NEW YORK, Oct. 17, 2013 /PRNewswire/ -- Bernstein Liebhard LLP today announced that a class action has been commenced in the United States District Court for the Western District of Washington on behalf of all those (the "Class") who purchased securities of Atossa Genetics, Inc. (NASDAQ: ATOS) ("Atossa" or the "Company") between November 8, 2012 and October 4, 2013, inclusive (the "Class Period").
Atossa is a development-stage healthcare company. The Company is focused on the commercialization of cellular and molecular diagnostic risk assessment products and related services for the detection of pre-cancerous conditions that could lead to breast cancer.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about Atossa's business and financial condition. Specifically, Defendants made false and/or misleading statements and/or failed to disclose to Atossa investors that: (1) the Company was required, but failed, to submit an additional 510(k) notification to obtain necessary FDA clearance as it made material changes to the Nipple Aspirate Fluid specimen collection process; (2) the Company improperly marketed its devices by using certain promotional claims to market the ForeCYTE Breast Health Test and the MASCT device; (3) the Company was in violation of FDA Good Manufacturing Practices regulations; and (4) as a result of the foregoing, Atossa's statements were materially false and misleading at all relevant times.On February 25, 2013, the Company disclosed that on February 21, 2013, it had 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 alleged that "the Company changed the System in a manner that requires submission of an additional 510(k) notification to the FDA" and the letter also 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." On this news, Atossa shares declined $0.3869 per share or nearly 5.6%, to close at $6.54 per share on February 25, 2013. Then, on October 4, 2013, after the market closed, the Company announced "a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market" after receiving a warning letter from the FDA. On this news, Atossa shares declined $2.47 per share, or more than 46%, to close at $2.85 per share on October 7, 2013. Plaintiffs seek to recover damages on behalf of all Class members who invested in Atossa securities during the Class Period. If you invested in Atossa securities as described above during the Class Period, and either lost money on the transaction or still hold the security, you may wish to join in this action to serve as lead plaintiff. In order to do so, you must meet certain requirements set forth in the applicable law and file appropriate papers no later than December 9, 2013. A "lead plaintiff" is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as lead plaintiff. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain Bernstein Liebhard LLP, or other counsel of your choice, to serve as your counsel in this action.