Atossa Genetics (ATOS) Tanks on Recall

Jacob Harper |

Atossa Genetics (ATOS) has recalled ForeCYTE, a device used to withdraw breast fluid, seven months after  the FDA said the device needed additional clearance.

The company issued a statement on the recall, explaining the FDA’s concerns over the device being  “(1) the current instructions for use (IFU); (2) certain promotional claims used to market these devices; and (3) the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU. “



After issuing the recall, Atossa did not specify if or when the device, which withdraws fluid for cancer screening, would ever return to market. FOREcyte is Atossa’s only product, so the recall is an undeniably crippling blow to the company.

Atossa went public a mere 11 months ago, raising $4 million in the IPO. Last quarter the company reported a net loss of $2.2 million on revenues of just $500,000.

The company has not given up hope completely, saying they will explore developing other devices they have in the pipeline. But according to CEO Stephen Quay, they will be “reassessing the regulatory status of these products ... in light of our recent experience."

Atossa plunged in value following the recall. It lost 46.61 percent of its value, ending the day at $2.86 a share.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

Companies

Symbol Name Price Change % Volume
ATOS Atossa Genetics Inc. 0.38 -0.01 -2.44 352,657 Trade
LBARP Lba Rlty Fd Ii 7.625%B n/a n/a n/a 0

Comments

Emerging Growth

WRIT Media Group Inc

WRIT Media Group Inc produces films, television programs and similar entertainment programs for various media formats.

Private Markets

8tracks

Our mission is to be the best place for people who care about music to create and discover thoughtfully curated playlists. In essence, 8tracks is a platform for online mixtapes.

MyForce, Inc.

As parents, we constantly worry about the safety of our loved ones. The media bombards us with incidents from across the nation school shootings, frequent assaults on campuses, and crimes…