FRANKFURT AM MAIN, Germany–(BUSINESS WIRE)– Merz Pharma Group today announced CE Mark clearance of the Cellfina™ System, signifying its conformity with all EU regulations. Cellfina™ is intended for long-term reduction of cellulite by precise release of targeted structural tissue (fibrous septae). Results of treatment with Cellfina™ are expected to last up to two years. Cellfina™ is currently available in the U.S. and has the longest duration of results as cleared by the U.S. Food and Drug Administration (FDA).
“The European clearance of the Cellfina™ System emphasizes Merz’s commitment to innovation and demonstrates our ongoing leadership in the global aesthetics space,” stated Philip Burchard, CEO of Merz Pharma Group. “Recent research we conducted confirmed how widespread of an issue cellulite is globally, with women having “somewhat to extreme concern” about the condition. A truly revolutionary aesthetic treatment, Cellfina™ combines highly advanced, proprietary technology with a well-established procedure called subcision to treat the underlying structural problem that causes cellulite. With Cellfina™, Merz continues to build a portfolio of devices and injectables that provides aesthetic physicians with effective solutions for common but unmet patient needs.”
In the US IDE pivotal study, 55 patients underwent a single treatment. The Cellfina™ System improved the appearance of cellulite in 98% of treated patients at two years, according to independent physician evaluators. Importantly, 96% of patients reported satisfaction with their treatment at the two year mark, and noticeable improvement on the Global Aesthetic Improvement Scale (GAIS) was seen in 100% of treated patients at two years. The most common side effects reported were soreness, tenderness and bruising; these side effects resolved quickly with time.
“Data presented at the 2016 American Society of Aesthetic Plastic Surgery (ASAPS) Annual Meeting shows that the results from Cellfina™ last at least three years, with a 93% patient satisfaction rate three years post-treatment,” said Can Gumus, Vice President of Global Marketing Aesthetics for Merz Pharmaceuticals. “The Cellfina™ System is currently the only U.S. FDA-cleared and EU CE-Marked minimally-invasive procedure clinically proven to treat the underlying structural cause of cellulite. Both patients and physicians can be confident a single 45 to 60 minute treatment with Cellfina™ will deliver significant improvement in the appearance of cellulite on the buttocks and thighs.”
Following this CE Mark certification, the Cellfina™ System will be made available to licensed physicians in select markets in Europe through Merz’s direct European sales force in the second half of 2016.
The Cellfina™ System is intended for long-term reduction of cellulite, up to two years, by precise release of targeted structural tissue (fibrous septae). Safety and effectiveness in other anatomical areas have not been established. The most common side effects reported were soreness, tenderness and bruising. The Cellfina™ System is only available through a licensed physician. For full product and safety information, refer to the Instructions for Use.
For more information on Merz Pharma Group, please click on www.merz.com .