SkinHealth Systems secures new wrinkle clearance
- SkinHealth Systems received United States FDA clearance for the SkinStylus SteriLock MicroSystem to treat adult periorbital wrinkles.
- The regulatory milestone makes the device the only microneedling system cleared for facial acne scars, wrinkles, and abdominal hypertrophic scars.
- The expanded clinical indication targets a rapidly expanding United States microneedling market valued at $330 million.
SkinHealth Systems (NASDAQ:SKIN) received new United States Food and Drug Administration clearance for its specialized SkinStylus SteriLock MicroSystem to improve the appearance of periorbital wrinkles in adult patients.
The newly cleared regulatory update expands the clinical deployment of the platform to adults aged 22 years and older across all Fitzpatrick skin types.
"The expansion of our clinical indications addresses an essential treatment sector for practitioners," the company stated regarding its ongoing commercial product development.
The strategic validation builds upon the brand's primary treatment offerings, which are anchored alongside the company's proprietary professional Hydrafacial delivery system within the domestic market.
Following the announcement, SkinHealth Systems' share price was up at $0.75.
The expanded hardware profile establishes the device as the sole microneedling platform holding distinct clearances for facial acne scars, periorbital wrinkles, and abdominal hypertrophic scars.
This technological expansion positions the firm to capture increased market share within a rising domestic microneedling industry estimated at $330 million in 2025.
