Ultherapy® Décolletage Treatment Now FDA-Cleared
First Non-invasive Procedure Specifically Indicated by the FDA to Improve Lines and Wrinkles on the Décolleté
Mesa, AZ, July 07, 2014 - Ulthera, Inc., a global medical device company focused on developing and commercializing technologies for aesthetic and medical applications, announced today that its ultrasound platform device, the Ulthera® System, has received FDA clearance to non-invasively treat the chest to improve lines and wrinkles of the décolleté.
The Ultherapy Décolletage Treatment utilizes the System’s signature imaging and micro-focused ultrasound therapy capabilities and takes about 30 minutes to administer. The Treatment stimulates the natural formation of collagen and elastin in the skin’s foundation to gradually smooth chest wrinkles. Results are visible after about three months.
As with the FDA-cleared Ultherapy procedure for lifting the neck, eyebrow and under the chin, meaningful results are achieved in just one treatment, and there’s no downtime or post-treatment care requirements.
"At my practice, there is high patient demand for a safe and effective solution to treat the chest, but the only options available involved needles, multiple treatments, recovery time, and/or required restricted sun exposure," said principal investigator Sabrina Fabi, M.D., board certified dermatologist at Cosmetic Laser Dermatology in San Diego. “Now, with the Ultherapy Décolletage Treatment, I can offer women an FDA-cleared solution that consistently works and can be done on their lunch hour, at any time of year, without downtime."
"The décolleté indication fills a very clear void for patients and reinforces our commitment to expanding our platform technology. Our goal is to reward Ultherapy practices by bringing more value to the Ulthera System during each year of ownership," said Matthew E. Likens, president and CEO of Ulthera. “Now, the Ultherapy Treatment addresses four total treatment areas – from the brow to the chest – making it apparent that our investment in clinical advancements and dedication to R&D is producing results for our customers."
The Ultherapy Décolletage Treatment will be available in more than 1,500 physician practices across the United States, starting third quarter 2014. The Treatment is already cleared in more than 40 other countries worldwide and has been selectively available since 2012.
Photos "before and after" the procedure are available for viewing at the following link: http://www.NewUltherapy.com
More statements from Dr. Fabi and Likens are available in the following video: http://bit.ly/Ultherapy-Decolletage-Video
About Ulthera, Inc. Ulthera, Inc. is a global medical device company focused on developing and commercializing technologies for aesthetic and medical applications. The company’s signature technology is the Ulthera® System, which is FDA-cleared for use as an aesthetic ultrasound treatment – the Ultherapy® procedure – to non-invasively lift skin on the neck, under the chin and on the eyebrow as well as improve lines and wrinkles of the décolleté. Founded in 2004 and based in Mesa, AZ, Ulthera is a privately held company.
As of June 26, 2014, Merz Pharma Group and Ulthera have entered a definitive merger agreement, pursuant to which Merz will acquire Ulthera, in a transaction valued at up to $600 million in upfront cash and milestone payments. The acquisition is the largest in Merz’s history. The transaction has been approved by the boards of both companies and is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The transaction is expected to close in the third quarter of 2014.
For full product and safety information, including possible mild side effects, visit ultherapy.com/IFU.