Ivivi Technologies’ PEMF Signals Reduce Post Surgical Pain in Breast Augmentation Patients By 87 Percent, Study Reports
MONTVALE, N.J., July 31, 2008 (PRIME NEWSWIRE) — Ivivi Technologies’ targeted Pulsed Electromagnetic Field (tPEMF) therapy reduced the pain associated with post-surgical breast augmentation surgery by 87%, with a corresponding reduction in pain medication, researchers reported in the July 2008 issue of Aesthetic Plastic Surgery (http://www.springerlink.com/content/l54978335248u774/?p=22c317e604b941b4bd26e0002d0616cf&pi=4). Ivivi Technologies, Inc. (Nasdaq:IVVI) is a leader in non-invasive, electroceutical(r) therapy systems designed to target and enhance the body’s anti-inflammatory response.
“The post operative pain often experienced after breast augmentation surgery is currently treated with analgesics or narcotics, which can have a serious side effect profile,” commented Dr. Per Heden, Associate Professor in Plastic Surgery at Akademiklinken, in Stockholm, Sweden, and lead study author. “Identifying innovative technologies for improving postoperative comfort is important for all types of surgical procedures, including breast augmentation, and PEMF was shown to be extremely effective in reducing pain, and therefore reducing pain medication use. In the treated group, PEMF therapy caused a significant decrease in pain of approximately 2.7 times, or 87%, which persisted throughout the study, with a 2.9 times decrease in use of pain medication.”
“This study reinforces our clinical data that shows the ability of our technology to enhance post-surgical pain management,” commented Steven Gluckstern, Chairman of Ivivi Technologies. “Since the publication of the American Heart Association Guidelines urging restricted use of non-steroidal anti-inflammatory drugs (NSAIDs), the need for non-pharmacological pain control has become critical for a large population of patients. Our technology is cost effective, user friendly and has an excellent safety profile — important factors in patient acceptance. We also believe with regard to elective aesthetic procedures like breast augmentation surgery, the accelerated pain relief and anti-inflammatory effects of our targeted PEMF signals could help these patients return to their activities more quickly as well.”
About the Study
In a randomized double-blind, placebo-controlled pilot study of 40 healthy women undergoing breast augmentation surgery with silicon breast implants, 12 received bilateral PEMF therapy (a coil delivered PEMF signal for each breast); 14 received sham therapy (neither coil delivered signal); and 14 received contralateral therapy (each patient had one active and one sham treatment in each breast). For each patient, two battery powered coils (either delivering PEMF signals or no signal) were placed inside compression bras. Once activated, the PEMF device automatically provided a 30 minute treatment on a regular schedule for eight days. Sham devices operated on the same schedule, but delivered no signal. Pain data was measured using a Visual Analog Scale (VAS) from 1-100, which was recorded by each patient twice daily throughout the study. Patients were asked to rate their pain for each breast. Post operative pain medication use was also monitored for each patient.
The mean starting VAS score for all breasts in all cohorts directly after surgery was approximately 53. By 3 days after surgery (POD3), pain had decreased in the treated group (whether bilateral or contralateral) to approximately 28.5 on the VAS scale, versus approximately 40.2 for the sham group. There was little difference between pain measurements for patients receiving treatment in both breasts and those receiving it in one breast only. Researchers in the study theorize that this is because the sham coil may have captured up to 60% of the signal from the treated breast. For the data analysis, the cumulative, daily pain measurements were plotted for each group, and the slope of the group receiving treatment was compared to that of the placebo group. Mean daily cumulative pain measurements in patients receiving therapy decreased approximately 87% faster than those in the placebo group (p less than .001). Pill count for all patients in the study started out the same, but decreased in the active cohort from approximately 6.2 pills to 3.1 by POD 3, and to 4.9 for the sham group.
Dr. Arthur Pilla, Professor of Biomedical Engineering at Columbia University and Chair of the Ivivi Scientific Advisory Board was a co-author on the study and is a paid consultant to the Company.
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.
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. 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 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, including those related to the study regarding post-surgical pain in breast augmentation patients, our future studies, 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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