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).
