Pulse Biosciences Files 510(k) Submission with U.S. FDA for its CellFX® nsPFA™ Cardiac Clamp

Rhea-AI Summary

Pulse Biosciences, Inc. (PLSE) Files 510(k) Pre-market Notification for CellFX nsPFA Cardiac Clamp with FDA

Positive

• Innovative technology for the treatment of atrial fibrillation
• Filing of premarket notification 510(k) to the U.S. FDA for CellFX nsPFA Cardiac Clamp
• Expected completion of 510(k) review within 90 days
• Unique safety and performance benefits of nsPFA technology
• Potential to become the gold standard in cardiac ablation for cardiothoracic surgeons
• Seamless replacement for current radiofrequency ablation devices

Negative

• None.

Insights

Medical Device Analyst

Regulatory Progression: The submission of a 510(k) premarket notification for the CellFX nsPFA Cardiac Clamp represents a critical step for Pulse Biosciences in its quest to penetrate the cardiac ablation market. This regulatory milestone is pivotal as it directly affects the company's ability to market and sell the device. The 510(k) process is less rigorous than a premarket approval (PMA), which may facilitate a quicker path to market. However, investors should consider the FDA's capacity for timely reviews, which can be variable and influenced by the agency's workload and the complexity of the technology.

Competitive Advantage: The CellFX nsPFA technology is described as a nonthermal ablation technology, which contrasts with existing thermal ablation methods. The purported advantages include a reduction in procedure time and minimization of collateral tissue damage. If these benefits are substantiated in clinical settings, the technology could disrupt current standards of care. However, adoption rates will hinge on clinical outcomes, cost-effectiveness and the ease of integration into existing surgical workflows.

Market Potential: The cardiac ablation market is significant and growing, driven by the prevalence of atrial fibrillation and other cardiac arrhythmias. A device that offers a safer, quicker and equally or more effective alternative to current ablation technologies could capture a substantial market share. Nonetheless, the actual impact on Pulse Biosciences' revenue and market position will depend on the outcome of the FDA review, subsequent clinical adoption and the company's ability to scale production and distribution.

Healthcare Industry Analyst

Innovation Impact: The introduction of the CellFX nsPFA Cardiac Clamp could signify a technological leap in the field of cardiac surgery. The ability to perform continuous linear transmural ablations efficiently is a notable innovation. The broader implications for the healthcare industry include potential shifts in standard surgical practices and the possibility of improved patient outcomes due to reduced operative times and risks.

Strategic Positioning: Pulse Biosciences appears to be strategically positioning itself at the forefront of cardiac ablation technology. The company's focus on preclinical data dissemination at scientific meetings is an effective way to build credibility and interest among the medical community. This approach, combined with active collaboration with the FDA, is designed to facilitate a smooth transition from regulatory approval to clinical adoption.

Long-term Outlook: The successful commercialization of the CellFX nsPFA Cardiac Clamp could lead to follow-on innovations and a strengthened patent portfolio for Pulse Biosciences. Investors should monitor the company's research and development pipeline for additional products that leverage nsPFA technology, as these could further solidify the company's presence in the cardiac surgery market.

Financial Analyst

Investor Considerations: The premarket notification filing is a leading indicator of Pulse Biosciences' growth trajectory. Investors should weigh the potential of the CellFX nsPFA Cardiac Clamp against the inherent risks associated with the FDA approval process. The company's stock might see increased volatility as the market reacts to FDA communications and perceived likelihood of approval.

Cost Analysis: The financial impact of the CellFX nsPFA technology on Pulse Biosciences will be multi-faceted. A successful launch could lead to increased revenues through product sales and potentially through licensing deals. However, investors should also consider the costs associated with marketing, production scaling and post-market surveillance that are integral to the successful commercialization of a new medical device.

Risk Assessment: While the preclinical data and the technology's potential are promising, there are risks to consider. These include the possibility of FDA requests for additional information, which can delay approval and the challenge of market penetration against established competitors. Investors should track the company's progress closely and be prepared for possible shifts in the investment thesis as new information becomes available.

HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel CellFX nsPFA Cardiac Clamp.

Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information from the Company based on that review. FDA guidance suggests the goal is to complete 510(k) review within 90 calendar days, not including time required by the Company to respond to additional information requests. The time required to respond to any such requests will depend on the nature of the request.

“The comparative preclinical data included in this 510(k) submission clearly demonstrates the highly differentiated safety and performance benefits of nsPFA in cardiac ablation and its potential benefit to patients and physicians. The speed and precision of delivery and the quality of the lesions, independent of tissue type or thickness, along with the impressive safety profile are unique, and I expect will drive many cardiac surgeons like me to start utilizing the CellFX nsPFA Cardiac Clamp for their patients,” said Dr. Niv Ad, Chief Science Officer, Cardiac Surgery of Pulse Biosciences. “We look forward to sharing the preclinical dataset in upcoming scientific meetings and to collaborating with the FDA throughout its review process as we advance the clamp towards clinical use.”

Pulse Biosciences’ CellFX nsPFA Cardiac Clamp is designed to produce continuous linear transmural ablations during concomitant cardiac surgical procedures using the Company’s novel CellFX system. The bipolar clamp utilizes the Company’s proprietary nsPFA technology, a nonthermal ablation technology, and preclinical data suggest nsPFA may provide safety and performance benefits over the current thermal ablation technologies for cardiac ablation, such as the use of extreme heat or cold. A single CellFX nsPFA Cardiac Clamp ablation can be done in one-twentieth of the time of current thermal ablation technologies and, due to the nonthermal mechanism of action, does not have the risk of thermal spread leading to unintended collateral damage to adjacent tissue and structures.

“In my professional opinion, with FDA and worldwide regulatory clearance, the CellFX nsPFA Cardiac Clamp may become the gold standard in cardiac ablation for cardiothoracic surgeons. The consistency of continuous transmural ablations in a fraction of the time it takes for current radiofrequency or cryothermal ablation devices, combined with the safety benefits of nsPFA's nonthermal mechanism of action, may well be rapidly adopted by cardiothoracic surgeons like myself that perform cardiac ablations routinely, ” said Dr. Gan Dunnington, Chief Medical Officer, Cardiac Surgery of Pulse Biosciences. “The CellFX nsPFA Cardiac Clamp is designed to seamlessly replace current radiofrequency ablation devices, and based on the promising preclinical data we have in hand, we believe CellFX nsPFA has the potential to both expand adoption and increase procedure effectiveness, procedure volume and significant clinical use.”

“We are beyond excited to start 2024 with another milestone in the Company’s progress into the cardiac market. We expect the CellFX nsPFA Cardiac Clamp will demonstrate the superior safety and effectiveness of nsPFA for cardiac ablation in cardiac surgery and will serve as an entry point into this large and growing market. Along with our CellFX nsPFA 360 Cardiac Catheter, we plan to surround cardiac care teams with next generation nsPFA technology to drive better patient outcomes,” said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences.

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 Nanosecond Pulsed Field Ablation (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 CellFX nsPFA could have a profound positive impact on healthcare for both patients and providers.

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 non-thermally clear cells while sparing adjacent non-cellular tissue and to have a consistent effect on the heart independent of tissue type or thickness, statements concerning the Company’s expected product development efforts, such as advancement of its cardiac clamp to treat atrial fibrillation, whether in one-twentieth of the time of current thermal ablation technologies or otherwise, statements concerning the Company’s future clinical and regulatory strategies and possible government clearances and approvals, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action and clamp design will deliver fast and precise ablations in thick cardiac tissue, statements concerning market opportunities, customer adoption and future use of the CellFX System to address a range of conditions such as atrial fibrillation, statements concerning early clinical successes and whether they are predictive of the safety and efficacy of any medical device such as the CellFX nsPFA cardiac clamp, Pulse Biosciences’ expectations, whether stated or implied, regarding whether the Company’s CellFX nsPFA technology will become a disruptive treatment option for treating atrial fibrillation or any other medical condition, 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/20240102888326/en/

Investor Contacts:

Pulse Biosciences

Kevin Danahy, President and CEO

510.241.1077

IR@pulsebiosciences.com

or

Gilmartin Group

Philip Trip Taylor

415.937.5406

philip@gilmartinir.com

Source: Pulse Biosciences, Inc.

FAQ

What is the latest announcement from Pulse Biosciences, Inc. (PLSE)?

Pulse Biosciences, Inc. (PLSE) has filed a premarket notification 510(k) to the U.S. FDA for its novel CellFX nsPFA Cardiac Clamp.

What is the goal of completing the 510(k) review by the FDA?

The goal is to complete the 510(k) review within 90 calendar days, not including time required by the Company to respond to additional information requests.

What are the potential benefits of nsPFA technology for cardiac ablation?

The potential benefits include unique safety and performance benefits over the current thermal ablation technologies, as well as the ability to produce continuous linear transmural ablations in a fraction of the time of current ablation devices.

Who are the key individuals involved in the development of the CellFX nsPFA Cardiac Clamp?

Dr. Niv Ad, Chief Science Officer, Cardiac Surgery, and Dr. Gan Dunnington, Chief Medical Officer, Cardiac Surgery, are key individuals involved in the development of the CellFX nsPFA Cardiac Clamp.

What is the potential impact of the CellFX nsPFA Cardiac Clamp in the cardiac market?

The potential impact is to become the gold standard in cardiac ablation for cardiothoracic surgeons, as well as to seamlessly replace current radiofrequency ablation devices.