Contura Submits Registration Application for Aquamid(R) to the FDA
By Contura Inc., PRNEWednesday, April 14, 2010
SOBORG, Denmark, April 15, 2010 - Contura Inc. has submitted a Premarket Approval Application (PMA) for
Aquamid(R) 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(R) 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(R) 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.
About Aquamid
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.
About Contura
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(R) 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.
www.contura.com www.aquamid.us Media Contact Ruder Finn Susan Smirnoff +1-212-593-6323 smirnoffs@ruderfinn.com
Susan Smirnoff, Ruder Finn, +1-212-593-6323, smirnoffs at ruderfinn.com
Tags: April 15, Contura Inc., denmark, Soborg, Western Europe