Pulse Biosciences, Inc. Announces Receipt of FDA Breakthrough Device Designation for CellFX® nsPFA Cardiac Surgery System for the Treatment of Atrial Fibrillation
July 08 2024 - 8:00AM
Business Wire
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Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company” or “Pulse
Biosciences”), a company leveraging its novel and proprietary
Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today
announced that it has received the Breakthrough Device Designation
from the U.S. FDA for the Company’s Cardiac Surgery System for the
ablation of cardiac tissue for the treatment of atrial fibrillation
(AF).
Pulse Biosciences’ Cardiac Surgery System with Surgical Clamp is
designed to produce durable, continuous transmural ablation lesions
during cardiac surgery procedures for the treatment of atrial
fibrillation. The bipolar clamp utilizes the Company’s proprietary
nanosecond PFA technology. Based on pre-clinical studies, a single
application of less than 2 seconds with the Surgical Clamp creates
a consistent, transmural ablation, which is significantly faster,
requiring approximately one-twentieth the time of currently
available thermal ablation technologies. Also, due to the
non-thermal mechanism of action of nano-PFA, there is no risk of
thermal spread that may cause undesired injury to collateral
tissues, which compares favorably to thermal radiofrequency
ablation.
“The science behind nanosecond pulse field ablation was
immediately compelling to me. The theoretical benefits of
short-duration, high-amplitude energy pulses with a nonthermal
mechanism of action suggest the potential for a safer and more
effective treatment. The preclinical data convinced me this
technology could significantly advance the surgical treatment of
atrial fibrillation. The FDA recognized Pulse’s Cardiac Surgery
System as Breakthrough and we look forward to continuing our work
to provide access to this technology to patients and surgeons as
quickly as possible,” said Dr. Niv Ad, Chief Science Officer,
Cardiac Surgery of Pulse Biosciences.
The Breakthrough Devices Program is a voluntary program for
certain medical devices with the potential to provide more
effective treatment or diagnosis of life-threatening or
irreversibly debilitating diseases or conditions, such as atrial
fibrillation. The Breakthrough Devices Program is intended to
provide patients and health care providers with timely access to
medical devices by speeding up development, assessment, and review
for premarket approval, 510(k) clearance, and De Novo marketing
authorization. Breakthrough Devices must still meet the FDA’s
rigorous standards for device safety and effectiveness in order to
be authorized for marketing.
“The Breakthrough Device Designation granted by the FDA is an
exciting milestone for Pulse. It emphasizes the unique potential
benefits of nanosecond PFA,” added President and Chief Executive
Officer Burke T. Barrett. “We plan to fully leverage the benefits
of this designation and have chosen to seek PMA approval to achieve
a specific indication for the treatment of atrial fibrillation. We
look forward to aligning with the FDA on a pivotal clinical trial
design in the near-term and towards initiating our planned
first-in-human cases in the Netherlands soon.”
The Company now plans to pursue the premarket approval (PMA)
application pathway for FDA approval to market as opposed to the
510(k) route, and once FDA PMA approved, commercialize the nsPFA
Cardiac Surgical System in the United States as a treatment for
atrial fibrillation. Once granted by the FDA, a specific treatment
indication would permit direct marketing of the treatment benefits
provided by the device. The Company expects to begin its pivotal
clinical trial for AF in 2025 and will provide additional details
on the study and its regulatory and commercial implications later
this year.
“The preclinical results we have generated with the Cardiac
Surgery System have been outstanding and I expect to see similar
results in the initial clinical procedures in the Netherlands later
this year. Nanosecond PFA has the potential to be a revolutionary
advancement for the surgical treatment of atrial fibrillation. I am
excited to help design the pivotal clinical trial to support a
future PMA submission,” stated Dr. Gan Dunnington, Chief Medical
Officer, Cardiac Surgery 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®
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 is now headquartered in Miami, Florida
and maintains its office in Hayward, California.
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 future
clinical studies and regulatory submissions, whether with the U.S.
FDA or otherwise, statements concerning whether any clinical study
will show that the Company’s novel nsPFA mechanism of action 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 Cardiac Surgery System,
Pulse Biosciences’ expectations, whether stated or implied,
regarding whether the Company’s CellFX nsPFA technology will become
a disruptive, superior 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/20240708028800/en/
Investors: Pulse Biosciences, Inc. Burke T. Barrett,
President and CEO IR@pulsebiosciences.com
Or
Gilmartin Group Philip Trip Taylor 415.937.5406
philip@gilmartinir.com
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