Pulse Biosciences Announces Positive 60-Day Follow-Up Evaluations for Initial Patients treated in the CellFX® nsPFA™ 360° Cardiac Catheter First-in-Human Feasibility Study
February 14 2024 - 8:00AM
Business Wire
Pulse Biosciences, Inc. (Nasdaq: PLSE), a company with a primary
focus on leveraging its novel and proprietary CellFX Nanosecond
Pulsed Field Ablation (nsPFA) technology for the treatment of
atrial fibrillation, today announced favorable findings from the
60-day post-procedure evaluations for four initial patients treated
in the Company’s CellFX® nsPFA™ 360° Cardiac Catheter
First-In-Human Feasibility Study.
“The 60-day remap results for the initial patients treated with
the CellFX nsPFA 360° Cardiac Catheter in this feasibility study
reveal favorable durable pulmonary vein isolation data,” said Dr.
Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount
Sinai Fuster Heart Hospital, NY. “I look forward to sharing more
details on the findings from this feasibility study, including the
results of the 60-day mapping evaluation, at an upcoming scientific
meeting. In the meantime, we are quite excited to continue to
enroll and treat patients as we progress and assess this promising
and novel CellFX nsPFA technology.”
“The 60-day treatment durability in these initial patients is an
important step toward validating our unique nsPFA AF catheter
solution. We are encouraged by the ease-of-use, speed, versatility,
and now the initial durability outcomes of our novel catheter which
is designed specifically for use with our nsPFA energy. I am
extremely proud of the enthusiastic work and commitment to
excellence manifested by team Pulse Biosciences. Our goal is to
advance and reshape, for the betterment of all involved, the
treatment of atrial fibrillation with the deployment of our CellFX
nsPFA 360° Cardiac Catheter in electrophysiology,” said Kevin
Danahy, President and Chief Executive Officer of Pulse Biosciences.
“We are excited to complete this clinical trial and further
validate our game-changing technology.”
Using the Company’s CellFX nsPFA 360° Cardiac Catheter, 14
patients with atrial fibrillation (AF) have been successfully
treated at Na Homolce Hospital in Prague, Czech Republic. Patients
treated with the Company’s CellFX nsPFA 360° Cardiac Catheter
system are being evaluated at regular intervals to further document
the safety and effectiveness of the treatments, and the Company
expects to enroll up to a total of 30 patients in the current
feasibility study. The Company has remapped the first four of the
initial 14 patients treated. The observations to date have been
positive, but the broad set of risks associated with cardiac
surgery remain.
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 (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.
Note: Dr. Reddy serves as a consultant to Pulse Biosciences (as
well as other companies developing pulsed field ablation
catheters).
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 CellFX nsPFA 360° Cardiac Catheter to treat
atrial fibrillation, statements concerning whether any clinical
study will show that the Company’s novel nsPFA mechanism of action
and catheter design will deliver fast and precise ablations in
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 360° Cardiac Catheter, 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 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/20240214460459/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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