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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 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.
Action Potential
Synaptic® 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.
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