Healthcare Industry News: Allergan
News Release - March 6, 2009
BioForm Medical to Launch New 1.5cc RADIESSE(r) Volume Advantage Syringe and 0.8cc RADIESSE Moderate Fill Syringe; Announces Successful Results of RADIESSE Dermal Filler With Lidocaine Clinical StudySAN MATEO, Calif., March 6, 2009 -- (Healthcare Sales & Marketing Network) -- BioForm Medical, Inc. (NasdaqGM:BFRM ) today announced two new product forms of RADIESSE(r) dermal filler - the 1.5cc RADIESSE Volume Advantage syringe and the 0.8cc RADIESSE Moderate Fill syringe - which will be introduced at the American Academy of Dermatology's (AAD) 67th Annual Meeting in San Francisco, California. These product introductions are intended to provide physicians with greater value and versatility.
The 1.5cc RADIESSE Volume Advantage syringe is being launched as the new premier filler product format in the U.S. aesthetics market and will retain the same $295 list price to physicians as the 1.3cc RADIESSE dermal filler syringe that it is replacing. The Company increased the volume of the standard RADIESSE dermal filler syringe by 15% while maintaining the same price to provide physicians and patients with even better value and more versatility in aesthetic correction for multiple areas of treatment. BioForm expects to start shipping the 1.5cc RADIESSE Volume Advantage syringe on March 9, 2009.
Complementing our 1.5cc RADIESSE Volume Advantage syringe is the new 0.8cc RADIESSE Moderate Fill syringe, which is intended to offer physicians a less expensive way to use the long-lasting RADIESSE dermal filler in patients with moderate lines or wrinkles, where physicians have primarily relied on products with less volume, like Juvederm(r) or Restylane(r). The 0.8cc RADIESSE Moderate Fill syringe will be launched at a list price to physicians of $199, which the Company believes to be the first leading dermal filler list priced below $200, and an excellent value for physicians and patients in many typical filler treatments. BioForm expects to start shipping the 0.8cc RADIESSE Moderate Fill syringe on April 13, 2009.
``We have increased the value of the large RADIESSE dermal filler syringe with the new 1.5cc RADIESSE Volume Advantage, further enhancing an already great value. We also believe that physicians will embrace our low cost 0.8cc RADIESSE Moderate Fill syringe, especially for procedures in which they may not need as much RADIESSE dermal filler,'' said Steven Basta, Chief Executive Officer of BioForm Medical, Inc. ``With the new 1.5cc syringe, we hope to delight our current customers, and with the 0.8cc syringe, we believe we provide a compelling alternative for dermal filler treatments that might otherwise have been done with a competitor's syringe.''
At the AAD meeting, BioForm Medical will also present the results of its recent clinical trial evaluating the safety and effectiveness of mixing lidocaine with RADIESSE dermal filler. This 50-patient, split-face trial at two clinical sites, demonstrated that RADIESSE dermal filler mixed with 2% lidocaine was found to be less painful than RADIESSE dermal filler not mixed with lidocaine, while having comparable aesthetic correction. This mixing technique was developed by Dr. Mariano Busso and first published in the Journal of Dermatologic Surgery in June, 2008. The results from the clinical trial included:
* Approximately 60% reduction (p<0.0001) in pain scores immediately following treatment, measured on a Visual Analog Scale (VAS).
* 100% of patients found RADIESSE dermal filler mixed with lidocaine to be less painful than non-mixed RADIESSE dermal filler.
* 96% of patients found that the difference in pain level was significant enough to affect their preference for one treatment over the other.
* Both RADIESSE dermal filler mixed with lidocaine and non-mixed RADIESSE dermal filler were safe, with comparable local adverse events, typical of dermal fillers. There were no serious adverse events in the clinical trial.
This clinical study was conducted by Lawrence J. Green, M.D. Assistant Clinical Professor of Dermatology, George Washington University School of Medicine in Washington, DC and Ellen S. Marmur, M.D., Chief of Dermatologic and Cosmetic Surgery, Mount Sinai Medical Center in New York, NY.
The RADIESSE dermal filler mixed with lidocaine study was conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) and the results of this study have been submitted to the FDA as part of a Pre-Market Approval (PMA) Application.
About BioForm Medical, Inc.:
BioFom Medical, Inc. is a medical aesthetics company headquartered in San Mateo, California, developing products that enhance aesthetic procedures performed in dermatology and plastic surgery practices. BioForm Medical's lead product is RADIESSE(r) dermal filler, a long-lasting filler for use in facial aesthetics. BioForm Medical is developing several future aesthetics products, including a radiofrequency treatment to reduce nerve function in the forehead, a sclerotherapy treatment for spider veins, and a surgical adhesive for brow lifts. For more information about BioForm Medical, please visit http://www.bioform.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties, which may cause BioForm Medical's actual results to differ materially from the statements contained herein. Further information on potential risk factors that could affect BioForm Medical's business and its financial results are detailed in its latest Form 10-Q as filed with the Securities and Exchange Commission on February 13, 2009. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. BioForm Medical undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
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.
Juvederm(r) mark owned by Allergan Industrie SAS.
Source: BioForm Medical
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