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Neural Stimulation for Drug Resistant Epilepsy

Neural Stimulation for Drug Resistant Epilepsy

SYNERGIA MEDICAL SUCCESSFULLY IMPLANTS FIRST PATIENTS WITH NAO.VNS(TM)

Brussels, 23 September 2024 – Synergia Medical, a leader in the development of optoelectronic medical devices, is pleased to announce the successful implantation of its groundbreaking NAO.VNS system in the first two patients as part of the AURORA study. These first-in-human implantations took place on September 6, 2024, at Cliniques Universitaires Saint-Luc and UZ Gent. Two weeks after surgery, both patients have fully recovered, allowing the initiation of stimulation therapy as planned.

The AURORA study is designed to evaluate the safety of the NAO.VNS(TM) system for patients with Drug-Resistant Epilepsy (DRE). The successful implantations, performed by Dr. Herbert Rooijakkers at Cliniques Universitaires Saint-Luc and Dr. Frank Dewael at UZ Gent, mark a critical milestone in this first-in-human study.

"We are excited to be part of this optical revolution in neuromodulation," said Dr. Herbert Rooijakkers and Dr. Frank Dewael, the lead surgeons at Cliniques Universitaires Saint-Luc and UZ Gent, respectively. "This technology has the potential to transform how we treat epilepsy and other neurological disorders, offering new hope to patients who have exhausted traditional options."

Prof. Dr. Kristl Vonck, Principal Investigator at UZ Gent, and Dr. Riëm El Tahry, Principal Investigator at Cliniques Universitaires Saint-Luc, emphasized the significance of the NAO.VNS system's MRI compatibility. "Ensuring full access to the benefits of MRI in healthcare is crucial, and this device offers that advantage to all our patients implanted with VNS," said Prof. Vonck. Dr. El Tahry added, "This compatibility allows us to better personalize and improve VNS therapy in the future by leveraging MRI imaging."

"We are thrilled with the success of these first implantations, which brings us one step closer to providing a new, innovative treatment option for patients with drug-resistant epilepsy," said Attila Borbáth, CEO and co-founder of Synergia Medical. "The full recovery of the first 2 patients and the commencement of stimulation therapy demonstrate the potential of the NAO.VNSTM system to improve patient safety and outcomes."

The NAO.VNS(TM) system, developed by Synergia Medical, is a new generation neural stimulator that can reduce epileptic seizures by stimulation of the vagus nerve (VNS). 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.VNSTM 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.

The AURORA study will continue to monitor the safety of the NAO.VNS(TM) system over a 24-month period, focusing on key safety endpoints such as the incidence of device-related adverse events and procedure-related adverse events. Following the successful completion of the AURORA study, Synergia Medical plans to initiate a pivotal trial across Europe, the USA, and Canada to assess the efficacy of the NAO.VNS(TM) system.