Volume overload

Reprieve Cardiovascular Emerges from Stealth Mode after $42 Million Series A Financing to Bring Intelligent Fluid Management to Heart Failure Patients

Retrieved on: 
Tuesday, February 20, 2024
Health, Medical Devices, Health Technology, General Health, Clinical Trials, Cardiology, Biotechnology, Volume overload, Pacyna, Diuretic, Physician, Acute decompensated heart failure, Leg, Standard of care, Heart failure, ADHF, FASTR, Reprieve, Fatigue, Patient, Medtronic, Circulatory system, Pharmaceutical industry

Reprieve Cardiovascular , Inc., a development stage company focused on pioneering an intelligent automated diuretic and fluid management approach for acute decompensated heart failure (ADHF) treatment, today announced it has raised a total of $42 million in series A financing.

Key Points: 
  • Reprieve Cardiovascular , Inc., a development stage company focused on pioneering an intelligent automated diuretic and fluid management approach for acute decompensated heart failure (ADHF) treatment, today announced it has raised a total of $42 million in series A financing.
  • The total round was co-led by Lightstone Ventures and Sante Ventures and joined by Deerfield Management, Genesis Capital, and Arboretum Ventures.
  • The funding will advance the Company’s clinical and development programs, including the ongoing FASTR trial and its upcoming pivotal trial.
  • Pacyna continued, “Reprieve Cardiovascular is bringing intelligent decongestion management to heart failure patients.

Mallinckrodt Presents New Data on TERLIVAZ® (terlipressin) for Injection at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress

Retrieved on: 
Monday, January 22, 2024
Hypoxia, Patient, Alcoholic hepatitis, Cirrhosis, ACLF, Respiratory failure, Society, Risk, Critical care, Mallinckrodt, Oxygen saturation (medicine), Congress, Boxed warning, Critical Care Medicine (journal), Clinical trial, Volume overload, HRS, SCCM, Use, SCR, Dietary supplement

DUBLIN, Jan. 22, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of findings from a post hoc analysis of the Phase 3 CONFIRM clinical trial. In this analysis, treatment with TERLIVAZ® (terlipressin) for injection was associated with improvements in verified hepatorenal syndrome (HRS) reversal and HRS reversal vs. placebo in adult cirrhosis patients with alcoholic hepatitis (AH) and HRS with rapid reduction in kidney function.1,2 The results will be shared in an oral presentation at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress, taking place January 21-23, 2024, in Phoenix, AZ.

Key Points: 
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Mallinckrodt to Present Breadth of Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Association for the Study of Liver Diseases (AASLD) 2023 Liver Meeting

Retrieved on: 
Wednesday, November 8, 2023
Patient, Medical Affairs Bureau, Cohort (statistics), Respiratory failure, Oxygen saturation (medicine), Boxed warning, Use, Physician, MD, Blood, Kidney, Research, ACLF, Hepatorenal syndrome, American Association for the Study of Liver Diseases, Database, Risk, Volume overload, Safety, HRS, Abstract, Hypoxia, AASLD, Pharmaceutical industry, Dietary supplement, Nursing, Mallinckrodt, Hepatology

DUBLIN, Nov. 8, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced the presentation of 11 scientific abstracts with findings from the latest clinical and health economics research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 during the American Association for the Study of Liver Diseases (AASLD) 2023 Liver Meeting, taking place November 10-14, 2023 in Boston, MA.

Key Points: 
  • Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/9111651-mallinckrodt-aasld-2023-...
    Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
  • Data collected in retrospective, pooled, database, or post hoc analyses may have errors or omissions.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting

Retrieved on: 
Wednesday, November 1, 2023
Patient, Comorbidity, Incidence, Respiratory failure, Alcoholic hepatitis, Oxygen saturation (medicine), Boxed warning, Use, Renal replacement therapy, Blood, Health, Kidney, ACLF, Society, American Society of Nephrology, Hepatorenal syndrome, Phase, ASN, Risk, Volume overload, HRS, Hypoxia, Pharmaceutical industry, Dietary supplement, Mallinckrodt, MD

DUBLIN, Nov. 1, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three scientific abstracts evaluating treatment with TERLIVAZ® (terlipressin) for injection for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 – including its impact on patient care, key HRS endpoints and patient comorbidity – will be presented at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting in Philadelphia, Pennsylvania, taking place November 2-5, 2023.

Key Points: 
  • "1
    These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
    TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting

Retrieved on: 
Sunday, October 22, 2023
Gastroenterology, FDA, Comorbidity, Hepatorenal syndrome, American College, Respiratory failure, PDT, EDT, Heart rate, Boxed warning, Oxygen saturation (medicine), Use, DBP, Physician, ACG, Cirrhosis, Mortality, Effect, Treatment, Post hoc analysis, MAP, SBP, Acute kidney injury, American College of Gastroenterology, Research, ACLF, Baylor University Medical Center, Phase, White, Chronic liver disease, Risk, Hospital, Maryland School, Volume overload, University, Stanford University School of Medicine, CLD, Blood pressure, HRS, Hypoxia, Pharmaceutical industry, Dietary supplement, Medical device, Nursing, Communications satellite, Mallinckrodt, Patient, MD, Terlipressin

DUBLIN, Oct. 22, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three posters detailing findings from Mallinckrodt's latest clinical and health economics outcomes research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1,2,3,4 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, British Columbia, taking place October 20-25, 2023.

Key Points: 
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
  • If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the European Association for the Study of the Liver (EASL) Congress 2023

Retrieved on: 
Thursday, June 15, 2023
University College London, PFS, EASL, ACLF, Use, Royal Free Hospital, HRS, SCR, International Club Crosby, Research, Transplant, MNK, Doctor of Philosophy, EDT, Bachelor of Science, Congress, California Pacific Medical Center, Volume overload, Hepatorenal syndrome, Oxygen saturation (medicine), MD, Patient, Risk, CEST, Boxed warning, Kidney, Diagnosis, Terlipressin, Hypoxia, European Association for the Study of the Liver, ICA, Digestate, UCL Institute of Ophthalmology, NYSE, Respiratory failure, Dietary supplement, Pharmaceutical industry, Nursing, Mallinckrodt, Liver

DUBLIN, June 15, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that two scientific posters detailing Mallinckrodt's latest research findings on the clinical outcomes of treatment with TERLIVAZ® (terlipressin) for injection and clinical management criteria for adult patients with hepatorenal syndrome (HRS) will be presented at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria, taking place June 21-24, 2023. Both posters will be presented on June 24, 2023, 9:00 a.m. – 5:00 p.m. CEST / 3:00 a.m. – 11:00 a.m. EDT.

Key Points: 
  • Both posters will be presented on June 24, 2023, 9:00 a.m. – 5:00 p.m. CEST / 3:00 a.m. – 11:00 a.m. EDT.
  • The CONFIRM trial is the largest-ever prospective, randomized clinical trial of terlipressin compared to placebo in patients with HRS type 1 (HRS-1).
  • Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Newly Published Study Demonstrates Significant Clinical Utility of Daxor’s Blood Volume (BVA-100®) Diagnostic in the Evaluation of Heart Failure

Retrieved on: 
Thursday, November 3, 2022
Blood, Mortality, Journal of Cardiac Failure, Private Securities Litigation Reform Act, Journal, Hospital, Volume overload, Death, GLOBE, Blood volume, MPH, FDA, Heart failure, COVID-19, CEO, U.S. Department of Defense Strategy for Operating in Cyberspace, Heart Failure Society of America, HF, Forward-looking statement, Risk, Critical care, Common, NIH, SEC, Length of stay, Mayo Clinic, Medical imaging, Medical device, Pharmaceutical industry, Patient

Oak Ridge, TN, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces a new study in the prestigious Journal of Cardiac Failure demonstrating the importance and clinical utility of Daxor’s BVA-100 blood test in heart failure (HF). The researchers showed that Daxor’s BVA-100 was able to measure intravascular volume overload in heart failure patients – a key metric targeted to successfully manage heart failure. Common surrogate markers and clinical evaluation to assess volume overload in contrast were shown to be ineffective at making a comparative clinically actionable measure, despite common usage in many hospitals.

Key Points: 
  • The researchers showed that Daxors BVA-100 was able to measure intravascular volume overload in heart failure patients a key metric targeted to successfully manage heart failure.
  • The Journal of Cardiac Failure is the official peer reviewed journal of the Heart Failure Society of America and the Japanese Heart Failure Society.
  • The study titled, Blood Volume Analysis and Hemodynamic Measures of Vascular Compliance in Patients with Worsening Heart Failure, assessed the relationship between blood volume, resting, and stress cardiovascular pressures in worsening HF.
  • Daxor Corporation (Nasdaq: DXR), is the global leader in blood volume measurement technology focused on blood volume testing innovation.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Association for the Study of Liver Diseases (AASLD) 2022 Liver Meeting

Retrieved on: 
Thursday, November 3, 2022
Adult, Survival, Hepatorenal syndrome, ACLF, Division, Partial-response maximum-likelihood, University, MNK, University of Pennsylvania, Institute of Liver and Biliary Sciences, Acute kidney injury, Hypoxia, DC, AASLD, Kidney, American Association for the Study of Liver Diseases, Boxed warning, Safety, Volume overload, FDA, Association, Risk, Time, Oxygen saturation (medicine), HRS, Research, American Association, Efficacy, Terlipressin, NYSE, Mortality, Renal replacement therapy, 2021 Essex County Council election, Use, Health, Kidney failure, Completeness, ICA, Outcome, International Club Crosby, Pharmaceutical industry, Medical device, Poultry, Medicine, Gastroenterology, Patient, Mallinckrodt, Criterion, Hepatology

DUBLIN, Nov. 3, 2022 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that seven scientific abstracts on clinical and health economic outcomes research on treatment with TERLIVAZ® (terlipressin) for adult patients with hepatorenal syndrome (HRS) involving rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization2 will be presented at the American Association for the Study of Liver Diseases (AASLD) 2022 Liver Meeting in Washington, DC, from November 4-8. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS).1 

Key Points: 
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients.
  • For patients with high prioritization for liver transplantation (e.g., MELD 35), the benefits of TERLIVAZ may not outweigh its risks.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting

Retrieved on: 
Monday, October 24, 2022
CA, Terlipressin, Use, Risk, Oxygen saturation (medicine), Hepatorenal syndrome, American College of Gastroenterology, Patient, HRS, Mortality, Real, Kidney, Renal replacement therapy, ACG, Health, California Pacific Medical Center, Department, Disease, ACLF, Volume overload, Adult, Hypoxia, 2021 Essex County Council election, Survival, Boxed warning, American College, FDA, Kidney failure, Healthcare, Pharmaceutical industry, Transplant, Mallinckrodt

DUBLIN, Oct. 24, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that five scientific abstracts on the clinical and health economic outcomes of treatment with TERLIVAZ® (terlipressin) for adult patients with hepatorenal syndrome (HRS) involving rapid reduction in kidney function,1 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Charlotte, North Carolina from October 21-26. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2

Key Points: 
  • "With the recent FDA approval of TERLIVAZ, we are hopeful that we are one step closer to improving outcomes for these critically ill patients."
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients.
  • For patients with high prioritization for liver transplantation (e.g., MELD 35), the benefits of TERLIVAZ may not outweigh its risks.

Expert Panel Calls for Use of Blood Volume Measurement to Assess Heart Failure Patients at Key Scientific Meeting

Retrieved on: 
Wednesday, October 5, 2022
University of Texas Southwestern Medical Center, Pressure, Adoption, U.S. Department of Defense Strategy for Operating in Cyberspace, Method, Risk, Mayo Clinic, SEC, Growth, Duke University Health System, Patient, Critical care, Hospital, Research, NIH, Mortality, Device, Private Securities Litigation Reform Act, University of Minnesota Medical School, BVA, CEO, Heart failure, Volume overload, GLOBE, Forward-looking statement, University, FDA, COVID-19, Blood volume, Medical device, Pharmaceutical industry

Oak Ridge, TN, Oct. 05, 2022 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces that a scientific session titled “Debating Volume-based versus Pressure-based Methods and Devices to Measure Congestion in Heart Failure” was held during the Heart Failure Society of America Annual Scientific Meeting on October 3rd, 2022, in Washington, DC.

Key Points: 
  • In a debate format before hundreds of clinicians both on-line and in-person, the panel compared pressure-based vs volume-based measures to assess volume overload in advanced heart failure patients.
  • The panel unanimously agreed that pressure and volume do not give the same clinical information.
  • Daxor Corporation (Nasdaq: DXR), is the global leader in blood volume measurement technology focused on blood volume testing innovation.
  • We developed and market the BVA-100 (Blood Volume Analyzer), the only diagnostic blood test cleared by the FDA to provide safe, accurate, objective quantification of blood volume status and composition compared to patient-specific norms.