• Image 01
  • Image 02
  • Image 03
  • Image 04
  • Image 05
  • Image 06
Need assistance? Contact Us: 1-800-255-5897

Menu

  • Home
  • About Us
    • Company Overview
    • Management Team
    • Board of Directors
  • Your Loan Service Center
  • MAKE A PAYMENT
  • Business Service Center
  • Contact Us
  • Home
  • About Us
    • Company Overview
    • Management Team
    • Board of Directors
  • Your Loan Service Center
  • MAKE A PAYMENT
  • Business Service Center
  • Contact Us
Recent Quotes
View Full List
My Watchlist
Create Watchlist
Indicators
DJI
Nasdaq Composite
SPX
Gold
Crude Oil
Markets
Stocks
ETFs
Tools
Markets:
Overview
News
Currencies
International
Treasuries

Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia

By: Pulse Biosciences, Inc. via Business Wire
September 26, 2022 at 08:00 AM EDT

Additional 510(k) clearance recently received for use of larger spot size treatment tips with the CellFX System

Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. This specific indication clearance enhances the CellFX System’s general indication FDA clearance and enables the Company to support clinics in marketing and promoting CellFX treatments specifically for patients with sebaceous hyperplasia. The clearance was based on clinical data from the Company’s IDE approved study for the treatment of sebaceous hyperplasia.

The Company also recently received FDA 510(k) clearance of two additional treatment tips with larger spot sizes, specifically 7.5mm and 10mm tip sizes, for treating larger benign lesions. These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm and 5.0mm treatment tip sizes.

“We are pleased with the continued advancement of the CellFX System and its capabilities to enhance its value proposition for patients, clinicians and any potential commercial partner. These clearances provide further validation of the system’s strong safety and effectiveness profile,” said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. “We would like to thank all of the investigators, the staff at their clinics and the patients who participated in these trials, as well as the FDA for their ongoing collaboration as we endeavor to offer the benefits of NPS technology to more patients.”

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 conditions for which an optimal solution remains unfulfilled. The Company is actively pursuing application development in cardiology, oncology, gastroenterology, and other medical specialties. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model. Visit www.pulsebiosciences.com to learn more.

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 Company’s future product development in healthcare outside of dermatology and the Company’s other activities to develop and commercialize NPS technology to drive growth, statements about the Company’s ability to pursue and complete strategic transactions and its prospects to partner any of its programs, whether in dermatology or otherwise, 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 whether any regulatory clearances will enhance the value proposition of the CellFX System for patients, clinicians or others, 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/20220926005228/en/

Contacts

Investors:

Pulse Biosciences

Kevin Danahy, CEO

510.241.1077

IR@pulsebiosciences.com

or

Gilmartin Group

Philip Trip Taylor

415.937.5406

philip@gilmartinir.com

More News

View More
Johnson & Johnson's M&A Strategy Is the Real Story for Investors
Today 12:04 EDT
Via MarketBeat
Tickers JNJ KVUE PTGX
Tesla: Some Analysts Are Calling for A 30% Drop—Time to Panic?
Today 9:36 EDT
Via MarketBeat
Topics Artificial Intelligence
Tickers TSLA
Hedge Funds Flip on the Dollar—A Buy Signal for These 3 Stocks?
Today 8:35 EDT
Via MarketBeat
Topics Bonds Stocks World Trade
Tickers ABNB DAL DOW HD
Happy Third Birthday to the Bull Market
Today 8:22 EDT
Via MarketBeat
Topics Artificial Intelligence Stocks
Tickers NVDA PLTR TSLA
MarketBeat Week in Review – 10/13 - 10/17
Today 7:00 EDT
Via MarketBeat
Topics Artificial Intelligence Economy World Trade
Tickers ACHR AMZN APLD APP ASTS CRM

Recent Quotes

View More
Symbol Price Change (%)
AMZN  213.04
-1.43 (-0.67%)
AAPL  252.29
+4.84 (1.96%)
AMD  233.08
-1.48 (-0.63%)
BAC  51.28
+0.84 (1.67%)
GOOG  253.79
+1.91 (0.76%)
META  716.91
+4.84 (0.68%)
MSFT  513.58
+1.97 (0.39%)
NVDA  183.16
+1.35 (0.74%)
ORCL  291.31
-21.69 (-6.93%)
TSLA  439.31
+10.56 (2.46%)
FinancialContent
Stock Quote API & Stock News API supplied by www.cloudquote.io
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the Privacy Policy and Terms Of Service.
© 2025 FinancialContent. All rights reserved.

Having difficulty making your payments? We're here to help! Call 1-800-255-5897

Copyright © 2019 Franklin Credit Management Corporation
All Rights Reserved
Contact Us | Privacy Policy | Terms of Use | Sitemap