N-terminal prohormone of brain natriuretic peptide

BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, November 8, 2023
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The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.

Key Points: 
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • During the third quarter of 2023, BioCardia worked with the DSMB to unblind a small committee within the Company to review the closed session DSMB report of interim study results to better understand the rationale behind their recommendation.
  • The Company expects to complete the roll-in cohort of patients in the fourth quarter of 2023 and begin the randomized phase of the trial.
  • Third Quarter 2023 Financial Results:
    Revenues were approximately $357,000 for the three months ended September 2023, compared to approximately $212,000 for the three months ended September 2022.

Attralus Announces Publication of Two Studies Evaluating Iodine (124I) Evuzamitide (AT-01) using PET/CT in the Journal of American College of Cardiology (JACC CV Imaging)

Retrieved on: 
Tuesday, November 7, 2023
MCF, Quality of life (healthcare), HIV disease progression rates, CMP, ID, Amyloid cardiomyopathy, Echocardiography, MRI, MPH, Health, Troponin, Cardiology, Cardiac amyloidosis, GLS, Journal, BWH, University, Patient, N-terminal prohormone of brain natriuretic peptide, Amyloidosis, Heart, LV, Publication, JACC, PET, Quality of life, TBR, Editorial, PET/CT, CAA, Amyloid, Harvard Medical School, ATTR, Devouring Radiant Light, Literature, Alys, Diagnosis, ECV, SAN, Medical imaging, Hospital, AL amyloidosis, Medicine, Iodine, Brigham

124I-evuzamitide may be more sensitive than standard diagnostics, with cardiac uptake shown in ATTR patients who had negative 99mTc-PYP scans.

Key Points: 
  • 124I-evuzamitide may be more sensitive than standard diagnostics, with cardiac uptake shown in ATTR patients who had negative 99mTc-PYP scans.
  • The manuscripts from Brigham and Women’s Hospital (BWH) and from the University of Tennessee Graduate School of Medicine were published in the Journal of American College of Cardiology – Cardiovascular Imaging (JACC CV Imaging).
  • The manuscripts, entitled “Cardiac Amyloid Quantification Using 124I-Evuzamitide (124I-P5+14) Versus 18F-Florbetapir” and “Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study,” have been published online.
  • These studies suggest that 124I-evuzamitide is a promising novel radiotracer to detect and quantify cardiac amyloid in multiple types of amyloidosis.

Mindray Expands Its Cardiac Biomarker Portfolio with Cutting-Edge hs-cTnI and NT-proBNP Assays, Empowering Enhanced Cardiovascular Diseases Care

Retrieved on: 
Monday, October 23, 2023
URL, Mindray, N-terminal prohormone of brain natriuretic peptide, Myocardial injury after non-cardiac surgery, Biomarker, Antigen, Acute coronary syndrome, HyTest Ltd, Research, Antibody, ACS, CVD, AACC, CV, Lod, 99th Infantry Division (United States), Diagnosis, Death, Heart failure, SZSE, Medical device

The additions have enhanced Mindray's diverse portfolio of cardiac biomarkers for cardiovascular diseases (CVDs) diagnosis and management.

Key Points: 
  • The additions have enhanced Mindray's diverse portfolio of cardiac biomarkers for cardiovascular diseases (CVDs) diagnosis and management.
  • While CVDs are the leading cause of death worldwide, early detection is key in saving lives.
  • The two assays are the collaborative effort of Mindray and HyTest, a Mindray company and a prominent global provider of antibodies and antigens.
  • HyTest, renowned for its cardiac biomarker expertise, had its cardiac troponin complex material selected as the international troponin standard by AACC in 2004.

Mindray Expands Its Cardiac Biomarker Portfolio with Cutting-Edge hs-cTnI and NT-proBNP Assays, Empowering Enhanced Cardiovascular Diseases Care

Retrieved on: 
Monday, October 23, 2023
URL, Mindray, N-terminal prohormone of brain natriuretic peptide, Myocardial injury after non-cardiac surgery, Biomarker, Antigen, Acute coronary syndrome, HyTest Ltd, Research, Antibody, ACS, CVD, AACC, CV, Lod, 99th Infantry Division (United States), Diagnosis, Death, Heart failure, SZSE, Medical device

The additions have enhanced Mindray's diverse portfolio of cardiac biomarkers for cardiovascular diseases (CVDs) diagnosis and management.

Key Points: 
  • The additions have enhanced Mindray's diverse portfolio of cardiac biomarkers for cardiovascular diseases (CVDs) diagnosis and management.
  • While CVDs are the leading cause of death worldwide, early detection is key in saving lives.
  • The two assays are the collaborative effort of Mindray and HyTest, a Mindray company and a prominent global provider of antibodies and antigens.
  • HyTest, renowned for its cardiac biomarker expertise, had its cardiac troponin complex material selected as the international troponin standard by AACC in 2004.

BioCardia Announces Completion of Enrollment in Phase III CardiAMP HF Trial and Plans for CardiAMP HF Trial II

Retrieved on: 
Wednesday, October 11, 2023
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The proposed CardiAMP Heart Failure II study includes the requirement that all patients have an NT-proBNP at baseline greater than 500 pg/ml and has a modified primary endpoint.

Key Points: 
  • The proposed CardiAMP Heart Failure II study includes the requirement that all patients have an NT-proBNP at baseline greater than 500 pg/ml and has a modified primary endpoint.
  • Statistical calculations for this clinical study design support that a modestly sized clinical trial, based on the interim results, would achieve high power (probability of success).
  • Additional modifications to the trial design proposed include elements to simplify clinical logistics and reduce the cost of performing the study.
  • “Our world-class clinical leadership is supportive of pursuing the compelling and consistent interim results for patients with elevated NT-proBNP at baseline.

Cytokinetics Presents Baseline Characteristics From SEQUOIA-HCM at the HCM Society Scientific Sessions

Retrieved on: 
Friday, October 6, 2023
III, Research and development, Guideline, Calcium channel, Female, Disopyramide, VO2, N-terminal prohormone of brain natriuretic peptide, Obstruction, SD, LVEF, NYHA, Safety, Exercise, Patient, SAN, Cytokinetics, Medical Center, LVOT, Lahey Hospital & Medical Center, Pharmaceutical industry, HCM

SEQUOIA-HCM enrolled a total of 282 patients, with one third from the United States, one half from Europe and Israel, and the remainder from China.

Key Points: 
  • SEQUOIA-HCM enrolled a total of 282 patients, with one third from the United States, one half from Europe and Israel, and the remainder from China.
  • Background medical therapy consisted of beta-blockers (61%), calcium channel blockers (26.6%), and disopyramide (12.8%); combination background therapy was permitted.
  • At baseline, 75.9% of patients were NYHA functional class II, 23.8% were functional class III, and 0.4% were functional class IV.
  • Key baseline characteristics that remain blinded include left ventricular ejection fraction (LVEF), resting and Valsalva LVOT-G, and NT-proBNP.

Attralus Announces Presentation of Clinical Data for 124I-Evuzamitide (AT-01), a Novel Amyloid-Specific PET Imaging Agent, at the 28th Annual Scientific Session of the American Society of Nuclear Cardiology

Retrieved on: 
Monday, October 2, 2023
Columbia University, Columbia University Irving Medical Center, Male, ASNC, LV, LVH, N-terminal prohormone of brain natriuretic peptide, Cardiac amyloidosis, Serum, Secondary systemic amyloidosis, Echocardiography, IQR, Hypertrophic cardiomyopathy, ID, Assistant, SUV, ICC, ECV, CMP, ATTR, SAN, Map, Cardiology, Amyloidosis, Oregon Health and Science University Center for Women's Health, PET/CT, Genetic testing, Diagnosis, Liver, CMR, HCM, Society, Arnold, Disease, Medical imaging, Medical device, Hospital, Medicine, Patient, Heart

Attralus-Sponsored Test-Retest repeatability study demonstrates excellent repeatability and supports the potential use of AT-01 imaging to monitor disease progression in patients with cardiac amyloidosis.

Key Points: 
  • Attralus-Sponsored Test-Retest repeatability study demonstrates excellent repeatability and supports the potential use of AT-01 imaging to monitor disease progression in patients with cardiac amyloidosis.
  • AT-01 uptake in cardiac amyloidosis shows moderate and statistically significant correlations with traditional measures of cardiac structure and function.
  • These data were included in oral and poster presentations at the 28th Annual Scientific Session of the American Society of Nuclear Cardiology (ASNC) taking place September 29-October 1, 2023, in Toronto, Canada.
  • These findings support the potential use of this novel imaging agent to monitor disease progression in patients with cardiac amyloidosis.

Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Monday, September 11, 2023
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Heart, European Respiratory Society, International, PA, PAH, Echocardiography, The New England Journal of Medicine, MRK, Head, American Journal of Respiratory and Critical Care Medicine, Merck & Co., ERS, Resistance, Patient, N-terminal prohormone of brain natriuretic peptide, Mercury (element), Disease, Mortality, WHO, European Respiratory Journal, Orthostatic hypertension, International Congress on Tuberculosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Safety, Pharmaceutical industry, RV, Merck

Merck submitted an application for regulatory approval of sotatercept to the U.S. Food and Drug Administration and plans to submit applications to additional regulatory agencies worldwide.

Key Points: 
  • Merck submitted an application for regulatory approval of sotatercept to the U.S. Food and Drug Administration and plans to submit applications to additional regulatory agencies worldwide.
  • An exploratory post-hoc analysis from the STELLAR trial evaluated the effects of sotatercept on select hemodynamic parameters and right-ventricle (RV) function.
  • The STELLAR trial enrolled 323 adults with PAH, randomized to receive sotatercept (n=163) or placebo (n=160), on top of background therapy.
  • In the analysis, after 24 weeks, sotatercept was associated with meaningful improvements in certain measures of hemodynamic status and RV function.

Cytokinetics Announces Start of ACACIA-HCM, a Pivotal Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Retrieved on: 
Wednesday, September 6, 2023
Atrial flutter, RER, NYHA, Research and development, Heart failure, Cohort, Atrial fibrillation, LVEF, Quality of life, Part, KCCQ, New York Heart Association Functional Classification, Cytokinetics, Patient, N-terminal prohormone of brain natriuretic peptide, SAN, Mercury (element), VO2, Assessment, III, HCM, Pharmaceutical industry, Medical imaging

“As the first Phase 3 clinical trial of aficamten in non-obstructive hypertrophic cardiomyopathy, ACACIA-HCM represents an important advancement in the development program for aficamten alongside our two ongoing Phase 3 clinical trials in obstructive HCM,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development.

Key Points: 
  • “As the first Phase 3 clinical trial of aficamten in non-obstructive hypertrophic cardiomyopathy, ACACIA-HCM represents an important advancement in the development program for aficamten alongside our two ongoing Phase 3 clinical trials in obstructive HCM,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development.
  • The primary endpoint is the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score from baseline to Week 36.
  • ACACIA-HCM is expected to enroll 420 patients, randomized on a 1:1 basis to receive aficamten or placebo.
  • Patients who complete ACACIA-HCM will be eligible to participate in an open-label extension clinical trial.

LianBio Announces Results from Phase 3 EXPLORER-CN Trial of Mavacamten Presented at the European Society of Cardiology Congress and Simultaneous Publication in JAMA Cardiology

Retrieved on: 
Monday, August 28, 2023
NYHA, Heart failure, CYP2C19, Peking Union Medical College Hospital, Atrial fibrillation, JAMA Cardiology, LVEF, Health status of Asian Americans, European Society of Cardiology, Biomarker, GMR, Congress, New York Heart Association Functional Classification, LVOT, Patient, N-terminal prohormone of brain natriuretic peptide, Body mass index, CMR, Myocardial injury after non-cardiac surgery, ESC, Death, Phenotype, HCM, Safety, Pharmaceutical industry, Medical imaging, Medical device, Oxford Handbook of Clinical Medicine, Cardiology

Mavacamten also demonstrated improvement across all secondary endpoints, including LVOT obstruction, clinical symptoms, and health status.

Key Points: 
  • Mavacamten also demonstrated improvement across all secondary endpoints, including LVOT obstruction, clinical symptoms, and health status.
  • The data presented at ESC 2023 and published in JAMA Cardiology continue to demonstrate robust evidence of mavacamten’s therapeutic benefit.
  • As previously reported, safety results in the trial were consistent with previous studies of mavacamten in symptomatic oHCM, and no new safety signals were reported.
  • “The EXPLORER-CN trial demonstrates that the well-established therapeutic benefit of this drug also extends to Chinese patients.