ArteFill® is the First FDA-Approved Non-Resorbable Aesthetic Injectable Implant for the Correction of Nasolabial Folds

     ArteFill is a unique combination of homogeneous precision-filtered microspheres suspended in a solution of purified collagen gel and 0.3% lidocaine to alleviate discomfort during injection. ArteFill is manufactured in our dedicated 35,000 sq ft current good manufacturing practices (cGMP) compliant manufacturing facility and corporate headquarters in San Diego.

   In October 2006, ArteFill received final approval from the FDA, making it the first and only non-resorbable aesthetic injectable implant to gain FDA approval. 

ArteFill Is Different From Dermal Fillers

     ArteFill is designed with dual action to correct facial wrinkles, known as nasolabial folds. ArteFill does this as a result of its composition, which is a combination of precision-filtered microspheres (20% of total volume) made from polymethylmethacrylate (PMMA) and purified bovine collagen (80% of total volume). All microspheres have a defined size of 30 to 50 microns in diameter and have a smooth, round surface. Aesthetic results are visible immediately after injection. PMMA is not taken up by scavenger cells (macrophages) and cannot be degraded by enzymes. Thus, the microspheres will remain intact beneath the creases, providing a permanent support structure to support the wrinkle and to prevent further wrinkling. As with all products using bovine collagen, a skin sensitivity test must be performed prior to use.

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      In contrast, FDA-approved temporary "starter" filler treatments using biological fillers to increase the thickness of the skin, such as autologous fat, bovine collagen (Zyderm®, Zyplast®) human collagen (CosmoDerm®, CosmoPlast®), and hyaluronic acid (Restylane®, Hylaform®, Juvedérm®), provide only temporary effects because they are naturally absorbed by the body within a few months following implantation. Using temporary fillers makes it difficult to keep the improved look consistent over time because regular repeat injections are necessary, and the time, cost, and pain associated with such re-treatments are significant.

ArteFill Safety Features

• Precision-filtered, suspended, PMMA microspheres optimized over 3 generations
• Purified bovine collagen gel
• Collagen source is a closed herd in the U.S. (FDA-compliant)
• Proprietary, non-porous syringes contain 0.8 cc and 0.4 cc ArteFill
• Optimized injection flow characteristics
• Pharmaceutical-grade product manufactured in a fully dedicated cGMP facility in San Diego, California
• Company-sponsored ArteFill Physician Training Program

ArteFill®–3 Generations of Product Refinement, 20 Years of Research and Development

A Word About Artecoll®

     Artecoll is manufactured and distributed by unrelated companies located in The Netherlands.  Artes Medical has never manufactured or distributed Artecoll. In 2004, we acquired all worldwide intellectual property rights related to Artecoll and ArteFill and a facility to produce PMMA microspheres in Frankfurt/Main, Germany.

     Following our acquisition of this technology, we developed a new product called ArteFill. We have made further refinements to the PMMA manufacturing process that we believe improve the characteristics and purity of the PMMA microspheres. In addition, we have established our own dedicated QSR-compliant manufacturing facility in San Diego, California to produce the bovine collagen used in ArteFill and to complete the manufacturing, packaging, and labeling processes for ArteFill.