- CLINICAL TRIAL RESULTS PUBLISHED IN THE JOURNAL OF DERMATOLOGIC SURGERY -
SAN MATEO, Calif., Jan. 14 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM) today announced the publication of a post-marketing multi- center, randomized, blinded comparative study of nasolabial fold treatments reporting that RADIESSE(R) dermal filler was found to be significantly more effective than Restylane(R), the leading dermal filler on the market worldwide. The results of this study will be published in the February 2008 Issue of the Journal of Dermatologic Surgery, a peer-reviewed publication of the American Society of Dermatologic Surgery. The full published study is available for download at http://delivery.sheridan.com/index.php?ID=blk/BLK_132142_CP
This study is the first published direct comparison study of RADIESSE dermal filler against Restylane. The study concluded that 1) patients preferred RADIESSE dermal filler two to one over Restylane, 2) patients reported higher satisfaction and indicated they were substantially more likely to return for future treatments with RADIESSE filler than with Restylane, 3) at all time points through 12 months (9 months after the second injection), RADIESSE filler was found to provide greater improvement than Restylane in nasolabial fold ratings assessed by a blinded evaluator at each site, and 4) both products were safe and had similar adverse events related to local injection site events typical of dermal fillers. Approximately 30% less RADIESSE volume than Restylane volume was required to reach full correction in this split-face trial comparative trial.
In conclusion, the study authors noted that "In this head-to-head study with NASHA (Restylane), CaHA (RADIESSE) is the first product to demonstrate greater durability and comparable safety. We believe that CaHA (RADIESSE) will play a significant role in the practice of many aesthetic medicine practitioners."
"This study demonstrated that it takes less RADIESSE filler to achieve full or optimal correction, and the effect provides more improvement of the fold with results that last longer. We believe that this combination of benefits is what patients and physicians want in a dermal filler, and is why physicians are rapidly adopting RADIESSE in their practices," commented Steven Basta, Chief Executive Officer of BioForm Medical. "Along with the previously reported study results comparing RADIESSE filler with other leading fillers, this study further demonstrates that RADIESSE filler is the best value and provides the most satisfying outcomes among the leading fillers."
RADIESSE vs. Restylane Clinical Trial
A 60-patient blinded, comparative split-face study was conducted at two clinical sites in Europe to assess the aesthetic improvement in treating nasolabial folds with RADIESSE dermal filler as compared to Restylane, the leading hyaluronic acid filler on the market. The results of this prospective, randomized, controlled clinical study, led by Marion Moers-Carpi, MD, Hautok, Munich, Germany, and Jaime Ope Tufet, MD, Barcelona, Spain, demonstrated that at all time points, RADIESSE filler demonstrated longer lasting results, significantly higher patient and physician preference, and greater improvement as compared to Restylane filler. The study was designed to measure the results achieved by RADIESSE filler and Restylane filler on a split-face comparative basis. Each patient was evaluated at baseline and after the completion of two treatments at baseline and at three months in order to achieve full correction. The paper published in the Journal of Dermatologic Surgery reports on results achieved through a 12-month period (9 months following the second treatment).
The results of the study demonstrated that upon evaluation as measured by the Global Aesthetic Improvement Score (GAIS), a greater number of folds treated with RADIESSE dermal filler were rated as "improved" or better at six and nine months following treatment, as compared to the number of "improved" or better Restylane folds. At nine months following second treatment, 79% of folds treated with RADIESSE filler and 43% of folds treated with Restylane filler showed improvement as measured by the GAIS (p<0.0001). The blinded evaluators also determined that in nearly 47% of patients the RADIESSE-treated folds were more improved than the Restylane-treated folds, while only 5% of patients had Restylane folds more improved (p<0.0001).
The results of the Wrinkle Severity Rating System (WSRS) evaluation showed a greater average improvement in RADIESSE-treated folds as compared to Restylane-treated folds at three, six and nine months following the second treatment. On the patient preference evaluation, at each time point more than 60% of patients preferred the RADIESSE fold (p<0.05) to the Restylane fold. In addition, RADIESSE filler required significantly less material to achieve full correction, with an average total injection volume of 0.88cc in contrast to Restylane which needed an average of 1.26cc (p<0.001).
This study was conducted as a post-approval comparison of two leading fillers, and was not intended to support regulatory approval. This study has been accepted for peer-reviewed publication in the Journal of Dermatologic Surgery and will be published in the February 2008 issue.
About BioForm Medical, Inc.:
BioForm Medical, Inc. is a medical aesthetics company headquartered in San Mateo, California. BioForm Medical is dedicated to bringing doctors and their patients safe and effective products for use in the dermatology, plastic surgery and ENT markets. BioForm Medical's products include RADIESSE(R) filler for use in facial aesthetics and vocal fold insufficiency, and Coaptite(R) injectable implant for treating female stress urinary incontinence which is marketed through a partnership with Boston Scientific Corporation. BioForm Medical has licensed U.S. marketing rights to Aethoxysklerol(R) sclerotherapy agent, which is the leading worldwide sclerotherapy agent and is currently being evaluated in a Phase III clinical trial. BioForm Medical has also licensed BioGlue(R) surgical adhesive product for plastic surgery applications, which is being developed in a partnership with CryoLife, Inc.
RADIESSE(R) is a registered trademark of BioForm Medical, Inc.
Restylane(R) is a registered trademark of HA North American Sales AB, a
subsidiary of Medicis Pharmaceutical Corporation.
Vice President, Corporate Development
BioForm Medical, Inc.
|SOURCE BioForm Medical, Inc.|
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