News Archive
in Denver, Colorado
First FDA-approved dermal fillers that do not require a skin test prior to treatment
Santa Barbara, Calif., March 12, 2003 - Inamed Corporation (Nasdaq: IMDC), a global healthcare company and the market leader in the popular dermal filler market, today announced that it has received approval from the U.S. Food and Drug Administration to begin marketing and distribution of its new CosmoDerm™ and CosmoPlast™ human collagen products. CosmoDerm and CosmoPlast have been approved for the correction of facial wrinkles, acne scars and other soft tissue contour deficiencies, as well as for restoration of the lip border.
CosmoDerm and CosmoPlast are the first commercially available, FDA-approved dermal fillers in the United States that do not require a skin test prior to use. Based on more than 20 years of research into the science of the skin, CosmoDerm and CosmoPlast are new, innovative treatments for facial rejuvenation. CosmoDerm and CosmoPlast contain human collagen purified from human dermal tissue and manufactured under controlled laboratory conditions. CosmoDerm and CosmoPlast do not require a pre-treatment skin test and are uniquely formulated with an anesthetic for patient comfort. As a result, CosmoDerm and CosmoPlast provide new options to meet the need for a same-day, single-visit treatment.
"These approvals represent a significant milestone for Inamed's facial aesthetics business and for the Corporation overall," said Nick Teti, Chairman, President and CEO of Inamed Corporation. "CosmoDerm and CosmoPlast are the first of several important products emerging from our facial aesthetics pipeline that we plan to introduce over the next few years to meet the needs of the cosmetic dermatology market."
"CosmoDerm and CosmoPlast are powerful additions to our current franchise of products for the growing facial rejuvenation market in the United States. These two new products will strengthen our leadership position in dermal fillers," added Hani Zeini, Executive Vice President, Inamed Aesthetics, North America. "As CosmoDerm and CosmoPlast are the first dermal fillers to be approved by the FDA that do not require a skin test, they will address the need for a same day, single visit treatment. We see these products as significant additions to our existing dermal filler franchise with the potential to change the landscape of the facial rejuvenation market."
CosmoDerm
is the non-cross-linked formulation used in the treatment of
superficial lines, whereas CosmoPlast is cross-linked and is
primarily used in the treatment of more pronounced wrinkles.
CosmoDerm and CosmoPlast previously received regulatory approval
from the Canadian health authorities in December 2002.
If you are interested in cosmetic surgery in the Metro Denver, Boulder, Colorado area, contact us or call 303-321-3210 to schedule a consultation.
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