Venus Concept Inc. Announces CE Mark and Health Canada License to Market Venus Epileve
November 26 2019 - 6:05AM
Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ:
VERO), a global medical aesthetic technology leader, today
announced that it has received a medical device license issued by
Health Canada and CE Mark from DEKRA Certification B.V. to market
Venus Epileve. It is intended as a treatment for hirsutism,
permanent hair reduction and pseudofolliculitis barbae in Europe,
and for hair removal, permanent hair reduction, and the treatment
of pseudofolliculitis barbae in Canada.
Venus Epileve represents a new product introduction that expands
the Company’s diode laser hair removal offering beyond the Venus
Velocity which was introduced to the medical aesthetics market in
2017. The Venus Epileve is cost-effective, fast, comfortable, and
can be used on all skin types (Fitzpatrick skin types I-VI),
including tanned skin. The Venus Epileve is a portable and
versatile tabletop device that offers two modes of operation (SLIDE
and PULSE) and a real-time cooling system aimed at ensuring patient
safety and comfort. The Venus Epileve is integrated with Internet
of Things (IoT) technology that collects technical information to
help providers enhance business operations and improve treatment
efficiency.
“The receipt of CE Mark and Health Canada Authorization for our
new laser hair removal solution, the Venus Epileve, represents
another example of Venus Concept’s ability to introduce new and
innovative solutions designed specifically for the non-traditional
aesthetics market,” said Domenic Serafino, Chief Executive Officer
and Director of Venus Concept Inc. “Building on the success of the
Venus Velocity, we designed the Venus Epileve as a cost-effective
laser hair removal solution for customers outside of the medical
aesthetics market. We are preparing for a limited launch of the
Venus Epileve in Europe and Canada beginning in the second quarter
of 2020 with the full launch targeted for the second half of 2020.
We look forward to the commercial expansion of Venus Epileve in
these markets contributing to our solid growth profile next year
and we expect our expanded portfolio of laser hair removal
solutions will help us further penetrate the $1.4 billion global
hair removal market1 in the years to come.”
About Venus Concept
Venus Concept is an innovative global medical aesthetic
technology leader with a broad product portfolio of minimally
invasive and non-invasive medical aesthetic technologies and reach
in over 60 countries and 29 direct markets. Venus Concept focuses
its product sales strategy on a subscription-based business model
in North America and in its well-established direct global markets.
Venus Concept’s product portfolio consists of aesthetic device
platforms, including Venus Versa, Venus Legacy, Venus Velocity,
Venus Fiore, Venus Viva, Venus Freeze Plus, and Venus Bliss. Venus
Concept’s hair restoration division includes NeoGraft, an automated
hair restoration system that facilitates the harvesting of
follicles during a FUE process and the ARTAS® and ARTAS iX™ Robotic
Hair Restoration Systems, which harvest follicular units directly
from the scalp and create recipient implant sites using proprietary
algorithms. Venus Concept has been backed by leading healthcare
industry growth equity investors including EW Healthcare Partners
(formerly Essex Woodlands), HealthQuest Capital, Longitude Capital
Management, and Aperture Venture Partners.
Cautionary Statement Regarding Forward-Looking
Statements
This communication contains “forward-looking” statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. These
statements, as they relate to Venus Concept, including the expected
revenue, operating results and other financial information, involve
risks and uncertainties that may cause results to differ materially
from those set forth in the statements. These statements are based
on current plans, estimates and projections, and therefore, you are
cautioned not to place undue reliance on them. No forward-looking
statement can be guaranteed, and actual results may differ
materially from those projected. Venus Concept undertakes no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise,
except to the extent required by law. Forward-looking statements
are not historical facts, but rather are based on current
expectations, estimates, assumptions and projections about the
business and future financial results of the medical device
industry, and other legal, regulatory and economic developments. We
use words such as “anticipates,” “believes,” “plans,” “expects,”
“projects,” “future,” “intends,” “may,” “should,” “could,”
“estimates,” “predicts,” “potential,” “continue,” “guidance,” and
similar expressions which are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Actual results could differ materially
from the results contemplated by these forward-looking statements.
Material factors that could cause actual results to differ
materially from current expectations include, without limitation,
the following: the progress of the commercialization, marketing and
manufacturing capabilities for the combined company’s products; the
number of Venus Concept systems that are sold; the success of the
commercial launch of Venus Bliss; the timing or likelihood of
regulatory filings and approvals for products; the expected
synergies from the merger; and the expected revenue for the
combined company. Venus Concept cannot give any assurances that the
combined company will achieve its expectations. The foregoing list
of factors is not exhaustive. You should carefully consider the
foregoing factors and the other risks and uncertainties that affect
the business of Venus Concept described in the “Risk Factors”
section contained in the Registration Statement on Form S-4 and the
prospectus and definitive proxy statement contained therein for the
merger of Restoration Robotics and Venus and described in the “Risk
Factors” section of Restoration Robotics Annual Report on Form 10-K
for the year ended 2018 filed on March 20, 2019 and as amended on
April 29, 2019, the Restoration Robotics’ Quarterly Report on Form
10-Q for the quarter ended September 30, 2019 filed on November 14,
2019, as well as any reports that Venus Concept may filed with the
SEC in the future. All forward-looking statements included in this
press release are based upon information available to Venus Concept
as of the date hereof, and Venus Concept assumes no obligation to
update or revise such forward-looking statements to reflect events
or circumstances that subsequently occur or of which Venus Concept
hereafter becomes aware.
1 Source:
https://www.globenewswire.com/news-release/2019/07/25/1888128/0/en/Laser-Hair-Removal-Market-Size-to-Hit-USD-3-9-Billion-by-2026.html
Investor Relations Contact:
Westwicke Partners on behalf of Venus Concept
Mike Piccinino, CFA
VenusConceptIR@westwicke.com
For Further Information:
Melissa Kang
Phone: (888) 907-0115, ext. 139
Fax: (855) 905-0115
Email: mkang@venusconcept.com
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