CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP Certification
04 nov. 2024 07h00 HE
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CytoSorbents
CytoSorbents submits DrugSorb-ATR Medical Device License Application to Health Canada following MDSAP Certification. Expects regulatory decision in 2025
FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
22 oct. 2024 07h00 HE
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CytoSorbents
FDA Accepts DrugSorb-ATR De Novo Application To Reduce CABG-Related Bleeding Severity Due To Brilinta, Starting Substantive Review, 2025 Decision Expected
CytoSorbents Submits DrugSorb-ATR Marketing Application to U.S. FDA to Reduce the Severity of Bleeding in Heart Bypass Surgery Patients on the Blood Thinner Ticagrelor and Provides Business Update
01 oct. 2024 07h00 HE
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CytoSorbents
CytoSorbents files for FDA De Novo marketing approval of DrugSorb-ATR to reduce the severity of CABG-related bleeding due to the blood thinner ticagrelor
CytoSorbents Secures $20 Million Credit Facility
02 juil. 2024 07h00 HE
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CytoSorbents
$20 million credit facility provides CytoSorbents with important non-dilutive capital to support its regulatory and commercialization objectives
Climate First Bank Exits De Novo Status and Brings Sustainable Finance Nationwide
04 juin 2024 09h00 HE
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Climate First Bank
ORLANDO, Fla., June 04, 2024 (GLOBE NEWSWIRE) -- Climate First Bank, the world’s first FDIC-insured bank founded to combat the climate crisis, today announces its exit from regulatory de novo...
OpGen Reports First Quarter 2023 Financial Results and Provides Business Update
15 mai 2023 16h15 HE
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OpGen, Inc.
Total revenue for the first quarter of 2023 was approximately $0.91 million, an increase of approximately 94% compared to the first quarter of 2022Expanded U.S. growth opportunities with the Unyvero...
OpGen Enters Into Distribution Agreement for Unyvero in the U.S. with Fisher Healthcare
18 avr. 2023 16h30 HE
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OpGen, Inc.
Fisher Healthcare, a part of Thermo Fisher Scientific, will become the non-exclusive national laboratory distribution partner alongside OpGen, Inc.’s direct sales in the U.S. for the Unyvero A50...
OpGen Submits De Novo request to the U.S. FDA for Unyvero Urinary Tract Infection Panel
18 avr. 2023 07h30 HE
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OpGen, Inc.
Based on large multi-center study with over 1,800 patient samplesPrimary endpoint for Unyvero UTI for urinary tract infection was successfully met and shows overall weighted average sensitivity of...
CORRECTION – OpGen Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
30 mars 2023 14h25 HE
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OpGen, Inc.
ROCKVILLE, Md., March 30, 2023 (GLOBE NEWSWIRE) -- In a release published March 29, 2023 under the same headline by OpGen, Inc. (Nasdaq: OPGN), the financial tables were incorrect. The corrected...
OpGen Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
29 mars 2023 16h15 HE
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OpGen, Inc.
Total revenue for 2022 was approximately $2.6 millionBalance sheet strengthened by recently closed public offering with gross proceeds of $7.5 millionConference call to be held March 29, 2023 at 4:30...