Pulse Biosciences Announces Publication in the Journal of Thoracic and Cardiovascular Surgery

Rhea-AI Summary

Pulse Biosciences (PLSE) announced the publication of preclinical study results in the Journal of Thoracic and Cardiovascular Surgery, demonstrating advantages of their nano-PFA Cardiac Surgical System over radiofrequency technology for cardiac tissue ablation. The study showed the system's ability to create consistent, transmural ablations in all four heart chambers within 1.25 seconds per application, without damaging adjacent organs.

The system, which received FDA Breakthrough Device Designation in July 2024, operates approximately twenty times faster than current thermal ablation technologies. The company is conducting a multi-center, first-in-human atrial fibrillation feasibility study in three Netherlands centers, with preliminary results expected in late 2025.

Positive

• FDA Breakthrough Device Designation received in July 2024
• System performs ablations 20x faster than current technologies
• Successful preclinical results published in leading scientific journal
• First-in-human trials underway in three European centers

Negative

• Preliminary trial results not available until late 2025
• Technology still in early clinical testing phase

Insights

Medical Research Analyst

The publication in the prestigious Journal of Thoracic and Cardiovascular Surgery presents compelling preclinical evidence for Pulse Biosciences' nano-PFA technology. Key advantages include 1.25-second ablation time (20x faster than current thermal methods), consistent transmural lesions and absence of collateral tissue damage. The technology's non-thermal mechanism particularly stands out for cardiac procedures. The ongoing first-in-human study in Europe, combined with the FDA Breakthrough Device Designation, suggests an accelerated pathway to market. However, investors should note that preliminary results won't be available until late 2025, indicating a significant waiting period for clinical validation.

Market Research Analyst

This publication represents a significant milestone for Pulse Biosciences in the $2+ billion cardiac ablation market. The nano-PFA technology's demonstrated advantages over existing radiofrequency methods - particularly the speed and safety profile - could position the company for substantial market penetration. The FDA Breakthrough Device Designation and TAP program inclusion indicate regulatory recognition of the technology's potential value proposition. While the European clinical trial progress is positive, the extended timeline to preliminary results may impact near-term market expectations. The cardiac surgery application expands PLSE's addressable market beyond their existing aesthetic applications.

Preclinical data demonstrates advantages of the nano-PFA Cardiac Surgical System over radio frequency technology for ablation of cardiac tissue

MIAMI--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nano-PFA or nsPFA™) technology, today announced a new publication in the Journal of Thoracic and Cardiovascular Surgery. This preclinical study demonstrates the advantages of the nano-PFA Cardiac Surgical System over radiofrequency technology for the ablation of cardiac tissue.

The study was designed to demonstrate the safety and efficacy of a new nanosecond pulsed field ablation parallel clamp, Pulse Biosciences’ nano-PFA Cardiac Surgical System, in ablating different cardiac tissue locations. Ablations were performed in all four heart chambers of porcine models by delivering a sequence of very short-duration high-amplitude electrical pulses taking 1.25 seconds per application, independent of tissue thickness or type. Results validated the expected clinical benefits of nano-PFA, as all lesions produced by this technology resulted in persistent exit block of pulmonary veins. This is consistent with the histology showing reliable, durable contiguous and transmural ablations without injury to adjacent organs.

“We are very proud to have this data published in the leading scientific journal in the field, the renowned Journal of Thoracic and Cardiovascular Surgery. The results of this study are extremely compelling because they demonstrate the potential for nano-PFA to consistently deliver contiguous and transmural ablations to tissues of varying thickness without injury to adjacent organs at much quicker speeds than radiofrequency technology. These benefits are very appealing to surgeons who always prioritize generating consistent positive outcomes for their patients,” said Dr. Gan Dunnington, Chief Medical Officer, Cardiac Surgery of Pulse Biosciences.

Dr. Niv Ad, Chief Science Officer, Cardiac Surgery of Pulse Biosciences commented, “Nano-PFA delivers short-duration, high-amplitude energy pulses which act as a nonthermal mechanism of action. Our preclinical work is validating the technology’s theoretical benefits to deliver safer and more effective ablations to advance the surgical treatment of atrial fibrillation. We look forward to continuing our clinical work and are thankful for the support of all the surgeons who are supporting our studies.”

Pulse’s Cardiac Surgery System with Surgical Clamp is designed to produce durable, continuous, transmural, ablation lesions during cardiac surgery procedures for the treatment of atrial fibrillation. The bipolar clamp utilizes the Company’s proprietary nanosecond PFA technology. Based on pre-clinical studies, a single application of less than two seconds with the Surgical Clamp creates a consistent, transmural, durable ablation, which is significantly faster, requiring approximately one-twentieth the time of currently available thermal ablation technologies. Also, due to the non-thermal mechanism of action of nano-PFA, there is no risk of thermal spread that may cause undesired injury to collateral tissues, which compares favorably to thermal radiofrequency ablation. The nano-PFA Cardiac Surgical System received FDA Breakthrough Device Designation in July 2024 and was enrolled in the FDA’s TAP program.

The company is progressing with a multi-center, first-in-human atrial fibrillation (AF) feasibility study in Europe. Currently, three centers in the Netherlands are enrolling patients into the study. The Company expects to share preliminary results of the trial in late 2025.

About Pulse Biosciences®

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Pulse Biosciences is now headquartered in Miami, Florida and maintains its office in Hayward, California.

Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the effectiveness of the Company’s CellFX nsPFA technology and CellFX System to safely and effectively provide symptomatic relief to patients with benign thyroid nodules or cause significant nodule volume reductions, whether within a month or otherwise, statements concerning the Company’s expected product development efforts and future clinical studies and regulatory submissions and whether the Company might obtain regulatory approval to market and sell the nsPFA Percutaneous Electrode System as a treatment for benign thyroid nodules, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action will deliver fast and precise ablations, statements concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device such as the nsPFA Percutaneous Electrode System, and Pulse Biosciences’ expectations, whether stated or implied, regarding whether the Company’s CellFX nsPFA technology will become a disruptive, superior and durable treatment option for treating benign thyroid nodules or any other medical condition or otherwise advance current medical standards of care, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241217004964/en/

Investors:

Pulse Biosciences, Inc.

Darrin Uecker, CTO or Kevin Danahy CCO

IR@pulsebiosciences.com

or

Gilmartin Group

Philip Trip Taylor

415.937.5406

philip@gilmartinir.com

Source: Pulse Biosciences, Inc.

FAQ

What are the key advantages of PLSE's nano-PFA Cardiac Surgical System?

The system performs ablations in 1.25 seconds, approximately 20 times faster than current thermal technologies, creates consistent transmural ablations, and avoids damage to adjacent organs due to its non-thermal mechanism.

When did PLSE receive FDA Breakthrough Device Designation for its nano-PFA system?

Pulse Biosciences received FDA Breakthrough Device Designation for its nano-PFA Cardiac Surgical System in July 2024.

When will PLSE release preliminary results from its European clinical trials?

Pulse Biosciences expects to share preliminary results from its European first-in-human atrial fibrillation feasibility study in late 2025.

How many centers are currently conducting PLSE's clinical trials?

Three centers in the Netherlands are currently enrolling patients for PLSE's first-in-human atrial fibrillation feasibility study.

What distinguishes PLSE's nano-PFA technology from traditional radiofrequency ablation?

PLSE's nano-PFA technology uses non-thermal, short-duration high-amplitude electrical pulses, eliminating the risk of thermal spread and tissue damage associated with traditional radiofrequency ablation.