Synergia Medical's NAO.VNS device has shown promising results in its first-in-human clinical study, offering a potential breakthrough for patients with drug-resistant epilepsy (DRE). The AURORA study, conducted at UZ Gent and Cliniques universitaires Saint-Luc in Belgium, evaluated the safety and performance of the NAO.VNS device implanted in five patients. The device met its primary safety endpoint, with no serious adverse events reported over the three-month study period.
The NAO.VNS device represents a next-generation neuromodulation platform designed to overcome limitations of traditional vagus nerve stimulation (VNS) devices. A key feature is the elimination of main metal components, ensuring immunity to electromagnetic interference (EMI). This allows for full compatibility with MRI and other EMI sources, such as electrosurgery and defibrillators, enhancing patient safety and care. The device also boasts a fast-recharge battery with an expected lifetime of 15 years with just one minute of daily charging.
Enhanced Patient Experience and Therapeutic Potential
According to Synergia Medical, the NAO platform has the potential to optimize therapy by remaining fully active during imaging, allowing physicians to adjust treatment in real time while observing brain responses. The long-lasting battery supports energy-intensive stimulation for potentially more effective therapeutic outcomes.
Prof. Dr. Kristl Vonck, Principal Investigator at UZ Gent, commented, "These results demonstrate both safety and reliability in real-world settings for this innovative technology. The MRI access without restriction represents a major leap forward in neuromodulation. Seeing already therapeutic benefits is promising and we look forward to the long-term impact."
Addressing Unmet Needs in Drug-Resistant Epilepsy
Drug-resistant epilepsy poses a significant challenge, with a substantial proportion of patients not achieving adequate seizure control with available medications. Vagus nerve stimulation has emerged as a valuable therapeutic option for these individuals, offering a non-pharmacological approach to reduce seizure frequency and improve quality of life. The NAO.VNS device aims to improve upon existing VNS therapies through its enhanced features and capabilities.
Prof. Dr. Riëm El Tahry, Principal Investigator at Cliniques universitaires Saint-Luc, added, "Patients were particularly appreciative of the extended battery life, which reduces the need for frequent surgical replacements. The ease of recharging has also been well received by both patients and caregivers, making long-term management more convenient."
Next Steps: Pivotal Trial
Charles Nolet, CEO of Synergia Medical, stated, "We are thrilled by the strong safety and reliability of our NAO.VNS device. The promising results and positive patient feedback bring us closer to a breakthrough for drug-resistant epilepsy. Building on this success, we are preparing to submit our request for a pivotal clinical study in the U.S. and Europe."
