Ivivi Technologies, Inc. Receives CE Approval for Certain of its Electrotherapy Devices
"Obtaining the CE approval is a significant milestone for our company in our efforts to commercialize our non-invasive electrotherapeutic technology throughout Europe," commented Andre DiMino, Co-CEO, Ivivi Technologies. "It supports our strategy of establishing channel partnerships with global medical device and healthcare companies."
Ivivi's electrotherapy devices consist of a signal generator and applicator and are programmed to provide therapy at optimal intervals throughout the course of therapy. As previously announced, a recent study conducted at Akademikliniken Hospital in Stockholm, Sweden by Dr. Per Heden, an internationally-recognized plastic surgeon and researcher, reinforced clinical data that shows the ability of Ivivi's technology to enhance post-surgical pain management. Preliminary data from a randomized double-blind, placebo-controlled clinical study entitled "Effect of Pulsed Electromagnetic Fields ("PEMF") on Post-Surgical Pain Reduction for Breast Augmentation" showed an 80% acceleration in pain relief in patients treated with the active technology as compared to patients treated with placebo units.
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.
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 the statements related to the preliminary data discussed above. 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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Source: Ivivi Technologies, Inc.