Syneron Medical Ltd (ELOS)

[surf1944]

9:08AM Syneron Medical UltraShape Contour I System met the primary hypothesis for clinically significant circumference reduction (ELOS) 9.00 : Co has completed the multi-site clinical study for the UltraShape Contour I System for non-invasive abdominal circumferential reduction. The results successfully met the primary hypothesis for clinically significant circumference reduction. Furthermore, the results demonstrated progressive improvement over time in circumference reduction, beginning after the first treatment session. No serious adverse events related to the device were reported. The treatment was administered without the need for anesthetic and was well tolerated by patients. Circumference Reduction achieved exceeded FDA-specified margin by over 50% and demonstrates significant abdominal circumference reduction with a high degree of statistical significance.