HAYWARD, Calif.--(BUSINESS WIRE)--Sep. 11, 2017--
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withdrawn its initial application to the United States Food and Drug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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170911005320/en/
Source: Pulse Biosciences, Inc.
Investors:
Pulse Biosciences, Inc.
Brian Dow
Sr. Vice
President and Chief Financial Officer
IR@pulsebiosciences.com
or
The
Trout Group
Mike Zanoni, 646-378-2924
mzanoni@troutgroup.com
or
Media:
Sam
Brown, Inc.
Christy Curran, 615-414-8668
christycurran@sambrown.com
