Venus Concept Inc. Announces CE Mark and Australian Regulatory Approval for NeoGraft 2.0, A Trusted Name in Hair Restoration
05 December 2019 - 11:00PM
Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ:
VERO), a global medical aesthetic technology leader, today
announced that it has received a CE Mark from DEKRA Certification
B.V. and Therapeutic Goods Administration (TGA) clearance in
Australia to market NeoGraft 2.0 for hair restoration.
NeoGraft 2.0 is intended as an automated hair transplant device
using the Follicular Unit Extraction (FUE) method of harvesting and
implanting hair follicles. With the introduction of NeoGraft 2.0,
Venus Concept has eliminated the inefficiencies of manual
extractions and implants and replaced it with advanced technology
that provides patients with the benefits of the FUE procedure,
while also enabling physicians to benefit from easier transplants
that yield superior clinical results. The NeoGraft® 2.0 is a next
generation version which offers an extended and double-jointed arm,
updated implant and extraction tools, a pneumatic motor, and
touchscreen interface, which together offer clinicians a more
efficient treatment room and more consistent clinical outcomes.
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 launched NeoGraft 2.0 on a limited basis in Europe and
Australia in the fourth quarter and look forward to a full
commercial launch in these markets in the first quarter of 2020,”
said Dom Serafino, Chief Executive Officer and Director of Venus
Concept Inc. “Our recent merger with Restoration Robotics allows us
to offer an end-to-end portfolio of minimally invasive solutions
unique from any competitor in the hair restoration market today
with ARTAS iX and NeoGraft 2.0. With more than 600,000 procedures
and an estimated $4 billion1 spent annually in global hair
restoration, our portfolio of unique technology solutions, combined
with our large global selling infrastructure, positions us well to
drive growth in an extremely attractive global hair restoration
market.”
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: International Society of Hair Restoration Surgery
(ISHRS): “2017 Practice Census Results Report”
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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