Fibrocell Science, Inc. (OTCBB:FCSC.OB) announced

Fibrocell Science, Inc. (OTCBB:FCSC.OB) announced that pivotal clinical trial data demonstrating the effectiveness of LAVIV™ (azficel-T) for the improvement of the appearance of moderate-to-severe nasolabial fold wrinkles (“smile lines&rdquo is published online by Dermatologic Surgery, the official, peer-reviewed publication of the American Society for Dermatologic Surgery. It will also be published in an upcoming print issue. LAVIV is a breakthrough aesthetic treatment made from millions of a person’s own living, cultured, collagen-producing fibroblast cells and then injected into smile line wrinkles. This data supported the FDA approval of LAVIV and the publication is another significant development in the company's stated goal of being the leader in fibroblast evidence-based science.

The publication in Dermatologic Surgery includes the combined results of two identically-designed, Phase III, multi-center, randomized, double-blind, placebo-controlled, studies of 421 patients that showed statistically significant efficacy results for LAVIV. The criteria for a positive response included a 2-point improvement on the Subject Wrinkle Assessment Scale and a 2-point improvement on the Evaluator Wrinkle Assessment Scale for both nasolabial fold wrinkles. LAVIV showed a good safety profile in the studies; the most common adverse events were mild to moderate injection site reactions. See Below for Important Safety Information About LAVIV (azficel-T).

“This large, comprehensive study included strict criteria for demonstrating improvement in the appearance of moderate to severe smile line wrinkles,” said Dr. Stacy R. Smith, Associate Clinical Professor in the Division of Dermatology at the University of California, San Diego and lead author of the publication. “LAVIV is the first personalized cell therapy for aesthetic improvement to show a statistically significant benefit in large, controlled trials,” he added.

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. LAVIV is the resulting formulation of a person’s own living, cultured fibroblast cells, which is then injected into smile line wrinkles. Each person’s formulation of LAVIV is unique because it is made from their own fibroblast cells.

“We are pleased that the results of our pivotal clinical trials are now published in a prestigious, peer-reviewed journal such as Dermatologic Surgery,” said David Pernock, Fibrocell Science Chairman and CEO. “Fibrocell Science takes pride in how we design and implement our clinical investigations, proving to the scientific community that our findings are sound.”

About the Publication in Dermatologic Surgery

This analysis combined results from two studies and required a 2-point improvement in both patient and investigator wrinkle assessments. Based on this standard, 30% of subjects who received at least one LAVIV injection had a 2-point improvement in the appearance of smile lines six months after completing treatment, as rated by investigators, versus 8% for placebo. In self-assessments, 59% of patients reported a two-point improvement six months after completing treatment, versus 26% for placebo. See the full prescribing information for LAVIV for results from the each of the two individual studies including the adverse reactions reported in = 1% of subjects. The safety and efficacy of LAVIV for areas other than the nasolabial folds have not been established.

“As the first personalized cellular therapy in aesthetic medicine, LAVIV offers an innovation option to patients who want to improve the appearance of their smile lines without using synthetic substances as active ingredients,” said Dr. Robert A. Weiss, Clinical Associate Professor, Johns Hopkins School of Medicine and Director, Maryland Laser Skin & Vein Institute, and also study author. “The safety profile of LAVIV is very good since it’s made from a patient’s own living, cultured fibroblast cells.”

“The positive effects of LAVIV were maintained six months after the third injection,” added Girish (Gilly) Munavalli, M.D., Medical Director, Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC, Assistant Professor of Dermatology at Wake Forest University School of Medicine, and another study author. “It was exciting to see that LAVIV showed no signs of degradation during this time and that the effect persisted. The efficacy of LAVIV beyond six months hasn’t yet been evaluated in adequate and well controlled clinical trials.”

About LAVIV™ (azficel-T)

LAVIV was approved by the FDA on June 21, 2011 for the improvement of the appearance of moderate-to-severe nasolabial fold wrinkles in adults and is the first and only personalized cell therapy approved by the FDA for aesthetic use. LAVIV is now available in major metropolitan areas throughout the U.S., exclusively through board-certified dermatologists and plastic surgeons who have been trained by Fibrocell Science on the treatment process. A list of trained and certified physicians is available at www.mylaviv.com and will be continually updated as new physicians are trained and begin offering LAVIV in their practice.

Fibrocell Science is conducting research to identify other potential uses of LAVIV and their proprietary fibroblast technology. There is no timeline regarding when Fibrocell Science will seek FDA regulatory approval for additional uses.

Important Safety Information About LAVIV™ (azficel-T)

LAVIV is made especially for you from your own skin cells. Using someone else’s cells can cause a serious reaction. Prior to injection, confirm with your physician that your information on the LAVIV vial is correct. The most common side effects of LAVIV are at the injection-site, including redness, bruising, swelling, pain, bleeding, lumps, irritation, and itchiness. In clinical trials with LAVIV, most injection-site adverse reactions resolved within one week and most required no treatment.

Your health care provider will help you to decide whether you are a candidate for LAVIV and may help you avoid some of the adverse reactions from LAVIV. Before getting LAVIV, tell your healthcare provider if you have any medical problems including allergic reactions to any drugs or food, bleeding disorders or take blood-thinning medicines like aspirin, ibuprofen, or Coumadin® (warfarin sodium), keloids or excessive scarring, skin cancer or any malignancy, genetic disorders affecting your skin, immune problems or take medicines that affect your immune system, or any other illness or medical problem. The full Prescribing Information for LAVIV includes additional warnings about adverse reactions that occurred in less than 1% of patients following LAVIV treatment in clinical trials. Talk to your healthcare provider about these warnings.

Please tell your healthcare provider if you are allergic to the antibiotics amphotericin or gentamicin, bovine materials (products made from cattle), or dimethyl sulfoxide (DMSO). Do not use LAVIV if you have a skin infection on your face because LAVIV treatment can make the infection worse.

For more information about LAVIV, please see the Full Prescribing Information at www.mylaviv.com.

About Fibrocell Science, Inc.

Fibrocell Science, Inc. (OTCBB:FCSC.OB) is an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well as its innovative cellular processing technology and manufacturing excellence. For additional information, please visit www.fibrocellscience.com.