The Company at present markets its devices only for the treatment of pain and does so under FDA guidelines which narrowly limit the claims the Company may make in the marketing of its devices to customers. However, in the course of treating patients for pain, medical practitioners have notified the Company of significant and sometimes dramatic patient improvements in a wide range of other symptoms of their diseases in addition to relief from pain.

The Company's understanding of why its devices effectively relieve pain lead the Company to believe that its devices might also predictably relieve a broad range of debilitating symptoms. Many of which the Company believes there is no truly effective treatment presently available to modern medicine. These diseases have in common that they rob the patient of the ability to live a life characterized by the ability to engage in normal activities. They are dead-end, vitality robbing diseases, sometimes physically fatal, but nearly always destructive of a normal and desirable quality of life.

The Company believes its technology holds promise for being the most effective, safest and most desirable treatment for these medical disorders. The Company therefore is organizing and designing clinical trials to support future FDA applications related to a range of serious illnesses. Our initial focus involves two additional neurological disorder treatment indications, with plans to continue with other FDA applications that, upon approval, would extend the use of the Company's medical devices for treatment of the these diseases.

Patient experience over many years, as well as certain studies measuring the effects of the technology, lead the Company to the above hypotheses. While they assist us to define our continuing research projects, no claim is intended.

The Company theorizes that Synaptic® technology induces electronic impulses that travel along sensory nerve pathways, usually reserved for pain impulses, where they appear to ascend to higher brain centers and then access the descending inhibitory pathways to produce a desirable biological process. To our knowledge, no previous technology has made such pathways accessible to external stimulation.

Based on its experience with patients being treated for pain, the Company believes that stimulating biological processes could control pain while enhancing the quality of life. The Company also believes that Synaptic® electrical impulses could follow the ascending pain pathways as illustrated and enter the Descending Inhibitory Pathways (DIP). The DIP begins in the cerebral cortex and descends to the thalamus and then to the Periaquaductal Gray (PAG) of the midbrain to enter regions of the brain rich in opiate receptors responsible for secreting morphine-like enkephalins and endorphins. It is theorized that Synaptic® electric impulses continue to descend to the brainstem responsible for the secretion of serotonin that plays an important role in elevating pain thresholds levels and combating depression. As the electrical impulses enter the spinal cord, other inhibitory inter-neurons are believed to be secreted, producing additional powerful anti-pain neurotransmitters such as gamma-amino butyric acid.

This mode of action accounts for pain relief, it is believed by the Company that other healing modalities could be brought into play by this type of stimulation for patients with various types of neurochemical deficiencies, which the Company believes could be the case of patients suffering from the neurological diseases referred to above.

ascending descending pathway

Ascending Pain Pathways/Descending Inhibitory Pathways

Future clinical trails are planned to further test and evaluate these theories.

Neuron Simulation

Simulating the action potential of an actual neuron, the Synaptic® waveform is designed to have a fast rise time followed by a slow decay, in an effort to mimic natural neuronal waveforms. The frequencies generated range from 400 Hertz to 40,000 Hertz. By contrast, conventional electrical stimulation devices have a typical frequency range of 50 to 180 Hertz and commence their activity at the low end of the range, increasing to their maximum. Synaptic® commences its frequency sweep in the fashion of a neuron, starting at the maximum end of the frequency range and then reducing the frequency in a pattern that imitates the body's own neuron action.

nerve impulse

Action Potential

synaptic waveform

Synaptic® Waveform

tens waveform

TENS Waveform

Clinical Studies

The only data in the possession of the Company related to these items at present constitutes only anecdotal evidence and would not by itself support claims for treatment of these symptoms or indications. Therefore the Company intends to conduct controlled clinical studies in pursuit of reliable evidence to submit to FDA in support of future claims related to these matters. Nothing stated in the discussion above should be understood to constitute any claim as to the mode of action or clinical results. Clinical trials will be undertaken to investigate and accumulate data about precisely these matters.

Until such time as the Company obtains the data referred to above, the above discussion should not be relied upon. It is offered solely for understanding of the course of action the Company intends to undertake and the reasons supporting it.

 
This material is copyrighted 2007. All Rights Reserved.