Now the only microneedling device FDA-cleared
for use on both the face and abdomen Milestone achievement in just
five months since BeautyHealth’s acquisition of the brand
The Beauty Health Company (NASDAQ:SKIN), home to hero brand
Hydrafacial, today announced the U.S. Food and Drug Administration
(FDA) has cleared its SkinStylus™ microneedling device for use on
facial acne scarring in Fitzpatrick skin types I, II, and III in
patients aged 22 years and older, making it the only microneedling
device FDA cleared for both the face and abdomen.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20230802207816/en/
SkinStylus™ (Photo: Business Wire)
The clearance from the FDA is a notable milestone for
SkinStylus™ since its acquisition by BeautyHealth in February of
this year, revealing of an ambitious and accelerated path for the
brand since coming under BeautyHealth’s leadership.
“SkinStylus’ new facial indication for acne scarring is a
testament to BeautyHealth’s innovation track record, proven brand
building expertise, and our commitment to creating the future of
skin health,” said BeautyHealth President and Chief Executive
Officer Andrew Stanleick. “Our goal is to become the world’s
leading beauty, health and wellness platform by bringing together
incredible brands and growing them into category leaders. This
SkinStylus indication further unlocks the potential of the highly
complementary treatments in our multi-brand ecosystem and positions
SkinStylus for exponential growth in the years ahead.”
Expected to reach $1 billion U.S. market size by 20301,
microneedling is a minimally invasive treatment that is quickly
becoming a favorite amongst providers and skincare lovers. Google
searches for microneedling are up +20% YoY and up +88% from five
years ago2; and the hashtag term #microneedling has over 4.4
million uses on Instagram3.
Microneedling uses small needles to create tiny, controlled
micro injuries that help trigger collagen and elastin production,
which is essential for smoother, firmer, and more even-toned
skin.
SkinStylus™ is an esthetician-founded brand, and the SkinStylus™
SteriLock® MicroSystem is designed to fit into the way medical and
aesthetic professionals work, with a combined feature set they
won’t find anywhere else.
Categorized by the FDA as a Class II Medical Device and under
its new clearance, SkinStylus™ SteriLock® MicroSystem is intended
to be used as a microneedling treatment to improve the appearance
of facial acne scars in Fitzpatrick skin types I, II, and III in
patients aged 22 years and older.
SkinStylus™ is already FDA-cleared for the indication to improve
the appearance of surgical or traumatic hypertrophic scars on the
abdomen in adults aged 22 years and older. This was supported by
the clinical data that was submitted to FDA during the clearance
process.
SkinStylus™ is available at providers across the United States.
Learn more by visiting SkinStylus.com.
About The Beauty Health Company
The Beauty Health Company (NASDAQ: SKIN) is a global
category-creating company delivering millions of skin health
experiences every year that help consumers reinvent their
relationship with their skin, bodies, and self-confidence. Our
brands are pioneers: Hydrafacial™ in hydradermabrasion, SkinStylus™
in microneedling, and Keravive™ in scalp health. Together, with our
powerful community of estheticians, partners, and consumers, we are
personalizing skin health for all ages, genders, skin tones, and
skin types in more than 90 countries. We are committed to being
ever more mindful in how we conduct our business to positively
impact our communities and the planet. Find a local provider at
https://hydrafacial.com/find-a-provider/, and learn more at
beautyhealth.com or LinkedIn.
Forward-Looking Statements
Certain statements made in this release, including statements
regarding the potential future market size for microneedling, are
“forward looking statements” within the meaning of the “safe
harbor” provisions of the United States Private Securities
Litigation Reform Act of 1995. When used in this press release, the
words “estimates,” “projected,” “expects,” “anticipates,”
“forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,”
“will,” “should,” “future,” “propose” and variations of these words
or similar expressions (or the negative versions of such words or
expressions) are intended to identify forward-looking
statements.
These forward-looking statements are not guarantees of future
performance, conditions, or results, and involve a number of known
and unknown risks, uncertainties, assumptions, and other important
factors, many of which are outside The Beauty Health Company’s
control, that could cause actual results or outcomes to differ
materially from those discussed in the forward-looking
statements.
Important factors, among others, that may affect actual results
or outcomes include The Beauty Health Company’s ability to execute
its business plan; market demand for SkinStylus; the ability to
effectively provide complementary beauty health products and
services; potential litigation involving The Beauty Health Company;
changes in applicable laws or regulations; and the possibility that
The Beauty Health Company may be adversely affected by other
economic, business, and/or competitive factors. The Beauty Health
Company does not undertake any obligation to update or revise any
forward-looking statements, whether because of new information,
future events, or otherwise, except as required by law.
Sources: 1. Emergen Research, Vision Research 2023. 2. Instagram
Insights; data pulled as of 7/31/23. 3. Google Analytics data
pulled as of 7/31/23.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230802207816/en/
BeautyHealth Media: Marina Maher Communications |
HydraFacial@hellommc.com BeautyHealth Investors: The One Nine Three
Group | BeautyHealthIR@the193.com
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