Multicenter Study Aims to Demonstrate NPS as
a Preferred Method for Skin Lesion Removal
Pulse Biosciences, Inc. (Nasdaq: PLSE) today announced treatment
of the first patients in its multicenter study to evaluate the
safety and efficacy of its Nano-Pulse Stimulation (NPS) technology
for eliminating Sebaceous Hyperplasia (SH), an unsightly benign
skin lesion that typically appears on facial skin and is considered
a difficult-to-treat condition with current modalities. NPS is a
non-thermal technology that utilizes ultra-short, nanosecond pulsed
electrical fields to directly affect cell membranes and
intracellular structures while sparing non-cellular tissues.
A previously published study of NPS in the treatment of
seborrheic keratosis skin lesions in 58 patients provided the first
human evidence that NPS’ mechanism of action is well suited to
target a broad range of difficult-to-treat benign and non-benign
skin lesions by targeting the cellular structures of lesions, while
sparing the surrounding non-cellular tissue of the dermal layer of
skin. The sparing of surrounding non-cellular skin tissues enables
the treatment of deeper cellular structures in the skin such as the
sebaceous glands that cause SH lesions.
According to one of the study’s principal investigators, Dr.
Gilly Munavalli, “The unique potential of NPS to target the
overactive sebaceous glands that cause these unsightly lesions
without damaging the surrounding dermal tissue shows great promise
in treating a common problem that my patients ask about every day.”
A renowned dermatologic and Mohs skin cancer surgeon, Dr. Munavalli
is the medical director and founder of Dermatology, Laser &
Vein Specialists of the Carolinas in Charlotte, NC.
Sebaceous Hyperplasia is a common benign skin condition caused
by cellular sebaceous glands in the deeper dermal layer of the skin
that become enlarged with an oily liquid called sebum, which
creates unsightly bulges, or lesions on the surface of the skin.
They present as single or multiple bulges that are yellowish,
shiny, small papules or bumps with a depressed center and a yellow
or white outer rim. If the oily facial bumps are unsightly or
embarrassing, patients often choose to have them treated for the
benefit of improved skin appearance. Sebaceous hyperplasia is
estimated to affect 1% of the healthy U.S. population.
Sebaceous Hyperplasia Study Design
The prospective multicenter study of the Pulse Biosciences NPS
device in the treatment of SH is expected to enroll up to a total
of sixty (60) patients at five leading medical centers across the
United States that specialize in the treatment of skin diseases.
Patients with a minimum of two SH lesions and up to five lesions
will be enrolled and followed for a 60-day period. The study’s
primary success measurement is the degree of clearing of benign SH
lesions as rated by the investigator at the final study visit.
Since these lesions frequently appear on the face, another
important outcome assessment is the return of normal appearance of
the skin after the lesion is cleared. Details can be found on
ClinicalTrials.gov.
Pulse Biosciences expects to complete the study by the end of
2018. In addition to Dr. Gilly Munavalli, other principal
investigators include facial plastic surgeon Dr. James Newman in
San Mateo, CA; and dermatologists, Dr. Thomas Rohrer in Boston, MA;
Dr. Suzanne Kilmer in Sacramento, CA; and Dr. Brian Zelickson in
Minneapolis, MN.
“We are pleased to begin the next clinical study of our
Nano-Pulse Stimulation technology for the treatment of Sebaceous
Hyperplasia,” said Darrin Uecker, President and CEO of Pulse
Biosciences. “We believe this study is an important next step in
developing our portfolio of dermatology applications and the
opportunity to further demonstrate the excellent safety profile and
favorable patient experience of NPS treatments as we look to
progress our NPS platform into non-benign applications.”
Ed Ebbers, Vice President and General Manager of Dermatology at
Pulse Biosciences added: “Today’s announcement marks the second
dermatology clinical program we’ve initiated to evaluate the
efficacy of our novel NPS treatment technology. In collaboration
with leading skin experts, we hope to prove the broad ability of
NPS to target cellular lesions while sparing the surrounding dermal
tissue as a unique and valuable mechanism for treating benign and
non-benign lesions, particularly the deeper lesions that are hard
to treat with available medical options.”
About Sebaceous Hyperplasia
Sebaceous Hyperplasia (SH) occurs when the sebaceous glands,
which are attached to hair follicles all over the body, become
enlarged with trapped sebum. This creates small, shiny, yellowish
lesions or bumps, usually between 2 and 4 millimeters wide, on the
skin. Sebaceous Hyperplasia typically appears on the face,
especially the forehead and nose, the back, groin, armpits and
shoulders. The bumps are harmless and painless, but some people
elect to treat them for cosmetic reasons. Sebaceous hyperplasia is
most common in middle-aged or older people, particularly those with
fair skin who have had a lot sun exposure. There is currently no
cure for sebaceous hyperplasia. Some medications, such as retinol
or oral isotretinoin, and home remedies may reduce the appearance
of bumps. Various professional methods such as chemical peels,
cryotherapy, laser therapy and electocautery are available, but a
few sessions or applications are often required for full removal
and prevention of rapid recurrence. These modalities are also
associated with a risk of skin discoloration in the treated
area.
About Pulse Biosciences and Nano-Pulse Stimulation
Pulse Biosciences is a publicly listed clinical stage
electroceutical company pursuing multiple clinical applications of
its proprietary Nano-Pulse Stimulation technology. Nano-Pulse
Stimulation (NPS) is a non-thermal, precise, focal tissue treatment
technology comprised of nanosecond (billionth of a second) range
pulsed electric fields that directly affect the cell membrane and
intracellular structures and initiates cell death in treated cells.
The initiation of cell death by NPS results in a minimal
inflammatory response, which improves healing outcomes and supports
the replacement of treated tissue cells with healthy tissue cells.
NPS’ unique mechanism of action to initiate cell death has the
potential to significantly benefit patients for multiple medical
applications in dermatology, immune-oncology, and in other unique
tissue targets. In cancerous lesions, NPS has been shown in
preclinical models to induce immunogenic cell death (ICD), which
exposes the unique antigens of the treated cells to the immune
system and enrolls immune system cells, such as cytotoxic T-cells
to mount an adaptive immune response. 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
the mechanism of action of NPS treatments, current and planned
future clinical studies, other matters related to its pipeline of
product candidates, future financial performance, regulatory
clearance and the timing of FDA filings or approvals, 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.
Pulse Biosciences’ Nano-Pulse Stimulation (NPS) is an
investigational use therapy.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180710006001/en/
Investors:Pulse Biosciences, Inc.Brian DowSr. Vice
President and Chief Financial
OfficerIR@pulsebiosciences.comorSolebury TroutGitanjali Jain Ogawa,
646-378-2949gogawa@troutgroup.comorMedia:Tosk
CommunicationsNadine D. Tosk, 504-453-8344nadinepr@gmail.com
Pulse Biosciences (NASDAQ:PLSE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Pulse Biosciences (NASDAQ:PLSE)
Historical Stock Chart
From Sep 2023 to Sep 2024