Company’s proprietary system used to treat initial five patients
in first-in-human feasibility study for patients with atrial
fibrillation
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 completion of the first
five procedures in its first-in-human feasibility study with its
novel CellFX nsPFA cardiac catheter. All patients were successfully
discharged by treating physicians. Patients will continue to be
monitored and evaluated over the coming months to assess safety and
effectiveness with the primary safety endpoint at 30 days.
Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at
Mount Sinai Hospital, NY, and Dr. Petr Neuzil, Chief of Cardiology
at Na Homolce Hospital, Prague, and colleagues used the Company’s
CellFX nsPFA 360 cardiac catheter integrated with 3D mapping and
navigation technologies (iMap System, CardioNXT) to successfully
treat five patients with atrial fibrillation (AF) at Na Homolce
Hospital, a renowned research institution hospital in Prague, Czech
Republic.
“We have been collaborating with Pulse Biosciences to bring
their novel nsPFA technology to the clinical realm, and are excited
to report that our experience with these first five patients has
validated our belief that this may represent the next generation of
PFA technology for the treatment of AF,” said Dr. Reddy. “The
results were consistent with our preclinical experience.
Importantly, the speed and ease with which we were able to isolate
the pulmonary veins with the nsPFA 360 catheter was impressive and
all patients tolerated the procedure well. Now we look forward to
completing enrollment in this study to fully assess the safety and
durability of nsPFA treatment.”
Pulse Biosciences’ CellFX nsPFA 360 cardiac catheter, which is
still in the investigational stage, is uniquely designed to produce
a nonthermal ablation, initially targeted for pulmonary vein
isolation, using the Company’s proprietary CellFX nsPFA energy in
the treatment of atrial fibrillation. The catheter is designed to
deliver a fast, transmural and fully circumferential ablation in a
single energy delivery. The CellFX nsPFA cardiac catheter is
integrated with 3D mapping and navigation to deliver a
comprehensive visualization and precise ablation delivery
solution.
“We’re honored to work with Dr. Reddy and his team and Prof.
Petr Neuzil and his team at Na Homolce to bring our next generation
nsPFA technology to the clinic. The unique value of nsPFA to
deliver fast, precise, transmural and contiguous ablations in thick
cardiac tissue is extremely exciting for the treatment of AF and we
could not have found better partners,” said Dr. Gan Dunnington,
Chief Medical Officer, Cardiac Surgery of Pulse Biosciences. “This
initial clinical experience delivered as expected. We look forward
to continuing our catheter clinical program and to starting our
cardiac surgery clinical program with our surgical nsPFA clamp in
2024.”
Kevin Danahy, President and CEO of Pulse Biosciences, having
attended all patient cases, remarked on the recent milestone, “As
we embark on this new era of advancement in medical device
technology, our mission is clear: to revolutionize healthcare with
CellFX nsPFA, with the intention of significantly improving
clinical outcomes for both patients and physicians. Through
relentless innovation, unwavering dedication, and commitment to
pushing the boundaries of what is possible in bioelectric energy,
we are reshaping the future of the treatment for atrial
fibrillation with our cardiac catheter in electrophysiology and
with our cardiac clamp in cardiothoracic surgery. CellFX nsPFA will
empower doctors, inspire patients to seek life-altering treatment,
and create a world where CellFX nsPFA technology can become a
catalyst for healing and hope.”
The Company expects to enroll up to a total of 30 patients in
the current feasibility study. Treated patients will be evaluated
at regular intervals to further assess the safety and effectiveness
of the treatments. The Company expects to provide additional
updates on the first-in-human procedures with the CellFX system in
the upcoming months. Pulse Biosciences will inform stakeholders
promptly if results differ materially from the stated expectations
addressing safety and efficacy. The observations to date have been
positive but the broad set of risks associated with cardiac surgery
remain. The Company anticipates initiating the regulatory process
with the U.S. FDA and appropriate regulatory authorities worldwide
including Europe in the coming quarters and expects additional
studies will be required.
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 cardiac catheter to treat atrial fibrillation,
statements concerning the Company’s future clinical and regulatory
strategies and possible government clearances and approvals,
including the possibility of successfully enrolling up to 30
patients in the ongoing clinical study in Prague, statements
concerning whether the ongoing clinical study or any other clinical
study will show that the Company’s novel nsPFA mechanism of action
and catheter design will deliver fast, precise, transmural, and
contiguous 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 catheter, 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/20231220013371/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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