Venus Concept Inc. Announces New Regulatory Clearances
14 Febbraio 2020 - 10:05PM
Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ:
VERO), a global medical aesthetic technology leader, today
announced that it has received CE Mark approval to market Venus
Bliss for non-invasive lipolysis of the abdomen and flanks, skin
tightening, circumferential reduction and cellulite reduction and a
medical device license issued by Health Canada to market NeoGraft
2.0 for hair restoration.
Venus Bliss is a non-invasive medical aesthetic device that
offers a comprehensive solution to fat reduction and cellulite
reduction with two technologies in one system. The system uses the
Company’s proprietary (MP)2 technology which combines Multi-Polar
Radio Frequency and Pulsed Electro Magnetic Fields with advanced
VariPulse™️ technology. The Venus Bliss treats focal fat in the
abdomen and flanks through non-invasive lipolysis, resulting in
circumferential reduction. The Venus Bliss treatment leverages the
(MP)2 applicator technology to tighten lax skin and to reduce the
appearance of cellulite – another popular treatment that providers
can offer to their patients.
NeoGraft 2.0 is an automated hair transplant device using the
Follicular Unit Extraction (FUE) method of harvesting and
implanting hair follicles. With NeoGraft 2.0, Venus Concept
minimizes many of the inefficiencies of manual extractions and
implants and replaces this process with advanced technology that
provides patients with the benefits of the FUE procedure, while
also enabling physicians to benefit from easier transplants.
NeoGraft 2.0 procedures are minimally invasive, require less
recovery time, and offer natural-looking results for all hair
types, males and females alike.
“We are pleased to announce regulatory clearances for our Venus
Bliss and NeoGraft 2.0 in Europe and Canada, respectively,
consistent with our strategy to bring innovative solutions to
market to further enhance our role as a leading player in the
global minimally invasive/non-invasive medical aesthetics markets
and global hair restoration market,” said Dom Serafino, Chief
Executive Officer of Venus Concept Inc. “Both products will now be
launched on a limited basis and we expect to begin full commercial
launches in the second quarter of 2020. Importantly, these two
launches follow our recent launches of the Venus Bliss in the U.S.
and Canada, the NeoGraft 2.0 in Europe and Australia and the Venus
Epileve in Europe and Canada in recent months. We expect the full
commercial launches of these innovative solutions to be important
contributors to our growth expectations in 2020 and beyond.”
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, including expected revenue, operating results and other
financial information, and projected product launch timing, 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 our
business and future financial results and 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 our products; the number of Venus
Concept systems that we sell; the success of the commercial launch
of Venus Bliss and NeoGraft 2.0; the timing or likelihood of
regulatory filings and approvals for products; the expected
synergies from the merger; and the expected revenue for the
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.
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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