GENESISPLUS RECEIVES FDA CLEARANCE FOR ONYCHOMYCOSIS
−Laser treatment provides an effective option for millions worldwide−
BRISBANE, CA- April 7, 2011-- Cutera, Inc. (NASDAQ: CUTR), a leading worldwide provider of laser and light-based aesthetic systems for practitioners worldwide, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its GenesisPlus. The complete list of the indications for use can be found in the FDA 510(k) clearance number (K) 103626.
Known medically as onychomycosis, nail fungus often causes the toenails to become discolored, thickened and separated from the nail bed. Approximately half of the population will have at least one infected toenail during the course of their lives. Current treatment options include prescription topicals and oral drugs, both with limited success rates. Some patients are not candidates for oral medications, due to concerns of liver damage and other treatment limitations.
"The GenesisPlus laser is a great innovation in the treatment of fungal nails and it has exceeded my expectations for safety and efficacy," said David Weiss, Doctor of Podiatric Medicine in private practice in Hammonton, NJ. "The options I've had in the past were limited because they didn't work very well and patients were concerned about side effects."
GenesisPlus utilizes Cutera's patented microsecond technology and features a proprietary delivery system with a temperature sensor to improve the practitioner and patient experience. "What impresses me about the GenesisPlus is the safety, effectiveness and speed of the treatments. In one 10-15 minute session, I can treat a patient who has been suffering for years with unsightly, deformed and discolored toenails," said Jeffrey Kleis, Doctor of Podiatric Medicine in private practice in Beverly Hills, CA. "There is no downtime and my patients have been extremely pleased."
Kevin Connors, President and CEO of Cutera said, "A significant number of affected patients are dissatisfied with the current treatment options, including topical therapies and oral medications. The GenesisPlus provides a fast and effective solution for onychomycosis, without the risks of serious side effects."
About Cutera, Inc.
Brisbane, California-based Cutera is a leading provider of laser and other light-based aesthetic systems for practitioners worldwide. Since 1998, Cutera has been developing innovative, easy-to-use products that enable physicians and other qualified practitioners to offer safe and effective aesthetic treatments to their patients. For more information, call 1-888-4CUTERA or visit www.cutera.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995: Specifically, statements concerning the features and effectiveness of Cutera's new products and ability to expand its product offerings, are forward-looking statements within the meaning of the Safe Harbor. Such forward-looking statements are subject to risks and uncertainties and may be affected by various factors that may cause actual results to differ materially from those in the forward-looking statements and those other factors described in the section entitled, "Risk Factors," in Cutera's most recent Form 10-K as filed with the Securities and Exchange Commission on March 15, 2011. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Cutera 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.