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Pulse Biosciences Inc (PLSE)

(85% Positive) Pulse Biosciences, Inc. (PLSE) Announces Enrollment Update for Surgeon Due to Patient Enrollment Issues, Regulatory Process, Safety Review, Efficacy Assessment

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  • News bot Oct. 24, 2025, 12:56 p.m.

    📋 Pulse Biosciences, Inc. (PLSE) - Clinical Trial Update

    Filing Date: 2025-10-24

    Accepted: 2025-10-24 08:54:21

    Event Type: Clinical Trial Update

    Event Details:

    Pulse Biosciences Inc (PLSE) Announces Clinical Trial Update Pulse Biosciences Inc (PLSE) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: Surgeon, planned
    • Diseases/Conditions: Adventist Health, concomitant surgical procedures
    • Collaboration: the nPulse Cardiac Surgical System
    • Updated Timeline: OCTOBER 24, 2025, Wire]–October 24, 2025
      • planned for patient enrollment. “After years of development, it is an honor to perform the first NANOCLAMP AF surgical procedure in the U.S. for the treatment of AF using nanosecond PFA with Dr. Aaron Kime and the team here at Adventist Health,” said Dr. Gan Dunnington, Cardiothoracic Surgeon for Adventist Health. “I’m excited for my fellow surgeon colleagues to experience this technology as we aim to bring faster, safer, and more effective treatment options to patients suffering from AF. While I have seen this technology used in the European clinical experience, my team was impressed by the nPulse Cardiac Clamp’s ease of use, and the speed of treatment exceeded their expectations.” “This trial marks a pivotal moment in our journey to transform patient care. nPulse technology has the potential to revolutionize how we approach concomitant ablation procedures. This device offers an improved safety profile as a result of the nonthermal mechanism of action while enabling consistent, precise, contiguous and durable full-thickness lesions in a fraction of the time compared to existing technology. This should ultimately translate to improved outcomes for our patients and expand treatment to more people in need,” said Dr. Matthew Romano, National Principal Investigator and Professor of Cardiac Surgery at the University of Michigan. The nPulse™ Cardiac Surgical System is a next-generation, bipolar surgical device engineered to create continuous, full-thickness ablation lines during concomitant cardiac procedures. The system utilizes a nonthermal energy modality which is expected to provide significant safety and procedural advantages over conventional thermal ablation methods. The nsPFA Cardiac Surgical System was granted FDA Breakthrough Device Designation in July 2024

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Pulse Biosciences Inc
    • CIK: 0001625101
    • Ticker Symbol: PLSE
    • Period End Date: 2025-10-24
    • Document Type: 8-K

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