Fourth Dermatology Study Will Evaluate Nano-Pulse
Stimulation™ in Treating Cutaneous Warts
Nano-Pulse Stimulation Clinical Studies in Treating Sebaceous
Hyperplasia (SH) and Basal Cell Carcinoma Continue to Make
Progress, Strong Interim SH Results
Dr. George Hruza to Present Seborrheic Keratoses Data at the
2018 American Society for Dermatologic Surgery Annual Meeting in
Phoenix on Friday, October 12, 2018
Pulse Biosciences, Inc. (Nasdaq: PLSE) today announced the
initiation of a clinical feasibility study using its novel
Nano-Pulse Stimulation™ (NPS™) platform to treat patients with
cutaneous warts. The initiation of this feasibility study reflects
the Company’s continued efforts to develop a portfolio of
dermatologic applications building on the success of recently
completed and ongoing clinical studies.
Nano-Pulse Stimulation is a novel, precise non-thermal treatment
technology delivering nanosecond duration energy pulses that impact
cells in treated tissue while sparing surrounding acellular tissue.
With its broadly applicable cell-targeting mechanism, NPS disrupts
the functions of internal cell structures while maintaining the
outer cell membrane. The unique NPS mechanism of action has been
shown in previous clinical studies to eliminate treated cells with
mild inflammatory response that results in favorable healing and
cosmetic outcomes, making NPS well suited for a broad range of skin
lesions.
Cutaneous warts are benign grainy skin growths that are
typically caused by the human papillomavirus (HPV). According to an
updated 2018 published article, 22.8 million patients per year
suffer from warts
(https://emedicine.medscape.com/article/1133317).
This feasibility study will include up to 20 subjects at the
prestigious Scripps Clinic in San Diego, CA. Eligible subjects
receive NPS treatment(s) followed by evaluations at 7-days,
30-days, and 60-days post-initial NPS treatment. Patient
enrollment, treatment and follow-up are expected to be completed
during the first quarter of 2019.
“Although common warts are a widespread skin condition that
every dermatologist sees regularly, we do not have reliable
solutions to offer our patients,” said E. Victor Ross, M.D.,
principal investigator and leading dermatologic surgeon at Scripps
Clinic, San Diego, who is initiating the first patient treatments.
“The unique non-thermal mechanism of NPS has been shown to affect
deeper cellular structures without damaging the adjacent dermis.
Our hope is that NPS treatment can reach and eliminate these deeper
warts with better efficacy and without as much collateral tissue
damage as thermal methods like laser heating or cryogen freezing of
the tissue.”
The clinical study announced today is one of several clinical
programs underway to evaluate Pulse Biosciences’ proprietary
Nano-Pulse Stimulation therapy. Beyond the initiation of the warts
feasibility study, Pulse’s clinical programs continue to
advance:
- NPS for the treatment of Sebaceous
Hyperplasia (SH). A multi-center study to evaluate the safety
and efficacy of Nano-Pulse Stimulation for the treatment of
Sebaceous Hyperplasia, a common but difficult-to-treat facial
lesion. The study has fully enrolled, and all patient NPS
treatments have been completed. Data on the first 79 treated
lesions (approximately 35% of study total) that have reached the
final 60-day post-treatment evaluation show lesion efficacy greater
than 95%. Data collection and analysis is on schedule to be
completed during the fourth quarter of 2018. (NCT03612570)
- NPS Basal Cell Carcinoma (BCC)
Biomarker Study. A multi-center “treat and resect” study
evaluating local lesion affect and immune response changes to NPS.
Direct evidence of basal cell elimination as well as immunologic
biomarker data are being collected and analyzed in collaboration
with the Fred Hutchinson Cancer Research Center. Study completion
is slated for year-end 2018 with data to be reported during the
first quarter of 2019.
Dr. George Hruza, a research leader in dermatologic and Mohs
surgery in St. Louis, MO, will present his positive results of a
data subset demonstrating 93% clinical efficacy rate for clearing
of Seborrheic Keratoses lesions with a single treatment of
non-thermal NPS. The full dataset was presented at the 2018
American Society of Lasers, Medicine and Surgery in April. His
presentation will take place on Friday, October 12, 2018 at the
American Society for Dermatologic Surgery (ASDS) Annual Meeting in
Phoenix.
“We’re pleased with the clinical progress we’re making in
dermatology as we drive towards commercialization in this exciting
market,” said Darrin Uecker, Pulse Biosciences’ President and Chief
Executive Officer. “We continue to demonstrate safety and efficacy
in compelling dermatologic indications that also provide proof of
the NPS mechanism in support of future indications in both benign
and non-benign conditions.”
About Pulse Biosciences and Nano-Pulse Stimulation
Pulse Biosciences is a novel medical therapy company bringing to
market its proprietary Nano-Pulse Stimulation™ (“NPS™”) platform.
NPS is a novel, precise, non-thermal, treatment technology
delivering nanosecond duration energy pulses that impact cells in
treated tissue while sparing surrounding acellular tissue. NPS’s
unique mechanism of action disrupts the functions of internal cell
structures while maintaining the outer cell membrane initiating a
cascade of events within the cell that results in regulated cell
death. In pre-clinical studies, NPS has demonstrated an ability to
induce immunogenic cell death in cancer cell lines. The novel
characteristics of NPS’s unique mechanism of action has the
potential to significantly benefit patients for multiple medical
applications, including dermatology, the Company’s first planned
commercial application, with future potential in other disease
states where an enhanced immune response may be beneficial. More
information is available at
http://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.
Caution: Pulse Biosciences’ Nano-Pulse Stimulation (NPS) is an
investigational use therapy.
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version on businesswire.com: https://www.businesswire.com/news/home/20181011005259/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
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