Merz Aesthetics® Announces New Knee Indication for Ultherapy PRIME®, Further Expanding Its Leadership as the First and Only FDA-Cleared Ultrasound With Real-time Visualization for Non-Surgical Skin Lifting

With this latest FDA clearance, Ultherapy PRIME^® continues to expand its body treatment portfolio^†, beginning with a U.S. launch followed by a global rollout.

RALEIGH, N.C.--(BUSINESS WIRE)--Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced that the U.S. Food and Drug Administration (FDA) has cleared Ultherapy PRIME^® to improve the appearance of skin laxity on the knees. With this clearance, the platform becomes the first and only energy-based aesthetic device indicated for this treatment area.

This milestone marks a significant expansion of Ultherapy PRIME^®’s growing portfolio of cleared body^† indications. Built on the legacy of Ultherapy^®, the world’s #1 energy-based aesthetic device^††, and powered by advanced microfocused ultrasound with vivid real-time visualization (MFU-V), the platform now offers a comprehensive approach to addressing skin laxity with indications to LIFT the face*, SMOOTH the décolleté, and FIRM and lift the skin on the abdomen, arms, and knees.^†

"Being the first to bring FDA-cleared real-time visualization to the knees represents a meaningful milestone," said Patrick Urban, President of Merz Aesthetics North America. "However, this launch is about more than a new indication; it’s about expanding the addressable market for non-invasive lifting and firming. Body aesthetics is no longer a secondary treatment category – there’s a stronger commercial demand and it's becoming central to how providers build their practices. Merz Aesthetics is well-positioned to continue to lead that shift here in the U.S.”

Ultherapy PRIME^® treats multiple skin depths, allowing practitioners to tailor treatment to each patient’s unique anatomy. By stimulating the body’s natural collagen and elastin production, it delivers a non-surgical lift with natural-looking, long-lasting** results for the face^* and body^†. Designed with patient convenience in mind, it typically requires a single session with no downtime and is safe for all skin tones.^1,3,5-8

“The new knees indication marks another monumental moment for Ultherapy PRIME^®,” said Dr. Samantha Kerr, Chief Scientific Officer at Merz Aesthetics. “It underscores our commitment to advancing science-backed innovation and expanding non-invasive treatment possibilities for healthcare professionals and their patients.”

Ultherapy PRIME^® builds on the proven legacy of Ultherapy^®, recognized as the Gold Standard in non-invasive skin lifting, with more than 4 million treatments performed globally and 95% patient satisfaction at year one.^1,3,4

“As patients become more informed about aesthetic treatment options, we’re seeing increasing interest in areas beyond the face and neck,” said Dr. Jennifer Levine, double board-certified facial plastic surgeon in New York City. “The knees are a common concern for patients who have skin laxity in this area as their skin loses collagen and elastin with age. The advancement of Ultherapy PRIME^® for the knees represents an important advancement and personalized approach to addressing these concerns and growing patient demand.”

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 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, posterior arms and knees. 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, posterior arms and knees.
^†† Based on the total revenue of Ultherapy^® + Ultherapy PRIME^® as of September 2025.
* Face refers to the FDA-cleared indications for Ultherapy PRIME^®.
**Ultherapy PRIME^® results can last up to 6 months in the body and a year or more in the face.

References:

1. Ulthera^® Instructions for Use.
2. Based on total revenue from non-invasive aesthetic energy-based devices, derived from earnings reports (Bausch Health, InMode, Classys, Sofwave, Wontech and Beauty Health), independent market data, and internal data on file, September 2025.
3. 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.
4. Ultherapy PRIME Letter of Treatments Sold. Merz Aesthetics^®, Herring L, Sr Director, Regulatory Affairs, Advertising and Promotion. July 16, 2025. Data on File.
5. 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.
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. 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.

© 2026 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.