Periodic Reporting for period 1 - NPX-101 (NPX-101 is a portable home device for the treatment of moderate to severe depression, boasting more effective and safer outcomes, based on information deposited and received from the Cloud.)
Reporting period: 2016-06-01 to 2016-09-30
As a result of the feasibility study, the phase 2 project will carry forward from the Feasibility Study and Feasibility Tests conducted by NeuroPrex, into the development of a finalised CE mark NPX device. NPX will then be trialed in a Pilot Study as part of the CE mark conformity process, combining literature data gathered from predicate TMS devices. This will set the stage for NeuroPrex’s Phase 3 commercialisation activies, which involve a larger-scale clinical trial for communications purposes, and first distribution of the NPX product.
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.