Pulse Biosciences, Inc. (Nasdaq:PLSE), a medical technology
company developing a therapeutic tissue treatment platform based on
its proprietary Nano-Pulse Stimulation (NPS) technology, today
announced treatment of the first patient in the Company’s
multi-center study evaluating the safety and efficacy of the NPS
technology for the treatment of seborrheic keratosis (SK). SK is
one of the most common types of skin lesions, impacting over 80
million patients in the United States.
“We are excited to announce the first patient treatment in this
important study of our NPS technology for a common skin lesion, one
of many types of skin lesions for which NPS’s non-thermal cellular
mechanism is uniquely well suited,” stated Ed Ebbers, Vice
President and General Manager of Dermatology at Pulse
Biosciences.
The recently initiated study is expected to include treatment of
at least 45 adult patients with four or more non-facial SK lesions.
The presence or absence of lesions will be evaluated over the
course of the 106-day period following NPS treatment. Pulse
Biosciences expects the study to be completed by the end of
2017.
“As an investigator on this study, I am excited to be involved
in evaluating this novel approach for treating SK lesions. I
believe that Nano-Pulse Stimulation has the potential to provide
patients with a unique option that is quick and easy to perform
with a potentially favorable cosmetic outcome when compared to
current treatment options, such as cryotherapy or
electrodessication” said James Newman, MD, FACS, the Stanford
University-trained Chief of Plastic Surgery at Premier Plastic
Surgery Clinics in San Mateo and Palo Alto, CA. “I frequently see
patients who are looking for an effective, cosmetically appealing
and patient-friendly treatment option for these lesions.”
In addition to Dr. Newman, principal investigators in the
multi-center study include dermatologists George Hruza, MD, in St.
Louis, MO, Thomas Rohrer, MD, in Boston, MA, and Brian Zelickson,
MD, in Edina, MN. David Kaufman, MD, a plastic surgeon in Folsom,
CA, and the principal investigator in the Company’s previous
dose-response study, will also be enrolling patients for the
study.
“We continue to make excellent progress towards demonstrating
the benefits of NPS across a number of compelling application
areas,” said Darrin Uecker, President and Chief Executive Officer
of Pulse Biosciences. “The first patient treatment in this
seborrheic keratosis study is an important milestone for Pulse
Biosciences and our dermatology program. We believe NPS offers a
unique and compelling treatment profile for both benign and
non-benign skin lesions.”
About Seborrheic Keratosis
Seborrheic keratosis (SK) typically appears as a raised skin
lesion with a waxy, scaly texture that can vary in color from light
tan to dark brown or black. It affects more than 80 million people
in the United States, and is often associated with aging skin. A
recently published study in the Journal of Clinical and Aesthetic
Dermatology found that 61% of patients took action to hide,
disguise, or distract attention from their SK lesions. The
published study also noted that 86% of SK sufferers were somewhat
or extremely interested in a removal treatment in a dermatologist’s
office and willing to pay a reasonable out-of-pocket fee.
The treatment of the first patient in the Company’s SK study
announced today represents Pulse Biosciences’ first endeavor into
the self-paying aesthetic and medical dermatology markets, which
are expected to grow to $12 billion and $29 billion, respectively,
by 2020, according to data obtained from MarketsandMarkets and GBI
Research. The selection of SK as the initial dermatology target
application for NPS builds upon the data derived from the Company’s
earlier clinical data in dermatology suggesting the unique cellular
response from NPS provides a favorable profile for successfully
treating SK, in addition to other dermatological conditions.
Leading clinicians generally agree that the effective treatment of
SK lesions with a non-surgical and nonthermal procedure represents
a highly desired alternative to patient inaction due to limitations
of existing treatments.
Pulse Biosciences’ NPS treatment is expected to offer clinicians
and patients an efficient, patient-friendly treatment alternative
that takes advantage of NPS’s unique treatment characteristics.
Specifically, NPS’s non-thermal destruction of undesired skin
lesions results in a minimal inflammatory response while
maintaining healthy structures of the treated tissue, thereby
resulting in a favorable healing profile and positive cosmetic
result. Current treatments are often invasive, painful, or carry a
significant risk of undesired cosmetic results such as scarring or
pigment changes. Over two-thirds of SK lesion removal procedures
currently entail cryosurgery, which uses the extreme cold of liquid
nitrogen (-320 degrees Fahrenheit) to destroy lesions. Other less
frequently used methods include extreme heat (high energy lasers or
radio frequency energy) to burn off SK lesions or the
scraping/shaving of SK lesions using a surgical tool called a
curette. Sometimes multiple methods are required to remove thicker
lesions.
About Nano-Pulse Stimulation
Nano-Pulse Stimulation (NPS) is a non-thermal, energy-based
technology that can stimulate unique behaviors in cells by applying
ultra-short nanosecond duration electrical pulses that affect the
cell membrane and intracellular structures. NPS can be used for
lesion removal by inducing cell death in targeted tissue cells with
minimal inflammatory response, which improves healing and supports
the replacement of treated tissue cells with healthy tissue
cells.
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’ current and planned
future clinical studies, the timing and outcomes of such trials,
expectations regarding regulatory clearance and the timing of FDA
filings or approvals, the mechanism of action of NPS treatments,
and other matters related to commercialization of and size and
growth of markets for its pipeline of product candidates 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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Pulse Biosciences, Inc.Investors:Brian DowSVP 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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