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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)
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Dose-response study of clinical and histological effects of NPS energy
in human skin wins Best of Basic Science and Translational Research
Session Award
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Results to be featured at the 2018 American Society for Laser Medicine
and Surgery (ASLMS) Annual Conference in Dallas on April 11-15, 2018
HAYWARD, Calif.--(BUSINESS WIRE)--Apr. 12, 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 Meeting
http://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180412006391/en/
Source: Pulse Biosciences, Inc.
Investors:
Brian Dow
Sr. Vice President and Chief
Financial Officer
IR@pulsebiosciences.com
or
Solebury
Trout
Bill Kadel
Bkadel@Troutgroup.com
or
Media:
Tosk
Communications
Nadine D. Tosk, 504-453-8344
nadinepr@gmail.com
