SOBORG, Denmark, April 15 /PRNewswire/ -- Contura Inc. has submitted a Premarket Approval Application (PMA) for Aquamid® to the U.S. Food and Drug Administration (FDA) requesting marketing approval in the U.S. for the aesthetic treatment of moderate to severe facial wrinkles and folds.
The application includes a successful U.S. pivotal study, in which the safety and efficacy of Aquamid was compared to Medicis' Restylane® for 12 months after treatment. The study results were presented last year at the American Society of Dermatologic Surgery's Annual Meeting and at Plastic Surgery 2009, and showed that Aquamid was as effective as Restylane® at 6 months follow-up based on the study endpoints and maintained this effectiveness at 12 months follow-up. Both treatments were safe and well tolerated. Also included in the application is a study extension that followed the Aquamid-treated subjects up to two years and demonstrated a consistent effectiveness and safety profile.
If approved for the U.S. market, Aquamid will be produced at Contura's new manufacturing facility in Denmark, which was designed to meet FDA requirements, and was recently approved by the European authorities.
Aquamid is composed of 97.5% water for injection and 2.5% cross-linked polyacrylamide. The patented hydrogel is homogeneous: it contains no micro particles; hence its filling effect is due solely to the injected volume. Unlike particle-based fillers, the hydrogel does not rely on an intended foreign body reaction to achieve the desired augmentation. Therefore, the filling effect is immediate and predictable. Aquamid does not degrade over time and provides a choice for patients who are looking for a long lasting aesthetic solution. Aquamid was approved in Europe in 2001 for facial augmentation and minor body contouring and is available in several countries in Europe, Asia, the Middle East and Latin America. In those countries, Aquamid is used mainly for treating nasolabial folds, lip augmentation, cheek contouring, nose enhancement, and for treating facial lipoatrophy. More than a quarter of a million people have been treated with Aquamid. Aquamid is not yet approved for sale in the United States.
Contura is a medical technology company based in Denmark that develops, manufactures, and commercializes soft tissue fillers in compliance with the European regulatory requirements for medical devices. Contura's products -- Aquamid for facial contouring and Bulkamid® for the treatment of female urinary incontinence -- are manufactured using the company's patented polyacrylamide hydrogel technology. Aquamid is sold through a network of local distributors in several countries in Europe, Asia, the Middle East and Latin America. Ethicon Inc., a Johnson & Johnson company, holds the exclusive worldwide distribution rights for Bulkamid.
SOURCE Contura Inc.