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CORPORATE OVERVIEW
- Data supports claims addressing
symptoms for multiple disease states
Multiple preclinical and human clinical
studies are completed or underway using
magnetic resonance technology produced by the Resonator™ via Pico-Tesla’s proprietary Magneceutical® Therapy protocols.
- Phase III pivotal clinical trial in Parkinson’s Disease will be conducted
at the Company’s three sites; after completion, a 510(k) submission follow.
- Significant intellectual property portfolio includes devices, systems, and
method patents.
- Non-invasive, non-significant risk technology platform The Resonator™
generates a low-level electromagnetic field (EMF) designated a ‘Non-Significant Risk’ by the FDA.
- “Software as a Service” (SaaS) model creates recurring revenues Neurologists
pay for treatment sessions ‘downloaded’ via access of Pico-Tesla’s website.
- Experienced, successful management team CEO has track record of starting
and operating small companies and growing them into large, successful businesses.
- Strong lead product in one of the fastest-growing sectors of healthcare
‘Neuromodulation’, which is electrical or electromagnetic stimulation of the body, is
projected to be a $4.5 billion worldwide sector of healthcare by 2012.
- Large existing markets The PD market alone affects more than 1.5 million persons
in the U.S., with 60,000 news cases diagnosed annually.
- Multiple exit alternatives With a technology platform and at least one commercial
product, Pico-Tesla would be an attractive partnering candidate.
Magneceutical® Therapy for Five Signif icant Clinical Needs
- Atrial Fibrillation
Univ. of Oklahoma’s Heart
Rhythm Institute has demonstrated
that Pico-Tesla’s low
level magnetic fields reduced
A-Fib inducibility in an in
vivo study. A-Fib affects more
than 2 million people in the
U.S. Human clinical study
expected to commence soon
at Univ. of South Florida.
- Alzheimer's
Alzheimer’s study protocol is
being developed at the Univ.
of South Florida. The Company
expects to seek regulatory
approval and begin
enrolling patients before
year-end. National Institute
on Aging estimates that
more than 5 million people
in U.S. have Alzheimer’s.
- Fibromyalgia
Company expects to submit
for regulatory approval to
begin patient enrollment in a
fiibromyalgia study in 3Q.
About 5 million people in
the U.S. have fibromyalgia, a
chronic disorder characterized
by widespread musculoskeletal
pain, fatigue, and
multiple tender points.
- Osteoarthritis
Results of two international
studies indicate that pain associated
with osteoarthritis
was significantly reduced.
These human studies were
randomized, placebo-controlled,
double-blinded, and
included 250+ people. About
27 million people in the U.S.
have osteoarthritis.
- Parkinson's
Phase III clinical trial under
way to demonstrate efficacy
of Magneceutical™ Therapy
as adjunctive therapy to improving
aspects of health
and quality of life for PD
patients. 510(k) to be submitted
to FDA at completion
of trial. About 1.5 million
people in U.S. have PD.
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 Magneceutical® Therapy generally available outside of Investigational Review Board (IRB)- approved clinical studies. |
