Solta Medical, Inc. (Solta) (Nasdaq: SLTM), a global leader in the medical aesthetics market, today announced that Medicis Technologies Corporation (formerly LipoSonix, Inc.), a subsidiary of Medicis Pharmaceutical Corporation (Medicis) has received U.S. Food and Drug Administration (FDA) clearance of the second generation LipoSonix system specifically indicated for non-invasive waist circumference reduction. The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue to provide a non-invasive approach to achieve a desired aesthetic effect. Per the terms of the agreement announced on September 13, 2011 for Solta to acquire the LipoSonix subsidiary from Medicis, with the closing of the acquisition, Solta will make a one-time payment to Medicis of $20 million with respect to this clearance, in addition to the $15 million due at closing.

"Compared to its predecessor, the second generation LipoSonix system provides a treatment area that is 2.7 times as large for faster treatment times, has improved ergonomics and ease of use for the practitioner, and has a much smaller footprint in the physician's office," said Stephen J. Fanning, Chairman, President & CEO of Solta Medical. "We congratulate Medicis on receiving FDA clearance for the second generation LipoSonix system prior to our previously anticipated timeframe of first quarter 2012. We look forward to closing the transaction and entering the fast growing non-invasive fat reduction market."

The transaction is expected to close during the fourth quarter of 2011. Solta expects to fund the acquisition through existing cash balances and credit facilities.

The first generation LipoSonix system is currently marketed in Canada, the European Union and Japan. Medicis will continue supporting existing LipoSonix 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)