EXTON, Pa.--(BUSINESS WIRE)--Fibrocell Science, Inc. (OTCBB: FCSC.OB), a cell therapy company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced today that it has begun the launch of LAVIV™ (azficel-T) in major metropolitan areas throughout the U.S. LAVIV is a revolutionary treatment for “smile line” wrinkles made from a person’s own skin cells and was approved by the FDA on June 21, 2011 as the first and only personalized cell therapy for use in aesthetics. LAVIV was recently named a 2011 Allure Best of Beauty Award winner in the magazine’s annual cover story (October 2011 issue).
“We will be offering LAVIV exclusively through board-certified dermatologists and plastic surgeons who have been trained by Fibrocell Science on the treatment process. We are launching initially in key cities across the country and are on track to expand into other markets in 2012 as more physicians are trained and manufacturing capacity increases,” said David Pernock, Fibrocell Science Chairman and CEO. “Our goal is to provide excellent customer service to the physicians we work with, and a high level of satisfaction to the patients they treat.”
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 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 cells.
“LAVIV offers an entirely new approach to smoothing smile line wrinkles and we are thrilled to be making this personalized treatment more widely available,” added Mr. Pernock. “To date, we have received very positive feedback from physicians who are offering LAVIV in their practices now, or who want to begin offering it.”
With LAVIV now available, Fibrocell Science, Inc. has also launched mylaviv.com, a new resource for interested patient candidates. This website includes product information, frequently asked questions and will soon feature a physician finder, which will be continually updated as new physicians are trained and begin offering LAVIV in their practices.
Conference Call
Mr. Pernock will host an investor conference call to discuss LAVIV business strategy tomorrow, Tuesday, October 4th, at 5:00 PM Eastern Time. Fibrocell Science, Inc. invites all interested parties to join the call by dialing 888-329-8903 for domestic participants and 719-457-2731 for international participants. They will also broadcast the call live over the Internet. The investor conference call can be accessed on the Investors section of Fibrocell Science’s website at www.fibrocellscience.com.
A telephone replay will be available for two weeks following the call by dialing 877-870-5176 for domestic participants and 858-384-5517 for international participants. When prompted, the Company requests that those interested enter replay pin number 2826334. For those who are not available to listen to the live webcast, the call will be archived for 90 days on Fibrocell Science, Inc.’s corporate website.
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. Do not let anyone else use your LAVIV.
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, 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 a cell therapy company focused on the development of autologous (personalized) cell therapies 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.
Forward-Looking Statements
All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, without limitation, the future appeal of LAVIV, the Company’s ability to increase manufacturing, to increase the number of physicians trained and to expand the number of cities served. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company's control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2010, as updated in "Item 1A. Risk Factors" in the Company's Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company's public filings with the SEC.
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