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.
Wolf Haldenstein has represented 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 December 9, 2013 if you own
Atossa securities and wish to discuss this matter with us, or have any
questions concerning your rights and interests:
Gregory M. Nespole, Esq.
Wolf Haldenstein Adler Freeman & Herz LLP
270
Madison Avenue
New York, New York 10016
Phone Numbers:
(800) 575-0735
(212) 545-4657
(917)
515-6161
Email:
Classmember@whafh.com
or nespole@whafh.com and please
reference “Atossa Investigation.”
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Copyright Business Wire 2013