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- 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 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 successfully closed a €9 million Series B funding round to support the development of NAO.VNS, a non-metal optoelectronic neurostimulator. - The funding will facilitate First-In-Human clinical trials planned for 2023 and the submission of an Investigational Device Exemption (IDE) to the FDA. - NAO.VNS targets vagus nerve stimulation for treating drug-resistant epilepsy, offering a novel approach for patients with limited treatment options. - Synergia Medical has raised over €26 million since 2016, supporting its preclinical studies, R&D, and regulatory efforts.
