Merz Aesthetics® launches the new indication for RADIESSE® as an aesthetic injectableto improve moderate and severe wrinkles in the décolleté area.
In the EU, Merz Aesthetics® has announced the approval for Radiesse® to treat the décolleté area. Radiesse® is a regenerative biostimulator with calcium hydroxylapatite capable of regenerating multiple components of the skin tissue, resulting in healthier-looking skin [1,4,5] and is now approved for use in the décolletage, adding to the product’s versatility.
This new regulatory milestone directly answers patient demand, given there is a significant shift toward regenerative biostimulation as a preferred method of aesthetic treatment for patients [3].
"Despite being one of the most visible areas of our bodies, the décolleté area is often overlooked when it comes to aesthetics" says Dr Samantha Kerr, Chief Scientific Officer, Merz Aesthetics®. "Radiesse® presents a unique solution to improving décolleté wrinkles and provides our customers and their patients a non-surgical, effective option to address ageing décolleté skin.”
Recent data from the ‘International Society of Aesthetic Plastic Surgery’ reveal a 171.8% increase in worldwide non-surgical procedures minimally invasive treatments between 2018 and 2022 involving calcium hydroxylapatite further showcasing the patient need [2]. Various studies [3-6] have found that:
- 5% of patients experienced improved décolleté wrinkles, 16 weeks after their last treatment [i].
- 1% of patients demonstrated an enhancement in skin quality over the same period [3,ii].
- Notably, physicians reported a high level of satisfaction among 77% of patients 16 weeks after their last treatment [3].
This year Radiesse® celebrates its 20th anniversary, having sold more than 15 million syringes globally since 2005. Merz Aesthetics demonstrates a longstanding legacy and commitment to scientific innovation in the aesthetics field.
Even in the current landscape, findings from Medical Insight’s 2024 Global Aesthetic Market Study suggest that Radiesse® has emerged as a category leader [7]. This success is backed by over two decades of scientific data and clinical experience by Merz Aesthetics® [4,8] with 250 publications, and availability in over 85 countries [3].
"It’s patients who drive the need for the aesthetics market to adapt their offering," says Gonzalo Mibelli, EMEA President, Merz Aesthetics®. "We know that the current evolution in patient demand for products like Radiesse® is set to grow. We predict an increase in year-on-year growth between 2023 and 2026 within the regenerative biostimulation category and this is an area we want to own for our patients."
References
- Kim J. Clin Cosmet Investig Dermatol 2019;12:771–84.
- International Society of Aesthetic Plastic Surgery, ISAPS international survey on aesthetic / cosmetic procedures (2022).
- Merz Aesthetics®. Data on File (2023).
- González N, Goldberg DJ. Dermatol Surg 2019;45(4):547–51.
- Yutskovskaya YA, Kogan EA. J Drugs Dematol 2017;16(1):68–74.
- Fabi SG, et al. J Drugs Dermatol 2021;20(5):534–7.
- Medical Insight, Inc. The Global Aesthetic Market Study (2024).
- Fisher GJ, et al. Arch Dermatol 2008;144(5):666–72.
- Improved at-rest appearance defined as a ≥1-point improvement on the Merz Aesthetics Scales Décolleté Wrinkles-At Rest assessed by the blinded live rater, analysed using a modified full analysis set with missing data replaced by a multiple imputation approach. 83% of patients showed improvement in the appearance of at-rest décolleté wrinkles following two treatments. In the primary endpoint of the study, 73.5% of patients pooled across treatment groups showed an improvement in the at-rest appearance of décolleté wrinkles 16 weeks after their last treatment.
- Level of improvement in skin quality assessed according to iGAIS – Investigator Global Aesthetics Improvement Scale.
