Drug Resistant Epilepsy Therapy

Belgium, April 29^th, 2024 – Synergia Medical, a clinical medical device company that has developed NAO.VNS, the first quartz optoelectronic neurostimulator for the treatment of drug-resistant epilepsy with Vagus Nerve Stimulation (VNS), today announced that it has received authorization from the FAMHP (Federal Agency for Medicines and Health Products), to carry out "A first in human study for drug resistant epilepsy with the vagus nerve stimulation device.”

The primary study objective is to confirm the overall safety of the device and therapy at 3 month follow up.

“This go ahead from the Belgium health authority is a major milestone in our development of the world’s first optoelectronic neural stimulator. We expect to start the FIH study in the coming weeks. This next phase will bring huge hope for the many adults and children living with the challenges of drug-resistant epilepsy. I would like to thank our team for their unwavering commitment as well as our investors' loyal and unrelenting support.”declared Attila Borbath, CEO & Co-founder of Synergia Medical. “I am particularly proud as well that our FIH trials will take place in Belgium, home to Synergia Medical and this exciting groundbreaking technology” he added.

About Epilepsy and Drug-Resistant Epilepsy

Epilepsy is the 4^th most common neurological disorder affecting over 6 million adults and children in the EU & US. The conventional medical treatment is with anti-epileptic drugs but 30% of the epilepsy population see their symptoms poorly controlled and continue to have seizures that impair their health and daily lives.  Of the 150.000 new epilepsy patients diagnosed every year in the US and in Europe, 50.000 suffer from drug-resistant epilepsy and are in dire need for a safe treatment that will help them control their seizures.

About NAO.VNS – Optoelectonics for Vagus Nerve Stimulation

NAO.VNS is a new generation neural stimulator that can reduce epileptic seizures by stimulation of the vagus nerve (VNS), using novel materials to improve patients’ life. Neural stimulation is a clinically proven solution and the last resort for patients suffering from drug-resistant neurological diseases. It involves the implantation of a small pacemaker that delivers mild electric signals to targeted nerves or brain cells. NAO.VNS unique design allows for safe and easy MRI & fMRI scans which therefore enable a personalized treatment, adapted to each patient’s needs. It is powered by a rechargeable battery, extending the device lifespan, as well as enabling continuous collection of patient data through dedicated biomarkers.

About Synergia Medical – www.synergia-medical.com

Synergia Medical is an ISO 13485 certified medical device company that has developed NAO.VNS, the first quartz optoelectronic neurostimulator for the treatment of drug-resistant epilepsy with Vagus Nerve Stimulation (VNS). More than 1.15 million epilepsy patients are currently waiting for an effective therapy, representing an estimated obtainable market of ca.€20 billion. Operational since 2015, Synergia Medical is based in Belgium, employing more than 25 employees. It was founded by Attila Borbath, CEO, and Pascal Doguet, the inventor of NAO.VNS.

Contacts