Powering the next generation in bioelectric medicine with Nanosecond Pulsed Field Ablation technology.
Pulse Biosciences pioneers in the research, design and production of our patented Nanosecond Pulsed Field Ablation™ (nsPFA™) technology for use in high impact areas of healthcare. We are currently focused on applying our proprietary CellFX® nsPFA™ technology within cardiology. We believe there may be several applications in cardiology for CellFX® nsPFA™ platform, including as a potential treatment of atrial fibrillation.
CellFX® nsPFA™ energy is a novel technology that has the potential to not only help patients with atrial fibrillation but also patients across many different therapy areas.
Our website and newsfeed contain forward-looking statements such as statements relating to the anticipated safety and effectiveness of our CellFX® nsPFA™ technology, statements concerning the Company’s expected product development efforts, statements about possible government clearances and approvals, and statements concerning market opportunities, customer adoption and future use of the CellFX® System to address a range of conditions such as atrial fibrillation. These statements are not historical facts but rather are based on our current expectations, estimates, and projections. You should not place undue reliance on forward-looking statements because they involve risks, uncertainties, and assumptions that are difficult or impossible to predict. Actual results may differ materially from our forward-looking statements for a number of reasons, including those described in our filings with the SEC, which you should read before making an investment in our Company.
February 14, 2024
Pulse Biosciences announces promising results from First-in-Human CellFX® nsPFA™ 360 Cardiac Catheter Study
Pulse Biosciences announced today promising results from the 60-day follow-up evaluations of the initial patients treated in the CellFX® nsPFA™ 360 Cardiac Catheter First-in-Human Feasibility Study. This landmark study, utilizing our novel and proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology for atrial fibrillation treatment, has demonstrated favorable durability of pulmonary vein isolation, a critical success factor in AF management. Led by Dr. Vivek Reddy of the Mount Sinai Fuster Heart Hospital, NY, these findings mark a significant step forward in our commitment to advancing cardiac care. With 14 patients already treated and plans to expand, Pulse Biosciences is at the forefront of developing innovative solutions for electrophysiology and cardiac health.
February 3, 2024
Prof. Stefano Spiezia Presents on CellFX® nsPFA™ Technology at NASIT 2024
Prof. Stefano Spiezia presented groundbreaking data from the first-in-human clinical study conducted in Naples at the recent NASIT Annual Meeting 2024. This pioneering research focuses on the application of the CellFX® nsPFA™ Percutaneous Electrode in the treatment of benign thyroid nodules.
Prof. Spiezia's presentation shed light on the significant findings and potential implications of this innovative therapy, offering a new horizon in the nonthermal, minimally invasive treatment of thyroid nodules. 30 patients have been treated in the study, which is to determine the efficacy and safety of the CellFX® nsPFA™ technology for benign thyroid nodules, positioning it as a promising alternative to conventional treatments with the potential to revolutionize patient care for benign thyroid nodules. The CellFX® nsPFA™ Percutaneous Electrode is not cleared by FDA and is for investigational use only.
February 2, 2024
Dr. Vivek Reddy Presents First-In-Human Studies for CellFX® nsPFA™ 360 Cardiac Catheter
Dr. Vivek Reddy participated at the 29th Annual AF Symposium 2024, where he delivered a compelling presentation on the CellFX® nsPFA™ 360 Cardiac Catheter. Dr. Reddy's presentation meticulously outlined the cutting-edge differences and potential advantages of the CellFX® nsPFA™technology over conventional microsecond PFA devices, emphasizing its potential to significantly enhance atrial fibrillation therapies.
The Company takes this opportunity to express its appreciation to Dr. Reddy for his expert contribution and to acknowledge the essential role of the clinical team, whose dedication and hard work were instrumental in facilitating this event. The presentation was met with enthusiastic participation from attendees, underscoring the medical community's interest in innovative solutions for atrial fibrillation treatment.
This event marks a significant milestone in the ongoing efforts to provide advanced therapeutic options to patients worldwide, reinforcing Pulse Biosciences' position at the forefront of medical innovation and the potential treatment of atrial fibrillation. The CellFX® nsPFA™ 360 Cardiac Catheter is not approved by FDA and is for investigational use only.
January 2, 2024
Pulse Biosciences Submits Two Devices for 510(k) Clearance to US FDA
Pulse Biosciences has recently announced two significant 510(k) submissions to the U.S. Food and Drug Administration (FDA), marking important milestones in the company’s expansion of its CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology into new medical fields. The first submission, for the CellFX® nsPFA™ Cardiac Clamp, represents a novel approach to surgical cardiac ablation, designed to produce continuous linear transmural ablations during cardiac surgical procedures. This technology promises to deliver significant safety and performance benefits over existing thermal ablation technologies, potentially reducing procedure times and minimizing the risk of collateral damage to adjacent tissues. The company's leadership expressed confidence in the clamp's ability to set new standards in cardiac ablation, highlighting its nonthermal mechanism and the impressive preclinical data supporting its efficacy and safety.
In addition to the cardiac focus, Pulse Biosciences has also filed a 510(k) for its innovative CellFX® nsPFA™ percutaneous electrode, aimed at non-cardiac applications. This needle device leverages the precision of nsPFA energy to achieve complete nonthermal ablation of cellular tissue, sparing noncellular structures. The submission of these two 510(k)s, underscores the company's commitment to advancing medical treatment options across a broad spectrum of applications. Pulse Biosciences' leadership expressed enthusiasm for the potential for these technologies to significantly impact patient care and outcomes, signaling a robust growth trajectory for the company's proprietary nsPFA technology in both cardiac and non-cardiac fields. Neither device has yet been cleared by FDA and are for investigational use only.
Oct 24, 2023
Pulse Biosciences Appoints Dr. Niv Ad as Chief Science Officer, Cardiac Surgery
“After working with the Pulse Biosciences’ team and participating in preclinical studies using the nsPFA clamp for cardiac ablation, it was immediately clear to me that nsPFA has the potential to not only replace all other energy modalities in cardiac ablation, including radiofrequency and cryo, but due to the speed, safety, and ablation performance of the system, it has the potential to significantly expand the number of patients we treat in cardiac surgery,” said Dr. Niv Ad, Chief Science Officer, Cardiac Surgery. “Because of this and how far along the Company is in the development of a commercially viable system, I decided to join this experienced team as it enters this next exciting phase of bringing CellFXTM Technology from the lab to the clinic to make a positive impact on patient lives and healthcare. I look forward to working alongside this impressive team.”
Dr. Ad is a leading authority in surgical treatment of atrial fibrillation, minimally invasive heart surgery and other advanced heart surgery techniques and transcatheter therapies. Dr. Ad has published more than 200 research articles in peer-reviewed publications. He has led the development of national and international clinical practice guidelines for the different cardiovascular societies for ISMICS, AATS and STS, and serves on multiple leadership positions and committees in the leading cardiothoracic societies. He is the past president of The International Society of Minimally Invasive Cardiothoracic and Vascular Surgery (MICS), the leading entity for minimally invasive procedures globally and he is the Editor in Chief of INNOVATIONS: Technology and Techniques in Cardiothoracic and Vascular Surgery.
Oct 21, 2023
Pulse Biosciences achieved the successful completion of the first five procedures using our proprietary CellFXTM Nanosecond Pulsed Field Ablation (nsPFA) cardiac catheter in a first-in-human feasibility study for atrial fibrillation treatment. This significant accomplishment took place at Na Homolce Hospital in Prague, with the help from Dr. Jacob Koruth, Dr. Iwanari Kawamura, Dr. Moritz Nies, Dr. Kaita Watanabe, Dr. Vivek Reddy, Dr. Moritoshi Funasako, Dr. Petr Neuzil, and the rest of the Na Homolce Team, in particular Stepan Kralovec, who helped guide the process and was instrumental in making this First-In-Human the experience it was.
Dr. Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Hospital, NY, shared, “We are excited to report that our experience with these first five patients has validated our belief that this may represent the next generation of PFA technology for the treatment of AF. The speed and ease with which we were able to isolate the pulmonary veins with the nsPFA 360 catheter was impressive, and all patients tolerated the procedure well."
May 23, 2023
Pulse Biosciences' proprietary Nanosecond Pulsed Field AblationTM (nsPFATM) Technology was recently featured in multiple presentations at the 2023 Heart Rhythm Society Meeting (HRS 2023). These presentations demonstrated preclinical evidence on the use of nsPFA energy for the treatment of heart rhythm disorders. “This data is a validation of the quality of the preclinical work completed with our physician collaborators and our opportunity to advance the treatment of atrial fibrillation. We are excited to continue on the path towards first in-human clinical use," said Kevin Danahy, Chief Executive Officer.
Creating Deep Ventricular Lesions with Nanosecond Pulsed Field Ablation: Pathological and Imaging Insights from Preclinical Evaluation (Iwanari Kawamura MD, et al)
Electron Microscopic Insights from An Acute Pulsed Field Myocardial Lesion (Iwanari Kawamura MD, et al)
Feb 2, 2023
Pulse Biosciences announces poster presentation at the 2023 AF Symposium describing the novel use of Nanosecond Pulsed Field Ablation (nsPFA) technology in cardiac ablation for the treatment of arrhythmias. View press release.
Our proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology delivers nanosecond pulses of electrical energy to nonthermally clear cells while sparing adjacent noncellular tissue. nsPFA energy is delivered from the powerful and versatile nsPFA™ generator platform. The nsPFA platform was developed to be capable of connecting to multiple types of applicators from superficial to surgical to catheter-based therapies. Our system has already been used to treat over 6,000 patients safely and effectively outside of Cardiology.
These ultrafast electrical energy pulses have pulse durations from billionths up to a millionth of a second. When applied to targeted tissue, nsPFA energy pulses enter cells and alter the function of the internal cellular organelles, including the mitochondria and endoplasmic reticulum. The cascade of intracellular disruption leads to regulated cell death (RCD). RCD is a process exhibited by cells in the human body when they undergo stress and are unable to restore cellular homeostasis.
Pulse Biosciences has brought to market the first commercial product to harness the distinctive advantages of nsPFA technology.
Mechanism of Action
- Nonthermal modality that delivers nanosecond duration pulses of electrical energy
- Unlike thermal technologies, nsPFA™ energy directly impacts cellular structures while sparing non cellular tissue
- nsPFA™ energy pulses initiate nanopores in cellular membranes that allow ions, such as calcium, to move within the cell
- Triggers a cascade of intracellular disruption that stresses vital cell organelles
- Breakdown of vital cell organelles leads to regulated cell death (RCD)
Pulse Biosciences is the inventor and sole proprietor of Nanosecond Pulsed Field Ablation™ (nsPFA™) technology. We are committed to health innovation that has the potential to improve and extend the lives of patients. Our proprietary Nanosecond Pulsed Field Ablation technology delivers nanosecond pulses of electrical energy to nonthermally clear cells while sparing adjacent noncellular tissue.
The people at Pulse Biosciences are some of the top experts in pulsed electric field technologies and have a broad range of engineering expertise across multiple medical device domains and will utilize nsPFA™ technology to treat a variety of applications for which an optimal solution remains unfulfilled.
We have a deep and broad IP portfolio with over 130 issued patents globally owned and licensed. With this growing patent portfolio surrounding our innovative technology, Pulse Biosciences seeks to aggressively realize the potential of Nanosecond Pulsed Field Ablation technology by building a rich pipeline of transformative commercial applications.
To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients.
To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.
We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders, and our Pulse Biosciences team members.
Pulse Biosciences, Inc.
3957 Point Eden Way
Hayward, California 94545
- +1 833.257.3393