Pulse Biosciences Announces Withdrawal and Planned Resubmission of 510(k) Application for the PulseTxTM System
September 11 2017 - 8:00AM
Business Wire
Pulse Biosciences, Inc. (Nasdaq:PLSE), a medical technology
company developing a proprietary therapeutic tissue treatment based
on its Nano-Pulse Stimulation (NPS) platform, announced today that
it has withdrawn its initial application to the United States Food
and Drug Administration (FDA) for 510(k) clearance of its PulseTxTM
System.
The voluntary withdrawal on September 8, 2017, was the result of
the FDA’s appropriate request for additional data that could not be
provided within the Agency’s 90-day review period that would have
otherwise ended on September 10, 2017. Pulse Biosciences is
committed to generating the requested data and analysis, and the
company plans to submit the supplemental information in a
subsequent 510(k) application in the coming months.
“Over the past several months, we have been engaged in very
productive and positive conversations with the FDA staff, and we
remain confident in our ability to obtain a 510(k) clearance for
the PulseTx System and more broadly for Nano-Pulse Stimulation,”
noted Darrin Uecker, Pulse Biosciences President and Chief
Executive Officer.
About Pulse Biosciences
Pulse Biosciences is a medical technology company developing a
therapeutic tissue treatment platform based on Nano-Pulse
Stimulation, a proprietary cell signaling technology. Nano-Pulse
Stimulation is a non-thermal, precise, focal drug-free tissue
treatment technology that directly affects the cell membrane and
intracellular structures to stimulate unique behaviors in cells.
NPS can initiate a cell death process that allows for the treatment
of tissue cells with minimal inflammatory response which improves
healing outcomes and supports the replacement of treated tissue
cells with healthy tissue cells. In cancerous lesions, NPS has been
shown in preclinical models to induce immunogenic cell death (ICD)
exposing the unique antigens of the treated cells to the immune
system, resulting in the generation of cytotoxic T-cells and the
mounting of an adaptive immune response targeted against those
cells. Pulse Biosciences is investigating a variety of
applications for its technology that exploits the technology’s
unique biologic effect, including immuno-oncology, dermatology, and
veterinary medicine. More information is available at
www.pulsebiosciences.com.
Forward-Looking Statements
All statements in this press release that are not historical are
forward-looking statements, including, among other things,
statements relating to Pulse Biosciences’ expectations regarding
regulatory clearance and the timing of FDA filings or approvals,
current and planned future business plans, clinical studies, other
matters related to its pipeline of product candidates, future
financial performance 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: http://www.businesswire.com/news/home/20170911005320/en/
Investors:Pulse Biosciences, Inc.Brian DowSr. Vice President and
Chief Financial OfficerIR@pulsebiosciences.comorThe Trout GroupMike
Zanoni, 646-378-2924mzanoni@troutgroup.comorMedia:Sam Brown,
Inc.Christy Curran, 615-414-8668christycurran@sambrown.com
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