In the EU, Merz Aesthetics® announced today the approval for Radiesse® to treat the décolleté area. Radiesse® is a regenerative biostimulator1 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 Google Trends Data further support this showcasing a continual surge in searches for ‘collagen’ between 2016-2022, confirming a shift in aesthetic preferences 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 aging 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
A number of studies, including this large, multicentre clinical trial 3,5, have supported the décolleté approval and has provided substantial evidence of Radiesse®’s effectiveness, demonstrating a significant improvement in the appearance of décolleté wrinkles.3 The various studies have found that:
Up to 73.5% of patients experienced improved décolleté wrinkles, 16 weeks after their last treatment.3,ii
Furthermore, 76.1% of patients demonstrated an enhancement in skin quality over the same period.3,[iii]
Notably, physicians reported a high level of satisfaction among 77% of patients 16 weeks after their last treatment.3
"We know that patients are looking for treatment options that are minimally invasive, this launch not only expands the scope of Radiesse® but also showcases a new era of aesthetic procedures, empowering patients to feel their best. Our findings speak for themselves and demonstrate the possibility of what this new indication could achieve for patients who are looking to improve the overall appearance of décolleté wrinkles" says Dr. Tatjana Pavicic, who was part of the clinical study conducted by Merz Aesthetics®.
This year Radiesse® celebrates its 20th anniversary, having sold more than 15 million syringes globally since 2005.3 Merz Aesthetics demonstrates a longstanding legacy and commitment to scientific innovation in the aesthetics field.3
After two decades on the market, the new décolleté indication allows practitioners more versatility to expand the treatment spectrum from the face to more corporeal treatments. Additionally, with its increased product adaptability, also in diluted form, it allows for personalized treatment to address patient needs.
"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 category3 and this an area we want to own for our patients".
Mibelli continues, "Our data showcases Radiesse®'s effectiveness in reducing décolleté wrinkles. This launch also reflects a broader shift towards minimally invasive procedures driven by patients' evolving preferences for enhancing their body's anti-aging processes for aesthetic improvements."
Even in the current landscape, findings from Medical Insight’s 2024 Global Aesthetic Market Study suggest that Radiesse® has emerged as a category leader. This success is backed by over two decades of scientific data and clinical experience by Merz Aesthetics®,4, with 250 publications, and availability in over 85 countries.3
He continues, "The launch of the Radiesse® décolleté indication, this is an exciting time for Merz Aesthetics®. We can see that whilst there is a steady rise in the number of patients seeking an immediate lift to smooth wrinkles in the décolleté area, patients equally want more healthy-looking results and improved skin quality. This is something that Merz Aesthetics® can support them with".
Pivotal clinical study summary3 for RADIESSE®:
This EU approval stems from positive pivotal-study results demonstrating the effectiveness and safety of RADIESSE® (RADIESSE® Dilute; 1:2 RADIESSE: saline) for the treatment of décolleté wrinkles.
The RADIESSE® décolleté indication is based on a pivotal, prospective, randomized, multicentre, parallel-group, evaluator-blind study evaluating the safety and effectiveness RADIESSE® in 117 subjects aged 18-65 years of age, who presented with moderate to severe wrinkles in the décolleté. The study duration was 52 weeks. The primary endpoint was defined as a subject with ≥ 1-point improvement on the Merz Aesthetic Scale (MAS) Décolleté Wrinkles-At Rest compared to baseline.
RADIESSE® proved a clinically and statistically significant improvement in décolleté wrinkles and overall satisfaction, with 73.5% of the treated subjects achieving at least a 1-point improvement on the MAS décolleté wrinkles-At Rest scale at Week 16 after last treatment. This positive finding was confirmed by the secondary effectiveness endpoints including further investigator and patient-reported outcomes (MAS Décolleté Wrinkles-Dynamic scale, treatment satisfaction and Global Aesthetic Improvement of décolleté wrinkles). No treatment-related serious adverse events (AEs) occurred. The most common treatment-related AEs were injection site reactions (bruising, erythema, swelling, pain, nodule) and were mild, transient (duration of less than 14 days) and resolved without sequelae.
Patients reported a high level of satisfaction (70%) and in a studied subset of subjects 76.1% demonstrated an improvement in skin quality 16 weeks after their last treatment.
Notes to Editors
About Merz Aesthetics®
For Merz Aesthetics®, beauty and aesthetics is much more than an improved appearance. It is about feeling better and living a better life with more confidence and a positive attitude.
We believe each patient has their unique beauty, ideals and expectations – they need to be treated with these in mind. With over a century of experience within the Merz-Group, we firmly believe in innovation and trusted relationships to provide our patients with the optimal treatment. Our product portfolio includes injectables and devices designed to provide trusted treatment results.
Being family owned for more than 110 years, Merz® is known for building unique connections with customers who feel like family. Merz Aesthetics®’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 52 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com
1 Kim, J. Clin Cosmet Investig Dermatol. 2019;12:771–784
2 International Society of Aesthetic Plastic Surgery, ISAPS international survey on aesthetic/cosmetic procedures, 2022
3 Merz Aesthetics®. Data on File. 2023
4 González, N, Goldberg, DJ. Dermatol Surg. 2019;45(4):547–551.
5 Yutskovskaya YA, Kogan EA. J Drugs Dematol. 2017;16(1):68–74.
6 Fabi, SG, et al. J Drugs Dermatol. 2021;20(5):534–537.
7 Medical Insight, Inc, The Global Aesthetic Market Study. 2024
8 Fisher, GJ, et al. Arch Dermatol. 2008;144(5):666–672.
9 Landau M, et al. Dermatol Surg. 2016;42(7):842-52.
i Healthy-looking skin” is defined by the regeneration of Collagen I and III, elastin, proteoglycans, and angiogenesis.
ii 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.
iii Level of improvement in skin quality assessed according to iGAIS – Investigator Global Aesthetics Improvement Scale.