October 8, 2008 - Ivivi Technologies Inc. said yesterday the FDA reopened the submission for an additional round of review for its SofPulse M-10, Roma and Torino II targeted pulsed electromagnetic field (tPEMF) products 510(k) submission, in response to the company’s appeal of the FDA’s earlier “not substantially equivalent” (NSE) decision.
In addition to the information previously submitted to the FDA, the company will be submitting supplemental data to the FDA as requested. The company is developing electrotherapeutic technology with a primary focus on treatments for cardiovascular disease.
“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),” said Andre' DiMino, executive vice president and chief technical officer. “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.”
Ivivi’s research and development activities are focused specifically on targeted pulsed electromagnetic field, or tPEMF, 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.