Pulse Biosciences Files 510(k) Submission with U.S. FDA for its CellFX nsPFA Percutaneous Electrode
21 Novembro 2023 - 10:00AM
Business Wire
Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily
focused on leveraging its novel and proprietary CellFX Nanosecond
Pulsed Field Ablation (nsPFA) technology for the treatment of
atrial fibrillation, today announced the filing of a premarket
notification 510(k) to the U.S. Food and Drug Administration (FDA)
for its novel CellFX nsPFA percutaneous electrode.
The Company’s percutaneous electrode is an image-guided needle
designed to harness CellFX nsPFA energy to deliver precise and
complete nonthermal ablation of cellular tissue without damage to
noncellular structures. The percutaneous electrode is designed for
non-cardiac applications.
“We are very happy to make this announcement earlier than
expected in part due to the efficiency of the FDA’s new electronic
submission platform,” said Kevin Danahy, President and Chief
Executive Officer of Pulse Biosciences. “We look forward to
collaborating with the FDA throughout the review process.”
Pursuant to Section 510(k), once the application has been
accepted, the FDA will conduct its substantive review and may
request additional information from the Company based on that
review. FDA guidance suggests the goal is to complete 510(k)
substantive review within 90 calendar days, not including time
required by the Company to respond to additional information
requests. The time required to respond to any such requests will
depend on the nature of the request.
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 Ablation (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 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 non-thermally clear cells
while sparing adjacent non-cellular tissue, statements concerning
the Company’s expected product development efforts, such as
advancement of its percutaneous electrode to treat benign thyroid
nodules, statements concerning the Company’s future regulatory
strategies and possible government clearances and approvals,
including a possible clearance of the percutaneous electrode within
approximately 90 days, statements concerning market opportunities,
customer adoption and future use of the CellFX System to address a
range of conditions such as atrial fibrillation and 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 percutaneous electrode, Pulse Biosciences’
expectations, whether stated or implied, regarding whether the
Company’s CellFX nsPFA technology will become a disruptive
treatment option for treating benign thyroid nodules or any other
medical condition and whether future clinical studies will show the
CellFX System is safe and effective to treat benign thyroid nodules
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231121602596/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
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