Aesthetics

Merz Presents Key Findings Showcasing Five-Year Effectiveness of Cellfina® On Cellulite Removal And Physician Recognition Of Ultherapy As Gold Standard Treatment

Raleigh, N.C, US,October 19, 2018

Results on each aesthetic device were presented in oral sessions at the American Society for Dermatologic Surgery (ASDS) Annual Meeting

Merz is also presenting key updates on leading aesthetics products including a botulinumtoxin product, RADIESSE^® and DESCRIBE^®, with 15 presentations total

Merz, a global leader in medical aesthetics, presented five-year follow-up data on Cellfina^® System, which showed that a single treatment improved the appearance of cellulite on the thighs and buttocks for five years, building upon a previous study, which showed results lasting at least three years—the longest FDA clearance for a cellulite treatment. The pivotal study showed that, of the patients who completed the five-year follow up, evaluators rated 100% of the patients as having noticeable improvement after five years.¹ The Cellfina^® System is the only U.S. FDA-cleared, minimally invasive procedure that effectively improves the appearance of cellulite.

“With this new five-year data, patients and physicians should feel confident that Cellfina^® is the right step toward proven, noticeable and lasting results in the improved appearance of cellulite,” said Dr. Michael Kaminer, cosmetic surgeon and Cellfina^® five-year study group member. “Creams and other cellulite treatments lead to limited patient satisfaction², while Cellfina^® patients experience enduring results. The study results confirm what we regularly see in practice.”

Approximately 85% of women have cellulite – uneven dimpled skin most often found on the thighs and buttocks, which is hard to control with diet and exercise alone and may impact self-esteem. ² The primary structural cause of cellulite is the connective bands woven throughout fat in the thighs and buttocks. These tight bands pull down the skin, creating the puckering seen on the surface of the skin.

Merz also presented new guidelines for improving Ultherapy^® Treatment results and patient satisfaction developed by a panel of expert aesthetic physicians called the Ultherapy^® Treatment Consensus Group (Group). The Group, formed to provide physicians with a framework to customize their treatment approach, declared Ultherapy^® the gold standard treatment for lifting and tightening skin on the chin, neck and chest.³

Ultherapy^® is the only non-invasive treatment cleared by the FDA to actually lift and tighten the skin on the neck, chin and brow, and improves lines and wrinkles on the chest. The treatment uses the body’s own regenerative response to gently and gradually lift skin on the eyebrow, under the chin and on the neck, and smooth lines and wrinkles on the décolletage. It is also the only cosmetic procedure to use ultrasound imaging/visualization, which allows practitioners to see the layers of tissue targeted during the treatment to ensure the energy is deposited to where it will be most beneficial for skin lifting. The unique Ultherapy^® technology is supported by more than 50 clinical studies and more than 60 published, peer-reviewed papers. The Group concluded that the use of ultrasound visualization is the single-most important factor for selecting optimal treatment depth to achieve ideal outcomes and increase patient satisfaction.

“The expert physician panel agreed that Ultherapy^® is a key foundational aesthetic treatment and the gold standard for nonsurgical lifting of the skin,” said Dr. Sabrina Guillen Fabi, cosmetic dermatologist and lead author of the Ultherapy^® consensus guidelines. “The guidelines extend the clinical data and valuable evidence available for physicians to be confident that treating patients with Ultherapy^® leads to proven outcomes.”

The Group concluded that the use of ultrasound visualization is the single-most important factor for selecting optimal treatment depth to achieve ideal outcomes and increase patient satisfaction.

In addition to the two oral presentations, Merz will be presenting key updates on leading aesthetics products including:

• Diluted and Hyperdiluted Calcium Hydroxylapatite (RADIESSE^®) for Skin Tightening: Guidelines from a Global Consensus Panel
• Comparison of botulinum toxin type A formulation produced by Merz to botulinum neurotoxin type A formulations in Asia
• Escalating Doses of IncobotulinumtoxinA for Extended Treatment of Glabellar Frown Lines: Results from a Randomized, Double-Blind Study
• The DESCRIBE^® PFD Patch in Picosecond and Q-Switched Laser-Assisted Tattoo Removal: Safety in Fitzpatrick IV-VI Skin Types

“We are pleased to have a strong presence at the ASDS meeting with 15 data presentations,” said Dr. Kristina Yu-Isenberg, Vice President, North America Medical Affairs at Merz. “We are committed to delivering useful, relevant data to dermatologists and plastic surgeons to inform their practice and best meet the needs of the patients they treat.”

For full product and safety information, including possible mild side effects of Cellfina^® and Ultherapy^® visit www.cellfina.com and www.ultherapy.com, respectively.

US Visitors please click here for Botulinumtoxin Important Safety Information including Boxed Warning.

1. Kaminer, Michael. Multicenter Pivotal Study of the Safety and Effectiveness of a Tissue Stabilized-Guided Subcision Procedure for the Treatment of Cellulite – 5 Year Update. American Society for Dermatology Surgery Annual Meeting. October 11, 2018.
2. Sainio EL, Rantanen T, Kanerva L. Ingredients and safety of cellulite creams. Eur J Dermatol 2000;10:596-603
3. Fabi, Sabrina. Optimizing Patient Outcomes through a Customized Approach of Microfocused Ultrasound with Visualization Treatments: Consensus Guidelines from an Expert Panel. American Society for Dermatology Surgery Annual Meeting. October 11, 2018.