ACC preannouncement season begins with small company’s press release

I’d never heard of targeted pulsed electromagnetic field (tPEMF(tm)), or that it might be beneficial in ischemic heart disease, until I ran across the press release below. I’m always wary of press releases like these, especially when they come from tiny precarious companies. Nevertheless, there’s something intriguing about this, but I urge you to exhibit extreme caution. (Also, for the record, the Cleveland Clinic isn’t presenting anything here. Dr. Shen, who is affiliated with the Florida branch of the Cleveland Clinic, is the PI for the trial, but that hardly constitutes an endorsement.)

Update (January 16): A Cleveland Clinic spokesperson has told CardioBrief that the Cleveland Clinic did not approve or authorize the use of their name in this press release.

Source: Ivivi Technologies, Inc.

Cleveland Clinic to Present Results From Study Using Ivivi Technologies’ tPEMF(tm) On Cardiac Ischemia At American College of Cardiology Annual Meeting

MONTVALE, N.J., Jan. 15, 2009 (GLOBE NEWSWIRE) — Ivivi Technologies, Inc. (Nasdaq:IVVI), a leader in non-invasive, electrotherapy systems, today announced that previously announced results from a double-blind, randomized, placebo-controlled and prospective clinical trial on “no-option” cardiac patients utilizing the Company’s proprietary targeted pulsed electromagnetic field (tPEMF(tm)) technology have been peer reviewed and accepted for presentation at the American College of Cardiology (ACC) 58th Annual Scientific Meeting, March 29-31, 2009 in Orlando, Florida.       

The paper, titled “Use of Pulsed Electromagnetic Fields For Ischemic Cardiomyopathy Therapy (EFFECT Trial): A Randomized, Double-Blind, Parallel, Placebo-Controlled, Prospective Trial” will be presented by Dr. Michael Shen, a cardiologist at the Cleveland Clinic in Westin, Florida and Principal Investigator of the EFFECT trial.

As announced by Ivivi on June 30, 2008, in a study of 30 patients with cardiomyopathies and no other treatment options, patients in the active treatment arm demonstrated significant reductions in anginal pain and improvements in physical activity. These results began emerging at one month after commencement of treatment, with increasing significance at three and five month intervals. The changes in clinical outcomes were consistent with those seen in angina patients for whom a standard therapeutic intervention is possible.

The peer-reviewed abstract concludes: “This is the first study using PEMF in patients with angina and ischemic heart disease (IHD). This pilot trial demonstrates that PEMF is safe to use and effective in achieving and sustaining improvements in angina severity and physical capacity in patients with IHD and failed standard medical therapy and revascularization options. This device has the unique advantages of being non-invasive, non-pharmacological and self-operated at home. Future studies are warranted to investigate mechanistic effects, perfusion changes and clinical outcomes in a large clinical trial.”

Dr. Shen added, “In my experience PEMF clearly has significant potential to change clinical cardiology and could provide new hope to patients with angina and ischemic cardiomyopathy.”

Steven Gluckstern, Chairman of Ivivi Technologies, stated, “The ACC Meeting is one of the most important in the field of cardiology and we are pleased that research on our tPEMF(tm) technology was recognized for presentation. We believe this gives Ivivi credibility as we continue to evaluate our tPEMF(tm) technology in the field of cardiology with the intention to design and implement a larger, multi-center human clinical trial to confirm the important clinical outcomes and the perfusion benefits seen.”

About the EFFECT Trial

The objectives of this trial with tPEMF(tm) technology in this patient population were to evaluate safety; measure tPEMF(tm) effects on myocardial perfusion, ventricular function, clinical symptoms of angina, physical limitations; and the sustainability of any effects 2 months after treatment was completed. The patients administered treatment to themselves at home for 30 minutes, twice a day for 3 months. This consisted of placing a lightweight vest over the chest, which held a circular applicator over the left breast. Patients were evaluated at baseline, 1, 3 and 5 month intervals, with patients receiving the active treatment showing significant reductions in anginal pain and frequency. As the improvements at the 5 month point demonstrated the highest significance, these improvements persisted even after the therapy had been stopped for 2 months. There were dramatic increases in cardiac perfusion for some, but not most, patients at the 5 month period, which was expected because of the short study duration. Patients are currently being recalled to determine their present perfusion status. FDA approval for this indication is necessary in order for Ivivi to commercialize its product.

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, is believed to modulate biochemical and physiological healing processes to help reduce related pain and inflammation. The Company’s most recent clinical studies have shown reductions in anginal pain and increases in blood flow to the heart in certain cardiac patients; however, additional studies are required in this area. The Company expects to develop new tPEMF(tm) devices and to seek strategic partners to pursue the cardiac market and others, such as osteoarthritis, neurology and other inflammatory-related conditions if FDA marketing approvals or clearances can be achieved in these areas. Dr. Michael Shen, cardiologist at the Cleveland Clinic and Principal Investigator of the EFFECT trial, is a paid consultant to Ivivi Technologies in regard to his research on Ivivi’s tPEMF(tm).

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 additional clinical trials, 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 Form 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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