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Nexeon Begins Clinical Study with Non-Invasive Vagus Nerve Stimulator

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Nexeon MedSystems Inc announced its completion of an initial series of clinical studies evaluating the utilization of transcutaneous auricular vagus nerve stimulation (aVNS) for the relief of paroxysmal atrial fibrillation. The Company was previously awarded a €3.4M research grant from the Walloon Region government of Belgium in coordination with the region's health competitiveness cluster Biowin.

In collaboration with Dr. Jean-Benoit le polain de Waroux and Dr. Anais Gauthey at the University Catholique de Louvain (UCL), Nexeon tested the effects of auricular vagus nerve stimulation (aVNS) on the cardio-autonomic system in healthy subjects. In this study, researchers delivered aVNS to a subjects’ ear at varying stimulation parameters while continuously monitoring electrocardiography (ECG).

Nexeon’s Director of Clinical Research Dr. Navid Khodaparast commented on the study’s preliminary results by stating, “Our aVNS system supported our original hypothesis by demonstrating a significant stimulation-induced effect on heart rate variability, which may prove to be effective in treating atrial fibrillation. It is our belief that a more holistic approach to the application of neurostimulation will usher in a new era of neuro-technological advances. While our near-term target is to discover an improved therapy for patients with atrial fibrillation, we recognize the greater implication of monitoring, and potentially modulating, signals from the heart in a population of patients suffering from chronic diseases who are managing multiple comorbidities.”

Dr. Khodaparast is an expert at utilizing vagus nerve stimulation to treat neurological disease. In earlier years of his neuroscience research, he successfully demonstrated that VNS can greatly improve the physical rehabilitation in animal models of chronic stroke, which translated into multiple ongoing clinical trials. At Nexeon, Dr. Khodaparast is leading the team of neuroscience researchers in expansion of the Company’s neuro-therapeutic pipeline by partnering with university researchers in studies related to asthma, dysphagia, and cognitive disorders. Additionally, he is collaborating with Company engineers in the ongoing development of its aVNS device.

“As a scientist, we approach problems one at a time so that we know what effect we can have on a target variable,” said Dr. Khodaparast. “But we recognize that physicians do not have the luxury of treating a symptom or a disease in a perfect vacuum. Because a majority of chronic disease patients suffer from a list of ailments and are treated with an equally long list of medications and therapy, we are aiming to develop comprehensive therapy solutions that collect biometrics, iterate on therapy needs, and automate as much of the disease management process as possible.”

Nexeon CEO Will Rosellini stated that their team of researchers in collaboration with their partners in the Walloon Region is testing the efficacy of the stimulation therapy in parallel with ongoing engineering development of its aVNS system. Pictured below is a proposed next-generation device after receiving patient and physician feedback on the current version of the device.

Immediate next steps related to this clinical program will be the completion of a study on twenty patients suffering from paroxysmal atrial fibrillation. The protocol includes an assessment of therapeutic safety and feasibility while participants receive chronic aVNS to reduce their atrial fibrillation burden.

"Noninvasive modulation of the vagus nerve presents a promising opportunity to advance the treatment of patients living with a variety of chronic disorders,” said Daniel Powell, Nexeon’s Vice President of Sales and Marketing. “While the majority of our team is focused on the commercial launch of our leading product, we are grateful for the expanded research capacity we’ve found in our partnerships with these esteemed institutions and physicians who are eager to apply our innovation technology to a host of different disease conditions. We have high expectations that this study will bring us closer to improving the lives of patients living with atrial fibrillation, and we are optimistic about future research on how this technology can treat other diseases and potentially provide a platform for us to manage multiple disease states within a patient managing frequently associated comorbidities."

Mr. Powell has over 12 years in medical devices working with Abbott and LivaNova before joining Nexeon. During his tenure he has had extensive experience in interventional neuromodulation technology such as deep brain stimulation (DBS), spinal cord stimulation (SCS), and VNS for a variety of neurological disorders including Parkinson’s disease, essential tremor, dystonia, depression, OCD, chronic pain, chronic heart failure, and epilepsy.

VNS has been used for years to treat epilepsy, obesity, and depression. Researchers worldwide are investigating whether delivering gentle pulses of electricity to the nerve can help treat tinnitus, stroke, headache, asthma, Crohn's disease, and more.

"The support we have received from the Walloon Region and our neighboring partners has expedited our ability to develop advanced solutions for patients suffering from neurological diseases,” said Nexeon’s CEO Will Rosellini, who prior to Nexeon founded Microtransponder, a company developing VNS for the relief of impairment after stroke. “Belgium has been a world leader in these innovations for a number of years, and the Walloon Region has solidified an environment that facilitates the design, manufacturing, and testing of our implantable systems. Because of our ongoing success in this region, [we’re] eagerly investing in our collaborations with UCL, Lambda-Plus, University of Liege (Ulg), and Medi-Line S.A.”

Nexeon Medsystems joined the Walloon Region Consortium in 2013 via its wholly-owned subsidiary, Rosellini Scientific Benelux (RSB), renamed Nexeon Medsystems Belgium. Thanks to BioWin and the Walloon Region, Nexeon has benefited from consortium partnerships with iSTAR Medical, the Catholic University of Louvain, and the University of Liege as well as collaboration with other Wallonia-based companies including Medi-Line S.A., Lambda-plus, IOL, and recently the new Creative Wallonia supported WeLL (Wallonia E-health Living Labs).