The law firm of Wolf Haldenstein Adler Freeman & Herz LLP announces that it is investigating potential federal securities claims against Atossa Genetics, Inc. (“Atossa” or the “Company”) (NASDAQ:ATOS) and certain of its officers and directors in connection with allegations that the Company and certain of its officers and directors made materially false and misleading statements regarding its compliance with FDA rules and regulations, including Section 510(k) of the Food, Drug and Cosmetic Act.
In particular, the Company misrepresented or failed to disclose that (1) it was required to provide premarket notification to the FDA when it materially altered the design of its ForeCYTE Breast Health Test and Mammary Aspirate Specimen Cytology Test (“MASCT”); (2) the Company improperly marketed its devices by using certain promotional claims to market the ForeCYTE Breast Health Test and MASCT device; (3) the Company was in violation of FDA Good Manufacturing Practices regulations; and (4) as a result of the foregoing, the Company’s statements were materially false and misleading at all relevant times.
On February 25, 2013, the Company disclosed that it received a warning letter from the FDA regarding its MASCT System and MASCT System Collection Test (together, the “System”). Specifically, in the warning letter, the FDA charged that “the Company changed the System in a manner that require[d] submission of an additional 501(k) notification to the FDA” and raised “certain issues with respect to the Company’s marketing of the System and the Company’s compliance with FDA Good Manufacturing Practices (cGMP) regulations, among other matters.” Then, on October 4, 2013, after the market closed, the Company announced “a voluntary recall to remove the ForeCYTE Breast Health Test and the MASCT device from the market” after receiving the February 25, 2013 warning letter from the FDA.
On this news, the Company’s stock price fell $2.47 per share or more than 46%, to close at $2.85 on October 7, 2013.