Pulse Biosciences Provides Update on FDA 510(k) Submission for the CellFX System in Dermatology
February 13 2020 - 5:44PM
Business Wire
Schedules Business Update Call on February 18, 2020 at 2:00pm
PT
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric
medicine company, today announced an update on its U.S. Food and
Drug Administration (FDA) submission for the CellFX System.
Previously, the Company submitted a 510(k) to FDA seeking clearance
to commercialize its CellFX System. On February 13, 2020, the
Company received a Not Substantially Equivalent (NSE) letter from
FDA indicating that, based on the data provided, the Company has
not demonstrated that the CellFX System is substantially equivalent
to the predicate device. The Company will continue to work with FDA
in pursuit of a clearance via a new 510(k) submission and is
prepared to provide additional clinical data as required.
“We remain highly confident in the CellFX System and its safety
and efficacy profile in aesthetic dermatology. We look forward to
continuing to work with FDA to obtain a clearance for the CellFX
system in dermatology.” said Darrin Uecker, President and CEO of
Pulse Biosciences. “We will continue to generate additional
clinical data in support of that effort with the great group of
leading dermatologists we have been collaborating with in previous
studies.”
“I am pleased our Board of Directors has approved Pulse
Biosciences to take the steps necessary to pursue a rights offering
to raise an additional $30 million in net proceeds,” said Robert
Duggan, Chairman of the Board of Directors. “In my position as our
largest shareholder, I intend to subscribe to my ownership percent
interest and all additional shares that may become available. I am
a believer in our team, our technology, and what I perceive to be a
substantive human healthcare opportunity.”
Business Update Call
The Company has scheduled a business update call for Tuesday,
February 18, 2020 at 2:00pm PT. Investors interested in listening
to the call may do so by dialing (844) 494-0190 from the US or
(508) 637-5580 from outside the US, using conference ID: 2183594. A
live and recorded webcast of the call will also be available at
http://investors.pulsebiosciences.com/.
Financial Update (Unaudited)
As of December 31, 2019, cash, cash equivalents and investments
were $25.4 million.
A registration statement relating to these securities will be
filed with the SEC and has not yet become effective. The securities
may not be sold nor may offers to buy be accepted prior to the time
the registration statement becomes effective. When available, a
copy of the prospectus may be obtained free of charge at the
website maintained by the SEC at www.sec.gov. The rights will be
issued to all shareholders as of a record date which has yet to be
determined. The subscription price for the shares also has yet to
be determined. We will provide notice of the record date and
subscription price in the future at such time as they are
determined.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of
these securities in any state or other jurisdiction in which such
offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
state. Any offer, if at all, will be made only by means of a
prospectus forming a part of the registration statement.
About Pulse Biosciences
Pulse Biosciences is a novel bioelectric medicine company
committed to health innovation that has the potential to improve
and extend the lives of patients. If approved, the CellFX System
will be the first commercial product to harness the distinctive
advantages of the Company’s proprietary Nano-Pulse Stimulation
(NPS) technology to treat a variety of applications for which an
optimal solution remains unfulfilled. NPS technology delivers
nano-second pulses of electrical energy to non-thermally clear
cells while sparing adjacent non-cellular tissue. As a
multi-application platform, the CellFX System offers customer value
with a utilization-based revenue model across an expanding spectrum
of clinical applications. Subject to regulatory approval, the
initial commercial use is expected to be in the clearance of common
and difficult-to-treat skin lesions that share high demand among
patients and practitioners for improved and durable aesthetic
outcomes that could lead to greater overall satisfaction.
Pulse Biosciences, CellFX and Nano-Pulse Stimulation are
registered trademarks of Pulse Biosciences, Inc.
Caution: Pulse Biosciences’ CellFX System and Nano-Pulse
Stimulation (NPS) technology are for investigational use only.
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 ability of the Company to prepare and provide data to FDA, the
mechanism of action of NPS treatments, current and planned future
clinical studies and the results of any such studies, other matters
related to its pipeline of product candidates, the Company’s market
opportunity, the Company’s ability to raise capital through the
rights offering or consummate the rights offering, the intention of
Robert Duggan to participate in the rights offering, the final
terms of the rights offering including the offering amount, record
date and the subscription price and the related registration
statement, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200213005947/en/
Investors: Pulse Biosciences Sandra Gardiner, EVP and CFO
510.241.1077 IR@pulsebiosciences.com or Gilmartin Group Philip Trip
Taylor 415-937-5406 philip@gilmartinir.com
Media: Tosk Communications Nadine D. Tosk 504.453.8344
press@pulsebiosciences.com
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