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.
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.
