Over 1 % of the world’s population suffers from epilepsy – a neurological disorder that causes the individual to have sudden and recurring seizures. For most people, epilepsy can be managed using anti-epileptic drugs (AEDs). However, for about 30 % of epileptics, these drugs do little to treat their symptoms. Instead, they depend on neural stimulation – a treatment that involves delivering electrical impulses to, for example, the vagus nerve. Although vagus nerve stimulation (VNS) is a clinically proven method for treating certain types of intractable epilepsy, its efficiency remains limited. To help fill this treatment gap, Synergia Medical, a Belgian medical technology company, is developing a personalised vagus nerve stimulation (pVNS) therapy called NAO·VNS™. “Using a unique combination of advanced sensing capabilities, NAO·VNS™ will allow one to tailor the stimulation parameters to each patient,” says Attila Borbáth, CEO and co-founder of Synergia Medical. “As a result, epileptic patients will finally receive the personalised treatment they deserve.” With the support of the EU-funded NAOS project, Synergia Medical conducted a thorough feasibility study, meaning it is now one step closer to bringing its NAO·VNS™ solution to the market.
Breakthrough non-metal technology
Vagus nerve stimulators are typically implanted within a patient’s body, where they deliver electrical impulses via standard metal wires that run under a patient’s skin and connect to the nerve. The innovative NAO·VNS™ medical device, however, is based on a breakthrough technology that replaces the metal wiring with implanted optoelectronics and non-metal transparent components. This use of optical fibres offers several key advantages, including improved safety, compatibility with MRI, better control of the stimulation parameters, and an increased device lifetime. “NAO·VNS™ enables epileptic patients and practitioners to overcome the constraints faced with existing implanted devices, hence improving the patient’s quality of life and paving the way for pVNS,” explains Borbáth.
Accelerating the route to marketisation
Thanks to the support of EU funding, Synergia Medical was able to test the technical and economic feasibility of the NAOS platform. This included running a ‘freedom-to-operate’ anteriority study on the future exploitation of the concept. This focused on reviewing the state-of-the-art of all aspects of the technology being developed. The company also began putting together its supply chain by confirming subcontractors to work with from across Europe. In addition to the range of verification tests and scale-up scenarios conducted, the company also established a strategy for bringing the device to market. According to Borbáth, this exercise allowed the company to fully understand the complex regulatory environment that surrounds bringing medical devices to market. “By working with key opinion leaders in the field of epilepsy, we were able to refine the specifications of our NAO·VNS™ neurostimulator,” he says. “In doing so, we have significantly accelerated its availability to patients.” With the NAO·VNS™ device’s feasibility confirmed, Synergia Medical is now seeking financing to get the device to patients. This will involve several key studies, starting with an animal study in 2020 and followed by human studies. The company aims to achieve CE Mark and FDA approval by 2025, with the device being made available on the market shortly after that.
NAOS, Synergia Medical, NAO·VNS, neural stimulation, epilepsy, seizures, anti-epileptic drugs (AEDs), Vagus Nerve Stimulation, MRI, neurostimulator