Pico-Tesla commences pilot study of its Resonator system for treating type 2 diabetes patients

Nov 2 2009

Pico-Tesla, The Magneceutical™ Therapy Company, announced today that it has commenced a randomized, double-blind, placebo-controlled Pilot Study of up to 165 persons who have type 2 diabetes, the most common form of diabetes. The Pilot Study seeks to determine whether the application of magnetic fields generated by the Company’s patented Resonator™ system can be effective as an adjunctive therapy to oral medications in reducing hemoglobin A1c levels. For more information about this Pilot Study, call Pico-Tesla at 303-795-3222.

The protocol for the Pilot Study was developed in consultation with Michael McDermott, M.D., Director, Endocrinology and Diabetes Practice, University of Colorado Hospital, Aurora, Colo.; and with Mitchell Gershten, M.D., an internist and staff physician at Saint Mary’s Hospital in Grand Junction, Colo.

“Type 2 diabetes has traditionally been considered a disease of adults, but it is being increasingly diagnosed in children in parallel with rising obesity rates,” said Allen Braswell, president and CEO of Pico-Tesla. “The subjects of this Pilot Study will be treated with our Resonator device three times a week for 13 weeks at approximately 90 minutes per treatment. The primary outcome measure of this Pilot Study will be the measurement of improvement in the subjects’ hemoglobin A1c level after 13 weeks of treatment compared to baseline. For people without diabetes, the normal range for the hemoglobin A1c test is between 4% and 6%. Because studies have repeatedly shown that out-of-control diabetes results in complications from the disease, the goal for people with diabetes is a hemoglobin A1c level of less than 7%. The higher the hemoglobin A1c, the higher the risks of developing complications related to diabetes,” said Braswell.

Diabetes mellitus type 2 or type 2 diabetes (formerly called adult-onset diabetes), a disorder characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency, is often initially managed by increasing exercise and dietary modification; prescription medications are typically needed as the disease progresses. There are nearly 24 million people in the U.S. (almost 8% of the population) with diabetes, with about 18 million being diagnosed—90% of whom are Type 2. With prevalence rates doubling between 1990 and 2005, CDC has characterized the increase as an epidemic.

Pico-Tesla recently commenced a Phase III clinical trial of its Resonator™ system to demonstrate the efficacy of Magneceutical™ Therapy as an adjunctive therapy to improving aspects of health and quality of life that are relevant to patients with Parkinson's Disease. Pico-Tesla intends to submit the Phase III data and analysis via a 510(k) de novo application to obtain FDA clearance to sell the device in the United States. The Phase III clinical trial was designed by consulting neurologist Rajeev Kumar, M.D., a movement disorder specialist and medical director of the Colorado Neurological Institute Movement Disorder Center, Englewood, Colo.