Synergia Medical's NAO.VNS Device Shows Promising Results in First-in-Human Study for Drug-Resistant Epilepsy
• Synergia Medical's NAO.VNS device met the primary safety endpoint in its first-in-human clinical study, with no serious adverse events reported over three months.
• The study demonstrated robust device performance with no device failures reported, showcasing the potential of the next-generation neuromodulation platform.
• Patients appreciated the extended battery life and ease of recharging, which could reduce the need for frequent surgical replacements and improve long-term management.
• Synergia Medical is preparing to submit a request for a pivotal clinical study in the U.S. and Europe, building on the positive outcomes observed.
Synergia Medical Implants First Patients with Novel Neurostimulator for Epilepsy
• Synergia Medical has implanted its NAO.VNS device in first-in-human study participants with drug-resistant epilepsy, testing a novel neurostimulation technology.
• The AURORA trial, conducted across sites in Belgium and Germany, will evaluate the safety and efficacy of Synergia's vagus nerve stimulation therapy.
• Synergia's device uses optical fibers instead of metal wires, potentially allowing patients to undergo MRI scans, which are typically restricted with conventional devices.
• The global neuromodulation device market is projected to reach nearly $11 billion by 2033, with vagus nerve stimulation contributing significantly to this growth.
Synergia Medical's NAO.VNS System Successfully Implanted in First-in-Human Epilepsy Study
• Synergia Medical successfully implanted its NAO.VNS system in two patients with drug-resistant epilepsy as part of the AURORA study.
• The first-in-human implantations occurred at Cliniques Universitaires Saint-Luc and UZ Gent, with both patients recovering fully and starting stimulation therapy.
• The AURORA study will assess the safety of the NAO.VNS system over 24 months, with plans for a pivotal trial in Europe, the USA, and Canada.
• NAO.VNS offers MRI compatibility, extended battery life, and enhanced cybersecurity through optoelectronic technology for personalized vagus nerve stimulation.
Synergia Medical Secures €9 Million in Series B Funding for Epilepsy Treatment Innovation
Synergia Medical, a preclinical medical device company, has successfully raised €9 million in Series B funding. This financial boost will support the company's preparation for First-In-Human clinical trials of its NAO.VNS device, aimed at treating drug-resistant epilepsy, and the submission of an Investigational Device Exemption to the FDA in 2023.
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