Clinical validation of a mobile EEG medical device for diagnosis and remote monitoring in epileptic patients

Informations projet

EpiHelmet

N° de convention de subvention: 717623

DOI

10.3030/717623

Projet clôturé

Date de signature de la CE 3 Mars 2016

Date de début 1 Avril 2016

Date de fin 31 Juillet 2016

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

A TLC SRL
Italy

Periodic Reporting for period 1 - EpiHelmet (Clinical validation of a mobile EEG medical device for diagnosis and remote monitoring in epileptic patients)

Période du rapport: 2016-04-01 au 2016-07-31

Résumé du contexte et des objectifs généraux du projet

Epilepsy is a disorder of the brain that affects more than 50 million people worldwide, determining a burden to both families and health and social care systems. The treatment gap to diagnose and follow up people with epilepsy is around 40% in Europe and misdiagnosis is not rare, translating into a huge societal cost.
The EEG systems are recognized as a golden standard in epilepsy diagnosis, but they are often subjective to clinician’s expertise, spatial and temporal limitations due to traditional equipment. Recently, mobile and wearable EEG systems are inculcating advanced cutting edge technologies for better diagnosis, drastically improving patients’ usability.
Our objective is to introduce in the market the first clinically validated mobile diagnostic device for supporting epilepsy diagnosis and remote monitoring, creating a killer application in an uncontested market space. The “EpiHelmet solution” is a fully integrated mobile medical device that allows for the remotely monitoring of epileptic patients by healthcare professionals, who are interested into longitudinal data collection to better understand the disease and the therapy. EpiHelmet is a wireless portable headset able to acquire, transmit, analyse and manage EEG signals, intended to be used at home (in accordance with the medical diagnostic device directives and guidelines). The system, being able to detect seizures through the extraction of useful and well known biomarkers, will support physicians in clinical decision-making, with a patient-centered, cost-effective and computer-aided tool, providing an efficient epilepsy care management.
Targeted customer segments are neurology/neuro-physiology hospital departments, epilepsy monitoring units and specialist centres.
Within this action, a study is carried out with the aim to assess the feasibility of the concept, to analyze the market and possible exploitation strategies, to explore opportunities for partnerships and to evaluate IPR, quality, risk and organization route as well as to develop the work plan.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

This SME Instrument Phase 1 project focused on the feasibility study for the EpiHelmet solution. It aimed to verify the actual applicability of the new solution from both the technological and the economic perspective.
The work performed included:
a) Market analysis: analysis of user needs, competitive scenario, client segmentation, estimation of target market dimension. This task was carried out through the study of specialized reports, the analysis of information on potential competitors and alternative products (gathered from secondary sources) and the involvement of professionals from healthcare providers and industrial sectors (i.e. direct interviews were conducted with specialists and domain experts); a SWOT analysis was conducted to define the commercialization strategy and support the planning.
b) Business model: the analysis of possible A TLC business model was described through the Business Model Canvas; it reported the rationale of how an organization creates, delivers, and captures value.
c) Partner search: in order to cover the gap that the company may encounter approaching the healthcare market, the partner useful to achieve the final objective (i.e. commercialization of the EpiHelmet solution) was identified.
d) Risk assessment: possible barriers in the development and dissemination of the final project’s results were identified. A preliminary analysis of the risks that are expected to be encountered during the validation, assessment and dissemination activities helped to define mitigation actions, eliminating the possibility of failure or slowdown during the project development. A specific product related risk analysis was completed.
e) Intellectual Property analysis: management of IPR was addressed, analyzing the possible measures in order to protect, preserve and disseminate results deriving from the project.
f) Quality and regulatory routes: standard regulations and medical devices directives has been addressed to ensure the quality compliance, at the scope to obtain the CE mark. A Quality Risk Management strategy has been set-up. A preliminary protocol for clinical validation studies was designed.
g) Organization and manufacturing route: analysis of A TLC’s organization, manufacturing and sales processes was conducted and possible changes to prepare the industrialization phase were considered.
h) Dissemination and exploitation strategy: it is considered a key for the success of the commercialization of EpiHelmet; stakeholder analysis was carried out to identify target audience in different domains of interest. A TLC’s strategy to maximize the impact and returns from the expected results was designed considering the three phases: i) increasing the awareness about EpiHelmet and innovative ways to manage epileptic patients; ii) designing pre-product launch and strategic alliances; iii) launching the product and the after-sale services.
i) Financials: a study of the potential Net Cash Flows (NCF) that EpiHelmet may generate was carried out. The analysis focused on the opportunity that A TLC has to launch a new business and organize a new Business Unit to commercialize the EpiHelmet medical device. The economic and financial forecasts cover the years from 2017 to 2021 and five target Countries that have been selected as initial target for the EpiHelmet business plan. Lastly, a sensitivity analysis was performed to verify if and how deviations from the hypothesis may lead to different financial outcomes.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

EpiHelmet will be the first “clinically validated” mobile diagnostic tool for epilepsy diagnosis and remote monitoring, tuned to the European population data and developed by European researchers. EpiHelmet is a patient-centered, cost-effective and computer-aid innovation tool that overcomes standard EEG equipment limitations, both spatial and temporal.
EpiHelmet success is built upon acquiring unique selling points, with significant competitive advantage over potential competitors: 1) revolutionary, proprietary and superior technologies (i.e. dry electrode, wireless transmission, alert and seizure video recording, etc.) and innovative features (seizure detection algorithms); 2) in-house expertise in wireless and remote data transmission, coming from hand on and not only theoretical background; 3) research and scientific team with previous experiences in wireless diagnostic medical devices development; 4) a multi-disciplinary approach, derived from a unique confluence of electrical engineering and life science disciplines.
EpiHelmet will be initially addressed to Epilepsy Specialist Centre/Monitoring Unit and Hospital neurology/neurophysiology department and it will offered to two groups of potential users: i) patients with initial symptoms of epilepsy who take an EEG in ambulatory within the traditional diagnostic pathway and may need further investigations through a wireless mobile EEG such as EpiHelmet to specify or clarify the diagnosis; ii) who do not respond well to the prescribed treatment may benefit from an extended monitoring period during their daily life activities.
The EpiHelmet solution may improve the processes of diagnosis and treatment of Epilepsy as well as their outcomes. Thanks to the extended monitoring and the data collected during daily life activities, it may significantly increase the accuracy in the diagnosis and support the identification of the most appropriate therapy. The magnitude of potential impacts is relevant considering that about 25-30% of patients do not respond to the treatment. Consequently, EpiHelmet may also guarantee a better quality of life for patients and caregivers. Moreover, the EpiHelmet research gives attention to psychosocial and cognitive aspects, while doing a comprehensive epilepsy care. In fact, in most cultures, misunderstanding and social stigma have surrounded such brains disorders for thousands of years and current factors such as social isolation and unemployment are examples of why the life standards of people with epilepsy are unsatisfactory.

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