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MERZ AESTHETICS® ANNOUNCES NEW ARMS AND ABDOMEN* INDICATION FOR ULTHERAPY PRIME

Latest FDA Clearance Expands to Improve the Appearance of Skin Laxity on the Anterior Arms, Posterior Arms and Abdomen.

RALEIGH, NC – November 5, 2025

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.

Ultherapy PRIME is the only FDA-cleared device with real-time visualization to treat the face**, neck, décolleté and now body*.1

“This expanded FDA clearance is a testament to our unwavering commitment to advancing innovation that puts patients first,” said Patrick Urban, President, Merz Aesthetics North America. “Building on last year’s successful U.S. Ultherapy PRIME launch, we are extending this trusted, proven technology to address a gap in the market and meet customer and patient needs. With these new body* indications, providers now have an advanced and trusted device to address the root cause of skin laxity and help achieve personalized firming in the arms and abdomen.”1,2,3

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 percent satisfaction rate.1,2,4 The skin lifting market is expanding rapidly and is expected to grow approximately 9% by 2030, driven largely by life stage (post-partum, post-menopausal), weight loss related skin laxity, and a growing male patient demographic.5

By stimulating the body’s own collagen and elastin production, Ultherapy PRIME lifts the brows, the skin under the chin and on the neck, and smooths lines and wrinkles on the décolleté, and now firms and tones the skin on the arms and abdomen* in just one session with no downtime and safe for all skin types.1,6 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.2,7,8

“Ultherapy PRIME has been a cornerstone in my practice for lifting the skin of the face** and neck,” said Dr. Jennifer Levine, a double board-certified facial plastic surgeon in New York City. “I’m excited to offer patients a noninvasive option to firm and tone the arms and abdomen – places where noninvasive solutions were once limited. The ability to visualize tissue in real time and target collagen-rich layers sets Ultherapy PRIME apart, delivering results patients can truly see and feel.”

As Ultherapy PRIME continues to redefine the future of nonsurgical skin lifting, Merz Aesthetics will transition away from the legacy Ultherapy device, with full service and support concluding on September 30, 2027. Merz Aesthetics is committed to ensuring a smooth transition and will provide guidance and resources throughout the process.

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., 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 us.merzaesthetics.com.

About Ultherapy®:
The Ulthera® System is U.S. FDA-cleared to lift the eyebrow, 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. The most common side effects reported in clinical trials were redness, swelling, pain and transient nerve effects. Reported adverse events from post-marketing surveillance are available in the Instructions for Use (IFU). Please see the IFU for product and safety information, including a full list of these events at Ultherapy.com/IFU.

*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. 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.
  4. Ultherapy PRIME Number of Treatments Sold. Merz Aesthetics®, Herring L, Sr Director, Regulatory Affairs, Advertising and Promotion. July 16, 2025. Data on File.
  5. Data on File. Merz Custom Market Forecasting 2025.
  6. 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.
  7. Vachiramon V, Triyangkulsri K, Iamsumang W, Chayavichitsilp P, Efficacy and safety of microfocused ultrasound with visualization in abdominal skin laxity: a randomized, comparative study. Lasers Surg Med. 2020;52(9):831-836. doi: 10.1002/lsm.23234. Epub 2020 Mar 15.
  8. Sasaki GH, Tevez A. Microfocused ultrasound for nonablative skin and subdermal tightening to the periorbitum and body sites: Preliminary report on eighty-two patients. J Cosmet Dermatol Sci Appl. 2012;02(02):108-116. doi:10.4236/jcdsa.2012.2220 22.

© 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, ULTHERAPY PRIME and ULTHERAPY PRIME THE LIFT YOU CAN SEE 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.

Media Contact
Dan Strickford
Senior Director, U.S. Brand Communications, Merz Aesthetics
dan.strickford@merz.com