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From pills to bio-electronics: a wearable neurostimulator for the personalised treatment of chronic pain

Periodic Reporting for period 2 - AuriMod (From pills to bio-electronics: a wearable neurostimulator for the personalised treatment of chronic pain)

Reporting period: 2020-10-01 to 2021-09-30

One in five individuals suffers from chronic pain, one of the most common causes of long-term disability in the world, with a devastating impact on the quality of life of over 1.5 B people. Chronic pain is strongly associated with serious co-morbidities and with an increased risk of death by suicide. The cost to society due to productivity loss and healthcare costs for pain management amounts to around € 441 B annually for Europe only – or 1.5%-3% GDP.
Current pain management solutions only partially address the needs of chronic pain patients: pharmacological therapies often induce side effects and in some cases drug addiction, limiting their efficacy and applicability for many patients; more recent non-pharmacological treatments based on neurostimulation are either associated with surgery and related risks or lack techniques for necessary personalization of treatment.

SzeleSTIM has developed the AuriMod system, the first chronic pain management system based on neurostimulation that enables tailoring the stimulation – hence, pain perception – on the individual patient’s needs non-invasively. The AuriMod system is composed of a discrete wearable device for controlled stimulation of the vagus nerve in the ear according to the measured patient’s physiological parameters and pain, a smartphone application, and of an online therapy management platform for data visualization and remote monitoring of the therapeutic progress.

Within the proposed project, SzeleSTIM aims at optimising the AuriMod design and performance, completing the therapy management system, preparing for industrial-scale production, and executing clinical validation through a European multi-national trial for CE marking.
During the project, we have been actively working on the system optimization: the AuriMod wearable is now enabled for continuous monitoring and recording of electrical stimulation settings as well as of physiological and health parameters. The smartphone application and the therapy management platform for assessing patient reported outcome measures and an objective pain scale, as well as remote monitoring have been developed. In parallel, we were able to achieve CE marking for VIVO, our first product for personalized auricular vagus nerve stimulation based on subjective feedback of the patient. In collaboration with our partnering contract manufacturers, we have successfully set-up a manufacturing line for industrial production, have produced devices for clinical validation, and have ramped-up our commercial production of VIVO. We are currently performing a multicentre, multinational clinical trial to evaluate performance and safety of our AuriMod system. Our system and project results have been presented in several publications, conferences and events, enabling us to strengthen our network of Key Opinion Leaders.
We aim to demonstrate safety and performance of our AuriMod system in the ongoing clinical trial, and obtain the clinical evidence needed for CE marking of our AuriMod system. The SME Instrument Phase II project will enable the launch of the AuriMod system into the European marketplace to provide the first non-invasive, non-pharmacological, and sustainable therapy management system to help acute and chronic pain patients.
The AuriMod system for Individual Pain Therapy