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New Parkinson’s Disease
Treatment
Is Attractive
To Neurologists
Pico-Tesla has designed, patented
and manufactured a system that
provides an internet-enabled platform
technology to therapeutically
address several major areas of disease.
The Company’s lead indication
and current area of focus is
Parkinson’s disease (PD). Pico-Tesla
is planning a Phase III clinical trial
and subsequent 510(k) application
to obtain FDA clearance to sell the
system (the Resonator™) as a treatment
for PD. The system utilizes
precisely tuned, extremely lowlevel
electromagnetic fields (EMFs).
Unlike other treatments for PD,
Magneceutical® Therapy, which is
not FDA-cleared at this time, is
designed to have major advantages:
it is an adjunctive therapy that is
noninvasive, non-systemic and nonsignificant
risk. The ultimate vision
of the Company is to bring to market
a complete system that provides
an internet-enabled, database driven,
personalized treatment regimen,
for multiple disease states.
PD, which is Pico-Tesla’s initial
focus, is a chronic, degenerative
neurological disorder affecting over
1.5 million people in the U.S. with
60K+ new cases diagnosed every
year. Worldwide, over 6 million people
are estimated to have PD. There
is no cure for PD and current FDAapproved
therapies have their own
risks or possible complications.
While drug therapies help alleviate
some motor symptoms, side effects
can be significant (e.g., depression,
hypotension, abnormal movements
and hallucinations).
Only 15-20% of PD 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,
Pico-Tesla’s device is both non-invasive
and a non-significant risk.
Clinical impact was demonstrated
by the company’s pilot II study, suggesting
the treatment has a large
benefit across a broad spectrum of
motor and non-motor symptoms,
with no adverse side effects.
Specifically, pilot study data suggest
that improvements in motor symptoms
vs. placebo ranged from 20-
53%. Improvements in non-motor
symptoms ranged from 17-46% after
8 weeks (endpoint) of treatment.
Equally significant, improvement of
several symptoms lasted up to two
months after their last treatment.
Of note: the approximately 15,000
neurologists in the U.S. have limited
“therapy” or “procedure” options
for their PD patients and typically
see them during two or three office
visits per year. Currently the most
common treatment of PD patients is
prescription drug-focused.
Magneceutical® Therapy, on the
other hand, changes the “call
point” of this traditional structure
and actually offers the neurologist
an opportunity to offer his PD
patient base an adjunctive therapy
and a chance of improvement in his
patient’s “Quality of Life”.
Pico-Tesla is an emerging
medtech company based
in Clearwater, FL. Three
pilot studies suggest its
Magneceutical® Therapy may give neurologists a
whole new way of treating
Parkinson’s disease.
“There’s no cure
for Parkinson’s.
But early clinical
data suggest
Magneceutical®
Therapy may
improve symptoms
beyond
that achieved
by standard
medicine.”
Allen Braswell, CEO
"Via whole body immersion into a homogenous electromagnetic field, Magneceutical® Therapy provides a specifically tuned treatment for clinical effect."
Jerry Jacobson, PhD
Chief Science Officer, Pico-Tesla;
inventor of the Resonator™, making
possible Magneceutical® Therapy.
"Our system is designed to be cost-effective for the Payor community while simultaneously providing a compelling return on investment for our customers—the neurologists."
James Doran
Chief Financial Officer,
Pico-Tesla; Certified Public Accountant (CPA).
"If this therapy achieves FDA clearance, it will expand our toolset for combating PD and help our patients achieve a better quality of life."
Rajeev Kumar, MD
Neurologist; Medical Director,
Movement Disorders Center,
Colorado Neurological Institute;
Principal Investigator, Current Clinical Trial |
