According to the company, the approval was supported by clinical data demonstrating statistically significant improvement in décolleté wrinkle appearance following treatment. 

RADIESSE is a calcium hydroxylapatite-based injectable biostimulator designed to provide immediate structural support while stimulating endogenous collagen production over time. The product is already approved for facial wrinkles and volume loss indications. 

The company stated that the new approval reflects increasing demand for regenerative and skin-quality-focused treatments beyond the face, particularly in areas affected by photoageing and collagen decline.