Merz Aesthetics Secures FDA Approval for RADIESSE® Décolleté Treatment

Merz Aesthetics has received U.S. FDA approval for RADIESSE to treat wrinkles in the décolleté area in patients aged 22 and over, marking the product’s fourth indication.

The approval expands RADIESSE®’s role as a regenerative biostimulator for both face and body, addressing growing demand for non-surgical treatments that target visible signs of ageing beyond the face.

Often overlooked, the décolleté is one of the earliest areas to show ageing.

RADIESSE® works by stimulating collagen and elastin production, improving skin firmness and texture over time.

Clinical data supporting the approval showed strong results, with over 80% of patients satisfied with skin tightness and 90% of healthcare providers reporting visible improvements within four months. Additionally, 83% of patients said they would repeat the treatment after one year.

Cosmetic dermatologist Jeremy Green, involved in clinical studies, noted increasing patient interest in treatments that deliver natural-looking results without surgery.

She said: “Collagen and elastin decline is a major driver of aging skin. Patients love RADIESSE® because it jump-starts the skin’s regenerative process, giving them firmer, smoother, more radiant-looking results without surgery.”

The announcement comes amid rising demand for non-invasive procedures, with global figures indicating a 39% increase in skin-lifting treatments for both face and body.

With more than 20 years of clinical use, over 250 scientific publications, and distribution in more than 85 countries, RADIESSE® continues to strengthen its position in regenerative aesthetics.

The new indication reflects a broader shift towards treatments that deliver longer-lasting, natural results by supporting the skin’s own regenerative processes.

Samantha Kerr, Chief Scientific Officer at Merz Aesthetics said: “The décolleté is one of the most visible – and earliest – areas to show signs of aging.

“Because it’s often overlooked in skincare routines and aesthetic care, this delicate area can benefit from RADIESSE® to help improve the appearance of wrinkles.”