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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - BE Therapy (A revolutionary digital therapeutics platform for personalized and effective neurocognitive rehabilitation)

Teaser

Summary

Cognitive impairment causes decline in cognitive abilities, including memory and thinking skills. It is fast growing, and affects around 450 million people globally . The major causes of cognitive impairment are Traumatic Brain Injury (TBI), stroke, ageing, depression, anxiety and Attention-deficit/hyperactivity disorder (ADHD). In Europe, around 2.1 million hospital discharges are associated with Traumatic Brain Injury (TBI) and around 250k people are diagnosed with post-stroke cognitive impairment . Neuro rehabilitation is a program to help brain-injured or otherwise cognitively impaired individuals to restore normal functioning, or to compensate for neural deficits. Nevertheless, the overall rehabilitation efficacy is surprisingly low, even for patients with mild conditions. Multiple studies indicate this low efficacy is due to insufficient recruitment of patientsâ€™ brain engagement to the therapy . Moreover the standard post treatment counselling, speech, occupational, cognitive, or behavioral therapy have high recurring costs ranging from â‚¬50 to â‚¬120 per session and needing 1 to 53 sessions . As a result, the current public healthcare system cannot indefinitely support overly lengthy therapy sessions and there is need for disruptive solutions. The overall objective is to develop and pioneer the digital therapeutics with strong clinical evidence for multiple neurological disorders. It aims to disrupt the status quo and truly provide the patients a continuous better quality of life.

Work performed

As part of the phase 1 of SME project, during the feasibility study, Brainmarc conducted a full analysis of the technical and business potential of their BE Therapy system. Throughout the assessment, Brainmarc has greatly expanded their knowledge regarding the technical objectives, potential target markets, validation studies, and regulatory approval required for the European market launch. Brainmarc has defined the remaining optimisations and upgrade activities required for the BE therapy before commercialisation and clinical trials to be performed during the phase 2 innovation project. It secured interest from 3 hospitals, Reuth Medical & Rehabilitation Center â€“ Israel, Fondazione di Ricercar in Neuroriabilitazione San Camillo Onlus â€“ Italy and Fondazione Don Carlo Gnocchi Onlus - Italy and a CRO (medicsense) for the forthcoming demonstration and validation. Brainmarc had also validated the value chain for scale-up operations and secured the multiple companies/organisations shown in the table below. The company analyzed in detail the go-to-market strategy to define the approach for accelerated and effective market uptake. It was concluded that sales through market specific health care distributors to clinics and individual users will allow easy penetration of multiple and diverse markets. Brainmarc also conducted an in-depth analysis of two business models: upfront sales (Model A) and leasing (Model B). It concluded that with the investment from EC Brainmarc will complete the activities required to advance toward the CE certification (medical) and market launch of the BE Therapy. In addition, further funding will also allow the company to undertake other key activities in enhancing their market positioning, including IP management, communication and dissemination and strengthening their commercial network.

Final results

BE Therapy is a clinical cum home-point-of-care platform for faster, personalised and effective neuro-rehabilitation. It is a â€˜closedâ€™ feedback-loop platform with the therapeutic contents digitally presented while allowing therapist intervention. BE Therapy introduces the ability to quantify therapeutic efficiencies of Neuro-rehabilitation by using direct and objective neural markers. Which, till data has been mostly subjective interpretation of results. This allows, BE Therapy to re-frame the rehabilitation process in a continual â€˜improvement cycleâ€™, supported by the quantitative data. BE Therapy significantly improves the treatment effectiveness for patients with neurological and motor impairments resulted from brain injury such as stroke or TBI. BE therapy is compact, simple and reliable cognitive therapy system which is practical for routine use. It is suitable for home and self-use reducing the need to travel to a healthcare institution. The user interface of the software is easy to understand, remotely accessed by doctor/therapist and adaptable to tablets and computers. It allows therapists/doctor to monitor multiple patients in parallel, significantly reducing manpower count per patient while enabling better attention for patients with more severe cases and assistant to larger number of patients.