Healthcare Industry News: IPLEX
News Release - April 2, 2009
Cynosure Announces Presentation of Favorable Results from Post-Marketing Studies of Smartlipo MPXFindings Demonstrate Statistically Significant Improvements in Skin Tightening and Tissue Shrinkage
Data to be Presented at 2009 American Society for Laser Medicine and Surgery Annual Conference
WESTFORD, Mass., April 2 (Healthcare Sales & Marketing Network) -- Cynosure, Inc. (Nasdaq: CYNO ) today announced the presentation of positive efficacy data from two post-marketing studies that demonstrate the skin-tightening and tissue-shrinking effects of the Company's Smartlipo MPX(TM) laser lipolysis workstation. The studies are being presented at the 2009 American Society for Laser Medicine and Surgery (ASLMS) Annual Conference, which is taking place April 1-5 at the Gaylord National Resort & Convention Center near Washington, D.C.
A randomized, blinded study, conducted by Barry DiBernardo, M.D., Medical Director of New Jersey Plastic Surgery & MedNet Technologies, Inc., compared Smartlipo MPX workstation against liposuction for their ability to improve skin elasticity and tighten tissue. A total of 10 women received a single treatment with liposuction on one side of the abdomen and the dual-wavelength Smartlipo MPX on the other. Skin shrinkage was evaluated through photographic imaging and measurement of temporary ink markings. Skin tightening was evaluated with the use of an elasticity device. Measurements were taken at baseline and at one and three months post-treatment.
At one and three months, skin treated with Smartlipo MPX had a statistically significant higher skin shrinkage ratio than skin treated with liposuction only, Dr. DiBernardo reported. Of the nine patients who were fully evaluated, eight, or 89%, had an average of 54% greater shrinkage at three months on the Smartlipo MPX side than the liposuction side. The study also showed a statistically significant difference in skin tightening. At three months, the average improvement in skin tightening was 62% with Smartlipo MPX compared with a 5% improvement on the side treated with liposuction.
"This is the first head-to-head quantitative study comparing the efficacy of the Smartlipo MPX workstation with that of liposuction, and the first study to illustrate the effects of subdermal applications of laser energy on skin laxity and tissue tightening," Dr. DiBernardo said. "The ability of Smartlipo MPX to lipolyze and remove unwanted areas of fat already has been clearly established. The results of our study now demonstrate that laser lipolysis can achieve greater skin tightening and skin shrinkage than liposuction alone."
Smartlipo MPX also was the focus of a post-marketing study conducted by Bruce Katz, M.D., Clinical Professor of Dermatology at The Mount Sinai School of Medicine and Director of the Juva Skin & Laser Center in New York. A total of 20 subjects with unwanted localized areas of fat and skin laxity were treated with Smartlipo MPX. In a subset of five patients, skin tightening through surface area reduction was measured with the use of temporary tattoo markings, and biopsies were performed before the procedure, as well as three days and one month post-treatment, to determine the presence of new collagen markers.
In addition to a reduction in localized fat deposits, the study demonstrated new collagen formation and an 18% decrease in skin surface area. "The data clearly indicate that Smartlipo MPX not only has a significant skin tightening effect, but also contributes to new collagen formation that is vital to skin tonicity," Dr. Katz said.
Cynosure President and Chief Executive Officer Michael Davin said, "These studies provide powerful scientific evidence that affirms the dramatic results already being observed by physicians and patients. We believe this research, and subsequent studies, will drive further adoption of Smartlipo MPX and amplify the benefits of our laser lipolysis technology as a complete solution for fat removal with the potential added advantage of skin tightening and body sculpting."
Dr. DiBernardo's study, "Evaluation of Shrinkage and Skin Tightening in Laser Lipolysis vs. Liposuction: A Randomized Blinded Split Abdomen Study," will be presented as part of the ASLMS Annual Conference's ePoster session. The poster is scheduled to be available for electronic viewing in the Exhibit Hall from 9:00 a.m. to 7:00 p.m. Friday and from 9:00 a.m. to 6:30 p.m. Saturday. Dr. Katz's abstract, "A Study of the Efficacy of a 1064nm and 1320nm Sequentially Firing Nd: YAG Laser Device with an Accelerometer Safety Mechanism for Lipolysis and Skin Tightening," is scheduled to be presented at 10:54 a.m. Sunday in the Maryland ballroom.
In addition to the two studies conducted by Drs. DiBernardo and Katz, Cynosure's technology is featured in seven scientific presentations at the ASLMS Annual Conference:
- "Efficacy of a New Fractional CO2 Laser in the Treatment of Photodamage & Acne Scarring," Bruce E. Katz, M.D., Clinical Professor, Mt. Sinai School of Medicine, Director, JUVA Skin & Laser Center, Director, Cosmetic Surgery & Laser Clinic, Mt. Sinai Medical Center, New York, New York
- "Laser Treatment of Vascular Lesions," Pablo Boixeda, M.D., Hospital Ramon y Cajal, Madrid, Spain
- "Smartlifting - Technological Innovation for Facial Rejuvenation," Richard Gentile, Northeastern Ohio University, Youngstown, Ohio
- "A Nd:YAG Laser with Sequential Emission of 1320nm and 1440nm Wavelengths with CAP Technology is Effective in Neck Rejuvenation," Adriana Ribe, Natalie Ribe, Institut Natalie Ribe, Carceloa, Barcelona, Spain
- "Evaluation of Laser Thermal Effects in Lipolysis Using a 1064/1320nm Nd:YAG Laser," Barry E. DiBernardo, Jennifer Reyes, New Jersey Plastic Surgery & MedNet Technologies, Inc., Montclair, New Jersey; Bo Chen, Mirko Mirkov, Cynosure, Inc., Westford, Massachusetts
- "Clinical Evaluation of a Single-Wavelength Fractional Laser and a Novel Multi-Wavelength Fractional Laser in the Treatment of Photodamaged Skin," Laurel Naversen Geraghty, Brian Biesman, New York University School of Medicine, New York, New York, Vanderbilt University Medical Center, Nashville, Tennessee
- "A Comparison of Three Separate Clinical Studies Evaluating the Safety and Efficacy of Laser-Assisted Lipolysis Using 1064nm, 1320nm and a Combined 1064/1320nm MultIPLEX Device," Katrina E. Woodhall, Raminder Saluja, Jane Khoury, Mitchel P. Goldman, La Jolla Spa MD, La Jolla, California
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 temporarily reduce the appearance of cellulite. Cynosure's products include a broad range of laser and other light-based energy sources, including Alexandrite, pulsed 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., including statements about the Company's expectations, 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 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 and Quarterly Report on Form 10-Q, which are 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.
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