Cardiac output

EchoNous Announces Revolutionary AI Enhancements in Upcoming Kosmos Release for Apple iOS

Retrieved on: 
Friday, April 5, 2024
Cardiac output, SHM, ACP, POCUS, AIUM, Abdomen, IOS, TDI, Torso, Doppler effect, Workflow, Heart, Cosmos, ACC, IPhone, Medical imaging

REDMOND, Wash., April 05, 2024 (GLOBE NEWSWIRE) -- EchoNous, a leading innovator in ultrasound technology, is thrilled to announce the upcoming Kosmos 2.2 release on Apple iOS, a monumental update enriched with powerful new automated enhancements and significant workflow improvements, setting a new standard in point-of-care (POCUS) imaging.

Key Points: 
  • REDMOND, Wash., April 05, 2024 (GLOBE NEWSWIRE) -- EchoNous, a leading innovator in ultrasound technology, is thrilled to announce the upcoming Kosmos 2.2 release on Apple iOS, a monumental update enriched with powerful new automated enhancements and significant workflow improvements, setting a new standard in point-of-care (POCUS) imaging.
  • This feature is especially beneficial for new users, ensuring that they operate under the preset that will give them optimal image clarity.
  • These AI-driven features exemplify EchoNous’ commitment to enhancing user control while streamlining procedures, allowing for uninterrupted scanning and optimal imaging results.
  • EchoNous is excited to showcase these groundbreaking features at ACC and forthcoming shows such as AIUM, ACP, SHM, and ASE in the weeks ahead.

Pharmazz Inc. and Dr. Reddy's Laboratories have entered into a licensing agreement to market Centhaquine (Lyfaquin) as a resuscitative agent for hypovolemic shock in India

Retrieved on: 
Friday, March 22, 2024
Cardiac output, U.S. FDA, Internal bleeding, Partnership, System, Patient, Research, Trauma, Diarrhea, Hypovolemic shock, Mortality, Gastrointestinal bleeding, Manuscript, Laboratory, Blood volume, Standard of care, DRUGS, Clinical trial, Resuscitation, Safety, DCGI, Phase, Vomiting, Blood, FDA, Food, Shock (mechanics), Emerging market, Generic drug

Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).

Key Points: 
  • Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).
  • As per the agreement, Dr. Reddy's has received exclusive rights to market and distribute Centhaquine in India.
  • For patients with hypovolemic shock, I believe Dr. Reddy's is the best partner for Pharmazz to market Centhaquine, an innovative, first-in-class novel resuscitative agent, in India."
  • U.S. FDA clearance of our Phase III IND is an important milestone for Pharmazz and the potential future treatment of hypovolemic shock patients.

Orchestra BioMed Announces Presentation of Results from Clinical Study Demonstrating Favorable Hemodynamic Effects of AVIM Therapy In Hypertensive Pacemaker Patients

Retrieved on: 
Wednesday, March 6, 2024
Blood pressure, PV, HOPE, Beat (music), Overalls, Cardiac output, Stroke, Safety, Hypertension, Aorta, Patient, Hemodynamics, RV, DDD, Heart failure, Medical device

These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.

Key Points: 
  • These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.
  • The PV loop study was conducted at Na Homolce Hospital in Prague by Prof. Petr Neužil, M.D.
  • AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure.
  • “Well-conducted invasive PV loop studies are a robust way to evaluate the impact of a novel therapy like AVIM on hemodymanics and overall cardiac function.

Morphic Announces Corporate Highlights and Financial Results for the Full Year 2023

Retrieved on: 
Thursday, February 22, 2024
Ulcerative colitis, BID, Research, Biotechnology, Friends, ATM, Cardiac output, AbbVie, Conditional sentence, DDW, Inflammatory bowel disease, Patient, TL1A, Clinical trial, Janssen, IBD, PIPE, Insurance, Pharmaceutical industry

WALTHAM, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and financial results for the full year 2023.

Key Points: 
  • -Ended 2023 with $704.3 million in cash and equivalents; cash runway into second half of 2027-
    WALTHAM, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and financial results for the full year 2023.
  • “Today, our conviction in MORF-057 as a potential oral, well tolerated, and efficacious treatment for inflammatory bowel disease (IBD) is stronger than ever, based on the clear success of the EMERALD-1 trial in UC.
  • Looking forward in 2024, we will work to translate this momentum into further progress with the GARNET phase 2 study in patients with moderately to severely active Crohn’s disease running in parallel with the EMERALD-2 phase 2b study in UC,” commented Praveen Tipirneni, Chief Executive Officer of Morphic.
  • We believe that our cash, cash equivalents and marketable securities of $704.3 million as of December 31, 2023, will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2027

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024
Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

Windtree Renews Agreement with Chang Gung University for Scientific Collaboration to Further SERCA2a Research

Retrieved on: 
Thursday, February 1, 2024
Partnership, Catecholamine, Mortality, Oxygen, Cardiomyopathy, Research, Heart, Cardiovascular disease, Patient, Prevalence, Windtree Therapeutics, Cardiogenic shock, Sarcoplasmic reticulum, Arrhythmia, Cardiac output, Blood, Brain, Therapy, Kidney, Heart failure, Risk, Cytoplasm, Chang Gung University, Pharmaceutical industry

The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.

Key Points: 
  • The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.
  • SERCA2a activity is decreased in heart failure and disordered calcium handling can play a role in cardiac arrythmias.
  • Windtree believes activation of SERCA2a could represent an important advancement in heart failure treatment for patients.
  • Outside of this scientific collaboration, istaroxime is being studied in the Phase 2 SEISMiC Extension Study in early cardiogenic shock.

Sensydia Completes Fifth Study for Heart-Sound AI

Retrieved on: 
Tuesday, January 16, 2024
Cardiology, University, Biotechnology, Education, Technology, Health, Medical Devices, Research, Artificial Intelligence, Science, Clinical Trials, Knowledge, Artificial intelligence, Patient, Associate, MD, Life, Multimedia, Cardiac output, Heart failure, Echocardiography, Algorithm, Principal investigator, University of Minnesota, NIH, FDA, UMN, CPS, Ronald Reagan, Diagnosis, Pulmonary hypertension, Medical device

Non-invasive cardiac assessment company Sensydia announced today that it has completed its 50-subject development study at the University of Minnesota (UMN).

Key Points: 
  • Non-invasive cardiac assessment company Sensydia announced today that it has completed its 50-subject development study at the University of Minnesota (UMN).
  • In January 2022, Sensydia announced that CPS was granted Breakthrough Device Designation by the United States Food and Drug Administration (FDA).
  • Sensydia plans to use data from this 50-subject study to develop the CPS pulmonary pressure algorithms.
  • The achievement of this 50-subject milestone comes at a time when Sensydia is actively executing Phase I of its new NIH award.

Windtree Therapeutics Announces Reduction In Arrythmias In A New Study With Istaroxime And A Pure SERCA2a Activator

Retrieved on: 
Tuesday, January 2, 2024
Patient, Survivor, Risk, Cardiogenic shock, ATPase, Acute decompensated heart failure, Catecholamine, Istaroxime, Mortality, Disease, Diabetes, Windtree Therapeutics, Blood, Incidence, Cardiomyopathy, Therapy, Clinical trial, Heart, Rat, Heart failure, Medicare, Cardiac output, Arrhythmia, Pharmaceutical industry

WARRINGTON, Pa., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced new preclinical data on the Company’s lead product candidate, istaroxime, and another preclinical pipeline drug candidate, CVie-216, showing reductions in ventricular arrythmias in a rat heart model of diabetes with restricted and restored coronary blood flow induced injury. Istaroxime and CVie-216 are each designed to act on pumps in the cardiac cells that are important in calcium handling. Istaroxime is a dual mechanism of action compound that has been shown to inhibit the sodium potassium ATPase and activates SERCA2a. CVie-216 is designed to selectively activate SERCA2a.

Key Points: 
  • Istaroxime is a dual mechanism of action compound that has been shown to inhibit the sodium potassium ATPase and activates SERCA2a.
  • Nearly 300 patients with acute decompensated heart failure were treated with istaroxime in three Phase 2 studies, including a study that evaluated patients with early cardiogenic shock.
  • Windtree is continuing to obtain data to evaluate the potential benefits of SERCA2a activation on arrythmia risk in all ongoing clinical trials.
  • This study demonstrated a reduction in arrythmias in the istaroxime and CVie-216 pretreated groups compared to the control group.

Nantworks AirStrip® and GE HealthCare Announce Agreement to Commercialize Integrated Patient Monitoring and Cardiac Data Visualization for Healthcare Systems

Retrieved on: 
Monday, December 4, 2023
Software, Managed Care, Professional Services, Telemedicine, Virtual Medicine, Apps, Applications, Technology, Hospitals, Artificial Intelligence, Health Technology, Data Analytics, Cardiology, Health, ECG, Pressure, STEMI, NantWorks, Patient, Multimedia, Creative, Communication, Environment, Health care, Aerodrome, AI, Cardiac output, Data, Vital signs, GE HealthCare, Wireless ambulatory ECG, Pharmaceutical industry, Medical imaging

GE HealthCare is now the exclusive distributor of AirStrip Cardiology and Patient Monitoring solutions in the U.S., offering data visualization technology that healthcare systems can purchase together.

Key Points: 
  • GE HealthCare is now the exclusive distributor of AirStrip Cardiology and Patient Monitoring solutions in the U.S., offering data visualization technology that healthcare systems can purchase together.
  • The combination of GE HealthCare and AirStrip provides a tightly integrated toolset under one solution set.
  • It brings together the wide range of GE HealthCare’s innovative and accurate ECG, cardiac output, and patient monitoring products with AirStrip’s advanced data visualization and monitoring capabilities - all available to clinical care teams on mobile devices and the web.
  • “We are proud to be the exclusive distributor of AirStrip’s innovative cardiac and monitoring technology,” said Catherine Estrampes, President and CEO, U.S. and Canada, GE HealthCare.

US FDA Grants the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study

Retrieved on: 
Wednesday, November 29, 2023
Cardiology, Biotechnology, FDA, Other Health, Health, General Health, Medical Devices, Research, Surgery, Science, Clinical Trials, Woman, Safety, Device, EFS, Exercise, Database, Patient, Male, The Texas Heart Institute, Heart, TAH, Heart failure, MD, Cardiac output, Dentistry, Medical device

The EFS will evaluate the safety and feasibility of BTAH as a bridge to a heart transplant in the treatment of subjects with biventricular heart failure.

Key Points: 
  • The EFS will evaluate the safety and feasibility of BTAH as a bridge to a heart transplant in the treatment of subjects with biventricular heart failure.
  • The study is anticipated to commence in 2024 and will pave the way for a subsequent pivotal study.
  • “I am eager to begin the BiVACOR Total Artificial Heart EFS to evaluate what I believe is a promising and potentially life-saving technology,” said Joseph Rogers, MD, National P.I.
  • “The FDA approval to begin The BiVACOR Total Artificial Heart EFS is a critical milestone for BiVACOR and is another validation of the remarkable work and accomplishments of the entire BiVACOR team.