Merz Aesthetics® Receives Approval from Health Canada for RADIESSE® as an Aesthetic Injectable for the Treatment of Moderate Wrinkles in the Décolleté Area
BURLINGTON, Ontario — Merz Aesthetics ® Canada announced today the Health Canada approval for Radiesse ® for the treatment of moderate wrinkles in the décolleté area. Radiesse ® is a regenerative biostimulator 1 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 décolleté area, adding to the product's versatility.
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This new regulatory milestone directly answers patient demand, given there is a significant shift toward regenerative biostimulation.
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'Despite being one of the most visible areas of our bodies, the décolleté area is often overlooked when it comes to aesthetics,'
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says Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics
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®
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'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.'
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According to the International Society of Aesthetic Plastic Surgery (ISAPS), non-surgical procedures/minimally invasive treatments between 2018 and 2022 involving calcium hydroxylapatite increased by 171.8% globally between 2018 and 2022. 2 This approval was supported by a large, multicentre clinical trial 3,5,1 which supported the décolleté approval and has provided substantial evidence of the effectiveness of Radiesse ®, demonstrating a significant improvement in the appearance of moderate décolleté wrinkles. 3 ' The décolleté is notoriously difficult to treat. Skin in this area is thin, chronically sun-exposed, low in sebaceous glands, prone to accelerated loss of elasticity, and tends to form more complex scars than other regions. Health Canada's new approval of Radiesse® for this area is therefore exciting and welcome news. It is a true biostimulator that has almost 20 years of safety data for the face, and an agent we turn to regularly in our clinic for this area. So, it is great to be able to officially use this amazing product on the décolleté as well. The biostimulatory effects work by triggering collagen, elastin, and micro-vasculature renewal, thickening the tissue and softening lines. It is a powerful treatment that gives natural-looking radiant results. This new approval now gives us a proven, regenerative tool to rejuvenate the skin on the chest, ' says Dr. Dusan Sajic, a leading Canadian medical and cosmetic dermatologist.
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This year Radiesse ® celebrates its 20 th 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 and hands to treatments for the décolleté. Additionally, the 1:2 dilution with 0.9% sterile saline increases the product adaptability allowing for personalized treatment to address patient needs.
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'This new indication for Radiesse ® to treat the décolleté area marks a significant milestone for the aesthetics market,'
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'It not only expands the versatility of Radiesse ® but also addresses a growing patient demand for regenerative aesthetic solutions. By offering a proven, effective treatment for décolleté wrinkles, we are enhancing our commitment to innovation and patient care. This approval underscores our dedication to providing advanced, minimally invasive options that cater to the evolving needs of our patients.'
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Even in the current landscape, findings from Medical Insight's 2024 Global Aesthetic Market Study suggest that Radiesse ® has emerged as a category leader. 6 This success is backed by over two decades of scientific data and clinical experience by Merz Aesthetics ®, 4,2 with 250 publications, 3 and availability in over 85 countries. 3 About Merz Aesthetics ® Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients, and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient's needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics 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 90 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.
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