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Clinical Data Demonstrates 5-Year Efficacy and Safety of Aquamid(R) in Facial Augmentation
Date:5/5/2008

sed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. The Aquamid(R) hydrogel is homogeneous: it contains no microparticles; 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. Moreover, the hydrogel does not cause tissue hardening or fibrosis. No skin test is needed before treatment.

The hydrogel integrates completely into the tissue and does not migrate from the injection site. It stays soft, feels like a natural part of the tissue and follows tissue movements. Because the hydrogel does not degrade over time, it provides augmentation that lasts for years.

Aquamid(R) is available in 40 countries worldwide and is under clinical investigation in the United States. Aquamid is being studied in a double-blind, randomized, multi-center, 2-arm parallel study involving 315 patients in 13 centers comparing the effectiveness of Aquamid(R) and Restylane(R) for the aesthetic treatment of facial wrinkles/folds. Data from this trial will support a PMA application with the FDA.

About Aquamid(R)

Aquamid(R) is a soft volume filler that gives a natural look and feel. Produced using Contura's patented hydrogel technology, Aquamid(R) is composed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. Aquamid(R) was approved in Europe in 2001 and is available in 40 countries worldwide. Over 300,000 Aquamid(R) injections have been performed to date. It is currently under clinical investigation in the U.S. for the aesthetic treatment of facial wrinkles/folds. Aquamid(R) is not approved for sale in the United States.

About Contura

Contura is a medical technology company based in Denmark that develops and commercializes soft tissue fillers. Contura's products -- Aquamid(R) for facial contouring and Bulkamid(R) for the treatment of fe
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SOURCE Contura
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