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Atossa Files $40M Shelf Registration, Meets with FDA on Planned Submission for Recalled Test

NEW YORK (GenomeWeb News) – Atossa Genetics has filed a shelf registration to potentially offer from time to time up to $40 million in securities.

The company also said that following a meeting last week with the US Food and Drug Administration, it plans to submit a 510(k) notification for its recently recalled breast cancer test and platform.

The Seattle-based firm filed its Form S-3 with the US Securities and Exchange Commission on Monday, saying proceeds from any offering will be used for general corporate purposes, including the future development and relaunch of the ForeCYTE test upon regulatory clearance, as well as the development of other pipeline products.

On Monday, Atossa also announced it met with FDA on Nov. 14 about the ForeCYTE test, which the company voluntarily recalled in October after the agency notified Atossa about concerns it had with the test. The firm also voluntarily recalled its Mammary Aspiration Specimen Cytology Test device at the same time.

In its pre-510(k) meeting, Atossa discussed the regulatory pathway and data requirements needed for its 510(k) submission for the ForeCYTE Breast Pump and patient kit. It said that the meeting was "productive and will help inform the strategy, content, and timing of the regulatory requirements for the medical device."

Atossa added that it believes it has the data and other information needed to support its submission, which it intends to file "as soon as possible."

Last week, it said that revenues in its third quarter fell 27 percent year over year to $76,597.

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