Boston, MA 03/04/2014 (wallstreetpr) – Atossa Genetics Inc. (NASDAQ:ATOS) has reported that the US Food and Drug Administration, the federal regulatory body, has sought more information and data to further review an application for a breast aspirator called ForeCYTE, developed by ATOS.
Atossa Genetics Inc. (NASDAQ:ATOS) reported that the relation was with respect to its 510(k) application seeking approval for its ForeCYTE Breast Aspirator. The company will expect to see an extension in the time line by which the company will place a response. If approved, the company would also see an extension of nearly 180 days to provide a response.
Atossa Genetics Inc. (NASDAQ:ATOS) reports that the response by FDA is the natural course of review and approval of a product and it would work hard towards providing the range of additional information the regulator is seeking to approve the final submission.
Atossa Genetics Inc. (NASDAQ:ATOS) which has been a reputed name in medical hardware, devices and medical accessories has been committed to developing critical post-natal care supplementary medical devices. One such product is the aspirator, which is being valued by the subsidiary.
Atossa Genetics Inc. (NASDAQ:ATOS) has since seen a sharp fall of nearly 20% following news of FDAs delayed response and seeking of further information. Early in January, the company had seen a drop of nearly 22% following the plan by ATOS to raise capital for the pet project. The company adopted shares and warrants method to raise nearly 5.8 million units. These funds will contribute to the corporate purposes which are necessary for breast health testing.
The aspirator has had a fair share of market shout-down after a ‘consumer update’ released by the company, reporting the product- ForeCYTE Breast Health Test as well as the Mammary Aspiration Specimen Cytology Test as they claimed it to be a ‘Pap smear for breast cancer.’
