Saturday, April 26, 2008 10:28:15 PM
>>> Core Technology
The core technology behind Radiesse® dermal filler and Coaptite® injectable has been through significant safety and effectiveness testing, including biocompatibility testing, preclinical studies and several multi-center human trials in more than 1,000 patients, which, along with five years of use by physicians and over 500,000 syringes shipped, has demonstrated its benefits and safety profile. RADIESSE dermal filler and COAPTITE injectable implant require no pre-injection skin testing to determine risk of allergic reaction because it contains no animal or human-derived materials.
RADIESSE dermal filler is a synthetic injectable material that is used by physicians as a dermal filler. RADIESSE dermal filler consists of 30% by volume smooth calcium hydroxylapatite, or CaHA, microspheres ranging in diameter from 25 to 45 microns suspended in an aqueous gel carrier which comprises 70% of the product. The size of the particles allows for delivery through a 27 gauge needle. The gel carrier allows for controlled placement and permits the practitioner to manipulate RADIESSE dermal filler after injection without unwanted migration of the particles. The product's unique calcium-based microsphere technology, along with the proprietary gel technology, helps to restore volume and promotes the growth of the body's own collagen, providing lasting, but not permanent, augmentation. Immediately following injection, the RADIESSE dermal filler adds volume to the space into which it is injected. This volume enhancement is predictable and controllable by the physician, resulting in immediate improvement in patient aesthetics after one treatment. In the first several months after injection, the gel carrier is absorbed by the body and new collagen is formed around the CaHA microspheres, which can reinforce the augmentation effect. Over time the CaHA microspheres, identical to a mineral component of bone and teeth, are also metabolized by the body.
In addition, BioForm Medical has created a strong intellectual property portfolio around its core CaHA technology with 5 issued U.S. patents with broad worldwide counterparts. Additional applications are currently on file and under review in the US. BioForm Medical is committed to creating a strong intellectual property portfolio that protects its current and future products. <<<
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