|
|
FOR IMMEDIATE RELEASE
Contact: Ronald Trahan, APR, Ronald Trahan Associates Inc.
508-359-4005, x108
Pico-Tesla starts Phase III clinical trial of its proprietary
magnetic (Magneceutical™) therapy for Parkinson's
disease
Randomized, double-blind, sham-stimulation-controlled study of
the application of magnetic fields using the Company's
Resonator™ device has begun at Colorado Neurological Institute
LITTLETON, Colo., Oct. 5, 2009 - Pico-Tesla, The Magneceutical™ Therapy
Company, announced today that it has commenced a Phase III clinical trial of its
patented Resonator™ system that facilitates the Company's proprietary magnetic
(Magneceutical™) therapy for treating Parkinson's disease patients. In a Phase II
clinical trial, Magneceutical™ 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™ 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 nonsignificant
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™ 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-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 Clearwater, FL. Three pilot studies suggest its Magneceutical™ Therapy-made possible by its proprietary Resonator™ 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™ device is an Investigational Device limited by federal (or
United States) law to investigational use. The Resonator™ device is not for sale, nor is
the Magneceutical™ Therapy generally available outside of Investigational Review
Board (IRB)- approved clinical studies.
|
