MERRIMACK, N.H., Oct. 15 /PRNewswire/ — Internationally recognized San Francisco plastic surgeon, Michael Kulick, MD, has developed a 3D imaging validation method for quantitatively measuring changes in cellulite. Dr. Kulick has been named one of the key investigators involved in an IRB-approved, multi-center, prospective, randomized clinical study to investigate the efficacy of the SmoothShapes(R) system(1). Dr. Kulick began his study in May and will present findings at the Chicago American Society of Plastic Surgeons meeting on November 2-4, 2008. More than 85 percent of women will develop cellulite at some point in their life and it can’t be controlled or eliminated through diet or exercise.
With an industry-leading practice of more than two decades, Dr. Kulick is using a validation method in his SmoothShapes study that is significantly more data oriented than traditional photography. He acquires specialized images with a 3D imaging camera for assessment of volumetric changes. The groundbreaking validation method documents improvement in cellulite in three dimensions.
“I chose to work with Eleme Medical on this study because the company is focused on body shaping technologies and dedicated to investigating the understanding of the tissue components responsible for cellulite and fat. The basic science behind the SmoothShapes technology is sound and my patients are very concerned about the irregularities of their skin contour and they are looking for a reliable way to smooth their skin’s surface,” commented Dr. Kulick.
Using the 3D system to validate results of the study will allow new data points for documenting improvement in the appearance of cellulite. “This system is designed to provide reproducible 3D photographs and measure change in the volume between two surfaces. Therefore, if a positive change is observed after treatment, we should be able to tell what kind of volume change provided these results,” explained Dr. Kulick. He adds, “The imaging process will also allow my study to track results over time.”
Perfected after seven years of development, the SmoothShapes device uses a proprietary technology called Photomology(R) which can ultimately result in longer-lasting cellulite improvement and the appearance of tighter, smoother skin. Thermal and non-destructive, Photomology’s unique mechanism of action combines dynamic laser and light energy with mechanical massage and vacuum to specifically impact the tissue components responsible for the appearance of cellulite. Collagen is regenerated, circulation is improved and metabolic processes are restored. The result is tighter and smoother looking skin.
Although the original SmoothShapes device gained FDA market clearance in July 2006, Eleme Medical pursued market preference studies at 16 test centers around the world before launching the device commercially in April of 2008. “At Eleme Medical we are serious about the science of cellulite for SmoothShapes system and dedicated to providing market leading technology in all areas of body shaping,” said Nancy M. Briefs, President and Chief Executive Officer of Eleme Medical, Inc. “Dr. Kulick’s study is providing valuable understanding of cellulite and subcutaneous fat and will add to the other validation methods we have used to prove SmoothShapes consistent results in the improvement of cellulite. In addition to using traditional photography to document cellulite improvement, and now Dr. Kulick’s 3D work, we also have studies with both MRI and ultrasound validations,” said Ms. Briefs.
About Eleme Medical:
Eleme Medical, headquartered in Merrimack, N.H., is dedicated to providing market leading technology in all areas of body shaping. SmoothShapes(R) system with Photomology(R) is the company’s preeminent product to launch. SmoothShapes is a medical device with FDA clearance to market for temporary reduction in the appearance of cellulite. The Company’s name, when spoken phonetically, suggests “lasers, medicine and aesthetics.” For more information, or to arrange an interview with Dr. Kulick about SmoothShapes and his study, please contact Behrman Communications at 212.986.7000.
(1) SmoothShapes has been demonstrated effective in improving the appearance of cellulite as been reported at the 28th Annual Meeting of the American Society for Laser Medicine and Surgery in Kissimmee, FL in April 2008 (K.Khatri et al, Effectiveness of SmoothShapes(R) Cellulite Treatment as Monitored with High-Frequency Ultrasound Imaging, Lasers Surg Med, 2008, S20: 13; M.Pankratov et al, Photomology(R) — Some Experimental Evidence in Support of Postulated Mechanism of Action, Lasers Surg Med, 2008, S28: 164).
Eleme Medical
CONTACT: Behrman Communications, +1-212-986-7000
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