Pulse Biosciences Announces Continued Expansion of Its Clinical Study Programs in Dermatology
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.
Investors:
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
or
Media:
Tosk Communications
Nadine D. Tosk, 504-453-8344
nadinepr@gmail.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20181011005259/en/