Pulse Biosciences Receives FDA 510(k) Clearance of Expanded Energy Settings for use with the CellFX® System

Rhea-AI Summary

Pulse Biosciences, Inc. (NASDAQ: PLSE) has received FDA 510(k) clearance for expanded energy settings for its CellFX System in dermatology. This allows U.S. clinicians to offer more customized treatment options for benign lesions. The FDA's expedited review took only 53 days, confirming the new settings' safety and efficacy. The CellFX System, powered by Nano-Pulse Stimulation technology, aims to improve dermatologic outcomes and deliver value through a utilization-based revenue model. The company remains committed to advancing its technology and expanding clinical applications.

Positive

• FDA clearance for expanded energy settings supports product capability.
• 53-day FDA review indicates strong data and effective communication with regulators.
• Customized treatment options enhance market competitiveness.

Negative

• None.

HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance of expanded energy settings for use with the family of CellFX System treatments tips in dermatology.

“Pulse Biosciences is dedicated to providing dermatologists a superior solution for the treatment of benign lesions and to advancing the CellFX System and its capabilities. Clinicians in the U.S. are now able to access broader treatment settings to provide more customized energy delivery specific to individual lesions,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “We are pleased with how quickly the FDA cleared these new energy settings based on the data we provided, requiring 53 of the allotted 90-day review period, to determine that the expanded settings are safe and effective for use with the CellFX System. We appreciate the ongoing collaboration with FDA as we continue to expand the clinical applications for the CellFX System.”

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 Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The CellFX® System is the first commercial product to harness the distinctive advantages of NPS technology to treat a variety of applications for which an optimal solution remains unfulfilled. The initial commercial use of the CellFX System is to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model. Visit pulsebiosciences.com to learn more.

To stay informed about the CellFX System, please visit CellFX.com and sign-up for updates.

Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS 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 Pulse Biosciences’ expectations concerning customer adoption and future use of the CellFX System to address a range of dermatologic conditions, statements relating to the effectiveness of the Company’s NPS technology and the CellFX System to improve the quality of life for patients, and Pulse Biosciences’ expectations, whether stated or implied, regarding its rights offering, financing plans 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/20220804005400/en/

Investors:

Pulse Biosciences

Sandra Gardiner, EVP and CFO

510.241.1077

IR@pulsebiosciences.com

or

Gilmartin Group

Philip Trip Taylor

415.937.5406

philip@gilmartinir.com

Media:

Tosk Communications

Nadine D. Tosk

504.453.8344

nadinepr@gmail.com or

press@pulsebiosciences.com

Source: Pulse Biosciences, Inc.

FAQ

What recent FDA approval did Pulse Biosciences (PLSE) receive?

Pulse Biosciences received FDA 510(k) clearance for expanded energy settings for its CellFX System.

How long did the FDA take to review Pulse Biosciences' application?

The FDA completed the review in just 53 days.

What benefits does the expanded energy setting provide to dermatologists?

It allows for more customized energy delivery for treating benign lesions.

What is the technology behind the CellFX System?

The CellFX System uses Nano-Pulse Stimulation technology to treat dermatologic conditions.

How does Pulse Biosciences plan to expand its clinical applications?

The company aims to continue advancing the capabilities of the CellFX System and enhance treatment options.