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ArteFill in Head to Head Investigator-Initiated Study to Test Comparative Duration, Safety, and Patient Preference for Dermal Fillers for the Treatment of Smile Lines.


Dr. Stacy Smith Stacy Smith is a news anchor at CBS owned and operated KDKA-TV, the market leader in Pittsburgh, Pennsylvania. He is also a contributor to OnQ, the Emmy-winning television news magazine program that airs on WQED-TV.  Launches Study to Compare ArteFill, Radiesse and Restylane, Other Studies Underway

SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay.  -- Artes Medical, Inc. (Nasdaq:ARTE), a medical technology company whose product ArteFill is the first and only FDA-approved non-resorbable injectable in·ject·a·ble
adj.
Capable of being injected. Used of a drug.

n.
A drug or medicine that can be injected.
 dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin.

der·mal or der·mic
adj.
Of or relating to the skin or dermis.
 filler for the correction of "smile line" wrinkles wrinkles

See bells and whistles.
, today announced that Dr. Stacy Smith, a leading San Diego based dermatologist der·ma·tol·o·gist
n.
A physician who specializes in the diagnosis and treatment of skin disorders.


Dermatologist
A physician that specializes in diagnosing and treating disorders of the skin.
, is conducting a head-to-head clinical study comparison of dermal fillers - ArteFill, Radiesse and Restylane. This 24 patient study will evaluate nasolabial fold, or smile line wrinkle Wrinkle

A feature of a new product or security intended to entice a buyer.
, correction over a two year period.

Stacy R. Smith, MD, President, Therapeutics Clinical Research, Assistant Clinical Professor of Dermatology, University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States).  San Diego, Division of Dermatology, is conducting this "split-face" study whereby patients will receive ArteFill on one side of their face and will receive a temporary dermal filler, either Restylane or Radiesse on the other. Every three months, photographs will be taken to allow a blinded evaluation of the patients' degree of wrinkle correction. Patients will also be asked to provide their assessment of wrinkle correction and level of satisfaction with the treatment on each side of their face. These patients will be followed for a total of two years and the possibility of announcing interim results will be assessed by Dr. Smith throughout the study. When one of the smile lines on the "temporary filler treated" side of their face returns to baseline, the patient will have the option to cross over and receive ArteFill.

Dr. Smith expects to enroll 24 patients by the end of March 2008. A patient satisfaction survey along with patient photos of the results are part of the study protocol. After study completion, these findings will be submitted and are expected to be published in a peer reviewed dermatology journal.

For more information on Dr. Smith or his study, please call (858) 571-6800 or visit www.therapeuticsresearch.com. Dr. Smith received a research grant from Artes Medical, Inc. to conduct this study.

Artes Medical is evaluating and anticipates awarding clinical research grants to other investigators for additional ArteFill studies. Press releases issued by physicians conducting clinical studies with research grants from Artes Medical will be posted on the Investor Relations Investor relations

The process by which the corporation communicates with its investors.
 section of our website at www.artesmedical.com under "Investigator-Initiated Studies."

About ArteFill[R]

ArteFill is the first and only FDA-approved non-resorbable injectable dermal filler for the correction of wrinkles known as smile lines or nasolabial folds. The unique microspheres in ArteFill are not absorbed by the body and therefore provide the first-of-its-kind permanent support for long-lasting wrinkle correction in one to two treatments.

ArteFill was approved by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 in October 2006 based on data from the Company's 12-month controlled, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-masked, multi-center U.S. clinical trial, which compared outcomes for patients treated with ArteFill with those of patients treated with the leading bovine collagen-based filler. At the 6-month evaluation, which was the primary efficacy evaluation period Evaluation period

The time interval over which funds assess a money manager's performance.
 for the clinical trial, the wrinkle correction in patients treated with ArteFill persisted and showed statistically significant improvement compared to the wrinkle correction in the patients treated with the collagen control, who returned to their pretreatment pretreatment,
n the protocols required before beginning therapy, usually of a diagnostic nature; before treatment.

pretreatment estimate,
n See predetermination.
 status. The ArteFill patients were also evaluated one year after treatment, demonstrating continued safety and wrinkle correction.

In February 2007, the Company announced it completed a 5-year follow-up study of 145 patients who were treated with ArteFill in the Company's U.S. clinical trial. In addition to demonstrating the safety profile of ArteFill, the study showed statistically significant (p<0.001) improvement in patient wrinkle correction five years after the patient's last ArteFill treatment, and a statistically significant (p=0.002) improvement in wrinkle correction at the 5-year point compared to the 6-month evaluation period. As part of the study, physician investigators and patients were asked to provide their assessment of ArteFill treatment. Over 90% of the physician assessments were either "completely successful" or "very successful"; and over 90% of the patient assessments were either "very satisfied" or "satisfied." In March 2007, the Company submitted the data from the study to the FDA for review in order to enhance the product labeling for ArteFill.

An ArteFill Skin Test is required before initial treatment. The most common adverse events associated with ArteFill treatment, similar to those observed with other dermal fillers, are lumpiness, persistent swelling or redness and increased sensitivity at the injection site.

ArteFill is a proprietary formulation comprised of polymethylmethacrylate, or PMMA PMMA polymethyl methacrylate. , microspheres and bovine collagen, and is the only PMMA-based injectable product that has been approved by the FDA for the treatment of facial wrinkles. Artes Medical is the sole manufacturer of ArteFill, which is only available in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  through Artes Medical, and Artes Medical has not entered into distribution or licensing arrangements with any third party for the distribution or sale of ArteFill, or any other PMMA-based dermal filler, outside the United States.

About Artes Medical, Inc.

Artes Medical is a medical technology company focused on developing, manufacturing and commercializing a new category of aesthetic injectable products for the dermatology and plastic surgery markets. The Company's initial product, ArteFill, is being marketed to men and women as a treatment option for the correction of nasolabial folds. There were approximately two million dermal filler procedures in the U.S. in 2006, an increase of 25% over the prior year, according to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 the American Society for Aesthetic Plastic Surgery The American Society for Aesthetic Plastic Surgery (ASAPS) is an organization devoted to the advancement of cosmetic surgery. It has approximately 2,400 members. U.S. members are certified by the American Board of Plastic Surgery. , or ASAPS ASAPS American Society for Aesthetic Plastic Surgery
ASAPS Advanced Surveillance Acoustic Prediction System
ASAPS Active Sonar Acquisition and Processing System
. Additional information about Artes Medical and ArteFill is available at www.artesmedical.com and www.artefill.com.

Forward-Looking Statements

This news release may contain 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 reliance on its sole FDA-approved product, ArteFill, its limited experience in commercializing ArteFill, its future receipt of FDA approval to enhance the product label for ArteFill to extend the efficacy period of ArteFill beyond six months and delays in the market acceptance of ArteFill, 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 www.sec.gov. 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved.

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Publication:Business Wire
Article Type:Clinical report
Date:Nov 27, 2007
Words:1123
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