Decompensation

89bio Announces Additional Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Compensated Cirrhotic (F4) Nonalcoholic Steatohepatitis (NASH) at AASLD The Liver Meeting® 2023

Retrieved on: 
Sunday, November 12, 2023
SAN, ALT, F3, Liver, Risk, Disease, Patient, Cirrhosis, Decompensation, FAST, Biomarker, Diabetes, NASH, Inflammation, F2, Fibrosis, Medical device, Boston, F4

SAN FRANCISCO, Nov. 12, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced additional data from a post-hoc analysis of the ENLIVEN Phase 2b trial evaluating treatment with pegozafermin in a subgroup of patients with F4 NASH. These data were featured in an oral presentation during the AASLD The Liver Meeting®, being held in Boston, Massachusetts.

Key Points: 
  • These data were featured in an oral presentation during the AASLD The Liver Meeting®, being held in Boston, Massachusetts.
  • “Patients with NASH and compensated cirrhosis face a critical imperative to mitigate the risk of decompensation, necessitating therapies that halt or even reverse the progression of fibrosis,” Dr. Hank Mansbach, Chief Medical Officer of 89bio commented.
  • “While the cohort of F4 patients in ENLIVEN was relatively small, we were encouraged by data suggesting that pegozafermin could potentially provide benefits to these patients by addressing both liver pathology and the metabolic irregularities that may contribute to the disease.
  • Treatment with pegozafermin led to clinically meaningful improvements in liver specific biomarkers of stiffness and fibrosis (Pro-C3, FAST, VCTE, FIB-4), inflammation (ALT and AST), and other key non-invasive markers.

FibroScan® by Echosens Recognized in AASLD Practice Guidance on Managing Portal Hypertension and Varices in Cirrhosis

Retrieved on: 
Friday, November 10, 2023
Elastography, Lipinski's rule of five, Dominique, Literature, AASLD, HVPG, Cirrhosis, Liver disease, Mortality, Patient, SSM, Varices, Prognosis, Diagnosis, Decompensation, Chronic liver disease, Platelet, Medical imaging

PARIS and WESTBOROUGH, Mass., Nov. 10, 2023 /PRNewswire/ -- The American Association for the Study of Liver Disease (AASLD) has released new guidance advocating noninvasive tests like FibroScan® for the management of advanced liver disease, including assessment of clinically significant portal hypertension and varices in cirrhosis. This evidence-based approach could impact health outcomes for the majority of asymptomatic patients with this condition.

Key Points: 
  • "Managing portal hypertension in cirrhotic patients is a daily challenge for healthcare professionals," said Jon Gingrich, CEO of Echosens North America .
  • "Given the high mortality rates associated with these conditions, there's an urgent need for effective treatments and early diagnosis.
  • The latest guidance underscores the promise of noninvasive methods for monitoring advanced liver disease patients."
  • This new guidance encapsulates optimal practices for identifying and managing portal hypertension and varices in chronic liver disease.

Akero Therapeutics Reports Encouraging 36-Week Analysis of 96-Week Phase 2b SYMMETRY Study, with a Trend on Fibrosis Improvement and Statistically Significant Results for NASH Resolution, Markers of Liver Injury and Fibrosis, Insulin Sensitization and Lip

Retrieved on: 
Tuesday, October 10, 2023
Lipoprotein, Liver injury, Health, Cirrhosis, Decompensation, Liver, Week, DSM-IV codes, Safety, NASH, Therapy, Fatty liver disease, F1, Collagen, Patient, Fibrosis, Terminal, EFX, Copper, Pharmaceutical industry, Medical imaging, Åkerö

SOUTH SAN FRANCISCO, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today reported a 36-week analysis of SYMMETRY, a 96-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH).

Key Points: 
  • In addition, 4% of patients in each of the EFX-treated groups experienced a three- or two-stage fibrosis improvement without worsening of NASH – from compensated cirrhosis (F4) to F1 or F2, compared with 0% for placebo.
  • Statistically significant improvements were also observed for both EFX groups in non-invasive markers of liver injury and fibrosis, insulin sensitization and lipoproteins.
  • I’m encouraged that statistically significant improvements on multiple measures of NASH pathogenesis were observed in EFX-treated patients.
  • This underlines the high unmet medical need to at least arrest progression or preferably reverse cirrhosis due to NASH.

Can-Fite Reports First Quarter 2023 Financial Results & Provides Clinical Update

Retrieved on: 
Thursday, June 1, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Acumen, Survival rate, Travel, Hepatocellular carcinoma, Pancreatic cancer, Liver cancer, Safety, Survival, American Society of Clinical Oncology, Rabin Medical Center, Journal, Hepatorenal syndrome, Patent, Patient, Liver failure, NYSE, HCC, A3, Disease, Therapy, NASH, Institutional review board, Food, EMA, Pancreas, Ascites, Liver, Cancer, Cirrhosis, FDA, Soroka Medical Center, Hepatic encephalopathy, Liver transplantation, Psoriasis, Fibrosis, Jaundice, CANF, Kidwai Memorial Institute of Oncology, TASE, Decompensation, American Journal of Clinical Oncology, Hepatology, Progression-free survival, Microsoft Access, WNT, ASCO, Green Light, Pivotal, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Pharmaceutical industry, Medical imaging, Cryptocurrency

(NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.

Key Points: 
  • (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.
  • Safety and efficacy endpoints including objective response, progression-free survival, duration of response, disease control, and overall survival will be monitored.
  • The mechanism of action entails de-regulation of the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.
  • The Company's consolidated financial results for the three months ended March 31, 2023 are presented in accordance with US GAAP Reporting Standards.

Bausch + Lomb Announces U.S. Launch of StableVisc™ Cohesive Ophthalmic Viscosurgical Device and TotalVisc™ Viscoelastic System

Retrieved on: 
Monday, April 24, 2023
Science, Biotechnology, Research, Pharmaceutical, Optical, Surgery, Health, Medical Devices, Inflammation, Infection, Tissue, TASS, Allergy, IOP, Cornea, Sodium, Surgeon, Use, Cataract, Eye, Clinical trial, Particulates, OVD, Decompensation, Sale, Direction, Aqueous humour, Intraocular pressure, Bausch & Lomb, Hurtigruten AS, Patient, Phacoemulsification, Freezing, Risk, Cannula, Radical (chemistry), Sorbitol, Paratriathlon, Regulation of tobacco by the U.S. Food and Drug Administration, IOL, NYSE, Posterior cerebral artery, Food, Veterinary medicine, Dentistry, Medical device, Birth control, Pharmaceutical industry, Dry cleaning

Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced the U.S. launch of StableVisc™ cohesive ophthalmic viscosurgical device (OVD) as well as TotalVisc™ Viscoelastic System.

Key Points: 
  • Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced the U.S. launch of StableVisc™ cohesive ophthalmic viscosurgical device (OVD) as well as TotalVisc™ Viscoelastic System.
  • TotalVisc Viscoelastic System includes both StableVisc and ClearVisc™, a dispersive OVD, and protects ocular tissue during the surgical procedure.
  • TotalVisc is the only dual pack in the United States that includes a dispersive and cohesive OVD formulated with sorbitol.
  • Federal (USA) law restricts this device to the sale by or on the order of a physician.

FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management

Retrieved on: 
Wednesday, March 22, 2023
Contraindication, Elastography, Pregnancy, Use, Liver disease, Decompensation, HIV disease progression rates, Patient, Physician, Risk, Liver, Diagnosis, FDA, Cirrhosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Biopsy, Dietary supplement, Medical imaging

PARIS and WALTHAM, Mass., March 22, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan®, the non-invasive liver management technology by Echosens.

Key Points: 
  • PARIS and WALTHAM, Mass., March 22, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan® , the non-invasive liver management technology by Echosens .
  • "These updated Indications of Use are another proof point for screening with FibroScan to become commonplace in the clinical care pathway," said Jon Gingrich, CEO of Echosens.
  • The update furthers FibroScan® accessibility to more people, enabling physicians to identify those at risk of suffering adverse liver outcomes and connecting them with preventative care and treatment options.
  • Designates FibroScan as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease as part of an overall assessment of the liver.

Can-Fite to Treat Decompensated Liver Cirrhosis Patients with Namodenoson Under Compassionate Use Setting

Retrieved on: 
Monday, March 13, 2023
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Disease, Liver transplantation, NASH, Hepatic encephalopathy, NYSE, Child, American Liver Foundation, Cirrhosis, TASE, Decompensation, Patient, CANF, Liver cancer, Ascites, Soroka Medical Center, Hepatorenal syndrome, Head, Liver, Jaundice, Liver failure, Cancer, Compassion, Pharmaceutical industry, Nursing, MD

Decompensated cirrhosis is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage.

Key Points: 
  • Decompensated cirrhosis is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage.
  • An estimated 10.6 million people globally had decompensated cirrhosis in 2017, with few treatment options available aside from liver transplants if the decompensated cirrhosis has reached an advanced stage.
  • Namodenoson’s unique characteristics of inducing hepato-protective effects make it suitable to treat patients with decompensated cirrhosis.
  • In a Phase II study, Namodenoson was found to increase overall survival in advanced liver cancer patients defined as Child Pugh B7, known to suffer from cirrhosis.

New AASLD Practice Guidance Calls for the Use of Noninvasive Liver Evaluations for Earlier Detection of NAFLD and NASH

Retrieved on: 
Monday, February 13, 2023
NASH, Cirrhosis, NAFLD, Elastography, Diagnosis, Type 2 diabetes, Patient, HIV disease progression rates, American Association for the Study of Liver Diseases, Hepatology, Gastroenterology, Mortality, Risk, Biopsy, Chronic liver disease, Fatty liver disease, Disease, Prevalence, AASLD, Decompensation, T2D, American Association of Clinical Endocrinologists, MD, Dietary supplement, Medical imaging

PARIS and WALTHAM, Mass., Feb. 13, 2023 /PRNewswire/ -- The growing prevalence of fatty liver disease in the U.S. has led the American Association for the Study of Liver Diseases (AASLD) to call for expanded use of noninvasive liver evaluations. The new Practice Guidance from the AASLD suggests the use of VCTE™, a patented technology used by FibroScan® solutions from Echosens, for detecting and diagnosing NAFLD in high-risk individuals, including those with type 2 diabetes (T2D).

Key Points: 
  • At least 25% of people worldwide have nonalcoholic fatty liver disease (NAFLD), and this number is expected to rise1.
  • Early identification and risk stratification of patients can help improve outcomes and significantly reduce downstream healthcare costs.
  • An estimated 70% of people with T2D are affected by NAFLD, but only 5% of this population is currently diagnosed2.
  • "Any practitioner caring for patients at risk for NAFLD should heed the guidance for noninvasive risk stratification with FibroScan (VCTE technology).

AI Metrics Research Received "Best of AJR" Award by the American Journal of Roentgenology

Retrieved on: 
Monday, December 19, 2022
American Journal of Roentgenology, Metric, Fasting, Patient, Chronic liver disease, MRI, Decompensation, AJR, Mayo Clinic, Duke University, Radiology, University, Cirrhosis, Cleveland Clinic, University of Wisconsin–Madison, CT, Hepatitis C, UC, LSN, University of California, San Diego, Oncology, Gastrointestinal tract, American Journal, Software, Research, UAB, Hospital, Biomarker, Medical imaging

BIRMINGHAM, Ala., Dec. 19, 2022 /PRNewswire-PRWeb/ -- AI Metrics, an early stage radiology software company, announced that the company's recently published research in the American Journal of Roentgenology (AJR) has been awarded the Best of AJR in the Gastrointestinal Imaging section for 2022.

Key Points: 
  • BIRMINGHAM, Ala., Dec. 19, 2022 /PRNewswire-PRWeb/ -- AI Metrics, an early stage radiology software company, announced that the company's recently published research in the American Journal of Roentgenology (AJR) has been awarded the Best of AJR in the Gastrointestinal Imaging section for 2022.
  • AI Metrics commercialized Dr. Smith's research by developing a software module that enables patient evaluation from standard CT scans.
  • "LSN dramatically reduces the equipment costs for hospitals," said Bob Jacobus, CEO, AI Metrics.
  • The company holds 20 U.S. and international patents, and its technology is currently in use at 10 healthcare institutions globally.

physIQ’s eVO2Max™ demonstrates breakout ability to estimate cardiopulmonary functional capacity from wearable sensor data during daily routine activity

Retrieved on: 
Wednesday, December 14, 2022
Data Management, Consumer Electronics, Technology, Professional Services, Medical Devices, Infectious Diseases, Hospitals, Fitness & Nutrition, Clinical Trials, Wearables, Mobile Technology, Cardiology, Biotechnology, Data Analytics, Health, Mobile, Wireless, Vital signs, Decompensation, Nike Air Max, Exercise, Biomarker, Patient, Quality of life, Multimedia, Digital health, Artificial intelligence, Safety, American Heart, Artificiality, Health, CPET, Medical imaging

This innovative biomarker, eVO2Max, can be generated using 24 hours of continuous vital signs and activity data captured during routine daily activities.

Key Points: 
  • This innovative biomarker, eVO2Max, can be generated using 24 hours of continuous vital signs and activity data captured during routine daily activities.
  • physIQ developed eVO2Max to meet the need for accurate and objective functional testing in a rising geriatric population amidst increasingly prevalent cardiopulmonary diseases.
  • The patient simply wears a small biosensor for several days and physIQ uses the wirelessly transmitted data to derive a daily VO2Max estimate for clinician remote monitoring.
  • It uses proprietary deep neural network architecture with millions of hours of data from the companys proprietary data trove to recognize the key features that capture cardiopulmonary performance during routine daily activities.