Argá Medtech SA

Today Dr Ante Anic from KBC Split presented during the Spotlight Session promising first-in-human preliminary results of BURST-AF. In total, 78 subjects were enrolled across 3 European sites.  All lesion sets were completed using the Coherent Sine-Burst Electroporation™ (CSE™) generator and CSE ablation catheter in either the circular, linear and/or focal configuration. Safety assessments included a brain MRI sub-study, microbubble observation during PFA application, PV stenosis, and esophageal injury. Seventy-seven of 78 subjects have undergone remapping at ~90 days. Dr. Anic shared preliminary study results demonstrating an excellent safety profile combined with a high acute procedural efficacy and chronic durability at 90-days. BURST-AF is a first in human study to evaluate the Coherent Sine-Burst Electroporation (CSE) Ablation system as a novel PFA platform. The study was designed as a prospective, single-arm, multi-center, non-randomized study to assess the safety, efficiency and effectiveness of the CSE ablation system. The CSE ablation system, designed for the treatment of atrial fibrillation, consists of a versatile, multi-configurable (circular, linear, focal) ablation catheter and CSE ablation generator. The CSE ablation system employs phased sine waves to deliver pulsed field energy providing unipolar, bipolar, and combination energy delivery modes. #ArgaMedtech #NextGenerationsCardiacAblation #PFA #BURST-AF #KBCSplit Giorgi Papiashvili #MedicalResearchClinicTbilisi #KBCZagreb #AFS Advent Life Sciences Earlybird Venture Capital Gilde Healthcare Argá Medtech SA #AFSymposium2025

Come and join us at the AF symposium in Boston on January 16th at 8.30AM during the Spotlight Session – New and Emerging Technologies in Arrhythmia Management. Dr Ante Anic from KBC Split will be presenting promising preliminary results of the Argá Medtech Coherent Sine-Burst Electroporation System First-In-Human BURST-AF study. We look forward to sharing these exciting developments. Stay tuned for more updates on BURST-AF results. #AFSymposium #SpotLightSession #AtrialFibrillation #ArgaMedtech #BURST-AF Gilde Healthcare Advent Life Sciences Earlybird Venture Capital Argá Medtech SA Ante Anic

🌍 **Global AF Aware Week: November 18-24, 2024** 🌍 At Arga Medtech, we are dedicated to advancing technology for the treatment of Atrial Fibrillation (AF). This week, we join the global community in recognizing **Global AF Aware Week**. Atrial Fibrillation is the most common heart rhythm disorder, affecting millions worldwide. It's crucial to raise awareness about AF because it significantly increases the risk of stroke and heart failure. Early detection and proper management can save lives and improve quality of life. 🔍 **Did you know?** - Over 38 Million people world wide alone have been diagnosed with AF, with many more undiagnosed. - AF can lead to severe complications such as stroke, heart failure, and chronic fatigue. - Regular pulse checks can help detect AF early, potentially saving thousands of lives each year. This year's theme, "Hearts Beating. Minds Meeting," emphasizes the power of collaboration in addressing AF. By working together, we can enhance AF care worldwide through the **Detect, Protect, Correct, and Perfect** approach. Let's use this week to spread awareness, educate others, and support those affected by AF. Together, we can make a difference. #GAFAW2024 #HeartsBeatingMindsMeeting #AtrialFibrillation #ArgaMedtech #HealthcareInnovation

Promising first-in-human preliminary results of the Argá Medtech Coherent Sine-Burst Electroporation System presented at Europe AF Earlier this week, Dr Ivan Sikiricć from KBC Split presented the initial results from the BURST-AF study during the Europa AF meeting in Milan. In total, 74 subjects were enrolled across 2 European sites.  All lesion sets were completed using the Coherent Sine-Burst Electroporation™ (CSE™) generator and CSE ablation catheter in either the circular, linear and/or focal configuration. Safety assessments included a brain MRI sub-study, microbubble observation during PFA application, PV stenosis, and esophageal injury.  Sixty-nine of 74 subjects have undergone remapping at ~90 days. Preliminary study results report on a favorable safety profile combined with high acute efficiency and chronic durability at the 90-day remap procedure. Initial long-term follow-up data for both the paroxysmal and persistent cohort confirm the effectiveness of this novel PFA platform. BURST-AF is a first-in-human study to evaluate the CSE Ablation system as a novel PFA platform. The study was designed as a prospective, single-arm, multi-center, non-randomized study to assess the safety, efficiency and effectiveness of the CSE ablation system. The CSE ablation system, designed for the treatment of atrial fibrillation, consists of a versatile, multi-configurable (circular, linear, focal) ablation catheter and CSE ablation generator. The CSE ablation system employs phased sine waves to deliver pulsed field energy providing unipolar, bipolar, and combination energy delivery modes. Stay tuned for more updates on BURST-AF results. #ArgaMedtech #NextGenerationsCardiacAblation #PFA #BURST-AF #KBCSplit #Israeli-Georgian MedicalResearchClinicTbilisi #KBCZagreb #afib

Argá Medtech: Investigating new applications for its next-generation cardiac ablation platform Dr. Sabine Ernst presented today at SCRN2024 the latest feasibility data for ventricular pulsed field (PFA) in an in vivo healthy swine model using coherent sine-burst electroporation (CSE) . The data shows that sine-wave electroporation combined with remote magnetic navigation achieved complete PV isolation and deep ventricular ablation lesions without creating microbubbles, thrombogenicity, or clinically significant hemolysis. Initially designed for treating atrial fibrillation, the CSE ablation system consists of a versatile, multi-configurable (circular, linear, focal) ablation catheter and  CSE ablation generator. The CSE ablation system employs phased sine waves to deliver pulsed field energy providing unipolar, bipolar, and combination energy delivery modes. A dual-purpose focal PFA catheter was developed to test the feasibility of CSE in the ventricle either manually or in conjunction with remote magnetic navigation. Stay tuned for more exciting updates on the CSE ablation system. #ArgaMedtech #SCRN #EuropeAF #AFsymposium #AFIB #Ventriculartachicardia #CardiacAblation Randy Werneth David Neale Melvin Lorenzo Micah Lee Mark Zurcher Brandon Lee Shahzad Malik John Yianni Henry Zubaida Ed Roschak Janice Barstad Annelies Vanderper Joerg Reinhardt David Leo Fischel

This week at the Stanford Biodesign New Arrhythmia Technologies Retreat, Argá Medtech presented its Coherent Sinewave Electroporation platform, a pioneering treatment for Atrial Fibrillation and other cardiac arrhythmias. Our CEO, David Neale, provided an insightful update on the BURST-AF study, highlighting that out of 54 patients treated, 18 have completed a 12-month follow-up, with 16 patients (88.9%) experiencing freedom from AF and other arrhythmias. As we gear up for the IDE study slated for early 2025, we're actively seeking partnership centers to join us on this groundbreaking journey. The first-in-human study by Argá Medtech has been a resounding success, enrolling 54 patients to date and showcasing promising results that promise to revolutionize arrhythmia management and patient care. Our ALL-in-ONE catheter allows for the treatment of Paroxysmal and Persistent AF without the need of using a second catheter. Simplicity at its best, the efficiency of a single-shot device with the flexibility of a linear/ focal catheter. We are thrilled to be at the forefront of cardiac health innovation. Our heartfelt thanks go to: - The Event Organizers for facilitating a retreat that sparks knowledge sharing and expert collaboration. - Our Argá Medtech team, whose relentless dedication has been the driving force behind our technological breakthroughs. - Our investors, whose unwavering trust has been instrumental in our journey. - The Enrollment Center Staff, whose commitment to patient care is the backbone of our progress. Argá Medtech is steadfast in its mission to enhance arrhythmia treatments. We invite you to follow our continued progress as we forge ahead with medical advancements that hold the promise of bettering patient lives. #StanfordBiodesign #ArrhythmiaTherapy #MedicalInnovation #PFA ##pusledfieldablation #cardiacablation #AtrialFibrillation, #EP, #EPeeps, #Electrophysiology Argá Medtech SA Randy Werneth, Micah Lee, Mark Zurcher, Brandon Lee, John Yianni Shahzad Malik Henry Zubaida Janke Dittmer HTGF | High-Tech Gründerfonds Biopôle Lausanne Earlybird Venture Capital Gilde Healthcare Advent Life Sciences WexMed II LLC, HBM-Medfocus LLC Ante Anic, Giorgi Papiashvili, Melvin Lorenzo

Argá Medtech SA to present its latest data at the Stanford Biodesign New Arrhythmia Technologies Retreat. May 15th, Boston. https://lnkd.in/efXzMtyG

We are pleased to share that we closed a €54M oversubscribed Series B raise to advance the clinical studies of our innovative pulsed field ablation system for treating #atrialfibrillation. The financing will enable us to validate the early clinical results for our Coherent Sine-burst Electroporation™ (CSE™) ablation technology through the execution of an IDE study in the US and a CE Mark study in the EU. To learn more, read our full press release: https://lnkd.in/dvvaR54j Earlybird Venture Capital Advent Life Sciences Gilde Healthcare #PFA #cardiacablation #argamedtech #epeeps #electrophysiology