August 25, 2008
Study Commences at Henry Ford Hospital to Examine Efficacy of Ivivi tPEMF Technology to Relieve Pain From Knee Osteoarthritis
MONTVALE, N.J., Aug. 25, 2008 (GLOBE NEWSWIRE) -- Ivivi Technologies, Inc. (Nasdaq:IVVI), a leader in non-invasive, electroceutical therapy systems designed to target and enhance the body's anti-inflammatory and angiogenic responses, today announced that patient enrollment has been initiated at the Henry Ford Hospital, Detroit, Michigan, for a randomized, double-blinded, placebo-controlled study on the efficacy of Ivivi's targeted proprietary pulsed electromagnetic field (tPEMF(tm)) technology for the treatment of knee osteoarthritis.
According to the Centers for Disease Control and Prevention (CDC) and the National Arthritis Data Workgroup, in a study published in the January 2008 issue of Arthritis & Rheumatism nearly one in five U.S. adults, or 46.4 million people, have arthritis, the nation's most common cause of disability, with osteoarthritis, the number one form of the disease. While estimates on specific conditions rely on small studies of uncertain generalizability to the U.S. population, the 2005 National Health and Nutrition Examination Survey showed that 12.1% of the U.S. population ages 25-74 years had clinically defined osteoarthritis of some joint. Knee osteoarthritis was expected to affect nearly 28% of adults over the age of 45 and over 37% of adults over the age of 60.
"While the Company's primary focus going forward will be the treatment of cardiovascular disease, we believe osteoarthritis remains a significant ancillary market opportunity for our technology," commented Steven Gluckstern, Chairman, President and Chief Executive Officer of Ivivi. "Our proprietary tPEMF(tm) technology works by targeting the anti-inflammatory pathway in the body to help manage pain. Positive benefits have been demonstrated in animal and human clinical studies for the treatment of chronic wounds and the reduction of pain and swelling after surgical procedures. We are hopeful that this trial will demonstrate the efficacy of our targeted PEMF signals to relieve pain from knee osteoarthritis and provide physicians with an alternative therapy to help patients deal with the lost independence and inability to work and remain active that is often associated with this debilitating disease."
The IRB-approved clinical trial at Henry Ford Hospital is designed to determine if Ivivi's proprietary, tPEMF(tm) is effective in reducing pain and improving function for persons with knee dependent full-time employment who have early to moderate knee osteoarthritis. The Company expects that the trial will include 100 patients. The specific aim of the study is to evaluate the effects of tPEMF(tm) treatment, two 15 minute applications daily, on pain and function over two, six, eight and 12 week intervals. The study is anticipated to continue for up to 18 months. Recruitment of patients for the study commenced shortly after IRB approval and the first patient began treatment on August 7, 2008.
The principal investigator of the study is Fred R. T. Nelson, M.D., Director of the Osteoarthritis Center at Henry Ford and past president of the Society for Physical Regulation of Biology and Medicine. Dr. Nelson was a post doctoral fellow in orthopaedic research with an emphasis on osteoarthritis and has published many papers dealing with osteoarthritis and cartilage in multiple peer reviewed journals.
"We are excited to be a part of this research effort with Ivivi," stated Dr. Fred Nelson. "Osteoarthritis is marked by various degrees of inflammation and according to the American Heart Association, current therapies such as common NSAID-based pain relievers can increase the risk of heart failure, stroke, hypertension and gastrointestinal bleeding in some patients. The technology could fit well with our collaborative multi-disciplinary approach to orthopaedic and rehabilitative conditions and we believe it holds promise not only for patients with osteoarthritis, but also in post surgical and post injury situations as well."
David Saloff, Executive Vice President, Chief Business Development Officer of Ivivi added, "The Company has developed a version of its tPEMF(tm) technology for prescription pain relief as a non-pharmacologic alternative to pain relievers such as non-steroidal anti-inflammatory drugs for inflammatory conditions. We are in discussions with partners for this market, although FDA clearance would be needed to market our product for this indication."
About Targeted PEMF
Targeted Pulsed Electromagnetic Field therapy delivers signals which reduce pain and inflammation and are believed to accelerate the body's natural healing process. There is accumulating and substantial clinical evidence that targeted PEMF therapy can have physiologically significant effects on tissue growth and repair through demonstrated acceleration of normal growth factor production. Ivivi's technology is drug-free, easy to apply and has an excellent safety profile.
About Henry Ford
The Henry Ford Medical Group is one of the nation's largest and most experienced group practices, with 1,000 physicians and researchers in more than 40 specialties who staff Henry Ford Hospital, a 903-bed tertiary care hospital, education and research complex, and outpatient medical centers. Founded in 1915 after consultations with physicians at Johns Hopkins Hospital and the Mayo Clinic, the Henry Ford Medical Group has established itself as one of the premier group practices in the nation. Henry Ford Hospital is listed in "Best Hospitals in America" (Visible Ink Press). Its doctors are routinely named among America's best.
About Ivivi Technologies, Inc.
Based in Montvale, NJ, Ivivi Technologies, Inc. is a medical technology company focusing on designing, developing and commercializing its proprietary electrotherapeutic technology platform, with a primary focus on developing treatments for cardiovascular disease. Ivivi's research and development activities are focused specifically on targeted pulsed electromagnetic field, or tPEMF(tm), technology, which, by creating a therapeutic electrical current in injured soft tissue, modulates biochemical and physiological healing processes to help repair the injured tissue and reduce related pain and inflammation. The Company's Electroceuticals(r) have historically 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. The Company's most recent clinical studies have shown significant reductions in anginal pain and increases in blood flow to the heart in certain cardiac patients. Additional studies will be focused in this area. The Company also expects to seek strategic partners to pursue other markets, such as osteoarthritis, neurology and other inflammatory-related conditions.
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, including those related to our current and future studies, regulatory clearance and approvals, strategic partnerships and future sales. 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 From 10-KSB for the fiscal year ended March 31, 2008. The Company assumes no obligation to update the information contained in this press release.
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