On the ComAware project we have management persons, software and hardware developers, quality management persons, validation persons for neuroscience and medical products, sales and marketing persons working. The project management is done by the CEO Dr. Christoph Guger, who also handles the communication with the EC. The advisory board was established in year 1 and is contacted for specific questions during the project. Several tasks like medical certification, business planning or housing design are done with external partners. The ComAware project is already in the process of getting CE certification and FDA listing for the developed mindBEAGLE system. The developed biosignal amplifier is already CE and FDA cleared and can be used in the mindBEAGLE system. Currently, the vibro-tactile stimulator, the head-phones and the electrical stimulation unit are CE and FDA cleared. The design of the system is done according to international medical normatives and we just received ISO clearance and had also an FDA GMP audit. The packaging, including housing, is already in a final stage of the design and will allow to ship the system internationally.
The mindBEAGLE system consists of a computer, head-phones, vibro-tactile stimulator and a functional electrical stimulator (FES) and DC stimulator. In the last period the FES and the DC stimulators were developed and put into a housing together with the vibro-tactile stimulator and the audio board for the auditory stimulation. This system includes also the power supply and is connected via a USB cable to the computing system. The computing system is running the BCI algorithms and experimental paradigms. In the last period the auditory paradigm was optimized to give higher classification accuracy and shorter recording time so that the patient assessment can be faster done. Furthermore, the signal analysis of the vibro-tactile paradigms was enhanced to have a shorter calibration time and to determine the assessment threshold when a communication run can be established with the mindBEAGLE system. The motor imagery paradigm was also improved to have a shorter calibration time and gives a higher accuracy. Furthermore, three new paradigms are currently added to mindBEAGLE: a mismatch paradigm to investigate low level brain functions, a local-global paradigm to check if a patient has awareness and a prediction protocol to see if a patient will improve. These two paradigms will extend the assessment battery and feedback from experts showed us that both paradigms are important to have in the system. The software and hardware design was done according to the medical normatives to have all documents ready for medical approval and for possible audits. The final system was designed to be mounted on a trolley so that it is easy to move the unit from one patient to another one. Production documents were designed in the last period with high enough quality to provide it to the production unit. This design transfer was done according to GMP and ISO requirements. The packaging of the system was part of the design transfer. Data security aspects were implemented according to the FDA Cybersecurity guidelines.
In the last period patients with locked-in syndrome (LIS), complete locked-in syndrome (CLIS) and disorders of consciousness (DOC, unresponsive wakefulness state and minimal consciousness state) were investigated. The mindBEAGLE system works technically fine and we can roughly say that 1/3 of the patients reach only a very low assessment accuracy which shows that they are not understanding the tasks, 1/3 has high fluctuations which means that on some days these patients are good and on other days are pretty bad, 1/3 reach high classification accuracies and can also communicate with the system. The acquired data is also used as a clinical study to get FDA and CE approval for the mindBEAGLE system. The data was already published in journal and conference papers.
The mindBEAGLE system is already disseminated with information on the web-page, press-releases, exhibitions, talks at conferences, workshops at conferences. In the last period we also organized the first mindBEAGLE conference in Graz. Many validation partners, distributors and possible clients were attending. The mindBEAGLE system got already a patent and a design patient. Furthermore the mindBEAGLE system is a registered trademark. Together with EY we developed also a commercialization plan for mindBEAGLE and for the mindBEAGLE-gyms. g.tec established already three mindBEAGLE-gyms in Austria, Spain and in the USA. These are important institutions for providing assessment for patients, but they act also as training facilities for other clients.
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