Subjects in ArteFill® U.S. clinical trial before treatment, 6 months post-injection, and 1 year post-injection.¹

Actual patient from the clinical trial.

*Primary endpoint

**No 12-month control per protocol

Demonstrated Efficacy in U.S. Clinical Trial

• The controlled U.S. clinical trial demonstrated that ArteFill provided facial wrinkle correction that persisted¹

• Improvement in nasolabial folds was significantly greater as compared to the Zyplast® control at the primary endpoint of 6 months (p<0.001)¹

Improvement in nasolabial folds was evaluated by masked observers using the Facial Fold Assessment (FFA) Scale, an objective measurement based on reference photographs.

Proven Safety

• The safety data base is composed of a pivotal study and an open label study with a total of 391 patients receiving ArteFill¹

• The pivotal study was a controlled, double-masked, randomized, prospective, multi-center trial comparing the safety and efficacy of ArteFill to Zyderm® or Zyplast®¹

• ArteFill patients in the randomized group (n=128) were followed for 1 year¹

• No positive skin test reactions to ArteFill Purified Bovine Collagen™ were reported during the clinical studies¹

Adverse Events Reported at an Incidence of 1% or Greater in U.S. Clinical Trials of ArteFill

No Severe Adverse Events Reported with ArteFill in U.S. Pivotal Clinical Trial (n=251)

¹ArteFill Instructions for Use. San Diego, Calif; Artes Medical, Inc.; 2006.