Pulse Biosciences Announces Positive Results from Its First Study Evaluating a Clinical Target at Major
Scientific Meeting
- 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 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.
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
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