EndyMed Ltd. (TASE: ENDY), which has developed a proprietary RF-based device for aesthetic treatments, today announced that it has obtained US Food and Drug Administration (FDA) approval for its product, Newa, for the treating wrinkles and fractional skin resurfacing. EndyMed's share price rose 40% by mid-afternoon to NIS 0.56, giving a market cap of NIS 70 million.
The approval comes two weeks after Health Canada approved the product, and allows the company to prepared for its commercial launch in both countries.
The FDA approved the Newa devices through its K510 track, and classified it as a Class II device for delicate and medium facial wrinkles, in line with FDA marketing guidelines for the annual registration of the product, good manufacturing, and labeling. The FDA has already approved two EndyMed products for the professional market, the EndyMed Pro and the EndyMed Glow/Pure.
EndyMed began sales of the EndyMed Pro in 2009 and the EndyMed Glow in 2012. It is now entering the home market, another important market for the company, after previously only targeting the professional market: private clinics, dermatologists, general practitioners, and cosmeticians.
EndyMed president CEO Uzi Blumensohn said, "This is basically the FDA's first approval of a RF device for home treatment for wrinkle reduction and fractional skin resurfacing. This is why the FDA approval gives EndyMed a competitive edge, as there is a severe shortage in the US of new products, because of the lack of FDA certification. The company's management will now try to fulfill the approval's business potential to improve its competitive standing."
Published by Globes [online], Israel business news - www.globes-online.com - on August 22, 2013
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