Clinical Data Demonstrates 5 Year Efficacy And Safety Of Aquamid(R) In Facial Augmentation

Contura International A/S announced that 5-year clinical data for its soft volume filler
Aquamid(R) was presented at the annual meeting for the American Society of
Aesthetic Plastic Surgery (ASAPS) in San Diego. Aquamid(R) is used to
rejuvenate or contour the face, either by restoring lost volume or by
adding extra volume where needed. Contura is currently conducting a
multicenter, comparative clinical trial of Aquamid(R) in the United States.


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
total of 116 patients attended the clinics for follow-up five years after
their first Aquamid(R) injection. The aesthetic outcome of injections with
the Aquamid(R) hydrogel showed that 96% of the 116 patients evaluated after
five years had "very good" or "good" aesthetic results according to the
physician investigators and 92% of the patients were "very satisfied" or
"satisfied". The safety data in the trial showed that injection of
Aquamid(R) over a period of 5 years was safe with few and no unexpected
adverse events. The 5-year results are consistent with the data from the
1-year, 2-year and 3- to 4-year follow-up visits.



"We are excited that our European 5-year clinical data demonstrates the
long-term efficacy and safety of Aquamid(R). Aquamid(R) is well positioned
to meet the global consumer needs for long-lasting aesthetic treatments to
restore facial volume. In 2008 we expect to complete the 12-month follow-up
in our US clinical trial and look forward to submitting the data to the FDA
for review," said Michael Peytz, Chief Executive Officer.



Produced using Contura's patented hydrogel technology, Aquamid(R) is
composed 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 female urinary
incontinence -- are manufactured using the company's patented
polyacrylamide hydrogel technology. Aquamid(R) is sold through a network of
local distributors in 40 countries. Ethicon Inc., a Johnson & Johnson
company, holds the exclusive worldwide distribution rights for Bulkamid and
has started to sell the product in Europe. Clinical trials evaluating
Aquamid(R) and Bulkamid(R) are ongoing in the United States. Data from
these trials will be used to support PMA applications for these products.
Contura's products are developed, manufactured and tested in Denmark in
compliance with the European regulatory requirements for medical devices.


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