The Power Of The Patch

The Status of LifeWave Clinical Research

Presented by David Schmidt, CEO
and Dr. Steve Haltiwanger, Director of Health and Science
Watch for future updates in the Member Virtual Office

Overview

As a technology-based company we have taken extreme care over the past four years in constructing a clinical research program that will properly support all of our LifeWave patch products. The scope of our research has been scientifically broad and has included independent evaluations of our products by researchers all over the world. The brief research update will give you a scope of the profound results that we have been achieving in supporting our mutual efforts.

Summary

All LifeWave patch products are constructed from organic materials (GRAS listed [Generally Recognized as Safe by the FDA])

All LifeWave patch products are manufactured at FDA registered facilities.
All LifeWave patch products are registered with the FDA as Class I medical devices.
The natural organic materials in the patches have been chosen because they are safe and have specific optical properties. All LifeWave patch products are designed so that none of the organic materials sealed within the patches will enter the body.

Summary of Research Completed

As of March 2006 LifeWave has completed a number of significant research studies that have scientifically proven that LifeWave patch products are both safe and effective. Here is a brief look at just a few of our studies.

In November 2004, the non-transdermal nature of the patches was proven by MVA Scientific Consultants. This study was done to prove that LifeWave patches do not put chemicals into the human body. Brown RS. Patch Permeability, (Report of Results: MVA6158). MVA Scientific Consultants, November 23, 2004.
In May 2005, Dr. Frank Shallenberger completed a placebo controlled, blinded pilot study and found that the LifeWave energy patches demonstrated significant and dramatic improvement in mitochondrial energy production after only one week of use. More notable yet is the fact that there was an even greater increase in the percentage of energy, both resting and under exertion that was derived from fat (Shallenberger, 2005).
From June 13- July 1, 2005, a study of the LifeWave sleep patch called Silent Nights was performed at the Atlanta Sleep Center. The study involved subjects who were studied three nights, each one week apart. The first night was the control night, when the subjects wore no patches. The subjects were then given Silent Nights patches to wear every night on their right temple leading up to and during the two additional studies of the subjects. Nocturnal polysomnography (eight hours of comprehensive physiological data during sleep) was conducted. The parameters of a standard polysomnography evaluation are measurements of breathing, heart activity, oxygen levels by oximetry data and sleep state. The sleep study results carried out in Atlanta showed that the Silent Nights patch was effective in promoting sleep efficiency in all subjects.
In May 2005, Dr. Dean Clark completed a study called “The LifeWave Nanotechnology Energy Patch.” This study was performed on 36 random individuals using infrared imaging as a method of measuring thermal changes that occurred when LifeWave energy enhancing patches were placed on the body. These measurements were done on people ranging in age from 22 to 72. The patches were placed on hyperthermic (warm) areas of the body that were identified with infrared imaging. The patches caused a cooling response in skin temperature readings both locally and distal from the site of application. The measured response of the patches is proof that the patches emit some form of energy to the body to cause a hyperthermic region to cool. This can only be explained by the patches emitting a form of energy that influenced the autonomic nervous system via the subcutaneous vascular beds. This study confirmed with a different technology (infrared imaging) that changes occurred in the autonomic nervous system (Clark, 2005). Changes in the autonomic nervous system were also observed by Dr. Nazeran when he did his HRV study. This study has been submitted for publication and is currently undergoing peer review.
In September 2005, Dr. Reenah McGill, D.O.M., M.A., L.Ac. completed a study called, “Investigative Study of Long Term Effects of LifeWave Patches Using Electro Meridian Analysis System (EMAS).” This study was submitted for publication. Participants acting as their own control were randomly assigned to begin using active LifeWave Energy Enhancer patches for three weeks or placebo patches for three weeks. Patch placement was white on the right at San Jiao 5 and tan on the left at Kidney 4. Each participant maintained a daily energy log. Once a week their meridian energy was measured using Electro Meridian Analysis System (EMAS). This measurement was completed by a technician who was experienced with the EMAS, but who had no knowledge regarding assignment of active or placebo patch use. EMAS was compared with perceived energy. Participants reported an increase of energy corresponding to that shown by the EMAS measurements and self-report logs. Reported and recorded energy increases ranged from 18 percent to 50 percent. No adverse effects were reported. Study results indicated a substantial and sustained increase in perceived energy during the three weeks participants were using the active LifeWave Energy Enhancer Patches.
In December 2005, Dr. Lauren DeRock published a study called “Responsiveness of Horses to Biofrequency Modulation after Acupuncture Palpation” in the Journal of the American Holistic Veterinary Medical Association. DeRock JL. “Responsiveness of Horses to Biofrequency Modulation after Acupuncture Palpation”. JAHVMA 2005 Oct-Dec;24(3):11-14. The objective of this study was to explore the use of acupuncture point palpation and application of biofrequency modulation (LifeWave Energy Enhancer patches) to specific points on the skin of horses. The goal was to see if LifeWave Energy Enhancer patches would relax the back and relieve back discomfort in horses. One hundred forty-two horses were evaluated. Four horses did not demonstrate back pain, and were not evaluated further. One hundred thirty-five of the remaining 138 horses with back pain showed elimination of back pain after patch placement for five minutes. Two horses who failed to respond initially showed elimination of back pain after reversal of patch position. One horse failed to respond. In conclusion LifeWave Energy Enhancer patches when placed according to the technique outlined in this paper, consistently alleviated back pain in horses, as assessed by acupuncture palpation.
On December 13, 2005, Dr. Dean Clark reported his conclusions of Infrared Imaging of the Silent Nights patch. This study was written up for publication. Initial studies of the Silent Nights Patch confirm the findings observed with the energy patches resulting in the nervous system response by localized cooling of a hyperthermic region. An initial Infrared Imaging scan was done prior to placement of a Silent Nights patch. The Silent Nights patch was then applied to the temple region. Another Infrared Imaging scan was repeated in five minutes, the results showed significant thermal changes to the localized region and systemic changes in temperature were also apparent. In studies conducted on approximately 150 people, LifeWave patches created an overall autonomic nervous system response to a generally cool hyperthermic region when measured with sophisticated infrared technology. Conversely, when a region is hypothermic (cold) the patches will have the opposite effect on the area in warming the localized region. The patches provide a thermo-regulating effect to the body causing the nervous system to respond in normalizing the anomalous response and changes of the body. The measured changes included such things as pain relief, range of motion changes to stiff joints, bowel function improvement, overall energy improvement, and mental focus to name a few.
December 2005, “LifeWave Energy Patches 60-Subject Test: Final Report” A completed human Clinical Trial using LifeWave Energy Enhancer patches. This study was prepared for publication. This 30 day study involved 60-subjects of various, age, race, sex, and health and exercise levels. This was done without providing any kind of information to the subjects about the intended outcome or scope of this study. No educational material or advertisements were provided to the 60-subjects for the length of this study. Upon completion of 30-day testing significant measurements were found such as (1) An increase of 22.3 percent was measured in the lipid side of the ATP cycle of energy production. As part of the Study for LifeWave Energy Patches, we found an average of 22.3 percent increase in the subject’s ability to convert fat into energy when the energy patches were applies to the subjects, (2) 30 percent of subjects reported an increased sense of well-being while wearing the patches, (3) Daily wear of the patches did not have any reported negative side effects or interactions for the length of this study, (3) Five subjects reported a weight loss of at least six pounds during this study, and (4) 100 percent of these subjects tolerated the patch test well.
February 2006, Dr. Frank Shallenberger completed a second LifeWave patch study with LifeWave Energy Enhancer patches that was a placebo controlled blinded study of 30 healthy patients of various ages. The results were prepared for publication. This study showed that LifeWave Energy Enhancer patches improved total aerobic ATP production (fat to energy). In addition 63 percent of subjects showed statistically significant improvements when compared to the placebo patch. The average level of improved fat burning was an incredible 25.5 percent. The range of improvement was from 15 percent to 38 percent.

To date, LifeWave has completed 16 double blind placebo controlled studies that show the safety and effectiveness of our products. In addition to these studies and the ones represented above, there are presently over 20 new studies that are underway that investigate our existing products as well as new products not on the market yet.

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