ASPR

Spectral AI Announces 2024 First Quarter Financial Results

Retrieved on: 
tisdag, maj 7, 2024
Sale, FDA, Administration, ELOC, ASPR, PBS, Burn, SWAT, Human services, FY, DFU, Trial of the century, Artificial intelligence, Development, Assessment, MDAI, RCSI, Spectral, Patient, Acquisition, Health, Marketing, Ulcer, Clinical trial, Avita Medical, Growth, Pharmaceutical industry

DALLAS, May 07, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the first quarter ended March 31, 2024 (“Q1 2024”) and provided an update on its ongoing business activities.

Key Points: 
  • DeepView AI®-Burn Devices Deployed in UK; Expect Commercial Revenue in 2H 2024
    DALLAS, May 07, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the first quarter ended March 31, 2024 (“Q1 2024”) and provided an update on its ongoing business activities.
  • “During the first quarter we continued to execute against our strategic priorities resulting in significant accomplishments across the enterprise,” said Peter M. Carlson, CEO of Spectral AI.
  • Completed enrollment in our DFU training study in the US with expected completion of our DFU validation study in 2H 2024.
  • Additionally, Spectral AI entered into a fixed price standby equity purchase agreement (“SEPA”) with a long-only investor that includes a $12.5 million prepaid advance (“Advances”).

T2 Biosystems Announces First Quarter 2024 Financial Results

Retrieved on: 
måndag, maj 6, 2024
FDA, ASPR, International, Research, ECCMID, U.S. FDA, ATM, Panel, Blood culture, CRG, Acinetobacter baumannii, Infection, Journal, Growth, Sepsis

LEXINGTON, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced unaudited financial and operational results for the first quarter ended March 31, 2024.

Key Points: 
  • LEXINGTON, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced unaudited financial and operational results for the first quarter ended March 31, 2024.
  • Advanced the T2Resistance Panel toward U.S. FDA 510(k) submission, expected to occur during the third quarter of 2024.
  • “Looking ahead, we plan to launch T2Lyme Panel and file the FDA submission for the T2Resistance Panel during the third quarter of 2024.
  • The Company raised $2.2 million in net proceeds through ATM sales in the first quarter of 2024.

Basilea reports presentation of new data for ceftobiprole (Zevtera®) at ESCMID Global 2024

Retrieved on: 
fredag, maj 3, 2024
Infection, Kidney, FDA, Administration, Staphylococcus, ASPR, HHS, SAB, Safety, Ceftobiprole, Methicillin-resistant Staphylococcus aureus, Food, Ceftriaxone, ESCMID, Daptomycin, Partnership, Fungal infection, Development, CABP, TARGET, ABSSSI, Patient, Staphylococcus aureus, Dialysis, Bronchopneumonia, MRSA, Vaccine

Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.

Key Points: 
  • Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.
  • In the group treated with ceftobiprole, fewer patients had Staphylococcus aureus-positive blood cultures after ten days compared to the comparator treatment group.
  • An oral presentation focused on a re-analysis of the previously conducted ceftobiprole phase 3 study in patients with community-acquired bacterial pneumonia (CABP).
  • Using the FDA-CABP-2020 primary endpoint of early clinical success at day 3 after study start, this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ± linezolid.

Vir Biotechnology Provides Corporate Update and Reports First Quarter 2024 Financial Results

Retrieved on: 
torsdag, maj 2, 2024
AIDS, Health, Infectious Diseases, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, Infection, HIV Vaccine Trials Network, Administration, Cirrhosis, ASPR, Bangladesh Technical Education Board, Congress, HHS, COVID, EASL, Investment, Safety, Peginterferon-alfa, Abstract, MedRxiv, Development, Hepatitis, GSK, Vir, HCMV, Bill, Data analysis, Influenza, Conditional sentence, HIV, MBA, Metapneumovirus, Vaccine

Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the first quarter ended March 31, 2024.

Key Points: 
  • Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the first quarter ended March 31, 2024.
  • The Phase 2 MARCH Part B trial is fully enrolled with 48-week end of treatment data expected in the fourth quarter of 2024.
  • Cash, cash equivalents and investments declined by approximately $118 million during the first quarter of 2024.
  • Revenues: Total revenues for the quarter ended March 31, 2024, were $56.4 million compared to $63.0 million for the same period in 2023.

U.S. Department of Health and Human Services Awards Kaléo with Contract to Develop Next Generation Organophosphate Nerve Agent Poisoning Countermeasure

Retrieved on: 
onsdag, april 17, 2024
FDA, Administration, ASPR, HHS, The Reconstruction (1970 film), Food, Nerve, ROCS, Development, Naloxone, Government, Food and Drug Administration

The full development contract with options totals $27.7 million.

Key Points: 
  • The full development contract with options totals $27.7 million.
  • Kaléo is a market leader in emergency use auto-injectors with more than 12 million devices manufactured to meet the FDA’s standard of 99.999% device reliability.
  • “The development of a novel, next generation pralidoxime chloride auto-injector is an exciting opportunity,” said Mark A. Herzog, Kaléo’s vice president of global corporate affairs, defense and homeland security.
  • The 2-PAM auto-injector is the third U.S. government medical countermeasure contract awarded to Kaléo in the last five years.

IBEX IT Business Experts, LLC Receives 2024 Woman-Owned Small Business of the Year Award by the U.S. Department of Health and Human Services

Retrieved on: 
tisdag, april 23, 2024
Administration, ASPR, HHS, WOSB, CDC, IBEX

ATLANTA, April 23, 2024 /PRNewswire/ -- IBEX IT Business Experts, LLC (IBEX), a leading provider of technology, training, and staffing services announces the receipt of the U.S. Department of Health and Human Services (HHS) Office of Small and Disadvantaged Business Utilization (OSDBU) 2024 Woman-Owned Small Business (WOSB) of the Year award. This prestigious accolade is a testament to IBEX's significant contributions and achievements within the federal contracting community.

Key Points: 
  • ATLANTA, April 23, 2024 /PRNewswire/ -- IBEX IT Business Experts, LLC (IBEX), a leading provider of technology, training, and staffing services announces the receipt of the U.S. Department of Health and Human Services (HHS) Office of Small and Disadvantaged Business Utilization (OSDBU) 2024 Woman-Owned Small Business (WOSB) of the Year award.
  • This prestigious accolade is a testament to IBEX's significant contributions and achievements within the federal contracting community.
  • "This award solidifies our leadership in a traditionally male-driven industry and reinforces our dedication to making a significant impact on global health security," states Tracey Grace, President & CEO of IBEX IT Business Experts, LLC.
  • "Being recognized as the WOSB of the Year by HHS is an honor and a reflection of our team's relentless commitment to excellence and innovation in public health services."

Basilea announces US FDA approval of antibiotic ZEVTERA® (ceftobiprole medocaril) for three indications

Retrieved on: 
torsdag, april 4, 2024
Disease, MSSA, MRSA, Development, TARGET, Associate, Partnership, CABP, New Drug Application, Patient, HHS, Mortality, NDA, Fungal infection, Staphylococcus aureus, Bronchopneumonia, Infection, Safety, SAB, ASPR, Staphylococcus, Ceftobiprole, Administration, FDA, ABSSSI, Pharmaceutical industry

David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.

Key Points: 
  • David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.
  • The positive decision by the FDA is a key milestone towards bringing ZEVTERA to patients in the US.
  • This approval is a landmark for ceftobiprole and reflects its broad clinical utility.
  • Through this partnership, Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

Spectral AI Announces 2023 Fourth Quarter and Full Year Financial Results

Retrieved on: 
onsdag, mars 27, 2024
De novo, DFU, Diabetic foot ulcer, Certification, Burn, Government, Development, FY, MDAI, Patient, Research, History, Artificial intelligence, Classification, Sale, Standard of care, Human services, Research and development, Wound healing, Trial of the century, Clinical trial, ASPR, ISO, FDA, Administration, Food, Pharmaceutical industry

DALLAS, March 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2023”) and full year (“FY 2023”) ended December 31, 2023 and provided an update on its ongoing business activities.

Key Points: 
  • DALLAS, March 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2023”) and full year (“FY 2023”) ended December 31, 2023 and provided an update on its ongoing business activities.
  • “Spectral AI achieved much in 2023, and our progress along multiple fronts has continued into 2024,” said Peter M. Carlson, Chief Executive Officer.
  • “
    In September 2023, we were awarded the largest contract in our history from the US Government valued at up to $150.0 million.
  • All comparisons to Q4 2023 and FY 2023 are to the comparable periods ended December 31, 2022, unless otherwise stated.

T2 Biosystems Unveils T2Lyme Launch Plans and Provides Additional Business Updates

Retrieved on: 
onsdag, mars 20, 2024
Sepsis, Development, Lyme disease, Growth, Panel, International, Laboratory, Instrument, LDT, ASPR, Journal of Clinical Microbiology, Pharmaceutical industry

LEXINGTON, Mass., March 20, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced plans for the T2Lyme Panel commercial launch and provided recent business updates.

Key Points: 
  • LEXINGTON, Mass., March 20, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced plans for the T2Lyme Panel commercial launch and provided recent business updates.
  • The Company is currently in discussions with potential LDT partners and plans to provide early Lyme disease results to U.S. reference laboratories nationwide.
  • Engaged Dr. Robin Robinson as a strategic advisor to aid in commercialization of the T2Biothreat Panel.
  • A live and recorded webcast of the call will be available on the “Investors” section of the Company’s website at www.t2biosystems.com .

EverGlade Funding Alert - ARPA-H Announces Mission Office-Specific Funding Opportunities

Retrieved on: 
tisdag, mars 19, 2024
DTRA, Organization, Biomedical Research, BAA, NIH, Consultant, DOD, Public sector, ARPA, ASPR, Mission, Multimedia, DARPA, ISO, DOE, Medical device

HOUSTON, March 19, 2024 /PRNewswire/ -- The Advanced Research Projects Agency for Health (ARPA-H) has announced a new funding opportunity through its Mission Office-specific Innovative Solution Openings (ISO). The funding opportunity aims to accelerate innovation and breakthroughs in health research by providing targeted support to projects aligned with ARPA-H's mission areas.

Key Points: 
  • The funding opportunity aims to accelerate innovation and breakthroughs in health research by providing targeted support to projects aligned with ARPA-H's mission areas.
  • The Mission Office Open ISOs represents a strategic effort by ARPA-H to focus resources on key priority areas, fostering collaboration and innovation within the health research community.
  • Through this opportunity, ARPA-H aims to address critical challenges in healthcare and drive transformative advances in biomedical research.
  • If your company has considered applying for ARPA-H funding, your federal funding journey starts here.