Pulse Biosciences Announces FDA 510(k) Clearance for its CellFX® nsPFA™ Percutaneous Electrode System
08 März 2024 - 7:17PM
Business Wire
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 CellFX nsPFA
Percutaneous Electrode System for use in the ablation of soft
tissue in percutaneous and intraoperative surgical procedures.
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the full release here:
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CellFX nsPFA Percutaneous Electrode
System (Source: Pulse Biosciences, Inc.)
“The FDA clearance of our Percutaneous Electrode System is the
initial major milestone for Pulse Biosciences in surgery. It opens
a new set of clinical applications and opportunities wherein our
proprietary, one of a kind, patented CellFX nsPFA technology is
highly differentiated and holds the potential to change the present
time standard of care. I couldn’t be more proud of the engineering,
clinical and regulatory teams at Pulse Biosciences for their
commitment to bringing the safety and effectiveness benefits of
nsPFA to our physician, caretaker and patient partners,” said Kevin
Danahy, President and Chief Executive Officer of Pulse Biosciences.
“Internally, our team is pleased with its manufacturing and
operational readiness as we initiate our training and
commercialization programs in the coming weeks. We look forward to
providing additional details and color on these commercial programs
in our upcoming fourth quarter and full year 2023 earnings
conference call scheduled for Thursday, March 28, 2024.”
The CellFX nsPFA Percutaneous Electrode System consists of a
percutaneous needle electrode for use with the Company’s
proprietary CellFX nsPFA Console. The novel electrode is designed
to harness and deliver the key advantages of nsPFA energy, enabling
precise, nonthermal removal of cellular tissue without damage to
noncellular structures or inducing thermal necrosis. This
percutaneous electrode is designed for non-cardiac
applications.
“The CellFX nsPFA Percutaneous Electrode System represents a
much needed and promising new minimally invasive nonthermal
treatment option for patients. For physicians, the system offers
intuitive usability, short procedure times and customizable energy
delivery to treat a variety of patients requiring soft tissue
ablation,” said Dr. Ralph P. Tufano, the Company’s Senior Advisor
and Scientific Advisory Board Chair, Head and Neck Surgery,
Clinical Professor of Surgery at the Florida State University
College of Medicine and Medical Director, Head and Endocrine
Surgery for the Sarasota Memorial Health Care System in Sarasota,
Florida. “I am extremely encouraged by the early study results by
my colleague, Professor Stefano Spiezia, demonstrating the rapid
clearance of ablated cellular tissue and absence of any evidence of
thermal damage or residual scarring.”
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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version on businesswire.com: https://www.businesswire.com/news/home/20240307706065/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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