Merz Aesthetics Secures FDA Approval for RADIESSE in Décolleté Treatment

Merz Aesthetics has received US Food and Drug Administration (FDA) approval for RADIESSE^® (calcium hydroxylapatite [CaHA]) for the treatment of moderate to severe wrinkles in the décolleté in adults aged 22 years and older, according to a company announcement. The decision expands the product’s labeled indications and reflects growing demand for nonsurgical treatments targeting both facial and body aging.

RADIESSE is a biostimulatory dermal filler composed of CaHA microspheres suspended in a gel carrier. It is designed to provide immediate volume correction while stimulating neocollagenesis and elastin production over time. The product has been used in aesthetic medicine for more than two decades and is currently approved for multiple facial indications as well as volume restoration in select areas.

The FDA approval for décolleté wrinkles was supported by clinical data evaluating treatment outcomes in this anatomically distinct area, where skin is thinner and more prone to photodamage. According to company-reported results, more than 80% of treated patients reported satisfaction with skin tightness, 90% of investigators observed visible improvement by 4 months, and 83% of patients indicated willingness to undergo repeat treatment after 1 year. Additional findings suggested sustained interest in further treatment, with 93% of patients expressing openness to other RADIESSE procedures. Study design details, including sample size and comparator arms, were not disclosed in the announcement.

“The décolleté is one of the most visible—and earliest—areas to show signs of aging,” said Samantha Kerr, PhD, 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.”

In a statement included in the release, Jeremy Green, MD, a board-certified dermatologist involved in company-sponsored studies, noted that the product’s mechanism targets structural protein loss associated with aging. 

“Patients love RADIESSE because it jump-starts the skin’s regenerative process,” Dr. Green said.