaires Saint-Luc and said it was preparing requests for pivotal trials for FDA and CE approval. On taking over as CEO, Charles Nolet named his priority as putting in place "a scalable manufacturing process and financing to meet the product needs for pivotal clinical trials". No pivotal trial or new funding round has been announced since. Equity fell to €3.0 million at the end of 2025.
"The promising results and positive patient feedback bring us closer to a breakthrough for drug-resistant epilepsy."
Charles Nolet, CEO, Synergia Medical, February 2025The Technology: Light Instead of Wire
According to CORDIS, the optical fibres replace traditional metal wires to make the implant MRI-compatible and allow therapy to be adjusted remotely. One investigator in the study, Kristl Vonck, said "MRI access without restriction represents a major leap forward in neuromodulation". The report adds that quality of life improved in four of five patients and mood in all patients with baseline depressive symptoms. Five patients without a control group cannot show whether the device beats existing stimulators.
What the EIC Project Promised, and What CORDIS Shows
The project promised both a pilot and a pivotal study in the EU and US. It completed the pilot, with a design dossier approved by Belgian authorities in February 2024, trial approval in April 2024 and 12 sterile implant systems made. The pivotal study, which market approval depends on, did not begin within the project. CORDIS still lists it as signed.
- First-in-human pilotDelivered5 patients.
- SafetyShownNo serious adverse events.
- Pivotal EU/US studyNot startedStill preparing.
- Scaled manufacturingPostponedTo 2026.
The Money
Synergia had raised over €30 million since 2016 by January 2023, when it extended its Series B to €12.8 million. It lost €4.5 million in 2022, €6.6 million in 2023, €6.2 million in 2024 and €8.0 million in 2025, and its equity fell from €18.6 million to €3.0 million over those four years.
What Cannot Be Checked
Questions for the EIC
How Synergia will fund a pivotal trial with €3 million in equity, whether the staff cuts reflect a change of plan, and when a CE or FDA application could be filed are not public.
Why Europe Should Care
A nerve stimulator that is safe in MRI scanners would matter to patients with severe epilepsy. The EIC paid for the first human test, which went well, but the company is now smaller, with €3 million in equity, and has not announced the financing its CEO said pivotal trials require.
What the project promised
Pilot and pivotal EU/US trials to start market approval, and €89 million in revenue by 2028.
What the record shows
A five-patient first study with no serious adverse events, no pivotal trial, half the staff and €3 million in equity.
The Verdict
Good first data, shrinking company
Synergia got its device into patients safely with EIC support. It fell well short of the pivotal trials it promised, and its accounts show a company contracting while it looks for the money to continue.
Synergia Medical and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
