Healthcare Industry News: computed tomography
News Release - June 29, 2007
Ivivi Technologies Announces Completion of Patient Enrollment for its Cardiac Clinical Trial at The Cleveland Clinic FloridaNORTHVALE, N.J.--(HSMN NewsFeed)--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(TM) 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.
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.
Source: Ivivi Technologies
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