Merz Announces the Commercial Launch of the Cellfina® System in Europe. The Cellfina® System is currently the only EU CE-Marked and U.S. FDA-cleared minimally-invasive procedure that treats the underlying structural cause of cellulite with results that last at least three years. Cellfina® is intended for long-term reduction of cellulite by precise release of targeted structural tissue (fibrous septae).
Recent market research conducted by Merz confirms that cellulite is a widespread concern for women globally1. A majority of women (ages 25-60) surveyed in the United Kingdom, Germany, France, Spain, Russia and Italy reported “somewhat to extreme concern” about the condition.
“Cellulite treatment is an aesthetic category where the market need has remained largely unmet and where patients have often been dissatisfied with available options,” said Stefan Brinkmann, Vice President and Regional Head for Merz in EMEA. “With the introduction of the Cellfina® System to the European market, Merz is now able to provide physicians with a technology that delivers an effective and long-term solution to the problem of cellulite dimples.”
A truly revolutionary aesthetic treatment, Cellfina® requires a single in-office procedure and combines highly advanced, proprietary technology with a well-established procedure called subcision to treat the underlying structural problem that causes cellulite.
“At Merz, we are well aware that science-backed treatment options that treat the underlying cause of cellulite are of paramount importance to patients and physicians alike,” said Yannick Grosskreutz, Vice President and Head of Global Marketing. “Clinical trial data shows that Cellfina® delivers consistently high aesthetic improvement and patient satisfaction rates even three years after the initial treatment session, evidence that the Cellfina® System meets the high standard of quality and efficacy that our customers have come to expect from the Merz portfolio.”
In the US IDE pivotal study, 55 patients underwent a single treatment. The Cellfina® System improved the appearance of cellulite in 97% of treated patients at three years, according to independent physician evaluators. Importantly, 93% of patients reported satisfaction with their treatment at the three year mark, and noticeable improvement on the Global Aesthetic Improvement Scale (GAIS) was seen in 100% of treated patients at three years. The most common side effects reported were soreness, tenderness and bruising; these side effects resolved quickly with time.
The Cellfina® System is intended for long-term reduction of cellulite, up to three 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.
With approximately 3,000 employees and 34 subsidiaries worldwide, Merz is a Global leader in Aesthetics and Neurotoxins. Privately held for more than 100 years, the company is distinguished by its in-house research and development, solid financial strength and continuous growth. Complementing its unique portfolio of products for minimally invasive and non-invasive skin rejuvenation and tightening, Merz also develops neurotoxin therapy for the treatment of movement disorders. Skincare products and a range of OTC medicines are also included in offerings from the company, which is headquartered in Frankfurt, Germany. In fiscal year 2015/16, Merz Pharma Group generated revenue of EUR 1,092.9 million. More information is available at www.merz.com.
1 Data on file