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August 20, 2014
08:10 EDTATOSAtossa Genetics submits additional information to the FDA in support of ForeCYTE
Atossa Genetics announced that it has submitted additional information to the FDA in response to the FDA's February 21 request. The information was provided in support of Atossa's 510(k) submission for the ForeCYTE Breast Aspirator. The response includes, among other things: Data from an IRB-approved, prospective, single-arm, multi-laboratory, non-randomized, non-masked clinical trial in adult women using the ForeCYTE Breast Aspirator for the collection, fixation, transport, and processing of NAF specimens for laboratory cytological testing at multiple, independent CLIA-registered laboratories. A study of the concordance of positive and negative control Reference Panel Specimens with a blinded cytological interpretation when the specimens were processed and read at multiple, independent laboratories. Study data to establish shelf life information and document shipping stability under adverse conditions of the ForeCYTE Breast Aspirator. Based on the information provided to the FDA, Atossa expects that the FDA will finalize their review process, which may include requests for additional information, and will either clear Atossa's 510(k) submission or provide a "not substantially equivalent" decision on Atossa's 510(k) submission.
News For ATOS From The Last 14 Days
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September 24, 2014
09:05 EDTATOSOn The Fly: Pre-market Movers
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05:30 EDTATOSAtossa Genetics to host conference call
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September 23, 2014
18:24 EDTATOSOn The Fly: After Hours Movers
UP AFTER EARNINGS: Bed Bath & Beyond (BBBY), up 7.4%. ALSO HIGHER: Lipocine (LPCN), up 15.9% after announcing webcast on Phase 3 study of LPCN 1021... ZS Pharma (ZSPH), up 5.1% after reporting positive top-line results from HARMONIZE, its second Phase 3 clinical trial of ZS-9. DOWN AFTER EARNINGS: AAR Corp. (AIR), down 3.5%. ALSO LOWER: Atossa Genetics (ATOS), down down 54.5% after ForeCYTE aspirator not awarded FDA clearance... Envision Healthcare (EVHC), down 2.2% after filing to sell 17.5M shares of common stock for holders.
18:14 EDTATOSAtossa Genetics down 54.5% after ForeCYTE not awarded FDA clearance
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16:05 EDTATOSAtossa Genetics to request pre-submission meeting with FDA on ForeCYTE
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16:05 EDTATOSAtossa Genetics reports FDA does not clear ForeCYTE aspirator for U.S. marketing
Atossa Genetics announced that the Food and Drug Administration has issued a determination that the ForeCYTE Breast Aspirator is "not substantially equivalent" to its predicate device. The ForeCYTE Breast Aspirator is, therefore, not cleared by the FDA for marketing in the United States. Based in part on the recent feedback received from FDA on the ForeCYTE submission, Atossa has decided to prioritize commercialization of its FullCYTE Breast Aspirator in the United States. The FullCYTE Breast Aspirator is an FDA-cleared device that was acquired by Atossa in 2012 and is a subset of Atossa's FullCYTE Microcather which Atossa has been preparing for commercialization over the past 12 months. CEO and President Steven Quay said, "While we are disappointed in the FDA's decision on the ForeCYTE device, we believe this alternative aspirator can help us reach our commercialization goals without a significant delay. We are highly encouraged that we presently possess an FDA-cleared, patented, commercially viable alternative that will permit us to return to the U.S. market with our FullCYTE Breast Aspirator device. We also remain optimistic that our ForeCYTE device will soon receive the CE Mark and we expect our ForeCYTE device will soon be available for commercial marketability in Europe. Our strategy to commercially launch our devices remains on track and we believe we have the appropriate and compliant solutions to enable us to return to revenue generation in the near future."
16:02 EDTATOSAtossa Genetics reports FDA does not clear ForeCYTE aspirator for U.S. marketing
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16:00 EDTATOSAtossa Genetics trading halted, pending news
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