NEW YORK (TheStreet) -- Shares of Atossa Genetics (ATOS) plummeted to a 52-week low of $1.07 on Wednesday after the company announced the FDA had determined Atossa's ForeCYTE Breast Aspirator is "not substantially equivalent" to its predicate device and would not clear it for U.S. marketing.
Atossa will now prioritize the U.S. commercialization of another breast aspirator, the FullCYTE. Atossa acquired the FullCYTE, which the FDA has already cleared, in 2012. The FullCYTE is a subset of Atossa's FullCYTE Microcather, which Atossa has been preparing to commercialize during the last 12 months.
The stock closed down 42.49% to $1.34. More than 2.6 million shares changed hands, compared to the average volume of 473,281.ATOS data by YCharts