Latest FDA Clearance Expands to Improve the Appearance of Skin Laxity on the Anterior Arms, Posterior Arms and Abdomen, to launch in the United States before worldwide expansion.

Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the U.S. Food and Drug Administration (FDA) clearance of Ultherapy PRIME to improve the appearance of skin laxity on the anterior arms, posterior arms and abdomen.

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Ultherapy PRIME is the only FDA-cleared solution with real-time visualization to treat the face**, neck, décolleté and now body*.¹ The new indications will launch in the U.S. before expanding to markets worldwide.

“This FDA clearance is proof of our incredible momentum, following last year’s successful Ultherapy PRIME launch.” said Bob Rhatigan, CEO, Merz Aesthetics. “By extending our reach from face** to body*, we’re unlocking new treatment possibilities, meeting rising patient demand, and reinforcing our leadership in non-invasive skin lifting and firming.”

Ultherapy PRIME builds on the legacy of Ultherapy^®, which is recognized as the Gold Standard in non-invasive skin lifting with over 3.5 million treatments performed globally and a 95% satisfaction rate.^1-3 The skin lifting market is expanding rapidly and is expected to grow approximately 9% by 2030, driven largely by life stage (post-partum, menopause), and weight loss related skin laxity patient demographics.⁴

Ultherapy PRIME stimulates the body’s natural collagen and elastin production precisely where it’s needed. In just one session, Ultherapy PRIME lifts the brows, the skin under the chin and on the neck, and smooths lines and wrinkles on the décolleté. Now, Ultherapy PRIME also firms and tones the skin on the arms and abdomen - with no downtime and safe for all skin types. ^1,5 It offers personalized, visible natural-looking results, along with younger looking skin, that can last up to a year or more on the face** and 6 months or more on the arms and abdomen.^4-7

“The Ultherapy PRIME platform offers all the signature benefits of Ultherapy for non-invasive skin lifting, plus the ability to improve the quality of skin on the abdomen and arms in a single session,” said Sabrina Fabi, MD, world-renowned, Double Board-Certified Dermatologist and Dermatological Cosmetic Surgeon from San Diego, California. “This is of great value for my patients who want to keep the skin on their body looking as youthful as the skin on their face.”^6,8,9

“These new indications for arms and abdomen* strengthen Ultherapy PRIME’s position as a multi-purpose skin lifting, smoothing and firming treatment solution,” said Alexis Stern, Chief Marketing Officer, Merz Aesthetics. “This exciting journey started a year ago when we launched Ultherapy PRIME as a platform to lift the face**, and with this next phase of growth we are able to firm and tone the body*.”^1,8

To highlight the latest body* indications, Merz Aesthetics is also launching a new global campaign for Ultherapy PRIME. To learn more about Ultherapy PRIME, visit Ultherapy.com and follow @Ultherapy on Instagram.

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.

About Ultherapy:

The Ulthera^® System is indicated to lift the eyebrow and the skin on the neck and under the chin, as well as to improve lines and wrinkles on the décolleté, and to improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms. Reported adverse events from post marketing surveillance are available in the Instructions for Use (IFU). Please reference the IFU for additional information, including specific indications in your country, full product and safety information, and possible side effects.

The most common side effects reported in clinical trials were redness, swelling, pain and transient nerve effects. Talk to your practitioner for additional safety information and possible side effects.

*Indicated to improve the appearance of skin laxity on the abdomen, anterior arms and posterior arms.

**Face refers to the FDA-cleared indications for Ultherapy PRIME.

References:

1. Ulthera^® Instructions for Use.
2. Werschler WP, Werschler PS. Long-term efficacy of micro-focused ultrasound with visualization for lifting and tightening lax facial and neck skin using a customized vectoring treatment method. J Clin Aesthet Dermatol. 2016;9(2):27-33.
3. Ultherapy PRIME Letter of Treatments Sold. Merz Aesthetics^®, Herring L, Sr Director, Regulatory Affairs, Advertising and Promotion. July 16, 2025. Data on File.
4. Data on File. Merz Custom Market Forecasting 2025.
5. Marquardt K, Hartmann C, Wegener F, et al. Microfocused ultrasound with visualization induces remodeling of collagen and elastin within the skin. J Cosmet Dermatol. 2025;24(1):e16638. doi:10.1111/jocd.16638.
6. Fabi SG, Joseph J, Sevi J, Green JB, Peterson JD. Optimizing patient outcomes by customizing treatment with microfocused ultrasound with visualization: gold standard consensus guidelines from an expert panel. J Drugs Dermatol. 2019;18(5):426-432.
7. Park JY, et al. Customized Treatment Using Microfocused Ultrasound with Visualization for Optimized Patient Outcomes: A Review of Skin tightening Energy Technologies and a Pan-Asian Adaptation of the Expert Panel’s Gold Standard Consensus. J Clin Aesthet Dermatol. 2021;14(5): E70-E79.
8. Sasaki G, Grossman J, Fabi SG, et al. Stimulation of Collagen Synthesis in Human Skin Following Microfocused Ultrasound Therapy. Presented at the ASDS 2018 Annual Meeting.
9. Goldie K, Kerscher M, Fabi SG, Hirano C, Landau M, Lim TS, Woolery-Lloyd H, Mariwalla K, Park JY, Yutskovskaya Y. Skin Quality - A Holistic 360° View: Consensus Results. Clin Cosmet Investig Dermatol. 2021 Jun 14;14:643-654. doi: 10.2147/CCID.S309374. PMID: 34163203; PMCID: PMC8214518.

© 2025 Ulthera, Inc. All Rights Reserved. MERZ AESTHETICS is a trademark and/or registered trademark of Merz Pharma GmbH & Co. KGaA in the U.S. and/or certain other countries. ULTHERA, ULTHERAPY and ULTHERAPY PRIME are trademarks and/or registered trademarks of Ulthera, Inc. in the U.S. and/or certain other countries.

Various features of the ULTHERA^® System are covered by U.S. patents identified at https://merzaesthetics.com/patents/. Other U.S. and international patents to which Ulthera, Inc. has rights are issued, published, or pending.

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