Healthcare Industry News: deep brain stimulation
News Release - October 5, 2009
Pico-Tesla Starts Phase III Clinical Trial of Its Proprietary Magnetic (Magneceutical) Therapy for Parkinson's DiseaseRandomized, double-blind, sham-stimulation-controlled study of the application of magnetic fields using the Company’s Resonator(TM) device has begun at Colorado Neurological Institute
LITTLETON, Colo.--(HSMN NewsFeed)--Pico-Tesla, The Magneceutical(TM) Therapy Company, announced today that it has commenced a Phase III clinical trial of its patented Resonator(TM) system that facilitates the Company’s proprietary magnetic (Magneceutical(TM)) therapy for treating Parkinson’s disease patients. In a Phase II clinical trial, Magneceutical(TM) Therapy “demonstrated significant improvement over placebo after 8 weeks (endpoint) of therapy…improvement…persisted up to 2 months (week 16) post-treatment…(and) no treatment-related adverse events were reported.”
The purpose of the Phase III clinical trial is to demonstrate the efficacy of Magneceutical(TM) 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.
“The data from the Phase II clinical trial was extremely positive,” said Dr. Kumar. “It strongly suggested a wider study of magnetic therapy is warranted. Given that we don’t know the mechanism of action of magnetic therapy, it’s therefore hard to speculate about what we’ll see in the larger Phase III study. Nevertheless I believe it’s realistic to expect some enhancement of motor and non-motor Parkinson’s symptoms from magnetic therapy that are refractory to conventional therapy,” added Dr. Kumar. “Therefore I am looking forward to further investigating the benefits of this unique, noninvasive and potentially promising treatment for Parkinson’s disease.”
“There is no cure for Parkinson’s disease and currently marketed therapies have risks or possible complications,” said Allen Braswell, president and CEO of Pico-Tesla. “For example, while drug therapies help alleviate some motor symptoms, their side effects can be significant—depression, hypotension, abnormal movements and hallucinations. And only 15-20% of Parkinson’s patients are candidates for surgical options that include implanting a probe into the brain, deep brain stimulation (DBS), or ablative destruction of targeted brain tissue. Such options are invasive and have potential for serious adverse side effects. In contrast, our device is both non-invasive and non-significant risk. Therefore we believe Pico-Tesla is well-positioned to uniquely address an important unmet need among Parkinson’s patients: Quality of Life. PD patients lead a significantly impaired quality of life because there are few options that address this aspect of their disease.”
Magneceutical(TM) Therapy involves the use of an extremely low-level electromagnetic field (EMF) applied by a specially designed device—the Resonator(TM), invented by Dr. Jerry I. Jacobson, along with proprietary therapeutic protocols—intended to improve a number of the signs and symptoms of Parkinson’s and other neurological-based diseases. Parkinson’s disease (also known as ‘PD’) affects 1.5 million people in the U.S., with 60,000 news cases diagnosed each year. PD is a chronic and progressive degenerative disease of the brain that is characterized by muscle rigidity, resting tremors and, in extreme cases, nearly complete loss of movement. The popular actor Michael J. Fox, who has PD, has raised awareness of the disease through the Michael J. Fox Foundation for Parkinson's Research (MJFF).
About Pico-Tesla Magnetic Therapies, Inc.
Privately held Pico-Tesla Magnetic Therapies is an emerging medical technology company based in Littleton, Colo. Three pilot studies suggest its Magneceutical(TM) Therapy—made possible by its proprietary Resonator(TM) device along with proprietary treatment protocols—may give neurologists a whole new way of treating Parkinson’s disease and other neurological-based disorders and diseases.
CAUTION: The Resonator(TM) device is an Investigational Device limited by federal (or United States) law to investigational use. The Resonator(TM) device is not for sale, nor is the Magneceutical(TM) Therapy generally available outside of Investigational Review Board (IRB)- approved clinical studies.
Source: Pico-Tesla Magnetic Therapies
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