Solta Medical Receives Health Canada Clearance for Second Generation LipoSonix® System

Nov 03, 2011, 16:05 ET from Solta Medical, Inc.

HAYWARD, Calif., Nov. 3, 2011 /PRNewswire/ -- Solta Medical, Inc. (NASDAQ: SLTM), a global leader in the medical aesthetics market, today announced that Health Canada has granted clearance of the second generation LipoSonix® system for non-invasive waist circumference reduction. The LipoSonix system uses advanced high–intensity focused ultrasound (HIFU) technology as a noninvasive, nonsurgical approach to permanently destroy targeted fat just beneath the skin in the treatment areas of the abdomen and flanks. The second generation LipoSonix system provides a treatment area that is 2.7 times as large for faster treatment times, improved ergonomics and ease of use for the practitioner, and a much smaller footprint in the physician's office.  

"The Health Canada clearance, along with the receipt of the CE Mark certification and clearance by the U.S. Food and Drug Administration (FDA), marks the third regulatory approval of the second generation LipoSonix system in the last month," said Stephen J. Fanning, Chairman, President & CEO of Solta Medical. "With the Health Canada clearance, we are positioned to expand our commercial launch activities in North America to include Canada.  The launch of the second generation product is expected in the first quarter of 2012."

About Solta Medical, Inc.

Solta Medical, Inc. is a global leader in the medical aesthetics market providing innovative, safe, and effective solutions for patients that enhance and expand the practice of medical aesthetics for physicians. The company offers products to address a range of skin issues under the industry's six premier brands: Thermage®, Fraxel®, LipoSonix®, Isolaz®, CLARO® and Clear + Brilliant®. Thermage is an innovative, non-invasive radiofrequency procedure for tightening and contouring skin. As the leader in fractional laser technology, Fraxel delivers minimally invasive clinical solutions to resurface aging and sun damaged skin. The LipoSonix system uses advanced high–intensity focused ultrasound (HIFU) technology to permanently destroy targeted fat just beneath the skin in the treatment areas of the abdomen and flanks as a noninvasive, nonsurgical approach to aesthetic waist circumference reduction. Isolaz was the first laser or light based system indicated for the treatment of inflammatory acne, comedonal acne, pustular acne, and mild–to–moderate inflammatory acne. CLARO is a personal care acne system that is the first FDA cleared over–the–counter IPL device that uses a powerful combination of both heat and light to clear skin quickly and naturally. Clear + Brilliant is a unique, cost–effective treatment that utilizes safe, fractional laser technology to correct and prevent early signs of aging and is FDA cleared and CE marked. Since 2002, approximately one million Thermage, Fraxel and Isolaz procedures have been performed in over 100 countries. For more information about Solta Medical, call 1-877-782-2286 or log on to www.Solta.com.

Forward-Looking Statements

This press release contains forward–looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Examples of such forward–looking statements include, but are not limited to, the expected timing of the commercialization of the second generation LipoSonix system. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause Solta's actual results or the occurrence of expected events to differ materially from the statements contained herein. Factors that might cause such a difference include risks arising in connection with the parties' efforts to comply with and satisfy applicable regulatory clearances, risks inherent in acquisitions of technologies and businesses, including the timing and successful completion of technology and product development, integration issues, costs and unanticipated expenditures, changing relationships with customers, suppliers and strategic partners, potential contractual, intellectual property, and tax or employment issues. Further information on potential risk factors that could affect Solta's business and its financial results are detailed in its Form 10–K for the year ended December 31, 2010, and other reports as filed from time to time with the Securities and Exchange Commission. Undue reliance should not be placed on forward–looking statements, especially guidance on future financial performance, which speaks only as of the date they are made. Solta undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.

SOURCE Solta Medical, Inc.



RELATED LINKS

http://www.solta.com