Pulse Biosciences, Inc.

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 

We believe safety and efficacy may come down to the nanosecond. Explore the practice-changing potential of our innovative CellFX® Nanosecond Pulsed Field Ablation (nsPFA™) technology and see how we’re advancing our mission to improve care and extend lives: https://lnkd.in/g7zhFZem Indications for Use: The CellFX Percutaneous Electrode System is FDA Cleared for use in the US and intended for ablation of soft tissue in percutaneous, and intraoperative surgical procedures. The CellFX System is also intended for dermatological procedures requiring ablation and resurfacing of the skin. #nsPFA #Ablation #PatientCare #CellFX

Dr. Speizia, we were honored to join you at the MD Anderson Cancer Center's HNS Surgery Research Lecture Series and hear you share your experience with #nsPFA technology. We greatly appreciate your dedication to advancing nsPFA technology, your collaboration and support, and the interest shown by the esteemed doctors at the event. Thank you for representing nsPFA technology and for your continued partnership.

Atrial fibrillation is on the rise, with over 12 million expected annual cases in the US by 2030.¹ Reducing this burden, on patients and healthcare systems alike, requires innovation beyond today’s standards of care. Review the risk factors below and learn how advancements like our CellFX® Nanosecond Pulsed Field Ablation (nsPFA™) technology are designed to offer a potentially safer, more effective solution: https://lnkd.in/gTTxduvQ Caution: Investigational Device. #AtrialFibrillation #nsPFA #PulsedFieldAblation

Thyroid nodules are extremely common and most often benign. But sometimes, they can make speaking, eating, or breathing difficult and may require intervention.¹ If you think you are experiencing symptoms of a thyroid nodule, speak to your doctor today. #ThyroidNodule #Thyroid #SaveYourThyroid

From surgical to catheter-based therapies, our Nanosecond Pulsed Field Ablation (nsPFA™) platform is designed to provide a foundation for diverse therapeutic applications. Why does this matter? Our architecture isn’t just flexible – it's proven. With over 6,000 patients already treated across various disciplines, discover how nsPFA™ technology has the potential to set new standards for patient care across the anatomy: https://lnkd.in/ecqttCuR Indications for Use: The CellFX Percutaneous Electrode System is FDA Cleared for use in the US and intended for ablation of soft tissue in percutaneous, and intraoperative surgical procedures. The CellFX System is also intended for dermatological procedures requiring ablation and resurfacing of the skin. #nsPFA #MedTech #Innovation

A recent study found high testosterone levels are linked to an increased risk of atrial fibrillation (AFib) in older men.¹ This #MensHealthMonth, join us in spreading awareness about other common risk factors and the importance of proper monitoring for AFib. If you think you might be suffering from Atrial Fibrillation, contact your doctor today. Read the study: https://lnkd.in/giEX8877 #AFib #MensHealth

It’s #WomensHealthMonth! Did you know that women are 5 to 8 times more likely to develop a thyroid disorder than men?¹ This often leads to the development of thyroid nodules, which, while usually benign, can impact your health and wellbeing. If you think you are experiencing symptoms of a thyroid nodule, speak to your doctor today. #WomensHealth #Thyroid

We’re on a mission to improve patient care through safe, nonthermal minimally invasive procedures. See how our now FDA-cleared CellFX® Nanosecond Pulsed Field Ablation (nsPFA™) technology is getting us there: https://bit.ly/3Sb9VnB Indications for Use: The CellFX Percutaneous Electrode System is FDA Cleared for use in the US and intended for ablation of soft tissue in percutaneous, and intraoperative surgical procedures. The CellFX System is also intended for dermatological procedures requiring ablation and resurfacing of the skin. #nsPFA #Ablation #PulsedFieldAblation

Regulated cell death is the driving force behind our CellFX® Nanosecond Pulsed Field Ablation (nsPFA™) technology – but how does it work? Dig into the science to learn how we harness the power of ultra-fast electrical pulses to precisely target and nonthermally clear cells while sparing surrounding healthy tissue: https://bit.ly/3Sb9VnB #nsPFA #Ablation #PulsedFieldAblation