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.
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