NEW YORK--(BUSINESS WIRE)--The law firm of Wolf Haldenstein Adler Freeman & Herz LLP announces that it is investigating potential federal securities claims against MiMedx Group, Inc. (“MiMedx” or the “Company”) (Nasdaq:MDXG) and certain of its officers and directors in connection with allegedly false and misleading statements regarding the Company’s compliance with the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.
On September 4, 2013, the Food and Drug Administration (“FDA”) posted an “Untitled Letter,” dated August 28, 2013, on its website concerning MiMedx’s amniotic/chorionic-based products, including AmnioFix Injectable, AccelShield Injectable, and EpiFix Injectable, intended for reducing inflammation and scar tissue formation, as well as for enhancing soft tissue wound healing.
According to the FDA’s Untitled Letter, “[n]one of the amniotic/chorionic-based products...are the subject of an approved biologics license application . . . nor are there [investigational new drug applications] in effect for any of these products. Based on this information, we have determined that your actions have violated the [Federal Food, Drug, and Cosmetic] Act and the [Public Health Service] Act.”
On September 4, 2013, MiMedx confirmed its receipt of the Untitled Letter from the FDA. On this news, MiMedx’s stock fell more than 36%, to close at $3.85 per share.
Wolf Haldenstein has been representing individual and institutional investors for many years, serving as lead counsel in numerous cases in United States federal and state courts. Please visit the Wolf Haldenstein website (http://www.whafh.com) for more information about the firm.
Please contact us no later than November 8, 2013 if you own MiMedx common stock and you wish to discuss this matter with us, or have any questions concerning your rights and interests with regard to this matter, please contact:
Gregory M. Nespole
Wolf Haldenstein Adler Freeman & Herz LLP
270 Madison Avenue
New York, New York 10016