-- Nano-Pulse Stimulation Technology Highlights Plenary Talk on
“Emerging Therapies in Dermatologic Surgery”
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric
medicine company bringing to market its proprietary CellFX™ System
harnessing Nano-Pulse Stimulation™ (NPS™) technology, today
announced that it will present results of three clinical studies
demonstrating high clearance rates across its benign skin lesion
portfolio during the upcoming American Society for Dermatologic
Surgery (“ASDS”) annual meeting on October 24-27, in Chicago. The
data will span the company’s CellFX procedure using NPS non-thermal
energy in clearing Sebaceous Hyperplasia lesions, non-genital warts
and back acne. The cellular-specific NPS technology was also
selected to be featured at the opening Plenary Session, which
highlights cutting-edge science and emerging therapies in
dermatologic surgery.
“The breadth and depth of the clinical data we are presenting at
ASDS points to the tremendous progress we are making
collaboratively to advance our CellFX System across a broad range
of benign lesions,” said Darrin Uecker, President and Chief
Executive Officer of Pulse Biosciences. “These results reflect the
ongoing commitment needed to introduce the CellFX System into the
clinic to improve clinical outcomes and quality of life for
patients.”
In prior studies, investigator assessments concluded that the
NPS procedure met efficacy endpoints in 99.5% of Sebaceous
Hyperplasia lesions and 82% of Seborrheic Keratosis lesions along
with normal and expected skin recovery periods. NPS technology
delivers nano-second pulses of electrical energy to non-thermally
clear cells while sparing adjacent healthy, non-cellular
tissue.
Dr. Tom Rohrer, a dermatologic surgeon in private practice at
SkinCare Physicians in Boston, MA, and former president of the
ASDS, will spotlight NPS technology in his lecture at the “Emerging
Therapies” plenary of the Society’s annual meeting.
“I am excited to share the science and clinical data on NPS
technology because it is a first-of-its-kind bioelectric technology
that is genuinely different from existing energy-based devices,”
said Thomas Rohrer, MD. “In our clinical experience, as well as in
peer-reviewed published studies, the cellular mechanism of NPS
energy points to a rapidly evolving and dynamic new technology with
a tremendous amount of upside for our patients.”
ORAL PRESENTATIONS:
Abstracts
Lead Authors
Key Findings
Schedule
First Clinical Use of Non-Thermal
Nano-Pulse Stimulation Technology for Treating Cutaneous,
Non-Genital Warts [Feasibility Study]
E. Victor Ross, MD, Girish Munavalli,
MD
The high rate of wart size reduction
suggests the utility of the unique NPS cellular mechanism for the
treatment of non-genital, cutaneous warts. In two instances, the
control wart showed 100% reduction in size, suggesting there may be
an immune response. Based on these initial results, a larger
pivotal study is warranted and will be conducted in the future.
Thursday, October 24th 7:30 -
8:45 am Central Time
General Dermatology
Oral Abstracts
A Feasibility Study for the Treatment
of Moderate to Severe Acne Vulgaris of the Back Using Nano-Pulse
Stimulation Energy
Mark S. Nestor, MD,
Brian Berman, MD, Jessica Jones, DO,
Taraneh Matin, DO
Initial data of two male patients suggests
the positive effect of treating back acne with NPS energy. A larger
study is needed to validate these promising early results and to
focus on achieving similar acne lesion reduction efficacy while
minimizing the rate and extent of hyperpigmentation.
Thursday October 24th 8:23 - 8:25
am
General Dermatology Oral
Abstracts
Emerging Therapies in Dermatologic
Surgery
Thomas Rohrer, MD
An overview of the science, mechanism and
clinical uses of Nano-Pulse Stimulation technology for clearing
benign and malignant skin lesions.
Thursday, October 24th 10:45a
Noon Plenary Session
A Multicenter, Pivotal Study Using the
Nano-Pulse Stimulation Procedure to Treat Sebaceous Hyperplasia
Lesions [Optimization Study]
Girish Munavalli, MD
Brian Zelickson, MD, Suzanne Kilmer, MD,
Brenda LaTowsky, MD,
Elizabeth Tanzi, MD Ava Shamban, MD
This second study of SH lesions evaluated
the use of lower energy levels for relative efficacy and recovery
periods, as well as lower side effect profiles.
The data reaffirms that NPS technology is
an effective method for safely clearing SH lesions. The reduced
energy levels utilized in this study demonstrated similar levels of
efficacy as in the previous study, while reducing the time of
normal skin recovery and decreasing the rate and duration of
residual skin effects, such as hyperpigmentation and volume
loss.
Thursday, October 24th 3:00- 3:05
pm
Cosmetic Derm Surgery Oral
Abstracts
About Pulse Biosciences
Pulse Biosciences is a novel bioelectric medicine company
committed to health innovation that improves and potentially
extends the lives of patients. The CellFX System is the first
planned commercial product to harness the distinctive advantages of
the Company’s proprietary Nano-Pulse Stimulation (NPS) technology
to treat a variety of applications for which an optimal solution
remains unfulfilled. NPS technology delivers nano-second pulses of
high amplitude electrical energy to non-thermally clear cells while
sparing adjacent non-cellular tissue. The cell-specific effects of
NPS technology have been validated in a series of ongoing clinical
trials. The CellFX System is preparing to launch in 2019 as a
multi-application platform designed to address a broad range of
dermatologic conditions. As part of the customer experience, the
Company is offering a utilization-based revenue model and
easy-access customer portal offering a suite of services. CellFX
procedures offer customer value across an expanding spectrum of
clinical applications. The initial commercial use will be in the
clearance of common and difficult to treat skin lesions that share
high demand among patients and practitioners for improved and
durable aesthetic outcomes that lead to greater overall
satisfaction.
Caution: Pulse Biosciences’ CellFX System and Nano-Pulse
Stimulation technology are for investigational use only.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20191017005987/en/
Investor Relations: Pulse Biosciences, Inc. Brian Dow Sr.
Vice President and Chief Financial Officer IR@pulsebiosciences.com
or Solebury Trout Gitanjali Jain Ogawa, 646-378-2949
gogawa@troutgroup.com Media: Tosk Communications Nadine D.
Tosk, 504-453-8344 nadinepr@gmail.com
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