- Multi-center study with leading
researchers shows positive results for treatment of seborrheic
keratosis lesions with a single treatment of non-thermal Nano-Pulse
Stimulation (NPS)
- Dose-response study of clinical and
histological effects of NPS energy in human skin wins Best of Basic
Science and Translational Research Session Award
- Results to be featured at the 2018
American Society for Laser Medicine and Surgery (ASLMS) Annual
Conference in Dallas on April 11-15, 2018
Pulse Biosciences, Inc. (Nasdaq:PLSE) announced clinical
efficacy results of its first multi-center study of Nano-Pulse
Stimulation (NPS) technology for the treatment of seborrheic
keratosis lesions (SKs) in humans. The findings will be featured at
the 2018 American Society for Laser Medicine and Surgery (ASLMS)
Annual Conference to be held in Dallas on April 11-15, 2018. The
company also will present data from the first-in-human clinical
study of NPS dose-response effects. These definitive studies
establish the foundation for future therapeutic applications of NPS
across a range of benign and cancerous skin growths.
In the clinical trial of SK elimination using the novel,
non-thermal NPS technology, seborrheic keratosis lesion reduction
assessments of a single, localized SK treatment showed that 82% of
174 treated lesions were rated as clear or mostly clear after 106
days in 58 adult patients. An independent, blinded photographic
review of lesion images scored 71% of lesions as clear or mostly
clear. Patients rated 78% of lesion outcomes as satisfied or mostly
satisfied, closely mirroring investigator ratings.
Thomas Rohrer, MD, a leading dermatologic and Mohs skin cancer
surgeon in Boston, MA will present study results on Friday, April
13 at 4:37pm CST in a talk titled First Clinical Use of Non-Thermal
Nano-Pulse Stimulation to Eliminate Seborrheic Keratosis Lesions.
“These impressive results demonstrate the reliable removal of SK
lesions with a single treatment using NPS technology,” said Dr.
Rohrer. “Pulse’s NPS technology has made a significant leap from
very promising pre-clinical results to its first successful
application in the removal of a common benign skin lesion with
consistent results observed at each of the four top medical centers
participating in the study. This unique mechanism of action of
non-thermal NPS shows great potential for treating a range of
benign and non-benign skin lesions.”
In addition to Dr. Rohrer, other investigators in the SK trial
included dermatologist George Hruza, MD, a Mohs skin cancer surgeon
in St. Louis, MO; facial plastic surgeon James Newman, MD, Chief of
Plastic Surgery at Premier Plastic Surgery Clinics in the San
Francisco Bay Area, CA; and dermatologist Brian Zelickson, MD of
Minneapolis, MN, who is widely recognized for his research in skin
tissue effects related to energy-based devices.
The second publication of Pulse Biosciences research at the
energy-based science and medicine conference was conferred the
ASLMS Best of Basic Science and Translational Research Award. The
winning paper is titled A Dose-Response Study of a Novel
Non-Thermal Method of Selectively Modifying Cellular Structures in
Skin with Low Energy Nanosecond Electrical Stimulation. Clinical
results showed that NPS demonstrates a non-thermal mechanism for
targeting cellular structures with very low-grade inflammation that
does not affect the viability of the non-cellular dermal tissue
across a wide range of energy levels as evaluated by clinical and
histological responses observed in human skin. This research will
be presented on Friday, April 13 at 10:05am CST.
According to dermatopathologist Dr. Mehregan, “Our
dermatopathology lab analyzed over 200 biopsy samples from
NPS-treated human skin and observed a pattern of unique
cellular-effects that spared the non-cellular dermis at most energy
doses. These basic tissue findings demonstrate real promise for
clinical studies of multiple future clinical applications.”
Publication co-authors included plastic surgeon David Kaufman,
MD, Folsom, CA; Michelle Martinez, RN, BSN, of Kaufman Plastic
Surgery in Folsom, CA; Brian Zelickson, MD; David Mehregan, MD, of
Detroit and Monroe MI; and Pulse Biosciences contributors Richard
Nuccitelli, PhD, Edward Ebbers, and Lauren Jauregui.
“We were pleased that histology results and clinical findings
from the dose response study were predictive of the high lesion
clearance rates observed in our first controlled study of a
seborrheic keratosis treatment,” said Ed Ebbers, Vice President and
General Manager of Dermatology at Pulse Biosciences. “These
impressive safety results and robust SK efficacy rates increase our
confidence in future planned study treatments of other benign
lesions, such as keloids and warts, and non-benign skin
lesions.”
“The presentation of our initial NPS clinical data at the
prestigious ASLMS annual meeting is an important milestone for our
dermatology program and Pulse Biosciences, as we continue to build
the evidence in support of NPS as a unique and compelling treatment
modality across a number of applications,” added Darrin Uecker,
President and CEO of Pulse Biosciences.
For more information: NPS study data presented at 2018 ASLMS
Annual Meetinghttp://www.pulsebiosciences.com/ASLMS
About the SK Study
Fifty-eight (58) adult subjects in four clinical centers were
required to have at least four (4) off-face lesions within study
criteria for size, and a clinical diagnosis of SK. A local
anesthetic was injected prior to treatment with the NPS device.
Three lesions were treated in a single session, and one lesion was
left untreated as a control. Subjects returned five times over a
106-day period for physician assessment of SK lesions and the
cosmetic appearance of treated areas.
About Seborrheic Keratoses
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. 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.
About Pulse Biosciences
Pulse Biosciences is a clinical stage electroceutical, an
electrical energy based therapeutic, company pursuing commercial
applications of its proprietary Nano-Pulse Stimulation (NPS)
technology. NPS is a non-thermal, precise, focal, drug-free tissue
treatment technology utilizing nanosecond (billionth of a second)
range pulsed electric fields that directly affect the cell membrane
and intracellular structures and initiates programmed cell death in
treated cells. The unique ability of NPS to initiate cell death has
the potential to significantly benefit patients in a wide variety
of medical applications including applications in immuno-oncology
and dermatology, and other potential applications we may pursue in
the future. The initiation of programmed 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. 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. Pulse Biosciences is
investigating a variety of applications for its technology that
exploits the technology’s unique biologic effect, including
immuno-oncology and dermatology. More information is available at:
www.pulsebiosciences.com
CAUTION: Pulse Biosciences’ Nano-Pulse Stimulation (NPS) is an
investigational use therapy.
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, 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 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.
ASLMS
The American Society for Laser Medicine and Surgery, Inc.
(ASLMS) has the ultimate responsibility for the planning,
development and content of continuing education programs and
presentations, including those highlighted above. Pulse Biosciences
did not direct content or influence the planning or implementation
of The ASLMS 38th Annual Conference. The spontaneous opinions
expressed by speakers and participants during these activities
belong to those individuals.
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version on businesswire.com: https://www.businesswire.com/news/home/20180412006391/en/
Investors:Brian DowSr. Vice President and Chief Financial
OfficerIR@pulsebiosciences.comorSolebury TroutBill
KadelBkadel@Troutgroup.comorMedia:Tosk CommunicationsNadine
D. Tosk, 504-453-8344nadinepr@gmail.com
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