Neurowave Therapy International Inc, subsidiary of NetImpact Holdings Inc, announced the preparations for the clinical trial phase of the NWT 4000. The FDA had previously approved the NWT 4000 as an investigational device and successful pre-trial testing allows Neurowave to move ahead to the clinical trials phase. Neurowave plans to perform poly-drug detox and chronic pain trials in two medical facilities in Mexico.
Testing thirty patients per facility using approved protocols, the compiled data will be submitted to the Institutional Review Board, U. S. Department of Health and Human Services, Office for Human Research Protections.
Neurowave is an electronic device that reduces the discomforts associated with a variety of pain-related and addiction problems. Average treatment lasts ten days, requires only minimal supervision by attending medical personnel, and is totally automated and pre-programmed. The size of a hand-held radio, it uses neurowave technology applied by attaching noninvasive electrodes behind a patient's ears. Upon concurrence of the Institutional Review Board, NetImpact can seek FDA approval to classify the NWT 4000 as a medical device. NetImpact expects to sell it over the counter as a treatment for pain.
Pre-trial testing treating hundreds of patients suffering from arthritis, chronic back pain, pain from terminal cancer, withdrawal from drug addiction, and severe depression have shown positive results.
The NWT 4000 evolved from the use of electro acupuncture as analgesia. It operates on a complex combination of waveforms and frequencies that affect the functioning of the brain and nervous system through external stimulation. With leads that attach to the mastoid area behind the ear, the NWT 4000 emits an undetectable current averaging three milliamps. The battery-powered device is the size of a walkman type radio.