Pulse Biosciences Files 510(k) Submission with U.S. FDA for its CellFX® nsPFA™ Cardiac Clamp
02 Janvier 2024 - 2:00PM
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 Cardiac Clamp.
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) 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.
“The comparative preclinical data included in this 510(k)
submission clearly demonstrates the highly differentiated safety
and performance benefits of nsPFA in cardiac ablation and its
potential benefit to patients and physicians. The speed and
precision of delivery and the quality of the lesions, independent
of tissue type or thickness, along with the impressive safety
profile are unique, and I expect will drive many cardiac surgeons
like me to start utilizing the CellFX nsPFA Cardiac Clamp for their
patients,” said Dr. Niv Ad, Chief Science Officer, Cardiac Surgery
of Pulse Biosciences. “We look forward to sharing the preclinical
dataset in upcoming scientific meetings and to collaborating with
the FDA throughout its review process as we advance the clamp
towards clinical use.”
Pulse Biosciences’ CellFX nsPFA Cardiac Clamp is designed to
produce continuous linear transmural ablations during concomitant
cardiac surgical procedures using the Company’s novel CellFX
system. The bipolar clamp utilizes the Company’s proprietary nsPFA
technology, a nonthermal ablation technology, and preclinical data
suggest nsPFA may provide safety and performance benefits over the
current thermal ablation technologies for cardiac ablation, such as
the use of extreme heat or cold. A single CellFX nsPFA Cardiac
Clamp ablation can be done in one-twentieth of the time of current
thermal ablation technologies and, due to the nonthermal mechanism
of action, does not have the risk of thermal spread leading to
unintended collateral damage to adjacent tissue and structures.
“In my professional opinion, with FDA and worldwide regulatory
clearance, the CellFX nsPFA Cardiac Clamp may become the gold
standard in cardiac ablation for cardiothoracic surgeons. The
consistency of continuous transmural ablations in a fraction of the
time it takes for current radiofrequency or cryothermal ablation
devices, combined with the safety benefits of nsPFA's nonthermal
mechanism of action, may well be rapidly adopted by cardiothoracic
surgeons like myself that perform cardiac ablations routinely, ”
said Dr. Gan Dunnington, Chief Medical Officer, Cardiac Surgery of
Pulse Biosciences. “The CellFX nsPFA Cardiac Clamp is designed to
seamlessly replace current radiofrequency ablation devices, and
based on the promising preclinical data we have in hand, we believe
CellFX nsPFA has the potential to both expand adoption and increase
procedure effectiveness, procedure volume and significant clinical
use.”
“We are beyond excited to start 2024 with another milestone in
the Company’s progress into the cardiac market. We expect the
CellFX nsPFA Cardiac Clamp will demonstrate the superior safety and
effectiveness of nsPFA for cardiac ablation in cardiac surgery and
will serve as an entry point into this large and growing market.
Along with our CellFX nsPFA 360 Cardiac Catheter, we plan to
surround cardiac care teams with next generation nsPFA technology
to drive better patient outcomes,” said Kevin Danahy, President and
Chief Executive Officer of Pulse Biosciences.
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 and to have a consistent
effect on the heart independent of tissue type or thickness,
statements concerning the Company’s expected product development
efforts, such as advancement of its cardiac clamp to treat atrial
fibrillation, whether in one-twentieth of the time of current
thermal ablation technologies or otherwise, statements concerning
the Company’s future clinical and regulatory strategies and
possible government clearances and approvals, statements concerning
whether any clinical study will show that the Company’s novel nsPFA
mechanism of action and clamp design will deliver fast and precise
ablations in thick cardiac tissue, statements concerning market
opportunities, customer adoption and future use of the CellFX
System to address a range of conditions such as atrial
fibrillation, statements concerning early clinical successes and
whether they are predictive of the safety and efficacy of any
medical device such as the CellFX nsPFA cardiac clamp, Pulse
Biosciences’ expectations, whether stated or implied, regarding
whether the Company’s CellFX nsPFA technology will become a
disruptive treatment option for treating atrial fibrillation 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/20240102888326/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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