Synergia Medical has successfully implanted its NAO.VNS neurostimulation device in the first two patients enrolled in a first-in-human study evaluating the technology for treating epilepsy. The surgeries, which took place earlier this month at sites in Belgium, mark a significant step forward in the development of personalized vagus nerve stimulation therapy.
AURORA Trial Details
The AURORA trial is being conducted across two sites in Belgium and one in Germany. The trial aims to enroll 10 participants with drug-resistant epilepsy. Following implantation, patients will receive vagus nerve stimulation two weeks post-surgery. The primary endpoint focuses on the incidence rate of NAO.VNS device-related treatment emergent adverse events (TEAEs) within the first three months of implantation. A secondary endpoint assesses the incidence of procedure or device-related adverse events one month after implantation.
NAO.VNS Technology
Synergia's NAO.VNS device represents a novel approach to vagus nerve stimulation. Unlike traditional devices that use copper wires, Synergia's technology employs optical fibers for photonic power transfer. This innovative design offers a crucial advantage: compatibility with magnetic resonance imaging (MRI). According to Synergia, approximately 30% of epileptic patients do not respond adequately to anti-epileptic drugs, making vagus nerve stimulation a vital treatment option. Vagus nerve stimulation works by delivering electrical pulses to the brain, helping to stabilize irregular neural activity.
MRI Compatibility
Conventional vagus nerve stimulation devices, which utilize metal wires, restrict patients from undergoing MRI scans due to safety concerns. This limitation not only hinders diagnostic imaging but also prevents researchers from effectively tracking therapy progress. Synergia's use of optical fibers addresses this critical issue, allowing for MRI compatibility and providing feedback on the direct effects and efficacy of the stimulation.
Market Outlook
The global neuromodulation device market is poised for substantial growth, with forecasts projecting a rise to nearly $11 billion by 2033, up from $5.7 billion in 2023. GlobalData analysis indicates that the vagus nerve stimulator segment is expected to contribute $1 billion to this market growth. Currently, Medtronic holds the largest market share, with Boston Scientific and Abbott also being key players in the field.
Synergia stated that both patients have fully recovered following the surgeries two weeks ago, “allowing the initiation of stimulation therapy as planned.”
