Vagus nerve stimulator and recorder for epilepsy treatment

2018年，全球迷走神经刺激（VNS）市场规模为5.052亿美元，预计到2026年，其复合年增长率将达到11.4%，达到11.95亿美元。VNS是更大的神经刺激市场的一部分，它结合了许多不同的刺激技术来对抗一系列不同的情况。1997年，fda批准了首个用于难治性癫痫（患者不适合切除手术）的VNS。在早期的设备中，刺激是通过在植入物上移动磁铁来开始的，然后磁铁会提供固定剂量。刺激的目的是减少癫痫发作的频率、严重程度或持续时间。标准的VNS装置已经进行了许多临床试验，成功地证明了它的安全性。然而，个体对VNS的反应是不同的。Mertens等[2019，[https://doi.org/10.2217/bem-2019-0004][0]]]将应答率定义为癫痫发作频率降低50%的患者比例。植入后1年，这一比例为20-40%，大约5年后为63%。最近的设备试图通过引入自动刺激功能来提高疗效(LivaNova, AspireSR（r)和SenTiva(r)， FDA于2015年和2017年批准）。自动刺激与磁开关一起工作，如果心率增加超过指定阈值，就会提供额外的刺激。临床试验表明，应答率为30-59%，大于或等于标准刺激器。此外，在63名将现有VNS刺激器升级为AspireSR的患者中，71%的患者癫痫发作减少了50%。SenTiva（tm）设备包括自动刺激，也可以与临床医生无线连接，远程控制设备刺激。electronRx的目标是建立下一代智能VNS设备，能够以比目前更高的精度检测癫痫发作。这需要识别感兴趣的生物标志物，并开发智能算法，利用这些数据来预测癫痫发作，从而使治疗方案针对患者，以最佳缓解症状。长期目标是将这些技术整合到eletronRx的神经调节平台中，并将一种通用的迷走神经神经调节剂推向市场，该调节剂可适应基于生理输入的应用治疗干预。除了癫痫，该装置还可能用于治疗与迷走神经功能有关的几种疾病。

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.