NYHA

Repairon Announces Completion of Dose-Finding Part of BioVAT-HF Phase 1/2 Trial in Advanced Heart Failure

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Martedì, Aprile 4, 2023
Heart, NYHA, EHM, Clinic, Heart failure, German Center for Pediatric and Adolescent Rheumatology, University Medical Center, University Medical Center Freiburg, Clinical trial, Philippine Heart Center, Toxicology, Research, Facial muscles, Trial of the century, Patient, UMG, Observation, Entrepreneurship, Principal, B cell, Berlin, Safety, Pharmaceutical industry, Medical device, Pharmacology

The clinical trial is evaluating the safety and efficacy of iPSC1 -derived engineered human myocardium (EHM) as Biological Ventricular Assist Tissue (BioVAT) in Advanced Heart Failure (NCT04396899).

Key Points: 
  • The clinical trial is evaluating the safety and efficacy of iPSC1 -derived engineered human myocardium (EHM) as Biological Ventricular Assist Tissue (BioVAT) in Advanced Heart Failure (NCT04396899).
  • Strongly encouraged by the emerging data from the BioVAT-HF study, Repairon will continue the commercial development of the EHM technology with the aim to establish it as the therapeutic option of choice for patients with advanced heart failure."
  • "Advanced heart failure treatment requires new reparative therapies; with BioVAT-HF remuscularization of the failing heart is becoming a clinical possibility," said Professor Stefan Anker Charité Berlin.
  • The open-label, non-randomized, multi-center trial is investigating the hypothesis that cardiomyocyte implantation as BioVAT results in sustainable remuscularization and biological enhancement of myocardial performance in patients with advanced heart failure.

Affluent Medical : 2022 full year results and update on clinical activities under development.

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Venerdì, Marzo 31, 2023
NYHA, Hospital, Marketing, EACTS, Anatomy, LVEF, Clinical trial, Pathology, Dispersive flies optimisation, Trial of the century, TAVI, Congress, MRI, Mitral regurgitation, Patient, Mitral valve, DPS, Regulatory News Service, ISIN, Tricuspid valve, Health, Death, Aix-en-Provence, III, Medtech, Disease, Safety, Urinary incontinence, Pharmaceutical industry, Medical device, Nursing

Affluent Medical : 2022 full year results and update on clinical activities under development.

Key Points: 
  • Affluent Medical : 2022 full year results and update on clinical activities under development.
  • Excellent interim results from the Optimise II pivotal study for the KaliosTM mitral ring and increase in the number of clinical centers.
  • New sources of financing to support the advancement of the three clinical studies and the next development steps.
  • On March 9, 2023, Affluent Medical announced the first successful clinical implantation of its Epygon transcatheter mitral heart valve in a patient in Italy.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Business Update

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Mercoledì, Marzo 22, 2023
Hypersensitivity, Furosemide, Oaktree Capital Management, NYHA, Congestion, Embolism, Hypoproteinemia, Organic acid, Heart failure, AT, Urine, Marketing, Creatinine, Cirrhosis, Dehydration, Tinnitus, Heart, Glucose, Huber loss, Deafness, Edema, Hepatic encephalopathy, Medicare Part D, Research, Oliguria, History, Diuresis, Uric acid, Medicare, New York Heart Association Functional Classification, Kidney, Bruise, Ototoxicity, Erythema, Patient, Investment, Urinary retention, Azotemia, Ascites, Coma, Blood volume, Benign prostatic hyperplasia, Therapy, Thrombosis, Cerebral edema, BUN, CO2, Conference, Anuria, Pharmaceutical industry, Cryptocurrency, Security (finance), Video game, Finance, BURLINGTON

BURLINGTON, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2022 and provided a business update. 

Key Points: 
  • Entered into $100 million secured debt financing agreement with funds managed by Oaktree Capital Management in October 2022.
  • scPharmaceuticals ended the fourth quarter 2022 with $118.4 million in cash, cash equivalents, restricted cash and investments, compared to $75.5 million as of December 31, 2021.
    scPharmaceuticals reported a net loss of $9.2 million for the fourth quarter of 2022, compared to $7.3 million for the fourth quarter of 2021.
  • Research and development expenses were $2.3 million for the fourth quarter of 2022, compared to $4.5 million for the fourth quarter of 2021.
  • General and administrative expenses were $7.2 million for the fourth quarter of 2022, compared to $2.2 million for the fourth quarter of 2021.

Two-Year Study Data for EVBA Procedure with Unique MobiusHD Device Presented at Technology and Heart Failure Therapeutics Meeting

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Mercoledì, Marzo 22, 2023
Health, Clinical Trials, Cardiology, Medical Devices, Exercise, Learning, NYHA, Heart failure, Carotid sinus, LVEF, Heart, Quality of life, Vanderbilt University Medical Center, City centre, VDI, KCCQ, Heart Failure Society of America, MD, N-terminal prohormone of brain natriuretic peptide, Patient, Autonomic nervous system, THT, Medical device, Medical imaging

Vascular Dynamics, Inc. (VDI) , a privately held medical device company focused on developing game-changing endovascular device-based solutions for patients suffering from heart failure, announced that two-year results from a study assessing its MobiusHD device to treat patients with chronic heart failure were presented today at the Technology and Heart Failure Therapeutics ( THT ) 2023 meeting in Boston.

Key Points: 
  • Vascular Dynamics, Inc. (VDI) , a privately held medical device company focused on developing game-changing endovascular device-based solutions for patients suffering from heart failure, announced that two-year results from a study assessing its MobiusHD device to treat patients with chronic heart failure were presented today at the Technology and Heart Failure Therapeutics ( THT ) 2023 meeting in Boston.
  • The data , presented by JoAnn Lindenfeld, MD, a heart failure specialist at Vanderbilt University Medical Center and Past President of the Heart Failure Society of America, focused on the efficacy of the MobiusHD device implantation in progressive heart failure patients who were previously highly symptomatic despite guideline-directed medical therapy.
  • These results provide evidence suggesting a clinically meaningful and durable benefit of endovascular baroreflex amplification (EVBA) in specific heart failure patients.
  • In this way, the MobiusHD offers a potential device-based solution for symptomatic heart failure patients who are not responding to drug treatment.

Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients

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Mercoledì, Marzo 22, 2023
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Ancora Heart, Inc ., a company developing a completely transcatheter device-based therapy to address heart failure (HF), today announced that patients treated with the investigational AccuCinch® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart.

Key Points: 
  • Ancora Heart, Inc ., a company developing a completely transcatheter device-based therapy to address heart failure (HF), today announced that patients treated with the investigational AccuCinch® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart.
  • The 12-month data were presented as part of a late-breaking clinical science session at the Technology and Heart Failure Therapeutics conference (THT 2023) and simultaneously published in the Journal of Cardiac Failure .
  • “This analysis shows patients treated with the AccuCinch System experienced meaningful improvement in efficacy measures important to both clinicians and patients,” said Dr. Hamid.
  • “We witnessed significant and progressive reverse remodeling of the left ventricle, as well as significant and sustained improvement in quality of life and functional capacity measures.

Positive Echocardiography Data from BioCardia Phase III CardiAMP Cell Therapy Heart Failure Trial Presented at American College of Cardiology Annual Meeting

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Lunedì, Marzo 6, 2023
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SUNNYVALE, Calif., March 06, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces that detailed echocardiography data from the roll-in cohort of the Phase III CardiAMP® Cell Therapy Heart Failure Trial is being presented today at the American College of Cardiology annual meeting by Peter Johnston, M.D., Assistant Professor of Medicine and Site Principal Investigator at Johns Hopkins University. The echocardiography results from baseline through one and two years showed a more than doubling in the number of heart segments functioning normally and restoration of function to 30 percent of previously non-functioning segments. This data expands upon data previously presented at the Heart Failure Society of America annual meeting last fall.

Key Points: 
  • This data expands upon data previously presented at the Heart Failure Society of America annual meeting last fall.
  • In completely non-functioning heart segments, 17 of 56, or 30 percent, of those heart segments resumed wall motion by two years.
  • In the previously presented data, patient demographics at study start demonstrated characteristics typical of the target population of NYHA class II and III ischemic heart failure patients with reduced ejection fraction.
  • “These early results lend further support to the potential efficacy of the autologous CardiAMP cell therapy and to our mission of restoring heart health,” said BioCardia CEO Peter Altman, PhD.

Cytokinetics Presents Positive Results From Cohort 4 of REDWOOD-HCM and Long-Term Results From FOREST-HCM at the American College of Cardiology 72nd Annual Scientific Session

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Sabato, Marzo 4, 2023
Research, Heart failure, Oxford Handbook of Clinical Medicine, Conference, Cytokinetics, Oregon Health and Science University Center for Women's Health, LVEF, American College, SAN, Disease, NYHA, Conference call, Cohort, Host, Research and development, Cardiology, Clinical study design, LVOT, New York Heart Association Functional Classification, Medical device, Pharmaceutical industry, Patient, HCM

SOUTH SAN FRANCISCO, Calif., March 04, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that positive results from Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), a Phase 2 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM), were presented at the American College of Cardiology 72nd Annual Scientific Session (ACC.23). Additionally, 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) were also presented at the meeting.

Key Points: 
  • Additionally, 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) were also presented at the meeting.
  • At 10 weeks, patients in Cohort 4 experienced significant improvements in NT-proBNP, with an average decrease of 66% (p
  • The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics ACC.23 Conference Call .
  • An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.

DREAM-HF Phase 3 Trial Results for Mesoblast Cell Therapy in Heart Failure Published in Journal of the American College of Cardiology (JACC)

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Lunedì, Febbraio 27, 2023
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NEW YORK, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced publication of the DREAM-HF Phase 3 trial results in the premier peer-reviewed journal for cardiovascular medicine, the Journal of the American College of Cardiology (JACC).

Key Points: 
  • NEW YORK, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced publication of the DREAM-HF Phase 3 trial results in the premier peer-reviewed journal for cardiovascular medicine, the Journal of the American College of Cardiology (JACC).
  • Locally, in the heart, the MPCs can protect cardiac muscle cells from dying and can improve blood flow and energetics.
  • In large blood vessels throughout the body, the reduced inflammation resulting from the activation of MPCs may decrease plaque instability, which is what leads to heart attacks and strokes.
  • “The results of DREAM-HF suggest those patients with heart failure with preserved ejection fraction (HFpEF) and other cardiomyopathies could potentially benefit from MPC therapy as well.

scPharmaceuticals Announces Launch and Commercial Availability of FUROSCIX® (furosemide injection)

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Martedì, Febbraio 21, 2023
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FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.

Key Points: 
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • “We are thrilled to announce the commercial availability of FUROSCIX for patients suffering from worsening heart failure due to congestion,” stated John Tucker, Chief Executive Officer of scPharmaceuticals.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

New Data Links Modulation of Key Immune-Related Proteins to Improvement of Specific Symptoms in Long COVID

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Giovedì, Febbraio 16, 2023
COVID-19, Research, Infectious Diseases, Biotechnology, Other Health, Health, General Health, Other Science, Science, Biomarker, PASC, Fatigue, NYHA, Trial of the century, Randomized controlled trial, Frontiers in Medicine, Diagnosis, Patient, MRC, Timeline of the COVID-19 pandemic in the United Kingdom, FSS, Medical Research Council (United Kingdom), New York Heart Association Functional Classification, Georgetown University School of Nursing, Medical Research Council, COMPASS, CDC, Survivor, Modified Rankin Scale, DSM-IV codes, Chronic, ME/CFS, Pravastatin, Clinical descriptions of chronic fatigue syndrome, Community, Alternative medicine, Classification, Pharmaceutical industry, Medical imaging, Maraviroc, COVID, Medicine

Data from a new clinical study show modulation of key immune regulating proteins with maraviroc and pravastatin correlates with symptom reduction in patients with post-acute sequelae of COVID (PASC), commonly known as long COVID.

Key Points: 
  • Data from a new clinical study show modulation of key immune regulating proteins with maraviroc and pravastatin correlates with symptom reduction in patients with post-acute sequelae of COVID (PASC), commonly known as long COVID.
  • The study results, published in Frontiers in Medicine, also support a precision medicine approach to diagnosis of long COVID as well as differentiation of long COVID from ME-CFS (myalgic encephalomyelitis/chronic fatigue syndrome), which presents with similar symptoms.
  • Subjective neurological, autonomic, respiratory, cardiac and fatigue symptoms scores all decreased by statistically significant margins.
  • In particular, the FSS (fatigue being the most common symptom) decreased and was closely correlated in decreases of IL-2 and TNF-α.