ArteFill

Generic Name: dermal filler
Date of Approval: October 27, 2006
Company: Artes Medical, Inc.

Treatment for: Correction of Nasolabial Folds

FDA Approves ArteFill

The United States Food and Drug Administration has approved ArteFill. ArteFill is the first and only non-resorbable aesthetic injectable implant approved by the FDA. The product is indicated for the correction of facial wrinkles known as nasolabial folds, or smile lines.

Unlike existing dermal fillers that are completely metabolized by the body, ArteFill represents the first product in a new category of non-resorbable dermal fillers providing a permanent support structure for enduring wrinkle correction. Artes Medical intends to begin marketing and selling ArteFill to dermatologists, plastic surgeons and cosmetic surgeons in the U.S. through the Company’s direct sales force.

ArteFill contains a proprietary combination of ArteFill Precision-Filtered Microspheres(TM) suspended in a carrier gel containing purified bovine collagen. Artes Medical produces the microspheres from one of the most commonly used synthetic implant materials in medicine, polymethylmethacrylate (PMMA). The size of the microspheres is strictly regulated to help ensure consistent and safe results. The microspheres are 30 to 50 microns in size, barely visible to the naked eye. Artes Medical produces the purified collagen gel in accordance with both FDA and USDA guidelines. After ArteFill is injected into a patient’s smile line, the microspheres provide a permanent support structure beneath the skin to support the wrinkle and to prevent further wrinkling.

About ArteFill

ArteFill is indicated for the correction of facial wrinkles known as nasolabial folds or smile lines. An ArteFill Skin Test is required before initial treatment. The most common adverse events associated with ArteFill injections, similar to those observed with other dermal fillers, are lumpiness, persistent swelling or redness and increased sensitivity at the injection site.

U.S. Clinical Study

The FDA approval of ArteFill was based on data from the Company’s 12-month, controlled, randomized, double-masked, prospective, multi-center U.S. clinical trial. Patients treated with ArteFill (n=251) showed significantly greater and persistent improvement compared to those treated with the collagen control (Zyplast). At the 6 month evaluation, which was the primary efficacy evaluation period, the wrinkle correction in the patients treated with ArteFill persisted, while the patients treated with the collagen control returned to their pretreatment status. The safety profiles for ArteFill and the collagen control group were comparable. ArteFill patients were also evaluated one year after treatment, demonstrating continued safety and wrinkle correction. Based on our clinical data, the FDA approved ArteFill as a safe and effective non-resorbable injectable implant for the correction of nasolabial folds in men and women.

ArteFill Patient Information

What is ArteFill?

ArteFill is the first and only FDA-approved non-resorbable injectable filler for the correction of wrinkles known as smile lines. It contains 20% tiny round and smooth particles (PMMA microspheres) and 80% purified bovine collagen gel with 0.3% lidocaine, an anesthetic.

How does ArteFill work?

ArteFill is a dual-acting injectable wrinkle filler. First, ArteFill visibly corrects the wrinkle. Then the microspheres provide the permanent support your skin needs for long-lasting wrinkle correction.

How is ArteFill injected?

ArteFill is injected underneath the wrinkle, just above the skin’s fat layer. ArteFill provides the soft, supportive foundation that your skin needs for long-lasting wrinkle correction.

Why is a skin test necessary prior to treatment with ArteFill?

A skin test is a safety precaution to make sure that you are not allergic to the bovine collagen or anesthetic in ArteFill.

Who should not have ArteFill treatments?

Some people are not good candidates for ArteFill. ArteFill is contraindicated in those who:

• Have a positive reaction to the ArteFill skin test.
• Have a history of severe allergies and hypersensitivity (anaphylaxis).
• Are allergic to the anesthetic (lidocaine) in ArteFill.
• Have a history of allergies to any bovine collagen products.
• Are prone to thick scarring (hypertrophic) formation and/or excessive scarring (keloid).
• Are undergoing or planning to undergo desensitization injections to meat products.

Are there any other treatment concerns with ArteFill?

If you have any skin outbreaks (e.g., cysts, pimples, rashes, hives, infection) near the injection site, you should postpone treatment until they clear.

If you are taking aspirin (NSAIDs) or anti-inflammatory drugs or have any medical condition that affects your blood, you may experience increased bruising or bleeding at the injection sites.

In addition, you should inform your doctor if:

• you have had any treatments for smile lines in the last 6 months.
• you are receiving UV light therapy.
• you are currently on immuno-suppressive therapy (medication commonly prescribed for those who have undergone an organ transplant, or are suffering from rheumatoid arthritis, psoriasis, inflammatory bowel disease, or cancer).

It’s important that you share your medical information with your doctor. Together, you can make an informed decision as to whether ArteFill is right for you.

Are there any further precautions with ArteFill?

Yes, you should know:

ArteFill contains microspheres that help provide the permanent support for wrinkle correction. Treatment results are lasting. The microspheres can only be surgically removed.

The safety of ArteFill in pregnant or breastfeeding women, and individuals under 18, has not been established.

There is always a risk of infection with any injection. Discuss the symptoms of infection with your doctor so you will be able to recognize them.

Check to see if your doctor is properly trained to provide ArteFill.

Are there any possible side effects with ArteFill?

As with any injectable wrinkle filler, you can expect mild swelling and reddening at the treatment site. These side effects are usually gone within 24 hours. Occasionally, there is mild bruising that typically disappears in 3 to 7 days. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, and increased sensitivity at some or all injection sites. Two other rare potential side effects of all dermal fillers may be lumps and granulomas, both of which can be treated by your physician.

Be sure to call your doctor immediately if you notice any unusual skin reactions around the treatment area.

For more information, please visit www.artefill.com