Ivivi Technologies Announces Completion of Patient Enrollment for its Cardiac Clinical Trial at The Cleveland Clinic Florida
June 29 2007 - 8:30AM
Business Wire
Ivivi Technologies, Inc. (AMEX:II), a leader in non-invasive,
electrotherapeutic technology, today announced that it has
completed enrollment in its 30 patient, double-blind, randomized,
placebo-controlled clinical trial utilizing the Company�s pulsed
electromagnetic field (PEMF) technology to treat patients with
ischemic cardiomyopathies. The trial is being conducted at The
Cleveland Clinic Florida, an affiliate of the Cleveland Clinic.
�Published studies have shown that our PEMF technology can enhance
blood flow and stimulate angiogenesis (growth of new blood vessels)
by 500% in animals,� commented Andre� DiMino, Vice Chairman and
Co-Chief Executive Officer. �Based on these promising results, we
are hopeful that our technology can make a difference in patient's
lives by providing a non-invasive therapy for cardiac ischemia.�
The Institutional Review Board (IRB)-approved clinical trial at The
Cleveland Clinic is designed for cardiac patients who are not
candidates for surgical intervention such as angioplasty, stenting
or cardiac bypass surgery. The trial looks at the use of Ivivi�s
PEMF technology over a period of five months on patients with
ischemic cardiomyopathy, a heart condition characterized by
decreased blood flow to the heart. The primary endpoint is the
improvement in regional myocardial perfusion (the flow of blood
through the heart) and function as seen with a 64-slice computed
tomography (CT) Scan. The secondary endpoint is patient improvement
for angina and exercise tolerance. As is standard with randomized,
blinded studies, efficacy cannot be determined until the conclusion
of the trial. Investigators will then examine the data and compare
patients who received the actual therapy with patients who received
the placebo therapy. Data analysis and results may be available by
the end of 2007. David Saloff, President and Co-Chief Executive
Officer added, "Based on the mechanism of action of our PEMF
technology, we believe that the non-invasive application of this
technology may improve cardiac circulation by increasing blood flow
and stimulating the growth of new blood vessels. If our study
successfully demonstrates this, the technology has the potential to
reduce the need for many invasive cardiac procedures. We anticipate
the results of this trial will be an important milestone for Ivivi
and patients, physicians and insurers, who are seeking a
non-invasive treatment for circulatory and cardiac conditions. In
addition, we expect these results will be of particular interest to
potential marketing partners in the field of cardiovascular
medicine." According to the American Heart Association, the
estimated cost of coronary heart disease was expected to reach
$142.5 billion in 2006. Of those with heart disease, an estimated 5
million patients are not candidates for existing interventions and
currently lack options for improving their cardiac function. About
Ivivi Technologies, Inc. Based in Northvale, NJ, Ivivi
Technologies, Inc. is a medical technology company focusing on
designing, developing and commercializing its proprietary
electrotherapeutic technology platform. Ivivi�s research and
development activities are focused specifically on pulsed
electromagnetic field, or PEMF, technology, which, by creating a
therapeutic electrical current in injured soft tissue, stimulates
biochemical and physiological healing processes to help repair the
injured tissue and reduce related pain and inflammation. The
Company�s Electroceuticals� have been used in non-invasive
treatments for a wide array of conditions, including chronic
wounds, pain and edema following plastic and reconstructive surgery
and chronic inflammatory disorders. Forward-Looking Statements This
release contains "forward-looking statements" made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. Forward-looking statements reflect management's
current knowledge, assumptions, judgment and expectations regarding
future performance or events. Although management believes that the
expectations reflected in such statements are reasonable, they give
no assurance that such expectations will prove to be correct and
you should be aware that actual results could differ materially
from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, the Company�s limited
operating history, history of significant and continued operating
losses and substantial accumulated earnings deficit, difficulties
with its financial accounting controls, the failure of the market
for the Company�s products to continue to develop, the inability
for customers to receive third party reimbursement, the inability
to obtain additional capital, the inability to protect the
Company�s intellectual property, the loss of any executive officers
or key personnel or consultants, competition, changes in the
regulatory landscape or the imposition of regulations that affect
the Company�s products and other risks detailed from time to time
in the Company�s filings with the Securities and Exchange
Commission, including the Company�s registration statement on Form
SB-2. The Company assumes no obligation to update the information
contained in this press release.
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