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     113  0 Kommentare Pulse Biosciences Announces FDA 510(k) Clearance for its CellFX nsPFA Percutaneous Electrode System - Seite 2

    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, 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 nonthermally clear cells without damaging adjacent noncellular structures or inducing thermal necrosis, statements concerning the Company’s expected product development efforts, such as commercial launch of its CellFX nsPFA Percutaneous Electrode System for soft tissue ablation in percutaneous and intraoperative surgical procedures, statements concerning the Company’s manufacturing and operational readiness to initiate a commercial launch of any product, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action and percutaneous electrode design will deliver fast and precise soft tissue ablations without evidence of residual scarring, statements concerning market opportunities, customer adoption and future use of the CellFX System to address a range of conditions such as benign thyroid nodules, statements concerning early clinical successes and whether they are predictive of the safety and efficacy of any medical device such as the CellFX nsPFA Percutaneous Electrode System, 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 any 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.

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    Pulse Biosciences Announces FDA 510(k) Clearance for its CellFX nsPFA Percutaneous Electrode System - Seite 2 Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its novel …

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