Fibrocell Science Extends Patent Protection for LAVIV® (azficel-T) Through 2031
Fibrocell Science Extends Patent Protection for LAVIV®(azficel-T) Through 2031
EXTON, Pa.--(BUSINESS WIRE)-- Fibrocell Science, Inc. (NYSE MKT:FCSC), creator of the first FDA-approved autologous cellular product, LAVIV® (azficel-T) for aesthetics, announced today that the United States Patent and Trademark Office (USPTO) has awarded a patent to the Company which covers azficel-Tfibroblast suspension, extending the patent exclusivity in the United States until 2031.
"The granting of this patent is a significant milestone for Fibrocell, further validating our autologous fibroblast technology," said David Pernock, Chairman and Chief Executive Officer of Fibrocell Science. "We are focused on unlocking the potential of the autologous fibroblast and look forward to developing our cellular technology for a wide variety of applications."
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (NYSE MKT:FCSC) is an autologous cell therapy 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.
About LAVIV® (azficel-T)
LAVIV is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. The safety and efficacy of LAVIV for areas other than the nasolabial folds have not been established. The efficacy of LAVIV beyond six months has not been established.
Important Safety Information about LAVIV® (azficel-T)
LAVIV (azficel-T) is an autologous cellular product for intradermal injection only. LAVIV is contraindicated for allogeneic use, in patients with allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO) or material of bovine origin and in patients with active infection in the facial area. The following reactions have been reported following treatment with LAVIV: hypersensitivity reactions, bleeding and bruising at the treatment site, vasculitis, herpes labialis, basal cell cancer; keloid and hypertrophic scarring may occur following post-auricular skin biopsies or LAVIV injections. Additional warnings and precautions to be considered include the use of LAVIV in patients with genetic disorders or formation of normal collagen matrices and in immunosuppressed patients, or those patients undergoing chemotherapy for malignancies or receive immunomodulatory therapies for autoimmune diseases.
The most common adverse reactions, occurring in ≥1% of patients who receive LAVIV, were injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis and pruritus.
For more information about LAVIV, please see the accompanying full Prescribing Information or visit www.mylaviv.com.
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. 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, 2012, 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.
The Ruth Group
Zack Kubow/Melanie Sollid-Penton, (646) 536-7020/7023
Marina Maher Communications, LLC
Heather Adamson, 212-485-6806
KEYWORDS: United States North America Pennsylvania
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