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From pills to bio-electronics: a wearable anti-inflammatory treatment for prevention of Peripheral Arterial Disease.

Periodic Reporting for period 1 - AuriMod (From pills to bio-electronics: a wearable anti-inflammatory treatment for prevention of Peripheral Arterial Disease.)

Reporting period: 2018-01-01 to 2018-04-30

SzeleSTIM’s mission is to provide personalised non-pharmaceutical therapy for patients with severe chronic and acute pain. The company has developed AuriMod, a wearable electro-medical device providing pain relief thanks to neurostimulation. With AuriMod, SzeleSTIM pioneers auricular Vagus Nerve Stimulation (VNS), a non-invasive alternative to traditional medications, thus avoiding the side effects of conventional drugs. The key objectives of the project are to demonstrate the safety, efficacy and usability of AuriMod when applied to the auricle, confirming also the performance and usability of a therapy management system put in place, in order to eventually achieve CE marking.
During the feasibility assessment, SzeleSTIM conducted a full analysis of the technical and business potential of the AuriMod solution, significantly expanded their knowledge regarding the clinical validation and regulatory approval required for the European market launch. The remaining optimisation activities and a detailed plan for the clinical validation of the wearable device and the patient / therapy management system were defined, and two partner CMOs for industrial scale-up, as well as all necessary suppliers and technical partners to support selected development / design activities, were selected. The go-to-market strategy was also defined. The Phase 1 feasibility assessment has clearly shown that the AuriMod development plan is technically and commercially viable, and that the implementation of an industrialisation and commercialisation plan should be pursued. SME Instrument Phase 2 funding could provide the necessary amount of funding to complete the activities required to advance toward the market launch of the AuriMod solution.
Chronic pain is one of the most underestimated healthcare problems in the world today, causing major consequences for the quality of life of the sufferer and a major burden on the healthcare system and society. One in five people in the general adult population – 150 million Europeans – have chronic pain, more than heart disease, cancer and diabetes combined. With an aging population, the problem is likely to be felt even stronger in the years to come. Conventional treatment options offer only a partial response to the problem, with many people continuing to suffer with their severe chronic pain on a daily basis despite receiving several treatments. Consequently, there is a true and significant unmet need in optimal pain management.
With its AuriMod device, SzeleSTIM offers an innovative patient-centred, non-invasive pain management system based on electrical stimulation of the vagus nerve in the ear. Its unique biofeedback-controlled algorithm uses patient real-time physiological data for automatically adjusting the therapy. In this way, SzeleSTIM paves the way for truly individualised therapy, based on the patient’s individual condition and dynamic needs. In addition to pain management, other potential future applications of the AuriMod device include vascular diseases such as Peripheral Arterial Disease (PAD), but also migraine, or autoimmune diseases.