SOURCE: CVAC Systems, Inc.

August 07, 2008 14:00 ET

Stanford University and Veterans Affairs Researchers Demonstrate Significant Glucose Reduction in Study of CVAC Process for Insulin Resistance and Diabetes

Clinical Studies in Diabetic Neuropathy Underway

PALO ALTO, CA--(Marketwire - August 7, 2008) - The Stanford University Center on Longevity and the U.S. Department of Veterans Affairs Palo Alto Health Care System (VAPAHCS) today announced positive data from their 10-week study of the Cyclic Variations in Altitude Conditioning™ (CVAC™) process, CVAC Systems Inc.'s new modality being researched for insulin resistance and diabetes. The blinded, controlled clinical trial, which exposed subjects to the CVAC process for 40 minutes, three times a week for 10 weeks, found that the subject group receiving active CVAC exposure demonstrated a significant reduction in fasting blood glucose and a significant decrease in blood glucose during an oral glucose tolerance test (OGTT) following the 10 weeks of exposure. There was no significant change in the control group. No significant safety concerns were observed during the study.

"The data from this study are very promising and suggest that CVAC could provide a unique way to lower blood glucose levels in certain individuals," said principal investigator Dr. Anne Friedlander, Director of the Major Project on Mobility at the Stanford Center on Longevity and a VAPAHCS research scientist. "Given that these positive results were achieved in middle-aged, non-diabetic volunteers, we are hopeful that CVAC will prove even more effective in diabetic subjects with higher initial fasting glucose levels. These data are consistent with our understanding of the mechanism by which hypoxia (or low oxygen levels) could impact glucose metabolism."

The study was conducted at VAPAHCS by Stanford and VA researchers. The study enrolled 21 healthy male subjects between the ages of 40 and 60. Fasting glucose levels were reduced from a baseline average reading of 96 to 90 mg/dl in the CVAC group (p < 0.05), while fasting glucose increased from 94 to 97 mg/dl in the control group. In addition, the change in OGTT area-under-the-curve values for blood glucose were significantly reduced in the CVAC group relative to the control group (p < 0.03). Dr. Friedlander has submitted an abstract describing the study and the data for presentation at the 6th Annual World Congress on the Insulin Resistance Syndrome to be held September 25-27, 2008 at the Hilton, Universal City, Los Angeles, CA.

"While we expect outstanding results from the application of CVAC in diabetes, our next clinical trial is in diabetic neuropathy," said Allen Ruszkowski, president and CEO of CVAC Systems, Inc. "Diabetic neuropathy afflicts 70 percent of the Type 2 diabetics in the US, with two-million patients displaying symptomatic neuropathy, which is often an extremely painful condition with no effective treatment. Furthermore, diabetic neuropathy is associated with more than 1000 amputations per week in the US, demonstrating a large, unmet clinical need for an effective therapy. Based on preliminary studies, we expect CVAC will do much more than alleviate pain. We expect the planned course of clinical studies to show that regular, long-term CVAC use restores the health and function of the damaged tissues in addition to alleviating pain."

The clinical protocol for the diabetic neuropathy trial was approved by the Stanford University Human Studies Review Board.

"We are excited about the potential for the CVAC process to produce an improvement in both the condition and quality of life for diabetes and diabetic neuropathy patients," added Dr. Friedlander. "We are still researching the mechanism, but if use of CVAC attenuates insulin resistance, it is possible that CVAC could also be useful in treating other disorders related to insulin resistance and the aging process."

The CVAC Process: A New Modality for the Mitigation of Insulin Resistance, Diabetes, and Related Conditions

The patent-pending CVAC process for the treatment of insulin resistance, diabetes, and related conditions involves the use of an altitude simulator in which users sit and are exposed to various levels of atmospheric pressure. Evidence exists that such changes in pressure levels, when combined with the intermittent hypoxia that occurs as a result of reduced atmospheric pressure, increase cellular mitochondrial density, nitric oxide concentrations and glucose transfer proteins. Such cellular level changes may explain the effectiveness of the CVAC process in reducing glucose levels.

About the Stanford Center on Longevity

The goal of the Stanford Center on Longevity (SCL) is to transform the culture of aging by combining scientific and technological discoveries with swift entrepreneurial action. The SCL links top scholars in their fields with government, business and the media to focus on practical solutions to assure that people arrive in their later years physically fit, mentally sharp, and financially secure.

About the U.S. Department of Veterans Affairs Palo Alto Health Care System

The U.S. Department of Veterans Affairs Palo Alto Health Care System is a teaching hospital, providing a full range of patient care services, with state-of-the-art technology, as well as education and research. VAPAHCS has 897 operating beds, including a 300-bed hospital, three nursing homes and a 100-bed homeless domiciliary. VAPAHCS is home to a variety of regional treatment centers, including a Spinal Cord Injury Center, a Polytrauma Rehabilitation Center, the Western Blind Rehabilitation Center, a Geriatric Research, Educational and Clinical Center, a Homeless Veterans Rehabilitation program and the National Center for PTSD. It also supports the third largest research program in the VA.

About CVAC Systems, Inc.

CVAC Systems, Inc. is a privately held medical device company headquartered in Temecula, CA focused on the application of its Cyclic Variations in Altitude Conditioning process to diseases and disorders associated with aging, including insulin resistance, diabetes, neuropathy, cardiovascular disease, Alzheimer's and declining testosterone levels. In addition to these medical applications, the company has scientific validation of the effectiveness of the CVAC process at improving physical performance and is developing studies to demonstrate improvements in cognitive ability. The company is currently partnered with revenue-producing sites in California, Arizona, and New Mexico for improving fitness and is seeking to place CVAC systems at key luminary research sites for the development of several patent-pending applications such as performance enhancement, disease prevention, therapy and advanced health. The company is also currently in discussions with potential partners for applications in executive health and wellness.

Copyright © 2008, CVAC Systems, Inc. All rights reserved. Cyclic Variations in Altitude Conditioning, CVAC and CVAC logo are trademarks or registered trademarks of CVAC Systems, Inc. in the United States and/or other Countries. All other trademarks belong to their respective owners. No affiliation is expressed or implied herein.

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