Pulse Biosciences Updates on Regulatory Progress
December 18 2019 - 9:00AM
Business Wire
Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company), a novel
bioelectric medicine company bringing to market its proprietary
CellFX™ System, today announced an update to its regulatory
timeline with the Food and Drug Administration (FDA). In connection
with the ongoing review of the Company’s 510(k) submission for its
CellFX System in dermatology, the Company requested a face-to-face
meeting with the FDA to discuss its proposed final responses. Due
to holiday schedules within the FDA, the meeting is planned for the
first half of January. The Company expects to submit its final
responses to the FDA following the meeting, and based on FDA
feedback, anticipates the 510(k) review to be concluded by the end
of January.
“We look forward to meeting with the FDA and believe
face-to-face meetings are an important part of the regulatory
process and are consistent with our efforts to develop a long-term
and collaborative relationship with the Agency,” said Darrin
Uecker, President and Chief Executive Officer of Pulse Biosciences.
“Though we hoped to have the meeting in December, we appreciate the
FDA’s efforts to schedule the meeting as soon as resources were
available, and for providing clarity on timing after we submit our
final responses. We understand this timing is important to all our
stakeholders and we will continue to provide updates as
appropriate.”
About Pulse Biosciences
Pulse Biosciences is a novel bioelectric medicine company
committed to health innovation that improves and potentially
extends the lives of patients. The CellFX System is the first
planned 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. The cell-specific effects of NPS
technology have been validated in a series of ongoing clinical
trials. The CellFX System is a multi-application platform designed
to address a broad range of dermatologic conditions. As part of the
customer experience, the Company is offering a utilization-based
revenue model and easy-access customer portal offering a suite of
services. CellFX procedures offer customer value across an
expanding spectrum of clinical applications. The initial commercial
use will 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 lead to greater
overall satisfaction.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the Company’s CellFX System,
including the progress and timing of the FDA’s review of the
Company’s 510(k) submission, the commercialization of the Company’s
Cell FX System, and the results of clinical study plans. These
forward-looking statements are based on current expectations and
estimates and involve a number of risks and uncertainties that
could cause actual results to differ materially from those
suggested or implied by the forward-looking statements. These
forward-looking statements should, therefore, be considered in
light of various important factors, including, but not limited to,
the following: the impact of governmental regulatory agencies,
including the FDA, and regulatory approvals, clearances and
restrictions or any dispute that may occur with any regulatory
body; risks inherent to the planning, design and execution of
clinical studies; the timing and success of product development;
and other risk factors under the heading “Risk Factors” in the
Company’s most recently filed quarterly report on Form 10-Q and as
periodically updated by the Company’s subsequent filings with the
Securities and Exchange Commission. Statements using words such as
“estimates,” “projects,” “believes,” “anticipates,” “plans,”
“expects,” “intends,” “may,” “will,” “could,” “should,” “would,”
“targeted” and similar words and expressions are intended to
identify forward-looking statements. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release. Pulse Biosciences, Inc.
undertakes no obligation to publicly update or release any
revisions to these forward-looking statements, except as required
by law.
Caution: Pulse Biosciences’ CellFX System and Nano-Pulse
Stimulation (NPS) technology are for investigational use only.
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version on businesswire.com: https://www.businesswire.com/news/home/20191218005207/en/
Investor Relations: Pulse Biosciences, Inc. Darrin Uecker
President and Chief Executive Officer IR@pulsebiosciences.com or
Solebury Trout Gitanjali Jain Ogawa, 646-378-2949
gogawa@troutgroup.com Media: Tosk Communications Nadine D.
Tosk, 504-453-8344 nadinepr@gmail.com
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