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First Patients Enrolled in IMPRoVED-AF Study Using vMap, a Non-Invasive ECG-Based Tool Designed to Guide More Effective AF Ablation

First Patients Enrolled in IMPRoVED-AF Study Using vMap, a Non-Invasive ECG-Based Tool Designed to Guide More Effective AF Ablation

Yahoo4 days ago
Prospective, Multi-Center Study Aims to Build Evidence Demonstrating How Arrhythmia Analysis Tool Enhances Treatment for Persistent and Recurrent AF
SAN DIEGO, July 09, 2025--(BUSINESS WIRE)--Vektor Medical, a medical technology company transforming standard ECG data into actionable insights that guide arrhythmia care, today announced that Baptist Health Lexington has enrolled the first patients in the IMPRoVED-AF clinical study. Baptist Health Lexington, a 434-bed acute care hospital, is a long-time leader in innovative approaches to treat heart disease and related conditions.
IMPRoVED-AF is a prospective, randomized, controlled, international, multi-center study designed to rigorously compare clinical outcomes in patients undergoing pulmonary vein isolation (PVI) alone versus PVI and additional driver ablation guided by vMap®, the only FDA-cleared non-invasive arrhythmia analysis technology designed to improve, enhance, and accelerate ablation procedures, utilizing data from a standard 12-lead ECG. The study aims to demonstrate the comparative clinical benefit of using vMap to identify and ablate non-pulmonary vein electrical drivers, when used alongside standard-of-care ablation techniques, including advanced technologies such as pulsed field ablation (PFA), in patients with persistent and recurrent atrial fibrillation (AF).
"Enrolling the first patient in the IMPRoVED-AF study marks an important milestone in our ongoing efforts at Baptist Health to further advance care for our patients suffering from cardiac arrhythmias," said Dr. Gery Tomassoni, Principal Investigator and cardiac electrophysiologist at Baptist Health Lexington. "For patients with persistent and recurrent AF, treatment has often been ineffective due to the inability to identify the source of the arrhythmia. Using vMap to determine a targeted ablation strategy beyond the pulmonary veins provides an opportunity to target drivers that were previously undetectable. That means better care and more effective, lasting results for patients."
With growing pressure to improve outcomes and reduce re-do procedures, physicians and hospitals are seeking non-invasive tools that can improve targeting while maintaining necessary workflow efficiencies. vMap is designed to address this need by delivering rapid analysis and insights from a standard 12-lead ECG.
"The IMPRoVED-AF study is an important validation of the meaningful impact vMap is already delivering in the EP lab," said Rob Krummen, CEO of Vektor Medical. "This isn't about incremental improvement; it's a leap forward in how we identify and treat complex arrhythmias. vMap is uncovering drivers that often go undetected, helping physicians deliver more effective and durable outcomes. This study is a critical part of our strategy to build the clinical evidence that drives confident adoption, supports value in health systems, and positions vMap as the new standard in arrhythmia care."
The IMPRoVED-AF study, managed by Veranex, a global leader in clinical research, will enroll up to 384 patients with persistent and recurrent AF at approximately 20 electrophysiology centers across the United States and Europe. The primary endpoint of the study is freedom from AF at 12 months.
To learn more about the IMPRoVED-AF study, explore vMap technology, or request a clinical or strategic briefing, visit www.vektormedical.com and connect with us on LinkedIn and X.
About vMap®
vMap is the only FDA-cleared, non-invasive solution that transforms data from a standard 12-lead ECG into actionable insights to guide arrhythmia care. The technology, developed with AI, localizes arrhythmia source locations across all four chambers of the heart — including both focal and fibrillation-type arrhythmias. vMap is used by electrophysiologists during triage, procedural planning, and ablation to help identify and target arrhythmia drivers more quickly and with greater confidence. Backed by growing clinical evidence, use of vMap has been associated with improved outcomes, reduced procedure time, and streamlined workflow across the arrhythmia care continuum.
About Vektor Medical
Headquartered in San Diego, Vektor Medical is redefining how arrhythmias are understood and treated. The company developed vMap®, the only FDA-cleared, non-invasive technology that uses standard 12-lead ECG data to localize arrhythmia source locations across all four chambers of the heart. By helping physicians identify arrhythmia drivers more quickly and with greater accuracy, Vektor is working to improve outcomes, enhance efficiencies, and accelerate access to effective treatment strategies. To learn more, visit www.vektormedical.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250709915203/en/
Contacts
Media Contact Stacey HolifieldLevitate(617) 233-3873vektor@levitatenow.com
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Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025
Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025

Business Wire

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Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) ('Amylyx' or the 'Company') today announced the presentation of new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for the treatment of post-bariatric hypoglycemia (PBH) at the Endocrine Society's annual meeting (ENDO 2025). In the Phase 2b trial, avexitide 90 mg once daily, the dose being evaluated in the pivotal Phase 3 LUCIDITY trial, led to a 64% least-squares (LS) mean reduction (p=0.0031) vs. baseline in the composite rate of Level 2 and Level 3 hypoglycemic events in PBH, with more than half of the participants experiencing no events during the treatment period. LUCIDITY is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in approximately 75 participants with PBH following Roux-en-Y gastric bypass surgery. The FDA-agreed-upon primary endpoint of LUCIDITY is reduction in the composite of Level 2 and Level 3 hypoglycemic events. Consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events also were seen with avexitide 45 mg twice daily studied in the Phase 2b trial and avexitide 30 mg twice daily and 60 mg once daily studied in the Phase 2 PREVENT trial. New pharmacokinetic (PK) and pharmacodynamic (PD) data were also presented demonstrating continuous pharmacologic activity of the 90 mg once daily dose regimen for a 24-hour period. 'Post-bariatric hypoglycemia can profoundly disrupt daily life, requiring individuals to carefully manage meals, social interactions, and routines, often while living in fear of their next hypoglycemic event. The new analysis presented at ENDO 2025 continues to support that avexitide may significantly reduce the frequency of these events,' said Marilyn Tan, MD, FACE, Principal Investigator of the LUCIDITY trial and Clinical Associate Professor at Stanford University. Camille L. Bedrosian, MD, Chief Medical Officer of Amylyx, added, 'Post-bariatric hypoglycemia is a serious and underrecognized condition with no FDA-approved treatments. The data presented show that, in an exploratory analysis from the Phase 2 PREVENT and Phase 2b clinical trials, avexitide significantly reduced the composite rate of Level 2 and 3 hypoglycemic events, including at the 90 mg once daily dose that is being studied in our pivotal Phase 3 LUCIDITY trial. We are particularly encouraged that over half of participants did not experience Level 2 or Level 3 hypoglycemic events during the treatment period. In addition, the pharmacokinetic and pharmacodynamic data demonstrated continuous pharmacologic activity of avexitide 90 mg once daily dose over 24 hours. We continue to be encouraged by avexitide's potential to deliver consistent, meaningful benefit to people living with PBH.' The population PK and PD analyses presented at ENDO 2025 demonstrated that avexitide 90 mg once daily maintained consistent GLP-1 receptor inhibition from morning to midnight and between doses. In vitro potency studies showed an IC₅₀ of approximately 20-30 nM (70-100 ng/mL), indicating robust target inhibition even in the presence of significant levels of GLP-1. PK modeling demonstrated that avexitide plasma levels exceeded IC₅₀ for a full 24-hour period. LUCIDITY was informed by data from five PBH clinical trials of avexitide showing consistent, dose-dependent effects, including statistically significant and clinically meaningful reductions in hypoglycemic events. 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In two Phase 2 PBH clinical trials, avexitide demonstrated highly statistically significant reductions in hypoglycemic events. These events can lead to autonomic and neuroglycopenic symptoms that can have a devastating impact on daily living. About Post-Bariatric Hypoglycemia (PBH) Post-bariatric hypoglycemia (PBH) is a condition that is estimated to affect approximately 8% of people in the U.S. who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux-en-Y gastric bypass (approximately 160,000 people in the U.S.). PBH is thought to be caused by an excessive glucagon-like peptide-1 (GLP-1) response leading to hypoglycemia and impaired quality of life. PBH can cause debilitating hypoglycemic events associated with inadequate supply of glucose to the brain, known as neuroglycopenia. Clinical manifestations can include impaired cognition, loss of consciousness, and seizures. 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Coca-Cola hit with massive recall as popular product is possibly contaminated: 'All impacted product has been removed from store shelves'
Coca-Cola hit with massive recall as popular product is possibly contaminated: 'All impacted product has been removed from store shelves'

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Coca-Cola hit with massive recall as popular product is possibly contaminated: 'All impacted product has been removed from store shelves'

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FDA Issues Risk Warning After Mushrooms Recalled Nationwide
FDA Issues Risk Warning After Mushrooms Recalled Nationwide

Newsweek

time13 hours ago

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FDA Issues Risk Warning After Mushrooms Recalled Nationwide

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