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Pulse Biosciences Submits 510(K) to U.S. FDA for CellFX™ System


Pulse Biosciences, Inc. (NASDAQ:PLSE), a novel medical therapy company
bringing to market its proprietary CellFX™ System today announced the
Premarket Notification 510(k) submission to the U.S. Food and Drug
Administration (FDA) for its CellFX System. The Company's FDA filing
requests clearance of the CellFX System for commercial use in common
dermatologic procedures to remove general benign lesions including
sebaceous hyperplasia (SH), a common but difficult to treat facial
lesion and seborrheic keratosis (SK), the most common benign raised
pigmented lesion.

Pursuant to Section 510(k), once the application has been accepted, the
FDA will conduct its substantive review and may request additional
information from the Company based on that review. FDA guidance suggests
the goal for FDA 510(k) review is 90 calendar days, not including time
required by the Company to respond to additional information requests.
The time required to respond to such requests will depend on the nature
of the request.

"We are pleased to announce this important milestone, a key step in
bringing the CellFX System to the aesthetic dermatology market," said
Darrin Uecker, President and Chief Executive Officer. "Our FDA
submission announced today is supported by the safety and efficacy data
from our clinical studies as well as pre-clinical and bench data in
support of the use of the CellFX System in dermatology. We look forward
to working with FDA throughout the review process and to achieving our
goal of an FDA clearance that will lead to commercialization."

About Pulse Biosciences

Pulse Biosciences is a novel medical therapy company bringing to market
its proprietary CellFX™ System. The Company's novel CellFX System
provides a precise, non-thermal delivery of nanosecond duration energy
pulses that impact cells in treated tissue while sparing acellular
tissue. This 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. The novel characteristics of the Company's CellFX System has
the potential to significantly benefit patients across multiple medical
applications, including dermatology, the Company's first planned
commercial application. In pre-clinical studies, NPS has demonstrated an
ability to induce immunogenic cell death in several cancer cell lines.
The Company believes its NPS platform technology may play a role in
immuno-oncology as a focal tumor treatment that can initiate an adaptive
immune response. More information can be found 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 or implying Pulse Biosciences' expectations regarding
commercialization of the CellFX System, regulatory clearance and the
timing of FDA filings or approvals for products and indications, matters
related to its pipeline of product candidates, future financial
performance and business strategies 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. 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' CellFX System and Nano-Pulse
Stimulation (NPS) are for investigational use only.

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