Periodic Reporting for period 2 - BQ System (An AI-based IoT medical device revolutionizing motor recovery following neurological disorders, inspiring hope and helping patients and their families regain their independence.) Reporting period: 2021-01-01 to 2021-12-31 Summary of the context and overall objectives of the project Today, 1B people live with neurodisorders worldwide. 1/5th of those suffer from motor disabilities, creating an unprecedent burden to society. Stroke and spinal cord injury (SCI) are two of the leading causes of motor impairment, which substantially impact the daily lives of patients and their families. There are approximately 1.1M people who suffer from a stroke in the EU each year, and only 1% of SCI survivors experience complete recovery. There is an accepted understanding among the scientific and medical communities that an integrative approach is needed to successfully treat neurodisorders; however the solutions currently on the market are invasive, costly, and don’t provide an effective and safe neurorecovery option. Additionally, the healthcare landscape has produced a fragmented treatment pathway for chronic patients, requiring high-risk patients to frequent medical facilities in order to receive treatment, which increases their risk of contracting a life-threatening infection. Furthermore, In light of the current COVID-19 pandemic, now more than ever, there is a clear need for an integrative therapeutic approach to treatment that is also fully accessible in remote setting (from home).BrainQ’s mission is to develop life-changing at-home therapy to reduce disability and promote recovery following in stroke, SCI and other neurodisorders. We are harnessing the power of AI to optimize an established and rapidly developing scientific approach, and revolutionizing it to create a digital, data-based therapeutic treatment to enhance the neurorecovery potential. Our goal is to facilitate measurable improvements in neurological and motor functions, and enable a better quality of life for patients. We believe the ideal treatment is not just effective, but is also a seamless and comfortable experience for the patients and their families, no matter where they are treated. BrainQ’s Network Targeting ElectroMagnetic (NTEM) Therapy is based on biological insights retrieved from brainwaves using explanatory machine learning tools with the aim of facilitating neuroplasticity, or the ability of the nervous system to modify its structure and organization and create new connections that can enhance neurorecovery. The NTEM Therapy is delivered via the non-invasive BQ System, a cloud-connected wearable designed for portable and patient-centric treatment at home. The ultimate objective of this project is to make BrainQ's device ready for market launch in Europe. BrainQ will develop and provide patients with home devices, allowing patients to be treated in the comfort of their homes. This entails the following technical and strategic objectives: finalization of software and hardware design for industrialization, completion of quality and regulatory processes and CE marking filing. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Company planed to penetrate the EU market first with SCI followed by stroke. Company had ongoing pilots on each of these indications and was to develop a cloud-connected therapeutic medical device that will allow remote therapy, but set the stage in the project for clinic use only, test it in a EU pre-market clinical trial and lay the ground for CE application. As part of the realization of the device, extensive quality processes, like QMS setup, were planned. COVID-19 posed several challenges, though for BrainQ it has actually accelerated the path to market. Initially pandemic caused delays in the SCI pilot and in parallel a stroke RCT pilot was terminated in interim. The results of the stroke RCT were very encouraging and demonstrated high level of safety and efficacy. Following to discussions with company’s EU regulation consultants, it has been suggested that the data obtained in the stroke RCT will allow already to submit a CE application for both stroke and potentially SCI, as a broad neurological indication (given BrainQ’s existing pilot data in SCI too). In practice accelerating BrainQ’s path to market in over a year. Furthermore, the rapid need of home therapy during the pandemic, allowed BrainQ to aim for CE approval of device which allows home use as well, instead of use in clinic only. Hence, BrainQ invested major resources to achieve tremendous progress on quality (WP2), regulatory (WP2) and product activities (WP3), in adaptation for the new reality and the broadness and scale of stroke in EU, relatively to the SCI niche population. The key achievements in RP1 were: (1) completion of establishment of QMS with needed SOPs and training for staff (WP2); (2) Securing agreement with leading Notified Body towards Technical File submission and Audit conduct in 2021 and towards receiving a CE, along with substantial progress on key documents needed for submission (e.g.: CEP, risk analysis, user information, etc.) (WP2); HW and SW adaptation to immediate home use (such as, miniaturization from previous model, cloud connectivity, Android-based app, battery-based operation rather than electricity (WP3); Development of automated AI-based pre-processing tools to support EEG analysis, and adaptation of HW to support EEG collection in non-sterile environment like patients’ home (WP1, WP3). Although the new potential scale of the stroke market required additional an previously unplanned for tools, BrainQ was able to steer and manage the process and to reach successful milestone, even in times of global pandemic, highlighting the importance of a well structure management system (WP5). Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) BrainQ developed a proprietary, data science approach to intelligently select oscillatory patterns to resonate with electromagnetic fields in order to maximize the neurorecovery potential. Our method stems from the insights learned from Brain Computer Interface (BCI) technologies developed over the past decade. We have collected and analyzed massive amounts of labelled electrophysiology data consisting of motor and cognitive tasks performed by uninjured individuals, as well as biomarkers from animals and cell culture models. We then apply signal processing and machine learning tools to extract the key patterns observed in the data and apply them to be used as treatment parameters. By utilizing electrophysiology and other biomarkers, BrainQ aims to develop personalized, precision medicine tools to treat stroke patients and eventually additional neurodisorders. It will be an effective and affordable solution for millions of patients in need in the EU, annually, and a disruption of a multibillion dollar market.The BQ System developed through this project is comprised of a wearable device and mobile application. The therapy has been determined to be of non-significant risk due to its non-invasive nature, allowing patients the flexibility to receive treatment from their homes and easily integrate it into their daily lives. This is especially relevant as the patient population that suffers from neurological conditions is often classified as high-risk for infection which is amplified in new environments, especially medical facilities.Our wearable treatment component is user-friendly and is intended to be operated in the patient’s home thanks to its integrated telemedicine tools. The component is designed to produce the tailored ELF-EMF treatment parameters directed at the patient’s central nervous system. The NTEM Therapy can also be combined with other treatment modalities for an amplified and synergistic effect, achieving an integrated approach for treating these patients. BQ System prototype Mobile application of BQ System
