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Elevess, a New FDA-Approved Hyaluronic Acid-Based Dermal Filler Launched

August 6, 2008 |

“The Feel Good Filler” Delivers Comfort, Affordability, and Immediate Results

SAN DIEGO–(BUSINESS WIRE)–Aug. 5, 2008–Artes Medical (NASDAQ:ARTE) today announced the immediate availability of Elevess(TM), a new, FDA-approved hyaluronic acid (HA) based dermal filler for the treatment of facial wrinkles, such as nasolabial folds. As the first FDA-approved HA filler formulated with an anesthetic for patient comfort, Elevess is a safe and effective alternative to more expensive fillers.

Elevess delivers immediate treatment results that are comparable to other fillers, while the anesthetic provides patients with an easier, more comfortable injection experience. In addition, as a more affordable treatment option, Elevess is an ideal choice for patients seeking cost-effective alternatives for treating their facial wrinkles. As a result, the product is expected to enhance physician practices by putting dermal fillers within reach of a greater number of patients.

“The market launch and commercial sale of Elevess marks an important milestone for both Artes Medical and the aesthetic injectable marketplace. We believe physicians and their patients will welcome a new choice in wrinkle fillers – one that is as comfortable and affordable as it is effective,” said Christopher J. Reinhard, executive chairman of Artes Medical. “By adding Elevess to their treatment arsenals, physicians can offer cost-effective wrinkle correction to more patients than ever before. Elevess may also help physicians build a funnel that moves patients towards a longer-lasting option like ArteFill, the first FDA-approved non-resorbable wrinkle filler. Together, these benefits make Elevess ‘The Feel Good Filler'(TM) for physicians and patients alike, and Artes Medical is pleased to bring this new product to market just weeks after the announcement of our distribution agreement with Anika Therapeutics.”

“I have treated a number of patients with Elevess with excellent results,” said Stacy Smith, M.D., Assistant Clinical Professor (volunteer) UCSD Division of Dermatology. “The product injection experience is easy and comfortable for the patient, while the correction is similar to that I’ve achieved with other HA fillers currently on the market. Elevess provides me with a new treatment option for patients averse to anesthetic blocks, and I look forward to integrating it into my practice.”

Elevess is indicated for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. In a randomized, controlled pivotal study of 208 patients, Elevess was shown to be safe and effective for up to six months.

Artes Medical’s dedicated sales force will market and sell Elevess, as well as the company’s flagship product, ArteFill, the first and only FDA-approved non-resorbable wrinkle filler for long-lasting correction of smile line wrinkles. As a result, Artes Medical becomes the first and only company in the U.S. with a product portfolio of approved dermal fillers that provide patients with a range of treatment options.

Elevess is available for sale to qualified physicians or properly licensed practitioners only. To order, please contact an Artes Medical sales representative or call 888-278-3345. For more information, please visit

About Elevess

Elevess is the first FDA-approved injectable dermal filler to combine hyaluronic acid (HA) and lidocaine, a local anesthetic that improves patient comfort, and provides physicians with a new alternative for their aesthetic practice. Designed, developed and manufactured by Anika Therapeutics, Elevess is formulated for durability based on its proprietary cross-linking technology and a high concentration of HA. Elevess is distributed by Artes Medical.

Elevess is indicated for injection into the mid to deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). In clinical studies, adverse events were usually mild to moderate in nature and generally resolved within seven days. The most common side effects were injection site reactions of swelling, redness, bumps, bruising and tenderness. Elevess should not be used by patients with severe allergies. For complete patient safety information, please consult the Elevess Instructions for Use.

About Artes Medical, Inc.

Artes Medical is a medical aesthetics company focused on developing, manufacturing and commercializing a new category of aesthetic injectable products for the dermatology and plastic surgery markets. The Company’s flagship product, ArteFill, is being marketed to men and women as a treatment option for the correction of nasolabial folds. Additional information about Artes Medical and ArteFill is available at and

Forward-Looking Statements

This news release contains forward-looking statements that are based on the Company’s current beliefs and assumptions and on information currently available to its management. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. As a result of these risks, uncertainties and other factors, which include the Company’s history of net losses, its ability to timely raise additional funds to support its operations, its ability to manage its operating expenses, its limited experience in commercializing ArteFill and Elevess, its need to complete a Post Approval study of Elevess in persons of color, its future receipt of FDA approval to extend the efficacy period of ArteFill beyond six months and eliminate the skin test requirement, and the risk that the Company’s revenue projections may prove incorrect because of unexpected difficulty in generating sales and market acceptance of ArteFill and Elevess, readers are cautioned not to place undue reliance on any forward-looking statements included in this press release. A more extensive set of risks and uncertainties is set forth in the Company’s SEC filings available at These forward-looking statements represent beliefs and assumptions only as of the date of this news release, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.

Artes Medical(R) and ArteFill(R) are registered trademarks of Artes Medical, Inc. All other trademarks referred to in this press release are the property of their respective owners.

    CONTACT: Manning, Selvage and Lee
             Kelley Childrey, 323-866-6003 (Corporate Media)
             Artes Medical
             Cheryl Monblatt Allen, 858-550-9999 (Investor Relations)

    SOURCE: Artes Medical, Inc.

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