Top Trial Firm, Cohen, Placitella & Roth, PC, Investigating Atossa Genetics, Inc, for FDA Warning Letter and Product Recall
By: Chris Placitella @ Apr 03, 2014
Cohen, Placitella and Roth, PC is investigating claims on behalf of investors who purchased Atossa Genetics, Inc. (“Atossa” or the “Company”) (Nasdaq: ATOS) stock between November 8, 2012 and October 4, 2013, inclusive. The investigation concerns whether Atossa and certain of its officers and/or directors disseminated material false and misleading information to investors in violation of Sections 10(b), and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder, and Sections 11, 12(a)(2) and 15 of the Securities Act of 1933.
Atossa is a healthcare company focused on the commercialization of cellular and molecular diagnostic risk assessment products for the detection of pre-cancerous conditions that could lead to breast cancer. On November 9, 2012, Atossa filed its Prospectus for its initial public offering (“IPO”), which forms part of the Registration Statement that became effective on November 8, 2012. Pursuant to the IPO, Atossa sold 800,000 shares at $5.00 per share, garnering proceeds of $3,720,000 to the Company. The Prospectus stated that Atossa’s medical devices were “cleared” by the U.S. Food and Drug Organization for, “collect[ing] fluid samples from the breast milk ducts, where, according to the National Cancer Institute, over 95% of breast cancers arise.” On February 20, 2013, in a warning letter, the FDA raised concerns about procedures leading to design changes to Atossa’s MASCT [Mammary Aspiration Specimen Cytology Test] System and potentially significant safety and effectiveness issues related to those changes. The FDA also noted Atossa’s failure to apply and receive marketing clearance for the design change to MASCT, a violation of U.S. law. On Friday, October 4, 2013, Atossa began voluntarily recalling from the market the ForeCYTE BreastHealth Test and the MASCT device. This voluntary recall includes the MASCT System Kit and Patient Sample Kit. In Atossa’s Form 8-K filed on October 4, 2013, the Company stated: “The vast majority of these [recalled] products (approximately ninety percent) are in inventory with Atossa’s distributors and the remaining quantities are at customer sites across the United States.” On this news, shares of Atossa fell $2.50 per share to $2.82, a loss of almost 47% on intraday trading on October 7, 2013.
If you have any information on Atossa’s medical devices, or you wish to discuss what rights you may have related to a loss in your investment in Atossa, please contact Eduardo Texidor Jr. at [email protected] or, toll free, at 1-215-567-3500. For those investors inquiring via email, please be sure to include “Atossa” in the subject line, the number of shares purchased, and your mailing address and telephone number.
Since 1973, Cohen, Placitella & Roth, PC has been recognized as one of the premier trial law firms in the country. The firm has extensive experience in prosecuting securities litigation involving violations of the federal securities laws, state law derivative actions and mergers and acquisitions cases, representing institutional investors such as public pension plans and union pension funds as well as individual shareholders suffering substantial investment losses due to corporate misconduct. LexisNexis Martindale-Hubbell® annually reports Cohen, Placitella & Roth’s peer rating-the highest AV® – “a testament to professional excellence.” Since the inauguration of its “Best Law Firms”‘ edition in 2010, U.S. News and World Report has annually listed Cohen, Placitella & Roth’s as one of the top-tier class action law firms in the country.
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