The Process

Progress & Intent

NET Recovery device therapy cannot be made available in the U.S. on a commercial basis until the device is cleared for marketing by the FDA.
 

  • Our team has submitted the results from two open label clinical studies of the NET Model 901 device to the FDA that were conducted in Kentucky and Scotland. The design of our proposed Randomized Controlled Trial (RCT) has been formed based upon feedback we received from the FDA on these previous studies.

  • Full funding of the RCT will enable us to conduct and complete the RCT, and to submit and support an FDA application for device approval or market clearance, although there can be no guarantee that the FDA will grant approval or otherwise clear the device for marketing.
     

  • A nationally renowned university-based addiction researcher has agreed to serve as the Principal Investigator for the RCT. As an objective independent researcher, this investigator will not receive any compensation from NET Recovery.
     

  • If more than the $720,000 funding goal for the RCT is raised, the surplus funds will be applied to other critical initiatives which will help to bring NET Recovery device therapy to market. If less than $720,000 is raised by September 1, 2020, some or all of the donated funds may be used for such alternate initiatives.
     

  • Donations are not tax-deductible at this time, although we hope to be able to offer deductible giving options in the future. 

A Study Guide

What is a Open-Label Clinical Study?
An open-label trial, or open trial, is a type of clinical trial in which both the researchers and participants know which treatment is being administered. This contrasts with a blinded trial where it is possible to hide the identity of the treatments, such that researchers and participants do not know which treatment is being administered; this helps to reduce bias.

What is a Randomized Controlled Trial (RCT)?
A study in which people are allocated at random (by chance alone) to receive one of multiple clinical interventions. One of these interventions is the standard of comparison or control. The control may be a standard practice or treatment, a placebo (for example, a "sugar pill"), or no intervention at all.

PHASE 1

Acquisition of underlying research and technology

 — COMPLETED —

PHASE 2

Development of commercial-grade neuro-stim device and service delivery platform

 — COMPLETED —

PHASE 3

Regulatory

compliance in EU

 — COMPLETED —

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The NET Model 901 medical device is approved for usage in the United Kingdom and European Union. In the United States, the NET Model 901 is available for use as an Investigational Device only.

© 2020 NET Recovery