Market Overview

Pulse Biosciences Treats Initial Patient in Its Human Study Evaluating the Effects of Nano-Pulse Stimulation in Basal Cell Carcinoma


Study aims to evaluate the cellular destruction and immune response
driven by Nano-Pulse Stimulation

Pulse Biosciences, Inc. (NASDAQ:PLSE) today announced the treatment of
the first patient in a clinical study to evaluate Nano-Pulse Stimulation
(NPS) in a common skin cancer, Basal Cell Carcinoma (BCC). Patients in
the study will be treated with NPS prior to resection of the BCC lesion,
which is the standard of care for BCC lesions. Post resection tissue
samples will be assessed for elimination of the BCC lesion in the NPS
treatment zone and for biomarkers indicating an immune response to the
NPS-treated BCC lesions. NPS is a non-thermal therapy that utilizes
ultra-short, nanosecond pulsed electric fields that directly affect and
disrupt intracellular structures and have been shown to induce
immunogenic cell death in pre-clinical cancer models.

Four leading skin cancer surgery centers in the United States will
participate in this multi-center trial, scheduled to enroll up to 75
patients with biopsy-confirmed BCC lesions that will be treated and
subsequently excised at the conclusion of the study. Both tissue and
blood samples will be evaluated to characterize BCC elimination and
changes in the immune response. A control group will be treated with
standard cryoablation treatment, commonly known as cryotherapy, and will
serve as a comparison between NPS and this commonly used method of
benign and non-benign tissue destruction.

"As a skin cancer specialist, I perform hundreds of surgical excisions
of skin cancers every year and am very excited about this initial study
to assess the potential of NPS in Basal Cell Carcinoma," said Thomas
Rohrer, M.D., of Skin Care Physicians of Chestnut Hill, MA, one of the
principal investigators in the study. "I am intrigued about the
potential of NPS to both directly eliminate treated basal cells and,
importantly, to stimulate the immune system. Demonstrating this type of
immunogenic response in BCCs may also provide important insights for
treating other types of cancers."

The purpose of the "treat and resect" human clinical study in BCC is to
take an important first step in evaluating NPS' treatment effect on
cancerous tumor cells in a human skin cancer. This unique BCC study
design provides the opportunity to obtain important NPS tissue and
immune response data. The study is expected to complete enrollment by
year-end 2018.

"We are pleased to be working with Pulse Biosciences to investigate its
NPS technology in BCC, which is a skin cancer with a high mutational
burden," said Robert H. Pierce, MD, Scientific Director of the
immunopathology Lab at the Fred Hutchinson Cancer Research Center in
Seattle, WA. "This project will leverage Fred Hutchison's expertise and
capabilities in translational oncology to assess the ability of NPS to
effectively eliminate the tumor and to increase tumor infiltrating

About the BCC Study

Pulse Biosciences expects patient enrollment during the second half of
2018 to achieve its goal of 75 enrolled patients by the end of 2018 and
complete data follow-up in Q1 2019. Principal investigators of the BCC
NPS study include the following dermatologic surgeons that specialize in
surgical removal of skin cancers (Mohs Surgeons): Dr. Christopher Harmon
in Birmingham, AL; Dr. Gilly Munavalli in Charlotte, NC; Dr. Thomas
Rohrer in Boston, MA; and Dr. Brian Zelickson in Minneapolis, MN. In
addition to Dr. Pierce, who will serve as an independent immuno-oncology
specialist, Dr. Darius R. Mehregan, Director of the Pinkus
Dermatopathology Lab in Detroit, MI will serve as an independent

"We are excited to commence the first of what we expect to be multiple
clinical studies in immuno-oncology using Nano-Pulse Stimulation with
such a highly regarded group of clinicians and scientists," said Darrin
Uecker, President and Chief Executive Officer of Pulse Biosciences.
"Data from this study, including evidence of BCC cellular destruction
and immune response changes as a result of NPS, will be important in
assessing NPS in BCC, which represents a significant opportunity, and,
potentially, in other applications."

About Pulse Biosciences and Nano-Pulse Stimulation

Pulse Biosciences is a publicly listed clinical stage electroceutical
company pursuing multiple clinical applications of its proprietary
Nano-Pulse Stimulation technology. Nano-Pulse Stimulation (NPS) is a
non-thermal, precise, focal tissue treatment technology comprised of
nanosecond (billionth of a second) range pulsed electric fields that
directly affect the cell membrane and intracellular structures and
initiate cell death in treated cells. The initiation of 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. NPS' unique mechanism of action to initiate cell
death has the potential to significantly benefit patients for multiple
medical applications in dermatology, immune-oncology, and in other
unique tissue targets. 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. More information is available at

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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