Jan 5 2011
Pico-Tesla, The Magneceutical Company, announced that it has expanded its ongoing Phase III pivotal clinical trial by adding three Principal Investigators, including two university-affiliated clinicians: one in Denver; and one in Tampa. In addition, Pico-Tesla announced that enrollment is approaching 50% of the patients required for this pivotal clinical trial.
“We now have six Principal Investigators participating in our pivotal trial in Parkinson's disease, and all three of our clinical sites are enrolling patients.”
"We are making great progress toward establishing the clinical potential of Magneceutical® Therapy for Parkinson's patients," said Allen Braswell, CEO of Pico-Tesla. "We now have six Principal Investigators participating in our pivotal trial in Parkinson's disease, and all three of our clinical sites are enrolling patients."
The purpose of the ongoing Phase III pivotal clinical trial is 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 principal investigator Rajeev Kumar, M.D., medical director of the Colorado Neurological Institute Movement Disorder Center, Englewood, Colo.
Pico-Tesla's Magneceutical Therapy involves the use of an extremely low-level electromagnetic field (EMF) applied by a specially designed device—the Resonator™, invented by Dr. Jerry I. Jacobson, along with proprietary therapeutic protocols—and is currently in clinical trials to determine its effectiveness for improving the signs and symptoms of several diseases, including Parkinson's disease, atrial fibrillation, Alzheimer's disease, fibromyalgia and osteoarthritis.
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