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Press Release: Pulse Biosciences, Inc. Announces Receipt of FDA Breakthrough Device Designation for CellFX® nsPFA Cardiac Surgery System for the Treatment of Atrial Fibrillation Pulse Biosciences has received Breakthrough Device Designation from the U.S. FDA for our CellFX® nsPFA Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation (AF). The CellFX nsPFA Cardiac Surgery System with Surgical Clamp, utilizing our proprietary nanosecond Pulsed Field Ablation (nsPFA) technology, is designed to produce durable, continuous transmural ablation lesions during cardiac surgery procedures for the treatment of atrial fibrillation. Based on pre-clinical studies, a single application of less than 2 seconds with the Surgical Clamp creates a consistent, transmural ablation, which is significantly faster, requiring approximately one-twentieth the time of currently available thermal ablation technologies. As Dr. Niv Ad, our Chief Science Officer, Cardiac Surgery, stated, “The theoretical benefits of short-duration, high-amplitude energy pulses with a nonthermal mechanism of action suggest the potential for a safer and more effective treatment.” The Breakthrough Devices Program is a voluntary program for certain medical devices with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as atrial fibrillation. Our President and CEO, Burke Barrett added that, “We plan to fully leverage the benefits of this designation and have chosen to seek PMA approval to achieve a specific indication for the treatment of atrial fibrillation. We look forward to aligning with the FDA on a pivotal clinical trial design in the near-term and towards initiating our planned first-in-human cases in the Netherlands soon.” More details about the FDA Breakthrough Designation and additional commentary can be found in the press release: https://lnkd.in/gVttBeZu #PulseBiosciences #CellFX #nsPFA #CardiacSurgery #AtrialFibrillation #BreakthroughTechnology 

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