WESTFORD, Mass., March 30, 2011 /PRNewswire/ -- Cynosure, Inc. (Nasdaq : CYNO ), a leader in laser- and light-based treatments for minimally invasive and non-invasive aesthetic applications, today announced the presentation of two new studies involving its Cellulaze™ workstation, the world's first minimally invasive surgical device designed to reduce cellulite appearance by restoring the normal structure of the skin and underlying connective tissue. The two studies are being presented at the 31st Annual Scientific Conference of the American Society for Laser Medicine and Surgery (ASLMS). "LASER 2011" will be held on March 30 - April 3, 2011, at the Gaylord Texan Resort and Convention Center in Grapevine, Texas.
The studies are being presented by Barry DiBernardo, M.D., Medical Director of New Jersey Plastic Surgery, and by Bruce Katz, M.D., Clinical Professor, Mt. Sinai School of Medicine, and Director of the Juva Skin and Laser Center in New York. Dr. DiBernardo's study was a report on the treatment of cellulite with one-year follow-up using Cellulaze. Dr. Katz's study was focused on the efficacy of a bi-directional sidelight optical fiber and Cellulaze in the treatment of cellulite, as measured by 3-D surface imaging.
Dr. DiBernardo's study concluded that a single treatment with Cellulaze improves the appearance of cellulite in this preliminary study of ten patients and that improvement persists for at least one year with minimal adverse effects. Skin thickness – as shown by ultrasound – and skin elasticity increased significantly at one-, three-, six- and 12-month intervals as shown by objective measurements. Physician and subject evaluations also indicated improvement, high subject satisfaction and minimal adverse effects.
"The results of our study one year post-procedure indicated that there are considerable potential benefits from the use of subcutaneous laser energy in addressing cellulite," said Dr. DiBernardo. "We observed positive results from patients both in terms of tissue tightening through tissue coagulation as well as the regeneration of collagen and connective tissue."
Dr. Katz's study concluded that a sidelight three-dimensional optical fiber and 1440 nm Nd:YAG laser (which is used in Cellulaze) appear "to have long-lasting benefits in the treatment of cellulite." The results of Katz's 15-person study were that 68% of subjects showed significant improvement in cellulite by photographic evaluation and 65% with Vectra 3D surface imaging. Patient and physician evaluations also revealed good to excellent results in 76% and 69% of cases, respectively.
"The results of our study demonstrate that a minimally invasive surgical approach to cellulite can be effective," Dr. Katz said. "By all objective and subjective measurements, Cellulaze was able to achieve significant improvements in two-thirds of the patients we treated. While studies of the device are still ongoing, it appears that Cellulaze is capable of delivering meaningful and long-lasting results with a single treatment."
Michael Davin, president and chief executive officer of Cynosure, said, "Cellulaze is the first minimally invasive surgical approach to target cellulite beneath the surface of the skin. Given the scope of the cellulite market, with more than 85 percent of women over age 20 being affected, patients and doctors are seeking a solution that confronts the underlying components of cellulite rather than just performing a superficial treatment. We are pleased to have scientific evidence that supports the role we believe Cellulaze can play in addressing the subdermal structure that forms the foundation of cellulite."
Having received CE Mark certification earlier this year, Cellulaze will be available for sale to physicians in the European Union in the second quarter of 2011. Cellulaze is not available in the United States. The company filed a 510(k) notification with the U.S. Food and Drug Administration (FDA) in late 2010, and regulatory action on that submission is expected in the second quarter. The FDA has approved an Investigational Device Exemption (IDE) for Cellulaze, and over 100 patients have been treated as part of a clinical IDE study.
In addition to the studies conducted by Drs. DiBernardo and Katz, Cynosure's technology is featured in other scientific presentations at the 2011 ASLMS Annual Conference:
- "Laser Assisted Facial Rhytidectomy and Facial Rejuvenation: A Review of the First 500 Procedures," Richard Gentile, M.D., Northeastern Ohio College of Medicine, Youngstown, OH
- "Bilateral Axilla Hair Removal Comparing a Single Wavelength Alexandrite Laser with Combined Multiplexed Alexandrite and Nd:YAG Laser Treatment from a Single Laser Platform," Eric Bernstein, M.D., University of Pennsylvania, Ardmore, PA
Cynosure's presence at the conference is further supported by the inclusion of its technology in three scientific posters.
- "Hair Removal with Alexandrite Laser on Skin Grafts after Reconstructive Facial Surgery," Cesar Arroyo, M.D., Madrid, Spain
- "Port Wine Stains Previously Treated with an Intense Pulsed Light System. Treatment with a Dual- Wavelength Laser System (595, 1064nm) in 40 Patients," Jesus del Pozo, M.D., University Rey Jaun Carlos, Madrid, Spain
- "Histopathology and Immunohistochemistry of Cuaneous Lupus Erythematosus After Pulsed Dye Laser Treatment," Pablo Boixeda, M.D., Ramon y Cajal Hospital, Madrid, Spain
The American Society for Laser Medicine and Surgery is the world's largest scientific organization dedicated to promoting research, education and high standards of clinical care in the field of medical laser applications. It provides a forum for the exchange of scientific information and participates in communicating the latest developments in laser medicine and surgery to clinicians, research investigators, government and regulatory agencies, and the public. Founded in 1980, the Society has more than 4,000 members.
About Cynosure, Inc.
Cynosure, Inc. develops and markets aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and pigmented lesions, rejuvenate the skin, liquefy and remove unwanted fat through laser lipolysis and reduce the appearance of cellulite. Cynosure’s products include a broad range of laser and other light-based energy sources, including Alexandrite, pulse dye, Nd:YAG and diode lasers, as well as intense pulsed light. Cynosure was founded in 1991. For corporate or product information, contact Cynosure at 800-886-2966, or visit www.cynosure.com.
Any statements in this press release about future expectations, plans and prospects for Cynosure, Inc., as well as other statements containing the words "believes," "anticipates," "plans," "expects," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the global economy and lending environment and their effects on the aesthetic laser industry, Cynosure's history of operating losses, its reliance on sole source suppliers, the inability to accurately predict the timing or outcome of regulatory decisions, changes in consumer preferences, competition in the aesthetic laser industry, economic, market, technological and other factors discussed in Cynosure's most recent Annual Report on Form 10-K, which is filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Cynosure's views as of the date of this press release. Cynosure anticipates that subsequent events and developments will cause its views to change. However, while Cynosure may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Cynosure's views as of any date subsequent to the date of this press release.
Sharon Merrill Associates, Inc.
Phone: (617) 542-5300
SOURCE Cynosure, Inc.