Merz warns against counterfeit Ulthera® Systems and fake Ultherapy® treatments
Merz Pharma Group, the parent company of Ulthera, Inc., is issuing an alert to consumers of potential illegal promotions of the non-invasive skin lifting Ultherapy® treatment. Merz has identified a number of companies selling fake versions of the Ulthera® System and physicians who purchase the fake device are falsely promoting Ultherapy® in their offices. Merz warns that these devices are not authentic Ulthera® Systems and in turn, the treatments being offered are not the authentic Ultherapy® treatment. Consumers who receive these fake treatments may not see results or may be susceptible to injury.
The Ulthera® System is the first and only ultrasound platform device to receive U.S. FDA clearance for lifting skin on the eyebrow, the neck, under the chin, as well as to improve the appearance of lines and wrinkles on the décolletage. The Ulthera® System is also FDA-cleared for the use of ultrasound imaging to help guide treatment. Copycat devices, which claim to offer similar benefits, do not have the same technology, clinical trials or years of studies that the Ulthera® System has to support their claims.
In Australia the Ulthera® System is intended for lifting and sculpting of skin by way of the deposition of micro-focused ultrasound energy at depths between 1.5mm and 4.5mm beneath the skin resulting in stimulation of new collagen and elastin as part of the healing process. Also intended for the treatment of Auxillary Hyperhidrosis by targeting the depth at which sweat glands reside. Coagulation takes place in tissue located at the dermal hypo dermal interface using a surface contact applicator.³
With over 800,000 treatments performed worldwide, over 50 clinical studies and more than 40 published peer-reviewed papers, Ultherapy® has proven to be the leader in non-surgical skin lifting.¹ The aesthetic lift indication differentiates Ultherapy® from every other energy device available in the market today. Many of the most esteemed aesthetic physicians in the world offer Ultherapy® and trust in the safety and satisfaction it provides their patients.
Reference 3: Ulthera Public ARTG Summary ARTG ID 225194
Reference 1: Date on File
Ulthera, Inc. acquired by Merz Pharma; Ultherapy joins the Merz Aesthetics portfolio of solutions for addressing the signs of aging
Merz is a privately held pharmaceutical company based in Frankfurt, Germany with branches in various European countries as well as the U.S., Canada, Mexico, Brazil, and Asia-Pacific. The company is active in research, development, and distribution of innovative products in the areas of aesthetic medicine and neurologically induced movement disorders.
In July 2014 Merz acquired Ulthera, Inc., a medical device company pioneering aesthetic and medical applications using its therapeutic ultrasound platform technology.
Merz Aesthetics offers a tailored and harmonized portfolio of products for minimally invasive treatments, including anti-wrinkle treatments and a range of dermal fillers. The company is an important player in the global aesthetics market. The addition of Ulthera’s energy device technology in mid-2014 complements Merz’s current offerings and expands the specialty pharmaceutical company’s aesthetics portfolio. Merz also offer a product to treat neurologically induced movement disorders.