Pulse Biosciences Provides an Update on Recent FDA 510(k) Submission
February 08 2022 - 8:45AM
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 an
update to its recent U.S. Food and Drug Administration (FDA) 510(k)
submission to add the specific indication for treatment of
sebaceous hyperplasia to expand the CellFX System’s current
labeling.
The Company submitted a 510(k) in December 2021 to add the
treatment of sebaceous hyperplasia to the CellFX System’s
indications for use in the United States. On February 5, 2022, the
Company received an Additional Information (“AI”) letter from the
FDA in response to the 510(k) submitted. In the AI letter, the FDA
stated it did not believe the Company provided sufficient clinical
evidence at this time to support the expanded indication for use,
and that the Company had not met the primary endpoints of the
sebaceous hyperplasia FDA-approved IDE study. The Company
anticipates meeting with the FDA to discuss the contents of the AI
letter and potential next steps, which may require additional
clinical data and potentially a new 510(k) submission. The AI
letter is a standard part of the 510(k) review process and places
the review on hold until the Company responds within 180 days of
the request in the AI letter. Based on FDA guidance, the Company
believes its meeting with the FDA will take place in Q1 2022.
In Europe, the CellFX System is approved for the treatment of
sebaceous hyperplasia, seborrheic keratosis and non-genital warts.
In the United States, the CellFX System is cleared for dermatologic
procedures requiring ablation and resurfacing of the skin and
intended use of treating benign lesions.
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 regarding
its ongoing discussions with the FDA about the Company’s sebaceous
hyperplasia clinical study and its ability to address the FDA’s
concerns, statements about the Company’s clinical and regulatory
plans, including statements about potential future regulatory
clearances more generally, statements relating to the effectiveness
of the Company’s NPS technology and the CellFX System to improve
patient outcomes, statements relating to the Company’s current and
planned future clinical studies, including the Company’s ability to
execute such studies, and the anticipated results of any such
studies, statements relating to the Company’s pipeline of product
candidates, market opportunities and commercial plans, as well as
other future events. These statements are not historical facts but
rather are based on Pulse Biosciences’ current expectations,
estimates, and projections regarding its 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 U.S. 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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version on businesswire.com: https://www.businesswire.com/news/home/20220208005812/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
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