Vagus nerve stimulator and recorder for epilepsy treatment

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The global Vagus Nerve Stimulation (VNS) market was $505.2 million USD in 2018, it is expected to have a compound annual growth rate of 11.4% till 2026, reaching $1,195 million. VNS is part of the larger neurostimulation market, which incorporates many different stimulation techniques to combat a range of different conditions.The first VNS for refractory epilepsy, where the patient is not suitable for resective surgery, was FDA-approved in 1997. In early devices, stimulation was started by moving a magnet over the implant which then delivered a fixed dose. The aim of the stimulation was to reduce the frequency, severity or length of seizures. The standard VNS device has been the subject of many clinical trials which have successfully demonstrated its safety. However, individual response to VNS is variable. Mertens et al. [2019, [https://doi.org/10.2217/bem-2019-0004][0]] defined a responder rate as the proportion of patients with =50% seizure frequency reduction. This rate was found to be 20-40% one year after implantation, and 63% after approximately five years.More recent devices have tried to improve efficacy by introducing an autostimulation feature (LivaNova, AspireSR(r) and SenTiva(r), FDA approved in 2015 and 2017). The autostimulation works alongside the magnetic switch, providing extra stimulation if the heart rate increases beyond a specified threshold. Clinical trials have shown a responder rate of 30-59%, greater than or equal to the standard stimulator. Additionally, of 63 patients who upgraded their existing VNS stimulator to the AspireSR, 71% experienced an additional >50% reduction in seizures. The SenTiva(tm) device includes autostimulation and also wirelessly connects to the clinician for remote control of device stimulation.electronRx aims to build the next generation of intelligent VNS devices that can detect seizures with a higher accuracy than is currently possible. This requires identifying the biomarkers of interest and developing smart algorithms that use this data to predict seizures, thereby allowing the treatment regime to be patient-specific for optimal alleviation of symptoms.The long term goal is to integrate the technologies in eletronRx’s neuromodulation platform and bring to market a universal Vagus Nerve neuro-modulator that adapts the applied therapeutic intervention based on physiological inputs. The device would potentially be used in the treatment of several conditions related to Vagal Nerve function in addition to epilepsy.