Merz Announces Clearance of the Cellfina™ System for the Long-Term Reduction of Cellulite
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 .
Om Business Wire
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
Sunny Optics Officially Licenses ImmerVision Panomorph Lens Technology for Global Production13.12.2017 12:47 | Pressemelding
ImmerVision, developer of exclusive and patented panomorph wide-angle imaging technology, is proud to announce that Sunny Optics (Zhongshan) Co., a subsidiary of Sunny Optical Technology (Group) Co. Ltd., a leading manufacturer of integrated optical components and products, has licensed panomorph lens technology for global production, and will deliver its first small form-factor panomorph high-resolution super-wide-angle lenses for smartphones and mobile devices in Q1 2018. Panomorph lens technology combines state-of-the-art optical design and advanced, optimized algorithms, including low-power dewarping, to produce high-resolution super-wide-angle images without distortion, even in low light conditions. Sunny Optical is the largest Chinese lens supplier for the most popular smartphone brands and OEM applications such as sports cameras, surveillance, 360 image capture, autom
Synacor Launches Enhancements to Zimbra Communications and Collaboration Suite13.12.2017 12:30 | Pressemelding
Synacor Inc. (NASDAQ:SYNC) today announced the commercial launch of Zimbra 8.8. The easy-to-use collaboration platform comes with new user experience features such as Zimbra Drive for enterprise-level file sync and sharing and Zimbra Chat. The Network Edition features tech stack enhancements including real-time backup, ActiveSync across mobile and desktop, hierarchical storage management (HSM) that enables customers to move archival data to less expensive storage solutions, and improved delegated admin functionality. “Zimbra 8.8 is an exciting update for end users and technical decision makers,” said Marcus Teo, Vice President, Enterprise Sales & Marketing, Synacor. “Customers look to Zimbra for security, privacy and transparency through open code, extensibility, accessibility on multiple devices and deployment flexibility. This update builds on these tenets and incorporates enhancemen
GSMA Urges Members of the World Trade Organization to Prioritise and Accelerate Investment in Digital Future13.12.2017 12:00 | Pressemelding
On the occasion of the 11th World Trade Organization (WTO) Ministerial Conference, GSMA Director General Mats Granryd called on government leaders to reform their regulatory frameworks in order to encourage a new wave of innovation and investment in digital infrastructure and services. Currently, 108 of the WTO's 164 members have made commitments to facilitate trade in telecoms services, such as the right to establish new telecoms companies, make foreign direct investment in existing companies and enable the cross-border transmission of telecoms services. “Today, more than 5.1 billion people – about two-thirds of the world’s population – subscribe to mobile services. With this broad reach, the mobile industry is a major driver in the global economy, expected to employ nearly 31 million people worldwide and contribute $4.2 trillion in economic value (4.9 per cent of GDP) in 2020,” said
DCS Telecom Selects LeoSat for Innovative Data Solution13.12.2017 10:03 | Pressemelding
LeoSat Enterprises, which is launching a constellation of up to 108 low-earth-orbit communications satellites, has entered into an agreement with DCS Telecom, a leading telecoms provider of satellite and networking solutions in the Middle East, Africa and Asia. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171213005443/en/ DCS Telecom Selects LeoSat for Innovative Data Solution (Photo: Business Wire) DCS Telecom will use LeoSat to upgrade its existing satellite solutions, giving customers access to a unique low-latency network which is expected to revolutionize data connectivity. LeoSat’s system of low earth orbit communications satellites can achieve lower latency and stronger end-to-end security compared to traditional satellite and terrestrial solutions used today. This is achieved through an adv
Andersen Global Expands Presence in Germany with Addition of Thierhoff Müller & Partner13.12.2017 08:01 | Pressemelding
Andersen Global is proud to announce an expanded presence in Germany as Thierhoff Müller & Partner, a tax and legal firm with offices in Leipzig and Frankfurt, combines its practice with Andersen Tax & Legal in Germany. Through its German member firms, Andersen Tax & Legal and Alegis Steuerberatungsgesellschaft mbH, Andersen Global now has more than 65 professionals focused on providing tax and legal services and business advice across five locations in Germany, including Cologne, Dusseldorf, and Merzig. “Thierhoff Müller is highly regarded in complex restructuring matters. Together with our existing legal and tax practice, we will be able to increase our service offerings for our clients,” said Stefan Kraus, Managing Partner of Andersen Tax & Legal in Germany. “We are dedicated to providing outstanding service and are adding additional competencies in tax and legal such as corporate r
Aprecia Pharmaceuticals and Cycle Pharmaceuticals Partner to Develop 3D-Printed Orphan Drugs13.12.2017 08:00 | Pressemelding
Aprecia Pharmaceuticals, LLC (“Aprecia”), The 3DP Pharmaceutical Company, and Cycle Pharmaceuticals, Ltd. (“Cycle”) today announced they have signed a partnership agreement to develop and commercialize orphan drugs using three-dimensionally printed (“3DP”) technology. The planned products will deliver quality-of-life improvements versus existing, approved orphan drugs, and will achieve this by utilizing Aprecia’s proprietary 3DP ZipDose® Technology platform. ZipDose® is the only three-dimensional printing technology used in a pharmaceutical drug product approved by the U.S. Food and Drug Administration. Antonio Benedetti, CEO of Cycle commented: “Many rare disease patients do not have a treatment option at all. For those rare diseases where there is an approved pharmaceutical treatment, patients continue to be burdened by sub-optimal drug formulations. Aprecia’s
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom