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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - VOIC (REVOLUTIONARY THERAPY OF APHASIA)

Teaser

Summary

Problem

Aphasia means losing the abilities to communicate. The affected patient is forced to withdraw from family, social, and professional life. The patient\'s intellect remains intact but cannot express himself / herself. There is no solution to this problem, which we could call satisfactory. Standard therapy session takes 45-minutes with a speech therapist which in many cases is not sufficient for effective therapy. Additionally, all over the world healthcare systems suffer from a lack of therapists.

Why is it important for society?

The most common cause of aphasia is ischemic stroke: ca 30% of individuals experience aphasia after their first stroke. In Europe, almost 1 million inhabitants suffer a stroke each year. It means 300 thousand new cases of aphasia every year. Such a number of patients has a considerable impact on health systems (healthcare costs and resources) and society. The economic implications of aphasia are enormous - in the EU, the total cost of aphasia was estimated to be as high as â‚¬13,5 billion every year. Aphasia is more common than Parkinsonâ€™s disease. Aphasia leads to a personâ€™s isolation. The person cannot carry out simple daily activities related to communication, thus also failing to come back to work or fulfilling their roles in the family. Complete recovery is highly variable, with reported rates ranging from 11% to 50% of patients. The reason behind these statistics is mainly the limited accessibility to the therapy directly after the aphasia occurs.

What are the overall objectives?

We propose to change the way how the aphasia treatment is performed radically. We want to introduce a complementary system for the treatment of aphasia (hardware-software), adapted to work in rehabilitation clinics and patient homes. The outcome of this innovative project is a dedicated headset (medical device class II), which can be used both at home (remotely) and at the neurorehabilitation centre. The complete solution will consist of: Hardware: headset working on the principle of neuromodulation, Software: exercise to be used during therapy, the internet platform with a database of exercises to personalize it for users. The platform will further collect data on the rehabilitation of individual patients to supervise the therapy and help the therapist with the assessment and feedback. The AI algorithms will allow the system to adjust the content to the patient level and therapist needs.

Work performed

Before starting the Phase I Voic project solution status was on TRL 6. We based Neuro Device Voic on our clinical tES stimulator - which was developed by NDG and is already on the market (TRL 9). We plan to utilize one of the work modes of the tES, which functionalities are already verified. The methodology of therapy is based on the thesis of the use of neurostimulation for aphasia therapy resulting from the knowledge provided by our medical team. A hardware review and equipment compatibility testing was performed. The most appropriate solution for monitoring specific parameters was established with the neuropsychologists through scientific research and medical expertise. The technological capabilities of the equipment have been initially tested in practice in 2017. The next stage (in phase 2) is the miniaturization of the selected hardware components to fit it inside the headset.

During our work in Phase I, the patent strategy was developed. On February 25th, 2019 a patent application No. EP19461515.9 was filed in Patent Office of the Republic of Poland with the request for grant of the European patent. We verified the market potential and established new contacts with business partners and stakeholders on chosen markets. The legal aspects of entering the market and healthcare system were researched and verified. We managed to go through a technical feasibility study which allowed us to create a detailed plan for miniaturization and variations of the solution for further tests. We analysed competition with detailed analyses of available software. It allowed us to find our unfair advantage and use it in our software project assumption. We also started the preparation for the clinical trials diagnosing all the requirements and formal aspects of this process. We will continue he selection process of the potential rehabilitation centre for clinical trials. On all stages, the costs of the project and its elements were verified and counted.

After gathering all the data, the business model was once more verified, and pricing offer was created. The estimation of revenues and costs on every chosen market was made. It allowed us to assess the break-even point and the turnover from the investment in the project.

Final results

Neuro Device Voic will be the first in the world comprehensive rehabilitation system for enhancing aphasia treatment based on non-invasive brain stimulation technology with a patient- centered approach. It is on its way to disrupt the quality of therapy, enhancing and accelerating its results while making it more accessible and affordable for patients all around the world. Neuro Device Voic will be a system for post-stroke therapy, which will be used in the treatment of aphasia by electrical brain stimulation. There were similar projects discovered that show the current state of the art. However, neither of them could be considered as prior art to the key features of the invention proposed by Neuro Device.

Opportunities for treating aphasia are currently very limited. The state-of-the-art therapy is based on the work of neuro-speech therapists and neuropsychologists. Exercises consist of solving language tasks and repeating words, phrases, or sentences. However, before this happens, the therapist\'s job is to monitor the patient\'s communication skills constantly and to establish eye-emotional contact, gesture and, if possible, verbal communication. If the therapy is conducted by public health, waiting time is up to 2-3 months (improvement in first months is critical). If it is done in private medical centres, the costs are high (40 - 200 EUR/hour), depending on the country, the qualifications of the therapist, and possible extra costs. The main challenge in the therapy is to make the initial contact with the patient where complete blockage of communication may occur. Traditional treatment, therefore, rarely yields the expected results in the total restoration of speech. We overcome this blockage by providing VOIC neural priming, which initially activates the brain mitigating the communication with the patient.