Pulse Biosciences Announces Positive 60-Day Follow-Up Evaluations for Initial Patients treated in the CellFX® nsPFA™ 360° Cardiac Catheter First-in-Human Feasibility Study
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Insights
The recent findings from Pulse Biosciences regarding their CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology signify a potentially significant advancement in the treatment of atrial fibrillation (AF). The 60-day post-procedure evaluations showing favorable durable pulmonary vein isolation are critical, as the success of AF treatments is often measured by the long-term stability of pulmonary vein isolation. This stability is essential to prevent AF recurrence, which is a common issue with current treatments.
From a research perspective, the positive remap results suggest that the nsPFA technology could offer a more reliable and durable solution compared to conventional ablation techniques. The implications for patients could include fewer repeat procedures and improved quality of life. However, it's important to consider that this is preliminary data from a small cohort. A larger sample size and longer follow-up period will be necessary to validate these early results and to fully understand the potential benefits and drawbacks of this technology.
As a cardiologist, the development of a new catheter-based technology like Pulse Biosciences' nsPFA is quite promising. Atrial fibrillation is not only a common cardiac arrhythmia but also a significant contributor to stroke risk. The mention of ease-of-use and speed of the nsPFA catheter system could translate into shorter procedure times and potentially lower risks for patients. Moreover, the versatility of the catheter might allow it to be used in different types of AF cases, broadening its applicability.
While the initial results are encouraging, it is important to remain cautious until more data is available. The full spectrum of risks associated with cardiac surgeries, including potential complications from the use of this new technology, must be thoroughly evaluated in subsequent studies. The upcoming scientific meeting where more detailed findings will be presented will be pivotal in understanding the place of nsPFA in the current treatment paradigm for AF.
From an industry standpoint, the successful development and eventual commercialization of Pulse Biosciences' nsPFA technology could disrupt the current AF treatment market. This technology represents a potential shift towards less invasive and more durable treatment options. For Pulse Biosciences, positive clinical trial results could lead to increased investor confidence and a stronger market position. The ability to enroll and treat up to 30 patients in the current feasibility study is a step towards a larger pivotal trial that would be required for regulatory approval.
Considering the prevalence of AF and the associated healthcare costs, a new effective treatment option could have significant economic implications. The company's stock could see fluctuations based on the outcomes of ongoing and future clinical trials. Investors and stakeholders will be closely monitoring the progress of this technology, as its success could lead to substantial market share in the AF treatment space.
“The 60-day remap results for the initial patients treated with the CellFX nsPFA 360° Cardiac Catheter in this feasibility study reveal favorable durable pulmonary vein isolation data,” said Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY. “I look forward to sharing more details on the findings from this feasibility study, including the results of the 60-day mapping evaluation, at an upcoming scientific meeting. In the meantime, we are quite excited to continue to enroll and treat patients as we progress and assess this promising and novel CellFX nsPFA technology.”
“The 60-day treatment durability in these initial patients is an important step toward validating our unique nsPFA AF catheter solution. We are encouraged by the ease-of-use, speed, versatility, and now the initial durability outcomes of our novel catheter which is designed specifically for use with our nsPFA energy. I am extremely proud of the enthusiastic work and commitment to excellence manifested by team Pulse Biosciences. Our goal is to advance and reshape, for the betterment of all involved, the treatment of atrial fibrillation with the deployment of our CellFX nsPFA 360° Cardiac Catheter in electrophysiology,” said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. “We are excited to complete this clinical trial and further validate our game-changing technology.”
Using the Company’s CellFX nsPFA 360° Cardiac Catheter, 14 patients with atrial fibrillation (AF) have been successfully treated at Na Homolce Hospital in
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 (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
Note: Dr. Reddy serves as a consultant to Pulse Biosciences (as well as other companies developing pulsed field ablation catheters).
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, statements concerning the Company’s expected product development efforts, such as advancement of its CellFX nsPFA 360° Cardiac Catheter to treat atrial fibrillation, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action and catheter design will deliver fast and precise ablations in 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 360° Cardiac Catheter, Pulse Biosciences’ expectations, whether stated or implied, regarding whether the Company’s CellFX nsPFA technology will become a disruptive and durable 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/20240214460459/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
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