The Phase 1 Feasibility Study was instrumental to NeuroPrex in investigating the market landscape, strengths, as well as lacking requirements, in order to ensure a successful commercialisation campaign for NPX. Utmost on the agenda, is ensuring NeuroPrex’ smooth transition of technology and equipment operations between its American and European offices. The Feasibility Study confirmed NeuroPrex’ initial hypothesis of choosing the European marketspace as the first location of commercialisation, ahead of North American expansion considering the pressing need of depression treatment as a continent, its welcoming nature of technology that has been vetted for safety (TMS devices), and channels that have been built up to this stage. rTMS being more widespread in Europe, having been approved in the treatment of Alzheimer’s disease, drug addiction, bipolar disorder, Parkinson’s disease, posttraumatic stress disorder, and other neurological-based issues, which have also been confirmed by Prof Joseph Classen. These approvals have mostly been approved in the dominant neuromodulation market of Germany, which will become NPX’s first entry European market. This is in contrast to the U.S market still undertaking approval of rTMS for the various conditions, apart from depression.
NeuroPrex is also able to take advantage of its regulatory consultant Omsbar ability to navigate EC requirements in an efficient and straightforward fashion. The NPX European collaboration of Omsbar, preliminary manufacturers and pilot study CRO have reached consensus on the ability to execute all necessary activities to ready NPX for European commercialisation within a proposed 24 month time frame.
Regulatory investigative work has been immensely important in NeuroPrex’s decision to first invest and commercialise in Europe, considering the clearly defined pathway it will have to follow under Annex IV of the conformity route for CE marking. The European system prizes safety and performance as highest in its approval process, of which will be able to be met through the small scale pilot study planned, as well as collected data from predicate device. This strategic change in first entry continent will save NeuroPrex up to 20 million in initial investment, if full-scale clinical trial were required for FDA approval, considering the added factor of improved efficacy and effectiveness has to be proved unequivocally, of which can only be afforded in 2 or 3 large scale clinical trials. In comparison, additional larger scale clinical trials will be adopted as part of further dissemination and communications, of which NeuroPrex still intends to carry out for purposes of increased penetration in the neighbouring EU states, and back into the U.S market.
In addition, the reimbursement pathway was clearly identified, making adoption of the solution a certainty for Germany’s public sector.
