Pulse Biosciences Announces First U.S. Procedure with the CellFX nsPFA Percutaneous Electrode System
09 Mayo 2024 - 7:00AM
Business Wire
Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its
novel and proprietary CellFX® Nanosecond Pulsed Field Ablation™
(nsPFA™) technology, today announced the first procedure with the
CellFX nsPFA Percutaneous Electrode System in the United States has
been completed. The successful case is the first in the Company’s
pilot program which follows the March 2024 U.S. FDA 510(k)
clearance for the ablation of soft tissue in percutaneous and
intraoperative surgical procedures with the system.
“I am very proud and excited that the first U.S. patient
treatment with soft tissue ablation by the CellFX nsPFA system was
performed this week in our Thyroid and Parathyroid Center here at
Sarasota Memorial Hospital,” said Dr. Ralph P. Tufano, Medical
Director, Head and Neck Endocrine Surgery for the Sarasota Memorial
Health Care System in Sarasota, Florida. “The cell-specific
mechanism of action of nsPFA allowed me to treat this patient with
confidence, knowing that I was not going to cause collateral damage
to acellular structures. The patient was treated for a large,
symptomatic, benign, thyroid nodule in our office with just local
lidocaine and tolerated the procedure extremely well, reporting no
pain during nsPFA energy delivery, and is doing great. Based on the
impressive results we have seen come out of Italy, I am confident
the outcome of the procedure will be excellent. I am looking
forward to continuing my collaboration with Pulse Biosciences to
further refine the procedure and offer this life-changing new
technology to my patients and to help to train other experts in
this exciting new procedure.”
The CellFX nsPFA Percutaneous Electrode System consists of a
percutaneous needle electrode for use with the Company’s
proprietary CellFX nsPFA Console. Our proprietary and 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 proprietary system is designed for non-cardiac
applications.
“Treating our first patient under our newly FDA-cleared nsPFA
percutaneous system is a fundamental and opportune milestone for
Pulse Biosciences,” said Mitch Levinson, Chief Strategy Officer of
Pulse Biosciences. “It is inspiring to see the difference our
physicians can make in their patients’ lives with our unique
proprietary technology, giving them the potential to set new
standards for safety and efficacy as well as decreased workflow
time from patient set-up to procedure finish. The administration of
local anesthesia at the treatment site with the patient awake,
without the need for general anesthesia, in cases to date, is a
noteworthy positive. Team Pulse Biosciences is deeply grateful to
Dr. Tufano for his partnership over the past 3 years. We are all
looking forward to evolving the standard of medicine as together we
optimize and introduce the CellFX nsPFA percutaneous procedure on a
controlled and measured basis through the balance of 2024.”
Thyroid nodule soft tissue ablation procedures were performed on
30 patients with the CellFX nsPFA Percutaneous System in Italy from
April 2023 through January 2024. Per amended study protocols,
patients were observed and evaluated in follow-up visits to assess
the procedure as early as one week post procedure, and up to this
point, as late as 180 days post procedure. Patient follow-ups were
conducted weekly for the first 4 weeks, then at 30-, 90-, 180-, and
360-day timepoints following the procedures. No evidence of
scarring or injury to surrounding tissue has been observed, and
patient treatments have been judged to be successful.
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 non-thermally clear cells
while sparing adjacent non-cellular tissue, statements concerning
the Company’s expected product development efforts and plans to
sell products commercially, such as its plans to demonstrate
advantages of its CellFX nsPFA Percutaneous Electrode over current
treatment options, statements concerning the timing and nature of
the Company’s pilot program to optimize and introduce the CellFX
nsPFA percutaneous procedure on a controlled and measured basis,
statements concerning customer adoption and future use of the
CellFX System to address a range of conditions, such as benign
thyroid nodules, and whether any future procedures using the CellFX
System may or may not require general anesthesia, 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, 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/20240509004793/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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