Syneron Medical Ltd (ELOS)

[midastouch017]

Syneron's cellulite treatment gets FDA approval

The company's share recovered by 6.26% yesterday, after falling 11% last week.

Avi Asher 14 Jun 05 09:23

Yokne'am based medical devices company Syneron Medical Ltd. (Nasdaq: ELOS) has obtained US Food and Drug Administration (FDA) 510(k) pre-marketing clearance for its VelaSmooth device for the temporary reduction in the appearance of cellulite.
The VelaSmooth also received clearance for the relief of minor muscle aches, pain and spasm and the temporary improvement of local blood circulation.

According to Syneron, the clearance of the VelaSmooth offers a new non-surgical, no downtime alternative for patients wishing to treat the appearance of cellulite.

In addition to the 510(k) clearance, the FDA created a new product code for the VelaSmooth. According to Dr. Amir Waldman, head of Clinical and Regulatory Affairs for Syneron, "The FDA's designation of a new product category specifically for the VelaSmooth reaffirms how technically innovative this device is for the treatment of cellulite."

Cellulite is the pitting, bulging and deformation of the skin usually affecting the thighs, buttocks, hips, breasts and the abdomen of women.

The VelaSmooth system is powered by elos (Electro-Optical Synergy). Elos uses bi-polar radio frequency (RF) and infrared light energy along with the added feature of negative pressure tissue mobilization.

Citigroup research arm Smith Barney estimates that the US market for Syneron's device will amount to $160 million in 2009.

Syneron's share fell 11% last week, but recovered by 6.26% to $32.94 yesterday following the announcement, giving the company a market cap of $805 million.

Published by Globes [online], Israel business news - www.globes.co.il - on June 14, 2005

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