Venus Concept Receives 510(k) Clearance for Use of its AI.ME™ Next Generation Robotic Technology for Fractional Skin Resurfacing
December 21 2022 - 7:00AM
Venus Concept Inc. (“Venus Concept” or the
“Company”) (NASDAQ: VERO), a global medical aesthetic technology
leader, today announced that it has received a 510(k) clearance
from the U.S. Food and Drug Administration (“FDA”) to market its
AI.ME next generation robotic technology for fractional skin
resurfacing.
“We are very pleased to receive the first FDA
regulatory clearance for our non-surgical robotic technology
platform, AI.ME, and believe it showcases Venus Concept’s ongoing
investment in technology, innovation, and clinical research towards
robotics applications in the field of medical aesthetics,” said
Rajiv De Silva, Chief Executive Officer of Venus Concept. “AI.ME is
a first-of-its-kind robotic platform offering physicians
minimally-invasive treatments for high-demand procedures requiring
fractional skin resurfacing. We see AI.ME as a versatile platform
and we will continue to develop the platform to provide innovative
solutions in various areas of medical aesthetics, starting with
fractional skin resurfacing. The AI.ME technology will be critical
to maximizing the synergy between our well-established medical
aesthetic business and our pioneering robotics business driven by a
robust R&D pipeline developed by our team in San Jose. This
510(k) clearance brings us one step closer to our goal of
commercializing AI.ME in the U.S., and we look forward to
introducing our first AI.ME systems with Venus Concept’s leading
physician partners in 2023.”
The AI.ME robotic system utilizes an advanced
visualization system, machine vision, and Artificial Intelligence
algorithms to target the dermis in a pre-planned selective, and
predictable manner. It uses a smart array of micro-coring hollow
punches to precisely core and excise micro-skin fractions at a
precise depth to remove up to 10% of skin in the treatment area,
leading to collagen deposition and fractional skin resurfacing of
the treated area.
“Integrating the advancements of robotics into
the area of minimally-invasive aesthetic procedures is very
promising,” said Girish (Gilly) Munavalli, MD, MHS, FACMS
board-certified dermatologist and advisor to Venus Concept. “This
new technology may become a real game-changer in the area of
medical aesthetics, offering a new level of consistency,
predictability, and visualization which will differentiate it from
existing energy-based solutions. We had the privilege to
participate in the early clinical studies of AI.ME and it is clear
that the advancements that its robotic technology presents to our
practice can go far beyond fractional skin resurfacing. I’m
encouraged to see some true innovation in the area of
minimally-invasive aesthetic treatments and I’m looking forward to
seeing the technology evolve to produce consistent transformational
results.”
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 16
direct markets. Venus Concept’s product portfolio consists of
aesthetic device platforms, including Venus Versa, 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 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; and general economic
conditions, including the global economic impact of COVID-19, 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, 2021. 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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