Clinical Data Demonstrates 5-Year Efficacy and Safety of Aquamid(R) in Facial Augmentation
The 5-year study presented at the ASAPS meeting is a multicenter,prospective study of safety and long-term aesthetic results of Aquamid(R)injections for facial soft tissue augmentation and facial contouring. A totalof 116 patients attended the clinics for follow-up five years after theirfirst Aquamid(R) injection. The aesthetic outcome of injections with theAquamid(R) hydrogel showed that 96% of the 116 patients evaluated after fiveyears had "very good" or "good" aesthetic results according to the physicianinvestigators and 92% of the patients were "very satisfied" or "satisfied".The safety data in the trial showed that injection of Aquamid(R) over a periodof 5 years was safe with few and no unexpected adverse events. The 5-yearresults are consistent with the data from the 1-year, 2-year and 3- to 4-yearfollow-up visits.
"We are excited that our European 5-year clinical data demonstrates thelong-term efficacy and safety of Aquamid(R). Aquamid(R) is well positioned tomeet the global consumer needs for long-lasting aesthetic treatments torestore facial volume. In 2008 we expect to complete the 12-month follow-up inour US clinical trial and look forward to submitting the data to the FDA forreview," said Michael Peytz, Chief Executive Officer.
Produced using Contura's patented hydrogel technology, Aquamid(R) iscomposed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. TheAquamid(R) hydrogel is homogeneous: it contains no microparticles; hence itsfilling effect is due solely to the injected volume. Unlike particle-basedfillers, the hydrogel does not rely on an intended foreign body reaction toachieve the desired augmentation. Therefore, the filling effect is immediateand predictable. Moreover, the hydrogel does not cause tissue hardening orfibrosis. No skin test is needed before treatment.
The hydrogel integrates completely into the tissue and does not migratefrom the injection site. It stays soft, feels like a natural part of thetissue and follows tissue movements. Because the hydrogel does not degradeover time, it provides augmentation that lasts for years.
Aquamid(R) is available in 40 countries worldwide and is under clinicalinvestigation in the United States. Aquamid is being studied in adouble-blind, randomized, multi-center, 2-arm parallel study involving 315patients in 13 centers comparing the effectiveness of Aquamid(R) andRestylane(R) for the aesthetic treatment of facial wrinkles/folds. Data fromthis trial will support a PMA application with the FDA.
Aquamid(R) is a soft volume filler that gives a natural look and feel.Produced using Contura's patented hydrogel technology, Aquamid(R) is composedof 97.5% sterile water and 2.5% cross-linked polyacrylamide. Aquamid(R) wasapproved in Europe in 2001 and is available in 40 countries worldwide. Over300,000 Aquamid(R) injections have been performed to date. It is currentlyunder clinical investigation in the U.S. for the aesthetic treatment of facialwrinkles/folds. Aquamid(R) is not approved for sale in the United States.
Contura is a medical technology company based in Denmark that develops andcommercializes soft tissue fillers. Contura's products -- Aquamid(R) forfacial contouring and Bulkamid(R) for the treatment of female urinaryincontinence -- are manufactured using the company's patented polyacrylamidehydrogel technology. Aquamid(R
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