Business Wire

Merz Announces Clearance of the Cellfina™ System for the Long-Term Reduction of Cellulite

Del

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.

About Cellfina™

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 .

Contact information

Merz Pharma GmbH & Co. KGaA
Global Corporate Communications
Mariana Smith
+49 69 1503-6246
mariana.smith@merz.com
www.merz.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Orange Acquires Basefarm Holding and Becomes a European Leader in Cloud Computing Services for the Enterprise Sector16.7.2018 07:22Pressemelding

Following a competitive tender process initiated by Abry Partners for its stake in Basefarm, the Orange Group, through its enterprise subsidiary Orange Business Services, has announced today the signature of a contract to acquire 100% of the company’s capital for an enterprise value of 350 million euros. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005214/en/ Basefarm is a leading European player in cloud-based infrastructure and services, as well as the management of critical applications and data analysis. The company, which recorded revenues of over 100 million euros in 2017, has enjoyed strong growth since 2015. Basefarm has a strong operational presence in several European countries, particularly in Norway, Sweden, the Netherlands, Austria and in Germany, where it boasts a cutting-edge big data activity. Its business proposition lies at the forefront of the most innovative services in cloud computing, Big Data a

Spirit AeroSystems and Norsk Titanium Announce Start of Production Qualification for Commercial Aircraft Parts16.7.2018 07:00Pressemelding

Spirit AeroSystems [NYSE: SPR] and Norsk Titanium US Inc. (NTi), have reached an agreement to initiate qualification of Spirit’s first additive-manufactured, titanium, structural component for the Boeing 787. This qualification will validate NTi’s production and industrialization processes, integrate Spirit’s workscope of machining final parts from additively manufactured near-net shapes and verify material and final part conformity to requirements. “Spirit has had a comprehensive and long relationship with Norsk Titanium, and this part will be our first additive structural titanium component incorporated into a commercial airplane program,” said Spirit AeroSystems Senior Vice President of Fabrication and Supply Chain Management, Ron Rabe. NTi is the world’s first FAA-approved, OEM qualified, supplier of additive-manufactured, structural titanium components. NTi’s proprietary Rapid Plasma Deposition™ (RPD™) process has been in serial production of Boeing 787 titanium components since A

New Study Investigates the Utility of Masimo PVi® as Part of Goal-Directed Fluid Management in Patients Undergoing Colorectal Surgery16.7.2018 05:00Pressemelding

Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Kocaeli University in Turkey compared the performance of conventional fluid management (CFM) to goal-directed fluid management (GDFM) using Masimo PVi® (pleth variability index, measured noninvasively and continuously using SET® pulse oximetry sensors) in patients undergoing elective colorectal surgery. The primary points of comparison were the amount of crystalloids administered and blood lactate and serum creatinine levels during the intraoperative period.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180715005048/en/ Masimo Radical-7® with PVi®, SpHb®, and RD rainbow SET™ Sensor (Photo: Business Wire) In the study, Dr. Cesur and colleagues, noting the importance of intraoperative fluid management in terms of postoperative organ perfusion and complications, sought to compare the effects of CFM (guided by clinical asse

Alipay and Singapore Tourism Board join hands to boost Chinese tourist spending16.7.2018 02:00Pressemelding

Alipay, the world’s leading mobile and online payment and lifestyle platform operated by Ant Financial Services Group, together with the Singapore Tourism Board (STB), have launched a series of joint marketing initiatives aimed at raising destination awareness of Singapore and driving tourist spending among Chinese visitors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180715005021/en/ Alipay and STB signed a Memorandum of Understanding (MOU) in September 2017 to enhance Chinese tourists’ overall experience in Singapore. Under the MOU, both parties agreed, among other things, to explore co-investing in joint-marketing initiatives to encourage Chinese tourists to spend with Alipay while in Singapore. Since signing the MOU, Alipay has experienced double-digit growth in user spending. China has also become Singapore’s top market in 2017 for both tourism receipts and visitor arrivals, contributing S$4.2 billion in tourism rece

Koza Altin Welcomes Court’s Rejection of Akin Ipek’s Share Purchase Agreement13.7.2018 15:58Pressemelding

A Turkish Court has found against businessman Akin Ipek this week – ruling that a share purchase agreement, which he had submitted as vital evidence in support of his case against the Turkish state, is null and void. The matter was brought to the Ankara Commercial Court in March 2017 by Koza Holding (parent company of Koza Altin) which, according to Mr Ipek’s share purchase agreement, purportedly transferred all of its shares to Ipek Investment Limited. Koza Holding filed the lawsuit for legal recognition that the share purchase agreement is void. The ruling in Turkey follows on from an earlier judgment set down by the English High Court, which rejected Mr Ipek’s attempt to use up to £3m of UK subsidiary Koza Ltd’s money to fund a claim against the Turkish State at the International Centre for Settlement of Investment Disputes (ICSID). In the English ruling, Deputy Judge Richard Spearman QC declared the “authenticity” of the share purchase agreement as “open to very serious doubt”. The

Mindbreeze Positioned in the Leaders Quadrant of the Gartner’s 2018 Magic Quadrant for Insight Engines13.7.2018 15:27Pressemelding

Mindbreeze, a leading global provider of appliances and cloud services for information insight and applied artificial intelligence with a focus on knowledge management for leading international companies, announced today that Gartner, Inc. has positioned Mindbreeze in the Leaders quadrant of the 2018 Magic Quadrant for Insight Engines. Mindbreeze is positioned highest on the ability to execute axis. The research and advisory firm Gartner, Inc. evaluated 13 different providers from all over the world. “Understanding the meaning of information is a key priority for today’s customers. Mindbreeze InSpire leverages the full power of our sophisticated AI engine to provide actionable insights and answers ̶ not just more data. Seeing our position in the Magic Quadrant, my first reaction was ‘AWESOME’. Insight Engine was positioned the highest on the ability to execute axis and we believe that's exactly what sets us apart from our competitors. We made the bold move to focus on product innovatio