CORDIS - EU research results

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.

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

NPX is a non-invasive magnetic stimulation device in the form of a patented wearable cover layer, with shield protection, and deeper energy delivery for treating depression and other potential neurological disorders of which 450 million people suffer. The device uses TMS (Transcranial Magnetic Stimulation) technology to treat depression in the brain's prefrontal cortex area, outperforming current TMS technology in terms of effectiveness and reduction of pain / discomfort in treatment. Daily TMS therapy has shown the potential for providing a longer-lasting reduction of treatment-resistant depression in the excitability of the stimulated site. NeuroPrex addresses a vast majority of drug resistant patients, essentially removing pitfalls associated with drugs, such as dependency, negative side-effects, and non-effectiveness. Treatment is quick and easily performed in a home environment, utilising the cloud for feedback on each therapy session, as well as communication progress with health workers.
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.
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.
In the Phase 1 Feasibility Study, NeuroPrex undertook an extensive competitor search and comparison to its NPX solution, comparing on the important metrics that influence ability for wide-spread adoption in the targeted customer demographic. Considering NeuroPrex’ strategic end goal to address the home-care depression customer demographic, highest on the agenda was affordability of the solution, and added benefits when comparing it to alternative outpatient rTMS and drug treatment. This was confirmed with all stakeholders spoke to in the Phase 1 Feasibility Study, where rising cost to medical facilities and patients has served added difficulty, and even as barriers to receive treatment in some instances. In addition NPX is double effective, and causes less pain and discomfort.