MONTVALE, N.J., Oct. 7, 2008 (GLOBE NEWSWIRE) -- Ivivi Technologies, Inc. (Nasdaq:IVVI), a leader in non-invasive, electrotherapy systems, today announced that in response to the Company's appeal of the U.S. Food and Drug Administration's (FDA) "Not Substantially Equivalent" (NSE) decision on its SofPulse 510(k) submission, the FDA has reopened the submission for an additional round of review. The reopening of the 510(k) overrides and supersedes the prior NSE decision. In addition to the information previously submitted to the FDA, the Company will be submitting supplemental data to the FDA as requested by them, during our current fiscal third quarter.
"We are extremely pleased that the FDA has taken the time to review the data submitted in support of our appeal, and has agreed to reopen our 510(k) covering the SofPulse M-10, Roma(3) and Torino II targeted pulsed electromagnetic field (tPEMF(tm)) products," commented Steven Gluckstern, Chairman, President and Chief Executive Officer. "This is a significant positive development for the Company and we will continue to work closely with the FDA to enable us to expand distribution of our technology in our target markets through our various partners."
Andre' DiMino, Executive Vice President and Chief Technical Officer added, "We are pleased the FDA has given us the opportunity to work with it to provide certain limited additional animal and other data to support substantial equivalence of our technology in the 510(k). The requested animal study should be completed within our current fiscal third quarter. While we await a final decision, we believe all our products are covered by the FDA clearance provided in 1991."
About Ivivi Technologies, Inc.
Based in Montvale, N.J., 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 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 if FDA marketing approvals or clearances can be achieved in these areas.
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 ability to achieve FDA clearance of our 510(k) submission, 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 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.