Pico-Tesla starts pilot study for type 2 diabetes with its proprietary magnetic (Magneceutical) therapy

Mon Nov 2, 2009 9:39am EST
 
[-] Text [+]
Randomized, double-blind, placebo-controlled study seeks to determine if
magnetic fields using Company`s Resonator device can be an adjunctive therapy to
drugs in slowing type 2 diabetes epidemic
LITTLETON, Colo.--(Business Wire)--
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. 

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 diseases,
including Type 2 Diabetes. 

Privately held Pico-Tesla Magnetic Therapies is an emerging medical technology
company based in Littleton, Colo. 

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.

Ronald Trahan Associates Inc.
Ronald Trahan, APR, 508-359-4005, x108 

Copyright Business Wire 2009

 

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