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Solta Medical Reports FDA Clearance Received for Second Generation LipoSonix® System
Date:10/24/2011

customers worldwide until Solta assumes this responsibility after closing.

Clinical Studies

The LipoSonix system was evaluated in a multicenter, randomized, sham–controlled, single blind study. Treatment with the LipoSonix system was shown to be superior to a sham control in reducing waist circumference, meeting the pre–specified primary endpoint of the study. The 59 J/cm2 treatment group demonstrated an approximately 1 cm greater waist circumference reduction as compared to sham. On average, the mean change in waist circumference of approximately 2.6 cm (1 inch) compared to baseline was demonstrated in the 59 J/cm2 treatment group. This could equal one dress or pant size.

The safety of treatment with the LipoSonix system was assessed through 24 weeks post–treatment. Safety was assessed by monitoring adverse events, results from a pre–specified battery of blood tests and physical examinations. The adverse events resulting from treatment with the LipoSonix system during this study included procedural pain, post–procedural pain, bruising and swelling. These were mostly mild, short–lived in duration, and resolved without incident. There were no serious adverse events or unanticipated adverse device effects related to treatment with the investigational device.(1)

The Market

The LipoSonix treatment is not intended as a replacement for liposuction surgery or a healthy lifestyle, or a way to lose weight, but as a noninvasive, nonsurgical approach to aesthetic waist circumference reduction when diet and exercise are not enough. According to the American Society for Aesthetic Plastic Surgery (ASAPS), liposuction represented the second highest number of surgical cosmetic procedures in 2010 with over 280,000 procedures. This equates to a combined U.S. market of over $1.6 billion for liposuction and abdominoplasty.(2)

About the LipoSonix System

The LipoSonix system tech
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