Reliant Technologies Announces Groundbreaking Clinical Results For Deep Dermal Tissue Removal - A First Of Its Kind
First Round of Clinical Study Results of Fractional Deep Dermal Ablation (FDDATM) Treatment to be Presented at 27th ASLMS Annual Meeting
Grapevine, Texas—April 12, 2007—Reliant Technologies, Inc., the market leader of fractional resurfacing, today announced it will present first phase results from a 230-patient multi-site clinical study of the new Fractional Deep Dermal Ablation (FDDA) treatment at the 27th American Society for Laser Medicine and Surgery (ASLMS) Annual Conference in Grapevine, Texas. The FDA-approved investigation is evaluating FDDA treatment for patients with severe photodamage including rhytids, skin laxity, acne scars, atrophic scars, vascular lesions and striae. The first round results, which were conducted utilizing the first prototypes of the Fraxel re:pairTM system, demonstrate that FDDA treatment is safe and effective without the extended recovery time and risks of adverse reactions associated with conventional ablative resurfacing lasers (also known as CO2 or erbium YAG lasers).
"Patients are often wary of CO2 lasers and surgical procedures because the post-treatment healing process can last as long as two weeks and disrupt their quality of life," said Zakia Rahman, M.D., clinical instructor of dermatology at Stanford University in Palo Alto, CA, and medical director of the Fraxel® Laser Clinic. "These study results indicate that by combining fractional and ablative technologies, FDDA treatment may be a new treatment paradigm in the skin resurfacing arena, providing dramatic results that patients and physicians want without significant risks."
Dr. Rahman will present the first round results of a 30-patient study from three investigational sites, which examined FDDA treatment for patients with severe photodamage, including rhytids and skin laxity. The results demonstrate that patients treated with the prototype Fraxel re:pair system sustained significant improvements through the final follow-up visit. More than 75 percent of patients experienced improved appearance of rhytides and pigmentation as well as skin laxity, while no adverse effects were observed.
FDDA treatmentcombines the benefits of conventional CO2 resurfacing with the safety of fractional photothermolysis. In contrast to conventional bulk ablative laser skin resurfacing where 100 percent of the epidermis is ablated leaving only superficially coagulated dermis, the Fraxel re:pair system treats to depths exceeding 1.6 mm. The ability to uniformly remove deep dermal tissue constitutes an entirely new paradigm. The Fraxel re:pair system induces ablation, followed subsequently by tissue contraction, tightening and collagen remodeling. The result is a multi-dimensional approach for treatment of photodamage which relies on a broader range of mechanisms than those employed with surgical procedures.
"Reliant is committed to ensuring that physicians have the most advanced treatments to offer their patients that don't compromise safety or patient quality of life," said Len DeBenedictis, chief technology officer of Reliant Technologies. "We continue to invest in research and clinical testing to expand the Fraxel product line to address the serious skin conditions that patients most want repaired, including skin laxity, severe photodamage, vascular lesions and wrinkles. We are excited to share at ASLMS the findings of our multi-center studyof FDDAtreatment performed by 10 of the industry's leading physician investigators."
Clinical presentations about FDDA treatment being presented at the 27th ASLMS Annual Meeting include:
- The study titled, "Ablative Fractional Resurfacing for the Treatment of Photodamge and Laxity," will be presented by Zakia Rahman, M.D., F.A.A.D from Stanford University on Friday, April 13, 2007 at 1:05 p.m.
- The study titled, "Fractional Carbon Dioxide Laser Resurfacing of Photodamage and Acne Scars," will be presented by Elizabeth K. Hale, MD, Roy G. Geronemus, MD, et al. of the Laser & Skin Surgery Center of New York, on Friday, April 13, 2007 from 5:41 p.m. - 5:46 p.m.
- The study titled, "Fractional Deep Dermal Ablation," with be presented by Christopher B. Zachary, MB.BS., FRCP of the University of California Irvine on Saturday, April 14, 2007 at 7:00 am.
- The poster presentation titled, "Report of a Novel Fractional Ablative Laser for Tissue Tightening," will be presented by Dr. Rahman on Saturday, April 14, 2007 from 5:00 p.m. - 7:30 pm.
- The study titled, "Why Fractional? Why Ablative? Why Deep?"will be presented by Christopher B. Zachary, MBBS, FRCP of the University of California Irvine at 7:00 am on Sunday, April 15.
About the Fraxel Systems and Reliant Technologies
Reliant Technologies develops clinical solutions to repair and rejuvenate aging and environmentally damaged skin. Reliant is dedicated to providing the most advanced research, engineering and products to the global aesthetic marketplace. The company pioneered the development of fractional laser resurfacing which relies on novel high speed scanning systems and the Intelligent Optical Tracking® system to produce safe and effective results with minimal recovery time. The Fraxel family of products has quickly become the industry standard for aesthetic laser skin treatment. Because of their gentle, non-invasive approach to skin resurfacing, Fraxel lasers are used primarily by aesthetic physicians to treat periorbital wrinkles, pigmented lesions, acne scars and surgical scars. Fraxel lasers have received multiple FDA clearances and have been found safe and effective in treating all skin types and all areas of the face and body. Reliant is headquartered in Mountain View, California. For more information visit www.fraxel.com.
Contacts:
Michael Hromadik
Reliant Technologies, Inc.
(650) 641-5828
mhromadik@reliant-tech.com
Helen Hunt
GCI Group
(310) 526-5503
hhunt@gcigroup.com
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