On April 8, 2026, Merz Aesthetics, one of the largest medical aesthetics businesses, announced the FDA approved RADIESSE for the treatment of wrinkles in the décolleté area in patients 22 years of age and older.
The news is a significant milstone in wellness science, as RADIESSE is the first and only regenerative biostimulator approved in the U.S. for face and body. The approval also marks the fourth indication for the aesthetic product.
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RADIESSE is a regenerative biostimulator designed to firm and tighten the skin by addressing the visible signs of aging at their source. Using an ingredient that is also naturally found in the body RADIESSE helps stimulate the production of collagen, elastin, and other essential proteins — supporting healthier looking skin with results that can last up to two years, according to studies.
“The décolleté is one of the most visible—and earliest—areas to show signs of aging,” says Samantha Kerr, Chief Scientific Officer at Merz Aesthetics. “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.”
“Collagen and elastin decline is a major driver of aging skin,” says board-certified cosmetic dermatologist Dr. Jeremy Green, who was part of clinical studies conducted by Merz Aesthetics. “Patients love RADIESSE because it jump-starts the skin’s regenerative process, giving them firmer, smoother, more radiant-looking results without surgery.”
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According to data referencing the ISAPS Global Survey, there has been an increase in consumers wanting to improve the look of both the face and body in the past couple of years: A 39% increase in demand for non-invasive skin lifting treatments (in the face and body).
Additionally, data supporting the décolleté approval demonstrated significant evidence of RADIESSE’s effectiveness.
- More than 80% of RADIESSE patients felt satisfied with skin tightness.
- 83% of patients reported they were likely to get RADIESSE treatment again, over a year after their initial treatment.
- 90% of healthcare providers reported RADIESSE patients with visible improvements by 4 months.
- 93% of patients were interested in other RADIESSE treatments.
“The new décolleté indication helps address increasing patient demand as today’s aesthetics market evolves towards regenerative biostimulation, or ‘reversing visible signs of aging from within’,” says Patrick Urban, President, North America, Merz Aesthetics.
