Study Shows Promise for Topical Application of Living Skin Cells Following Laser Treatment

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Data Presented as “Late-Breaker” at American Society for Laser Medicine and Surgery Annual Meeting

Topical application of fibroblasts may be a viable option for people who prefer laser therapy over needle injections, plus this laser therapy has the benefit of stimulating collagen, itself, as well as improving uneven skin pigmentation - Dr. McDaniel

Dr. David McDaniel today announced preliminary data supporting the potential for topical ‘needle free’ application of human skin fibroblast cells following fractional laser treatment. The data was presented Saturday as a “Late-Breaker” at the 2012 American Society for Laser Medicine and Surgery annual meeting in Kissimmee, FL. Azficel-T (LAVIVTM) is currently available as an injectable treatment for the improvement of the appearance of moderate-to-severe nasolabial fold (“smile line”) wrinkles. LAVIV is made from a person’s own living, cultured, collagen-producing fibroblast cells and is the first and only personalized cell therapy approved by the FDA for aesthetic use.

In an oral presentation accompanied by an “e-poster,” David H. McDaniel, M.D., assistant professor of Clinical Dermatology at Eastern Virginia Medical School and adjunct assistant professor in the Department of Biological Sciences at Old Dominion University, reported that pre-treatment with a 2940nm (nanometer) wavelength fractional skin resurfacing laser effectively enabled the topical application of fibroblast cells in a study of fresh skin samples. This laser was used to create precise microchannels in the skin to enable delivery of fibroblast cells into the skin. The Palomar LUX2940 laser is FDA cleared and is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue.

“Topical application of fibroblasts may be a viable option for people who prefer laser therapy over needle injections, plus this laser therapy has the benefit of stimulating collagen, itself, as well as improving uneven skin pigmentation,” commented Dr. McDaniel, who is also director of the Laser and Cosmetic Center and the McDaniel Institute of Anti-Aging Research, and co-director of the Hampton University Skin of Color Research Institute in Virginia. “What’s really exciting about this research is the potential to treat with a fractional laser and then apply fibroblast cells to the entire face rather than just treating individual lines and wrinkles. There is great potential for treating aging skin over extensive areas such as the décolleté and hands. In theory, we could deliver millions and millions of a person’s own cells via tens of thousands of microchannels – a technique you might call cell renewal therapy. I’m excited about moving this research forward in the future.”

About the Study

In the study that Dr. McDaniel presented, fibroblasts were injected into the skin samples or applied topically after the laser treatment. The skin biopsies were then examined under a fluorescent microscope to detect the presence and quantity of living, viable fibroblast cells. The fibroblast cells appeared to be healthy and viable 72 hours after treatment, although fewer cells may have been present. Eight different types of lasers and laser settings were tested to determine the optimal method for topical application of the fibroblast cells; the best effect was achieved with a 2940nm laser using gentle minimal coagulation settings. Dr. McDaniel said “Although the results need to be confirmed in additional studies, this provides the opportunity for research into other methods of azficel-T administration that may be appealing to patients.”

About McDaniel Institute of Anti-Aging Research

The Institute of Anti-Aging Research spans nearly three decades of research and innovation focused in particular on anti-aging and lifespan extension research as well as laser, LED and energy based device research. Dr. McDaniel and the Institute research team pioneered LED photomodulation and directed the first FDA clearance of LED for periorbital wrinkles as well as the first FDA clearance for this technology for home use. They have been involved extensively in laser skin resurfacing procedures and also the laboratory has a special research program for human skin fibroblasts. The Institute’s clinical and cosmetic affiliate is the McDaniel Laser & Cosmetic Center in Virginia Beach, VA. For more information: visit http://www.youthrenewed.com or http://www.drmcdaniel.com.

About LAVIV™ (azficel-T)

LAVIV is a breakthrough treatment that was approved by the FDA on June 21, 2011, for the improvement of the appearance of moderate-to- severe nasolabial fold (smile line) wrinkles in adults. The patented technology behind LAVIV is an advanced process that extracts a person’s fibroblast cells from a small skin sample and multiplies them in the Fibrocell Science lab. In normal skin, fibroblasts are responsible for producing collagen. Each person’s formulation of LAVIV is uniquely made from their own fibroblast cells.

About Palomar Medical Technologies, Inc. Palomar is a leading researcher and developer of laser- and light-based systems for aesthetic treatments. Palomar pioneered the optical hair removal field, when, in 1997, it introduced the first high-powered laser hair removal system. Since then, many of the major advances in light-based hair removal have been based on Palomar technology.

As a pioneer of fractional technology, Palomar is an owner of fundamental intellectual property in this area. In December 2009, Palomar received the first United States Food and Drug Administration (FDA) clearance for the treatment of stretch marks using a fractional non-ablative laser. In September 2010, Palomar received the first FDA clearance for a fractional ablative and fractional non-ablative combination treatment.

In June 2009, Palomar became the first company to receive a 510(k) OTC clearance from the FDA for a new, patented, home-use, laser device for the treatment of periorbital wrinkles. OTC clearance allows these products to be marketed and sold directly to consumers without a prescription. For additional information, please visit http://www.palomarmedical.com.

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