SOFA

Michigan Association of Nurse Anesthetists selects Jodie Emerson as new president for 2023-24 term

Retrieved on: 
Thursday, October 19, 2023
CRNA, Human, Certified Registered Nurse Anesthetist, Anesthetic, Trauma, MyMichigan Medical Center-Midland, Michigan Association of Broadcasters, MANA, United States Department of Veterans Affairs, Society, SOFA, Crna, Patient, Anesthesia, Emerson, Tuskegee Veterans Administration Medical Center, ICU, Nursing

LIVONIA, Mich., Oct. 19, 2023 /PRNewswire/ -- Jodie Emerson DNP, CRNA, a Certified Registered Nurse Anesthetist (CRNA), is the new president of the Michigan Association of Nurse Anesthetists (MANA) for the 2023-24 term.

Key Points: 
  • LIVONIA, Mich., Oct. 19, 2023 /PRNewswire/ -- Jodie Emerson DNP, CRNA, a Certified Registered Nurse Anesthetist (CRNA), is the new president of the Michigan Association of Nurse Anesthetists (MANA) for the 2023-24 term.
  • She also is an independent contractor who provides anesthesia care across Michigan.
  • Michigan has one of the highest numbers of CRNAs nationally, with approximately 2,700 nurse anesthetists currently practicing.
  • Emerson previously served as president elect of MANA during the 2022-23 term.

Measuring Nucleosomes Using Nu.Q® NETs is a Promising Biomarker for Septic Shock

Retrieved on: 
Thursday, October 19, 2023
Annals of Intensive Care, NYSE, Hospice, Intensive care medicine, Septic shock, Hospices Civils de Lyon, Human, Mortality, IL-6, Chromatin, Fungus, Virus, Pelvic floor dysfunction, Nucleosome, SAPS, Immune system, Animal, NETS, Cancer, SOFA, Sepsis, Patient, Death, Pharmaceutical industry, Veterinary medicine, Volition

Professor Monneret and his team used Volition's automated nucleosome quantification assay, Nu.Q® NETs, to measure nucleosome levels in patients with septic shock and to determine whether there is an association with mortality.

Key Points: 
  • Professor Monneret and his team used Volition's automated nucleosome quantification assay, Nu.Q® NETs, to measure nucleosome levels in patients with septic shock and to determine whether there is an association with mortality.
  • Nu.Q® NETs is a simple, low cost and routine blood test which can detect clinically elevated levels of NETs by identifying the unique biomarker H3.1.
  • Professor Guillaume Monneret, Head of Clinical Immunology Laboratory at Hospices Civils de Lyon, said:
    "This was the first study to investigate both nucleosomes and immunological parameters in septic shock.
  • We saw a significant elevation of nucleosomes in septic shock patients.

Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra™ In Patients With Sepsis

Retrieved on: 
Monday, July 31, 2023
Sepsis, Immunotherapy, Phase, Therapy, Patient, SOFA, Pharmaceutical industry

Nes-Ziona, Israel, July 31, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed under the amended protocol for the Company’s Phase II trial evaluating Allocetra™ in patients with sepsis.

Key Points: 
  • Nes-Ziona, Israel, July 31, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed under the amended protocol for the Company’s Phase II trial evaluating Allocetra™ in patients with sepsis.
  • As previously announced, the amended protocol allows a higher SOFA score inclusion range, which allows the recruitment of patients with higher levels of sepsis severity.
  • Additionally, the amended protocol provides for two cohorts (treatment and placebo) rather than the  prior protocol’s four-cohort structure.
  • “Therefore, we believe that the top-line data readout from the Phase II trial will be in Q1 2024, which is consistent with our previously announced timeline.”

Inotrem Announces Publication of Two Key Articles on Nangibotide Phase II Programs in Peer-reviewed Medical Journals

Retrieved on: 
Thursday, June 1, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Medical Devices, Research, Infectious Diseases, Science, COVID-19, Clinical Trials, SOFA, Infection, The Lancet, Inflammation, Septic shock, Patient, Manuscript, Mortality, Respiratory failure, Safety, COVID19, Disease, Pharmaceutical industry

The first article presents the ASTONISH Phase 2b trial in septic shock patients and the second one the ESSENTIAL Phase 2 trial for the treatment of critically ill COVID-19 patients.

Key Points: 
  • The first article presents the ASTONISH Phase 2b trial in septic shock patients and the second one the ESSENTIAL Phase 2 trial for the treatment of critically ill COVID-19 patients.
  • The findings presented further validate Inotrem’s innovative approach to treat inflammatory diseases by targeting TREM-1.
  • “Nangibotide is the first TREM-1 inhibitor and has the potential to become the first causal treatment of life-threatening immune dysregulations.
  • “We look forward to bringing this potential new treatment option to patients suffering from severe and often fatal inflammatory conditions.”

Brooke Army Medical Center (BAMC) Establishes Clinical Utility of Seraph 100 for Critically Ill Patients Suffering from Septic Shock Caused by Multiple Pathogens Including Candida

Retrieved on: 
Tuesday, May 2, 2023
FDA, COVID-19, Pharmaceutical, Professional Services, General Health, Medical Devices, Infectious Diseases, Hospitals, Clinical Trials, Science, Biotechnology, Data Analytics, Other Science, Health, Research, Blood pressure, Infection, BAMC, Hospice and palliative medicine, Partnership, SOFA, SARS-CoV-2, Public, Candidiasis, Extracorporeal membrane oxygenation, Survival, Angiotensin, ECMO, Army Medical School, Brooke Army Medical Center, Septic shock, Fungus, CDC, Hospital, Patient, Mortality, Bacteria, Dobutamine, SOFA score, Death, Virus, Auris, Pharmaceutical industry, Norepinephrine, Seraph

Brooke Army Medical Center published positive results for critically ill patients treated with ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter.

Key Points: 
  • Brooke Army Medical Center published positive results for critically ill patients treated with ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter.
  • CDC has issued a recent warning considering the threat of Candida auris to public health, so emerging evidence of Seraph 100 successful treatment of Candida infections is timely.
  • The Seraph 100 is an extracorporeal blood filter used to remove pathogens from the bloodstream of patients who are critically ill from infections that cause septic shock, i.e., the reduced blood pressure that often leads to cascading illness and death.
  • ExThera Medical previously confirmed that Seraph 100 is effective at removing many different bacteria, viruses and fungi, including the often-deadly Candida auris strain.

Spectral Medical Announces Positive Results of EUPHAS-2 Clinical Trial Evaluating PMX in Critically Ill Endotoxemic Septic Shock Patients

Retrieved on: 
Tuesday, April 18, 2023
Observational study, SOFA, Perfusion, Infection, EA, Research, Septic shock, Sepsis, Patient, PMX, TSX, Artificial organ, EAA, Pharmaceutical industry, Birth control

TORONTO, April 18, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced positive results in EUPHAS-2, an observational study in Italy using EAA-guided PMX hemoadsorption as a treatment for patients with endotoxemic septic shock. The results were featured in Artificial Organs, a premier, peer-reviewed journal publishing the latest in research, development, translation, and clinical application of organ replacement therapies, and organ machine perfusion preservation.

Key Points: 
  • TORONTO, April 18, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced positive results in EUPHAS-2, an observational study in Italy using EAA-guided PMX hemoadsorption as a treatment for patients with endotoxemic septic shock.
  • The study analysis included 50 patients with septic shock and endotoxin activity (EAT0) ≥ 0.6, who received Polymyxin-B hemoadsorption (PMX) therapy.
  • Among patients in the study, septic shock was mainly caused by 27 abdominal (54%) and 17 pulmonary (34%) infections.
  • Furthermore, as seen in EUPHAS-2 in patients with decreasing EAA, recovery from septic shock was faster.

Enlivex Announces Tislelizumab Clinical Collaboration, Full Year 2022 Financial Results, and Provides Business Updates

Retrieved on: 
Tuesday, April 4, 2023
DSMB, SOFA, BeiGene, Clinical trial, IP, Immunotherapy, Sepsis, Literature, Patient, Research, Phase, Therapy, Safety, Tislelizumab, Pharmaceutical industry, Cryptocurrency

Nes-Ziona, Israel, April 04, 2023 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced its full year 2022 financial results and provided strategic updates on its clinical programs.

Key Points: 
  • Planned amendment to be filed with regulators in early Q2 2023 for the sepsis Phase II clinical trial.
  • Received positive DSMB recommendation and IMOH clearance to continue Phase I/II clinical trial of Allocetra™ combined with chemotherapy in patients with peritoneal metastases arising from solid cancers.
  • Nes-Ziona, Israel, April 04, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced its full year 2022 financial results and provided strategic updates on its clinical programs.
  • As of December 31, 2022, Enlivex had cash, cash equivalents, short term deposits of $50.2 million.

Immunexpress to Present Data at ISICEM 2023 Indicating that SeptiCyte® RAPID Outperforms Other Rapid Measures for Sepsis Diagnosis

Retrieved on: 
Tuesday, March 21, 2023
Emergency medicine, SOFA, Respiratory rate, Temperature, Inflammation, Septic shock, PCT, Messenger, Sonneborn–Berger score, Intensive care medicine, International Symposium on Endovascular Therapy, Systemic inflammatory response syndrome, AUC, Rush Medical College, Diagnosis, Mortality, ICU, Intensive care unit, Rush University Medical Center, Gene, Critical Care Medicine (journal), SIRS, Medical imaging, Pharmaceutical industry, Sepsis, Patient

The poster presentation, entitled "Performance of a Molecular Host Response Assay in Patients Suspected of Sepsis and Stratified by qSOFA," will be presented on March 21, 2023.

Key Points: 
  • The poster presentation, entitled "Performance of a Molecular Host Response Assay in Patients Suspected of Sepsis and Stratified by qSOFA," will be presented on March 21, 2023.
  • The abstract will be published in Critical Care Medicine and will be available at www.septicyte.com/references .
  • SeptiCyte® RAPID differentiates sepsis positive patients from sepsis negative patients irrespective of qSOFA stratification (AUC 0.82 in qSOFA ≥2, AUC 0.81 in qSOFA
  • SeptiCyte RAPID outperformed other markers of sepsis at separating both higher and lower mortality ICU cases from patients that did not have sepsis.

Enlivex Receives Authorizations from French and Belgian Regulatory Agencies To Expand Its Phase II Sepsis Clinical Trial Into France and Belgium

Retrieved on: 
Wednesday, January 4, 2023
Hospital, FAMHP, Food, Therapy, ANSES, Biophysical environment, SOFA, Immunotherapy, Occupational safety and health, Sepsis, Patient, Mortality, Medication, Safety, Manifest and latent functions and dysfunctions, Time-invariant system, Phase, Pharmaceutical industry

The Phase II trial is expected to include 80 to 160 patients across four cohorts, receiving varying doses of either AllocetraTM or a placebo, all in addition to standard-of-care therapy.

Key Points: 
  • The Phase II trial is expected to include 80 to 160 patients across four cohorts, receiving varying doses of either AllocetraTM or a placebo, all in addition to standard-of-care therapy.
  • The trial is supported by previously reported positive results from a Phase Ib investigator-initiated trial that showed vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in AllocetraTM-treated sepsis patients, as compared to a group of matched historical controls who received standard-of-care therapy.
  • Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, “Expanding the study to France and Belgium with frozen formulation AllocetraTM is an important step in the execution of our ongoing Phase II sepsis trial.
  • We also believe that this is a notable regulatory achievement that provides additional validation for our amended study design and AllocetraTM frozen formulation.”

EQS-News: A Novel Immunotherapy That Could Bring Hope To Millions Of Sepsis Patients Received MultiCountry Clearance For Expanded Clinical Trial

Retrieved on: 
Sunday, December 18, 2022
Immunotherapy, Phase, SOFA, Septic shock, Time-invariant system, Merck, Clinical trial, Mortality, Animal, NYSE, Annual report, Failure, Advertising, Partnership, New York State Department of Health, Security (finance), Marketing, Hyperkinesia, Macrophage, Hospital, Sepsis, Safety, Neutralizing antibody, Manifest and latent functions and dysfunctions, Hope, CDC, Risk, Centers for Disease Control and Prevention timeline, Mab, Human, Homeostasis, Pfizer, Patient, Infection, Survival, COGS, Blood pressure, Immune system, End organ damage, MRK, Pharmaceutical industry, Vaccine, EU

The cleared amendments also allow Enlivex to use a newly developed frozen formulation of AllocetraTM — the macrophage reprogramming immunotherapy it’s evaluating as a potential sepsis treatment in the clinical trial.

Key Points: 
  • The cleared amendments also allow Enlivex to use a newly developed frozen formulation of AllocetraTM — the macrophage reprogramming immunotherapy it’s evaluating as a potential sepsis treatment in the clinical trial.
  • Despite the risks of sepsis, there is currently no specific treatment for the life-threatening condition.
  • That’s because it’s not a pathogen in its own right but an extreme response to an infection the patient already has.
  • In other words, patients need to receive treatment as soon as possible to increase the odds of survival.