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
(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
Ferring Pharmaceuticals and MSD Announce Completion of Largest Clinical Trial Ever Conducted in Postpartum Haemorrhage22.2.2018 06:00 | Pressemelding
Ferring Pharmaceuticals and MSD, known as Merck & Co., Inc., Kenilworth, N.J., U.S.A., through its MSD for Mothers initiative, today announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO). CHAMPION is investigating whether Ferring’s proprietary and heat-stable carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum haemorrhage or PPH).2,3 Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH.2,3 This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221006496/en/ Each year, 14 million mothers are affected by PPH.4 As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-09.1 Even when women survive, PPH can result in the need for serious medical interventions, including surgica
The Nippon Foundation: Project to Map Ocean Floor by 2030 Now Operational22.2.2018 05:00 | Pressemelding
The Nippon Foundation Chairman Yohei Sasakawa announced at a press conference today that The Nippon Foundation – GEBCO Seabed 2030 Project is now operational. The Project will realize Mr. Sasakawa’s vision of mapping the entire ocean floor by 2030. The Nippon Foundation has pledged US$2 million annually, and is calling for additional support from the global ocean community. Mr. Sasakawa noted, “The Nippon Foundation alone cannot achieve the objectives of this ambitious project. We will need the support of diverse stakeholders, including maritime corporations and technical experts. It is crucial that the ocean community comes together to achieve this goal”. He was joined by leading ocean-mapping experts, who emphasized that understanding the bathymetry of the global ocean is imperative for improving maritime navigation, and also for enhancing our ability to predict climate change and monitor marine biodiversity and resources. A comprehensive map of the seafloor will assist global effort
Vertex Initiates First Phase 3 Study of VX-659, Tezacaftor and Ivacaftor as a Triple Combination Regimen for People with Cystic Fibrosis21.2.2018 21:01 | Pressemelding
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it is initiating the first Phase 3 study of VX-659, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation. The study will enroll 360 patients, and the primary endpoint of the study is the mean absolute change from baseline in percent predicted forced expiratory volume in one second (ppFEV1) at week four of treatment. The study is designed to support the submission of a New Drug Application (NDA) in the U.S. using data from the 4-week primary efficacy endpoint together with safety data through 12 weeks of treatment. “Our goal is to bring the best triple combination to patients as rapidly as possible, and this first Phase 3 study of VX-659 in combination with tezacaftor and ivacaftor is a significant step toward that goal,” said Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical
Universal Laser Systems® Expands Portfolio of Laser Material Processing Systems with the ULTRA Platform Series21.2.2018 18:00 | Pressemelding
ULTRA platform-based laser systems are designed and ideally suited for precision laser cutting, laser ablation, and laser surface modification in manufacturing, research and development, academic research and prototyping environments. Major features of the series include rapid, high-accuracy laser beam positioning, and the flexibility to be configured with 9.3 and 10.6 µm CO2 lasers and 1.06 µm fiber lasers. All lasers are air-cooled in a range of power from 10 to 150 watts for CO2 and 40 to 50 watts for fiber lasers. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005364/en/ The ULTRA 9MW offers MultiWave processing of thin materials. (Photo: Business Wire) The variety of wavelengths and power ranges make the ULTRA platforms highly effective in the areas of organic material modification, including plastic films, industrial fabrics, engineering plastics, laminating adhesives, composite materials, and many others utilized
Luxoft One of Six Companies Collaborating with Amazon Web Services to Accelerate Blockchain Adoption21.2.2018 16:30 | Pressemelding
Luxoft Holding Inc (NYSE:LXFT), a global IT service provider, announces today that it is collaborating with Amazon Web Services (AWS) to enable corporates to adopt blockchain and Distributed Ledger Technologies (DLT). Luxoft is one of six IT and consulting services companies to make its blockchain advisory and development services available to AWS users. “We are very excited to be working with AWS to help users engage with blockchain and DLTs,” said Vasiliy Suvorov, Vice President of Technology Strategy at Luxoft. “Blockchain is about removing data silos, improving trust and operational efficiencies. By using AWS to deploy and integrate DLTs into day-to-day processes, businesses can revolutionize how they operate.” Luxoft helps accelerate the deployment and integration of blockchain and DLT-based projects on AWS and is already working on a number of DLT projects using the cloud. For example, Luxoft is building a healthcare claims processing system for a leading healthcare provider usin
Westinghouse Electric Company to Provide Engineering Support at Vandellós 1 in Partnership with EDF21.2.2018 16:30 | Pressemelding
Westinghouse Electric Company and Electricité de France (EDF), in partnership, announced today that they have been awarded a contract from Empresa Nacional de Residuos Radiactivos (ENRESA), the Spanish agency responsible for radioactive waste management and nuclear plant decommissioning. The agreement covers a four-year engineering support contract for the latency phase of the dismantling and decommissioning project at Vandellós I Nuclear Power Station in Spain and includes the preparation of technical and licensing documentation. “We are extremely pleased that ENRESA has selected Westinghouse and EDF to continue supporting the decommissioning activities at Vandellós I Nuclear Power Station,” said Yves Brachet, Westinghouse vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “This contract further demonstrates Westinghouse’s global capabilities and expertise in providing innovative decommissioning solutions.” Sylvain Granger, head of EDF's decommi