Acute decompensated heart failure

Revamp Medical Announces Appointment of Mike Favet as CEO

Retrieved on: 
Thursday, March 21, 2024
Mechanical, Champaign–Urbana metropolitan area, Acute decompensated heart failure, Boston Scientific, Business administration, Patient, Revamp, University, Medtech, THT, FDA, Pharmaceutical industry

NETANYA, Israel, March 21, 2024 /PRNewswire/ -- Revamp Medical , Inc., a privately held clinical-stage medical technology company committed to developing solutions for Heart Failure congestion management, today announced the appointment of Mike Favet as Chief Executive Officer and member of the Board of Directors.

Key Points: 
  • NETANYA, Israel, March 21, 2024 /PRNewswire/ -- Revamp Medical , Inc., a privately held clinical-stage medical technology company committed to developing solutions for Heart Failure congestion management, today announced the appointment of Mike Favet as Chief Executive Officer and member of the Board of Directors.
  • "Mike brings a distinguished track record of successful leadership in medtech and is ideally suited to build Revamp Medical from the solid foundation being demonstrated in the U.S.
  • Early Feasibility Study through the pivotal trial to support FDA approval" said Mike Berman, a Board Director of Revamp Medical.
  • "I am thrilled for the opportunity to join Revamp Medical at this significant juncture," said Mr. Favet.

Late-Breaking Data Highlighting Benefits of Ultrafiltration Therapy Using the Aquadex System for Heart Failure Patients was Presented at the Technology and Heart Failure Therapeutics Conference

Retrieved on: 
Thursday, March 7, 2024
Diuretic, Ultrafiltration, Hospital, Section, Artificial intelligence, Randomized controlled trial, Mount Sinai Health System, Quality of life, Acute decompensated heart failure, Hierarchy, Aquapheresis, Valvular heart disease, Risk, Heart failure, Arrhythmia, AUF, ALD, History, Yale School of Medicine, Patient, HF, Machine learning, Cerebrovascular disease, THT, Mortality, Roflumilast, Pharmaceutical industry

MINNEAPOLIS, March 07, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, announced results from two new clinical data analyses from the AVOID-HF trial, which demonstrate the benefits of its Aquadex System in reducing heart failure readmissions at 30 days. Results from the analyses were presented in a late-breaking session at the Technology and Heart Failure Therapeutics (THT) conference in Boston.

Key Points: 
  • Results from the analyses were presented in a late-breaking session at the Technology and Heart Failure Therapeutics (THT) conference in Boston.
  • Key findings demonstrating the benefits of AUF include:
    Fewer heart failure events and heart failure hospitalizations: AUF patients had significantly fewer heart failure events within 30 days compared to ALD (90% vs 77.3% p=0.0138) and fewer heart failure hospitalizations for the AUF patients compared to the ALD patients (90.0% vs. 79.2% p=0.0321) within 30 days.
  • Key findings from the analysis include:
    Top predictors for 90-day heart failure events: Using ML, the study identified the top 10 predictors for 90-day heart failure events.
  • Strong results for super-responders: 90% of patients categorized as super-responders to AUF therapy within this model did not experience any 90-day heart failure events.

WhiteSwell Announces Six-month Outcomes After eLym System Treatment for Acute Decompensated Heart Failure Patients in its DELTA-HF Study

Retrieved on: 
Wednesday, March 6, 2024
Medical Devices, Health, Surgery, Clinical Trials, Cardiology, Biotechnology, Peripheral edema, Thoracic duct, Acute decompensated heart failure, Ohio State University, Physiology, Drainage, Congestion, Heart failure, ADHF, Cell biology, Death, Patient, Lymphatic system, Medicine, THT, Tissue, Pharmaceutical industry

WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive six-month follow-up data on the initial nine patients treated in its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System.

Key Points: 
  • WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive six-month follow-up data on the initial nine patients treated in its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System.
  • Nine hospitalized patients with ADHF received eLym therapy in conjunction with diuretic therapy and were followed for six months.
  • Reduced rehospitalizations: Comparing patients’ clinical course before and after eLym therapy, in the six months prior to eLym therapy there were 13 heart failure related hospitalizations, while in the six months after eLym therapy there were just two heart failure hospitalizations and one heart failure related death, for a 77% reduction.
  • The minimally invasive catheter system was successfully deployed and removed in all patients, with a mean treatment time of 24 hours.

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.

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.

China Medical System: 4 Products Have Been Newly Included or Continued to be Included in the NRDL

Retrieved on: 
Wednesday, December 13, 2023
Marketing, Shanghai Stock Exchange, Quality of life, Epilepsy, A&B, Peptide, Absorption, National Healthcare, Methotrexate, National Healthcare Security Administration, Insurance, Safety, Tetrabenazine, Heart failure, CMS, Protein, Light, Recombinant, Acute decompensated heart failure, Sun Pharma, Nasal mucosa, PASI, Tablet, Patient, Psoriasis, Chemokine, Diazepam, Huntington's disease, Sale, Social Security, Tildrakizumab, Social, Vitamin E

China Medical System actively responds to national policies to promote innovative products to be included in the NRDL.

Key Points: 
  • China Medical System actively responds to national policies to promote innovative products to be included in the NRDL.
  • In addition, innovative drug Methotrexate Injection (Metoject) indicated for psoriasis approved in March 2023 has been included in category A of the National Reimbursement Drug List.
  • It is the first nasal spray formulation of diazepam in China and the first drug approved in China for the treatment of seizure clusters.
  • CMS actively responds to national policies to promote innovative products to be included in the National Reimbursement Drug List.

New Randomized Controlled Trial Demonstrates the Efficacy of Daxor’s BVA Guided-Care in Heart Failure Patients

Retrieved on: 
Monday, November 13, 2023
ADHF, RCT, An Inaccurate Memoir, Acute decompensated heart failure, Pennsylvania Convention Center, Duke University, Plasma, American Heart Association, Anemia, Patient, Tree volume measurement, Heart failure, NIH, Diagnosis, Biomarker, BVA, Medical imaging, Boston

Oak Ridge, TN, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces the presentation of data from a Phase I National Institute of Health (NIH) sponsored randomized control trial (RCT) from two Veterans Affairs Medical Centers (Boston , Minneapolis), validating treatment decisions guided by the Company’s BVA-100® diagnostic blood test benefitted patients with acute decompensated heart failure (ADHF). Data were presented at the American Heart Association Scientific Sessions 2023 at the Pennsylvania Convention Center in Philadelphia, PA on November 11, 2023.

Key Points: 
  • Data were presented at the American Heart Association Scientific Sessions 2023 at the Pennsylvania Convention Center in Philadelphia, PA on November 11, 2023.
  • Data showed that on average 7 out of 10 ADHF patients are not being accurately diagnosed.
  • Clinical assessments of volume status and anemia were collected for all patients prior to BVA measurement at hospital admission and post-discharge.
  • Patients in the BVA-guided arm received treatment informed by the BVA test results, in the blinded arm volume was only assessed using clinical tools and biomarkers absent the BVA results.

Inflammatix Completes Technical Development for TriVerity™ Acute Infection and Sepsis Test System

Retrieved on: 
Wednesday, November 15, 2023
SHIELD, Sale, Robert Trivers, Food, AHRQ, Risk, CLIA, Database, Sepsis, Patient, Medicine, Agency, Viral, FDA, Infection, Acute decompensated heart failure, RNA, Diagnosis, Genetically modified bacteria, Messenger, HCUP, Immunotherapy, Vaccine, Pharmaceutical industry, Myrna

SUNNYVALE, Calif., Nov. 15, 2023 /PRNewswire/ -- Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the company has completed technical development for its TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument, and for the TriVerity™ Cartridge. TriVerity is intended to be used in emergency department settings in patients with suspected acute infection and sepsis to assess the likelihood of a bacterial infection, a viral infection, and risk of acute decompensation (the need for ICU-level care).    

Key Points: 
  • SUNNYVALE, Calif., Nov. 15, 2023 /PRNewswire/ -- Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the company has completed technical development for its TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument, and for the TriVerity™ Cartridge.
  • TriVerity is intended to be used in emergency department settings in patients with suspected acute infection and sepsis to assess the likelihood of a bacterial infection, a viral infection, and risk of acute decompensation (the need for ICU-level care).
  • The TriVerity Acute Infection and Sepsis Test, Inflammatix's lead product, incorporates a panel of 29 mRNAs to "read" the body's immune response and thus aid in the diagnosis of patients with suspected acute infection and sepsis.
  • The TriVerity Acute Infection and Sepsis Test System is a product in development, is not for sale, and does not have marketing approval or clearance from regulatory authorities in any jurisdiction.

Truveta announces availability of millions of echocardiogram reports to advance cardiovascular research

Retrieved on: 
Wednesday, November 8, 2023
ADHF, Peripheral artery disease, Moyamoya disease, MD, Organization, Transthoracic echocardiogram, Health, Journal, Pulmonary embolism, TLM, Risk, Pulmonary hypertension, Stenosis, Reprieve, Acute decompensated heart failure, EHR, Society, AI, Patient, Boston Scientific, PAD, Heart failure, Pharmaceutical industry

BELLEVUE, Wash., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Today Truveta announced the availability of more than 56.6 million clinical observations from more than 2.7 million echocardiogram reports from more than 1.7 million de-identified patients, making it the market leader in real-world data to advance cardiovascular research at scale.

Key Points: 
  • BELLEVUE, Wash., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Today Truveta announced the availability of more than 56.6 million clinical observations from more than 2.7 million echocardiogram reports from more than 1.7 million de-identified patients, making it the market leader in real-world data to advance cardiovascular research at scale.
  • New peer-reviewed research using Truveta Data was published recently in the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI) comparing two treatments for pulmonary embolism and identifying risk for adverse events like major bleeding.
  • Existing methods, such as relying on registry data or physician referrals, have limitations in scope and timeliness, hindering large-scale research.
  • The availability of these data has the potential to propel cardiovascular research forward in ways never before possible, opening new horizons of discovery and innovation to improve patient care and outcomes and save lives."

WhiteSwell Announces Successful Treatment of Acute Decompensated Heart Failure Patients in its Early Feasibility DELTA-HF Study

Retrieved on: 
Saturday, October 7, 2023
Health, Clinical Trials, Cardiology, Medical Devices, ADHF, Heart Failure Society of America, Lymphatic system, Acute decompensated heart failure, Feasibility, Risk, ICCU, Creatinine, Ohio State University Wexner Medical Center, Cell biology, Congestion, Ohio State University, Thoracic duct, Kidney, Heart failure, Safety, Patient, Tissue, Drainage, Pharmaceutical industry, Medical imaging, Physiology

WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive initial results from its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System.

Key Points: 
  • WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive initial results from its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System.
  • The data were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023 in Cleveland, Ohio.
  • Nine hospitalized patients received eLym therapy in conjunction with diuretic therapy, while six patients received standard of care treatment with loop diuretics alone.
  • “It cannot be overemphasized how significant and challenging it is to fully decongest patients hospitalized with decompensated heart failure.