Pulse Biosciences Announces Treatment of First Patients in Study to Evaluate the Safety and Efficacy of Novel Nano-Pulse Stimulation for the Treatment of Sebaceous Hyperplasia Lesions

Pulse Biosciences, Inc. (Nasdaq: PLSE) today announced treatment of the
first patients in its multicenter study to evaluate the safety and
efficacy of its Nano-Pulse Stimulation (NPS) technology for eliminating
Sebaceous Hyperplasia (SH), an unsightly benign skin lesion that
typically appears on facial skin and is considered a difficult-to-treat
condition with current modalities. NPS is a non-thermal technology that
utilizes ultra-short, nanosecond pulsed electrical fields to directly
affect cell membranes and intracellular structures while sparing
non-cellular tissues.

A previously published study of NPS in the treatment of seborrheic
keratosis skin lesions in 58 patients provided the first human evidence
that NPS’ mechanism of action is well suited to target a broad range of
difficult-to-treat benign and non-benign skin lesions by targeting the
cellular structures of lesions, while sparing the surrounding
non-cellular tissue of the dermal layer of skin. The sparing of
surrounding non-cellular skin tissues enables the treatment of deeper
cellular structures in the skin such as the sebaceous glands that cause
SH lesions.

According to one of the study’s principal investigators, Dr. Gilly
Munavalli, “The unique potential of NPS to target the overactive
sebaceous glands that cause these unsightly lesions without damaging the
surrounding dermal tissue shows great promise in treating a common
problem that my patients ask about every day.” A renowned dermatologic
and Mohs skin cancer surgeon, Dr. Munavalli is the medical director and
founder of Dermatology, Laser & Vein Specialists of the Carolinas in
Charlotte, NC.

Sebaceous Hyperplasia is a common benign skin condition caused by
cellular sebaceous glands in the deeper dermal layer of the skin that
become enlarged with an oily liquid called sebum, which creates
unsightly bulges, or lesions on the surface of the skin. They present as
single or multiple bulges that are yellowish, shiny, small papules or
bumps with a depressed center and a yellow or white outer rim. If the
oily facial bumps are unsightly or embarrassing, patients often choose
to have them treated for the benefit of improved skin appearance.
Sebaceous hyperplasia is estimated to affect 1% of the healthy U.S.
population.

Sebaceous Hyperplasia Study Design

The prospective multicenter study of the Pulse Biosciences NPS device in
the treatment of SH is expected to enroll up to a total of sixty (60)
patients at five leading medical centers across the United States that
specialize in the treatment of skin diseases. Patients with a minimum of
two SH lesions and up to five lesions will be enrolled and followed for
a 60-day period. The study’s primary success measurement is the degree
of clearing of benign SH lesions as rated by the investigator at the
final study visit. Since these lesions frequently appear on the face,
another important outcome assessment is the return of normal appearance
of the skin after the lesion is cleared. Details can be found on
ClinicalTrials.gov.

Pulse Biosciences expects to complete the study by the end of 2018. In
addition to Dr. Gilly Munavalli, other principal investigators include
facial plastic surgeon Dr. James Newman in San Mateo, CA; and
dermatologists, Dr. Thomas Rohrer in Boston, MA; Dr. Suzanne Kilmer in
Sacramento, CA; and Dr. Brian Zelickson in Minneapolis, MN.

“We are pleased to begin the next clinical study of our Nano-Pulse
Stimulation technology for the treatment of Sebaceous Hyperplasia,” said
Darrin Uecker, President and CEO of Pulse Biosciences. “We believe this
study is an important next step in developing our portfolio of
dermatology applications and the opportunity to further demonstrate the
excellent safety profile and favorable patient experience of NPS
treatments as we look to progress our NPS platform into non-benign
applications.”

Ed Ebbers, Vice President and General Manager of Dermatology at Pulse
Biosciences added: “Today’s announcement marks the second dermatology
clinical program we’ve initiated to evaluate the efficacy of our novel
NPS treatment technology. In collaboration with leading skin experts, we
hope to prove the broad ability of NPS to target cellular lesions while
sparing the surrounding dermal tissue as a unique and valuable mechanism
for treating benign and non-benign lesions, particularly the deeper
lesions that are hard to treat with available medical options.”

About Sebaceous Hyperplasia

Sebaceous Hyperplasia (SH) occurs when the sebaceous glands, which are
attached to hair follicles all over the body, become enlarged with
trapped sebum. This creates small, shiny, yellowish lesions or bumps,
usually between 2 and 4 millimeters wide, on the skin. Sebaceous
Hyperplasia typically appears on the face, especially the forehead and
nose, the back, groin, armpits and shoulders. The bumps are harmless and
painless, but some people elect to treat them for cosmetic reasons.
Sebaceous hyperplasia is most common in middle-aged or older people,
particularly those with fair skin who have had a lot sun exposure. There
is currently no cure for sebaceous hyperplasia. Some medications, such
as retinol or oral isotretinoin, and home remedies may reduce the
appearance of bumps. Various professional methods such as chemical
peels, cryotherapy, laser therapy and electocautery are available, but a
few sessions or applications are often required for full removal and
prevention of rapid recurrence. These modalities are also associated
with a risk of skin discoloration in the treated area.

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
initiates 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 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.

Pulse Biosciences’ Nano-Pulse Stimulation (NPS) is an investigational
use therapy.

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