Venus Concept Receives 510(k) Clearance for the Venus Versa Pro System, Its New Multi-Application Platform
September 14 2023 - 7:00AM
Venus Concept Inc. ("Venus Concept" or the "Company") (NASDAQ:
VERO), a global medical aesthetic technology leader, announced
today that it has received a 510(k) clearance from the U.S. Food
and Drug Administration (“FDA”) to market its Venus Versa Pro
System, the Company’s new multi-application platform, for a variety
of aesthetic and cosmetic procedures.
Venus Versa is a modular system based on a multi-application
approach. It is customizable and upgradable and offers the most
in-demand aesthetic treatments by supporting 10 optional
applicators which utilize Venus Concept’s (MP)2, IPL and
NanoFractional RF technologies. Designed as a modular platform, the
Venus Versa can be configured to best suit any practice’s needs
with the ability to add additional applications as the practice
grows or changes.
The all new Venus Versa Pro System expands on the already
comprehensive Venus Versa platform by incorporating proprietary
advances in NanoFractional RF technologies from our dedicated skin
resurfacing system, Venus VivaMD, providing higher power and deeper
skin penetration for optimal results.
"This important clearance is a direct outcome of the new
strategic plan we implemented earlier this year," said Rajiv De
Silva, Chief Executive Officer of Venus Concept. "Our new strategy
has led us to prioritize the allocation of resources to our most
promising growth opportunities and focus on continued innovation to
accelerate our path to long-term, sustainable, profitability and
growth. We anticipate that the Venus Versa Pro System will be an
important contributor to revenue growth in 2024."
"The Venus Versa Pro System once again demonstrates our
commitment to continue to build upon our robust R&D pipeline,"
said Hemanth Varghese, President & Chief Innovation and
Business Officer of Venus Concept. "The advancements we are
introducing in the Venus Versa Pro System, will provide superior,
comprehensive technologies to support our existing and future
customers, and address the growing demand for multi-modal solutions
in aesthetics. Venus Versa has been one of the company’s
best-selling products over the last 5 years with thousands of
installations worldwide. We are confident that its new generation
Venus Versa Pro System, can surpass the success of Venus Versa,
offering our existing customer base an attractive upgrade option,
as well as offering new customers a new standard of care to address
nearly all their patient’s aesthetic concerns with one platform. We
look forward to formally announcing our commercial launch in the
coming weeks."
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 and hair restoration
technologies and reach in over 60 countries and 14 direct markets.
Venus Concept's product portfolio consists of aesthetic device
platforms, including Venus Versa, Venus Versa Pro, Venus Legacy,
Venus Velocity, Venus Fiore, Venus Viva, Venus Glow, Venus Bliss,
Venus BlissMAX, Venus Epileve, Venus Viva MD and AI.ME. Venus
Concept's hair restoration systems include NeoGraft® and the ARTAS
iX® Robotic Hair Restoration system. Venus Concept has been backed
by leading healthcare industry growth equity investors including EW
Healthcare Partners (formerly Essex Woodlands), HealthQuest
Capital, Longitude Capital Management, Aperture Venture Partners,
and Masters Special Situations.
Cautionary Statement Regarding Forward-Looking
Statements
This communication contains “forward-looking” statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended and Section 21E of the Securities Exchange Act of 1934, as
amended. Any statements contained herein that are not of historical
facts may be deemed to be forward-looking statements. In some
cases, you can identify these statements by words such as
“anticipates,” “believes,” “plans,” “expects,” “projects,”
“future,” “intends,” “may,” “should,” “could,” “estimates,”
“predicts,” “potential,” “continue,” “guidance,” and other similar
expressions that are predictions of or indicate future events and
future trends. These forward-looking statements include, but are
not limited to, statements about our financial performance; the
growth in demand for our systems and other products; the
contribution of the Venus Versa Pro System to our revenue; the
efficacy of the Venus Versa Pro System; and the anticipated
commercial launch date of the Venus Versa Pro System , and involve
risks and uncertainties that may cause results to differ materially
from those set forth in the statements. These forward-looking
statements are based on current expectations, estimates, forecasts,
and projections about our business and the industry in which the
Company operates and management's beliefs and assumptions and are
not guarantees of future performance or developments and involve
known and unknown risks, uncertainties, and other factors that are
in some cases beyond our control. As a result, any or all of our
forward-looking statements in this communication may turn out to be
inaccurate. Factors that could materially affect our business
operations and financial performance and condition include, but are
not limited to, those risks and uncertainties described under Part
II Item 1A—“Risk Factors” in our Quarterly Reports on Form 10-Q and
Part I Item 1A—“Risk Factors” in our Annual Report on Form 10-K for
the fiscal year ended December 31, 2022. You are urged to consider
these factors carefully in evaluating the forward-looking
statements and are cautioned not to place undue reliance on the
forward-looking statements. The forward-looking statements are
based on information available to us as of the date of this
communication. Unless required by law, the Company does not intend
to publicly update or revise any forward-looking statements to
reflect new information or future events or otherwise.
Investor Relations Contact:
ICR Westwicke on behalf of Venus Concept:
Mike Piccinino, CFA
VenusConceptIR@westwicke.com
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