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What's Going With Pulse Biosciences Stock On Monday?
Benzinga· 2026-02-09 14:18
Core Viewpoint - Pulse Biosciences Inc. is experiencing a stock surge driven by positive clinical data from its nPulse Cardiac Catheter feasibility study, despite a slight decline in the broader market [1]. Group 1: Clinical Data and Study Results - The nPulse Cardiac Catheter demonstrated successful treatment outcomes for atrial fibrillation in 150 patients, with rapid procedure times and minimal adverse effects, positioning the technology as a leading market option [2]. - Findings were presented at the Annual AF Symposium 2026 in Boston, highlighting the potential of the nPulse technology to advance atrial fibrillation treatment, with plans to initiate a pivotal IDE study for additional patient treatment [3]. Group 2: Stock Performance and Technical Analysis - The stock is trading 49% above its 20-day simple moving average (SMA) and 39.4% above its 100-day SMA, indicating strong short-term momentum, although shares have decreased by 7.20% over the past 12 months [4]. - The Relative Strength Index (RSI) is at 75.62, indicating overbought territory, while the MACD is above its signal line, reflecting bullish momentum, suggesting mixed signals regarding stock performance [5]. - Benzinga Edge ranks Pulse Biosciences' stock with a strong momentum score of 68.22, indicating outperformance relative to the broader market, but caution is advised due to the overbought RSI condition [6]. Group 3: Current Stock Price Action - Pulse Biosciences shares were up 4.05% at $21.59 during premarket trading, with key resistance identified at $24.50 and key support at $20.00 [7].
Late-breaking data presentations showcase the safety and efficacy of Abbott's ablation catheters to treat people with atrial fibrillation
Prnewswire· 2026-02-06 13:00
Core Insights - Abbott presented new clinical data at the AF Symposium demonstrating the safety and efficacy of its ablation catheters for treating atrial fibrillation (AFib) [1] Group 1: Volt PFA System - The Volt Pulsed Field Ablation (PFA) System achieved an industry-leading success rate of 84.2% for freedom from documented rhythm recurrence in paroxysmal AFib patients over 12 months [1] - Nearly 68% of patients with persistent AFib remained free from additional episodes after treatment with the Volt PFA System [1] - Patients reported significant improvements in quality-of-life scores, increasing from 63.6 to 91.4 for paroxysmal AFib patients and from 64.2 to 91.4 for persistent AFib patients [1] - The trial reported less than 6% of patients required repeat ablation, one of the lowest rates in the industry [1] - Physicians used an average of 4.6 therapy applications per vein, fewer than other competitive PFA systems [1] Group 2: TactiFlex Duo Ablation Catheter - The TactiFlex Duo Ablation Catheter demonstrated a clinically meaningful success rate of 81% for freedom from documented rhythm recurrence among paroxysmal AFib patients in the FOCALFLEX Global CE Mark trial [1] - Patient self-reported quality-of-life scores increased from 64.4 to 86.4 [1] - TactiFlex Duo is designed for focal ablation using a dual-energy platform, allowing tailored AFib therapy delivery [1] - The device received CE Mark approval, and the FDA granted Breakthrough Device Designation for treating Ventricular Tachycardia using PFA [1] Group 3: Market Position and Future Outlook - Abbott's Volt PFA System and TactiFlex Duo are positioned to empower physicians in treating a wide range of AFib cases, from newly diagnosed to complex cases [1] - The company aims to challenge the status quo in AFib treatment by developing better tools for physicians [1]
AtriCure (NasdaqGM:ATRC) FY Earnings Call Presentation
2026-01-14 18:30
Creating a World Class Platform JP Morgan Healthcare Conference Presentation January 2026 © 2026 AtriCure, Inc. All rights reserved. Forward Looking Statements and Non-GAAP Financial Measures This presentation and oral statements made in connection with this presentation contain "forward-looking statements," which are statements related to future events that by their nature address matters that are uncertain. Forward-looking statements address, among other things, AtriCure's expected market opportunity, gui ...
AtriCure to Participate in the J.P. Morgan 44th Annual Healthcare Conference
Businesswire· 2025-12-17 13:00
Core Insights - AtriCure, Inc. is a leading innovator in surgical treatments for atrial fibrillation (Afib) and related conditions, participating in the J.P. Morgan 44th Annual Healthcare Conference [1][2] Company Overview - AtriCure provides innovative technologies for the treatment of Afib, which affects over 59 million people globally [3] - The Isolator® Synergy™ Ablation System is the first FDA-approved device for treating persistent Afib [3] - AtriCure's AtriClip® Left Atrial Appendage Exclusion System is the most widely sold device for left atrial appendage management worldwide [3] - The Hybrid AF™ Therapy offers a minimally invasive solution for long-standing persistent Afib patients [3] - AtriCure's cryoICE cryoSPHERE® and cryoXT® probes are designed for temporary ablation of peripheral nerves to alleviate pain in various medical procedures [3]
Pulse Biosciences Gets FDA IDE Nod for Atrial Fibrillation Study
ZACKS· 2025-09-11 17:26
Company Overview - Pulse Biosciences (PLSE) received FDA approval for its Investigational Device Exemption (IDE) to initiate the NANOCLAMP AF study, which evaluates its Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System for atrial fibrillation (AF) [1][8] - The IDE approval is a significant growth catalyst for the company, validating its technology and enhancing its potential for broader clinical adoption in the cardiac ablation market [2][4] Market Position and Financials - PLSE currently has a market capitalization of $1.01 billion [6] - Following the announcement of the IDE approval, PLSE shares closed flat, with a year-to-date decline of 15.2%, compared to the industry's decline of 10.9% and the S&P 500's gain of 11.9% [3] Study Details - The NANOCLAMP AF study will involve up to 136 patients across 20 global sites, including two outside the United States, to evaluate the effectiveness of the nsPFA Cardiac Surgical System during concomitant cardiac surgeries [9][10] - Early clinical data from the EU indicate rapid and consistent ablation, with the device designed to minimize collateral tissue damage due to its nonthermal mechanism [10][11] Industry Prospects - The global atrial fibrillation market was estimated at $26.89 billion in 2024 and is projected to reach $65.33 billion by 2033, with a compound annual growth rate (CAGR) of 10.44% from 2025 to 2033 [12]
Boston Scientific receives FDA approval for expanded labeling of FARAPULSE™ Pulsed Field Ablation System
Prnewswire· 2025-07-07 11:00
Core Viewpoint - Boston Scientific Corporation has received FDA approval to expand the use of the FARAPULSE Pulsed Field Ablation (PFA) System for treating drug refractory, symptomatic persistent atrial fibrillation (AF) [1][2]. Group 1: Product Approval and Impact - The FARAPULSE PFA System is now approved for pulmonary vein and posterior wall ablation in patients with persistent AF, a condition affecting an estimated 59 million people globally [1][2]. - The updated instructions for use (IFU) now include the FARAWAVE PFA Catheter and FARAWAVE NAV PFA Catheter for treating patients with persistent AF [2]. Group 2: Clinical Evidence and Trial Results - The FDA approval was supported by clinical evidence from the ADVANTAGE AF clinical trial, which met primary safety and effectiveness endpoints, showing an 85.3% symptomatic AF recurrence-free rate among 260 patients [3]. - Among physicians performing three or more procedures, the symptomatic recurrence-free rate increased to 91.4% [3]. Group 3: Future Developments - Boston Scientific anticipates obtaining CE mark and approvals in Japan and China in the coming months [4]. - The company has initiated the ReMATCH IDE clinical trial to study the safety and effectiveness of the FARAWAVE PFA Catheter in patients with persistent AF who have previously undergone ablation [4].
Medtronic Affera™ pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients
Prnewswire· 2025-04-26 23:20
Core Insights - Medtronic announced positive clinical outcomes from studies on atrial fibrillation (AFib) patients using the Affera™ technologies, including the Sphere-360™ and Sphere-9™ catheters [1][6] Group 1: Sphere-360 Study - The Sphere-360 catheter demonstrated an 88% freedom from arrhythmia recurrence and 98% durable pulmonary vein isolation (PVI) in a one-year study [2] - No safety events were reported in the subgroup treated with the optimized waveform, highlighting the safety profile of the Sphere-360 [2] - The Sphere-360 catheter features a conformable lattice design and is integrated with the Affera Mapping and Ablation System, utilizing the smallest sheath in single-shot PFA technology at 8.5 Fr [2][3] Group 2: Sphere-9 Catheter - The Sphere-9 catheter was shown to safely create linear lesions in persistent AF patients, enhancing the chances of restoring normal heart rhythm [4] - This catheter is part of the Affera system, which received FDA approval in October 2024, indicating its efficacy in persistent AF treatment [4] Group 3: Medtronic's Position and Future Plans - Medtronic plans to initiate a U.S. pivotal trial for the Sphere-360 catheter later in the year, indicating ongoing commitment to innovation in AFib treatment [3] - The company is the only one offering two PFA solutions, with the PulseSelect™ system already available in over 30 countries, showcasing its leadership in the electrophysiology market [5] - Medtronic continues to expand the Affera system's availability globally, with current access in Europe, Australia, and New Zealand [5]