BioForm Medical, Inc. was incorporated in 1999 and acquired from Bristol-Myers Squibb certain proprietary technology and related assets, including the R&D and manufacturing facility currently housing many of our employees near Milwaukee, WI. BioForm Medical’s patented CaHA (Calcium Hydroxylapatite) technology platform has driven the development of a variety of injectable fillers that are made of small spherical particles of synthetic CaHA suspended in an aqueous gel carrier.
BioForm Medical's CaHA technology has been in development for many years, starting in the early 1990's with functional studies, stability studies, biocompatibility studies, preclinical studies and toxicology assessments performed on BioForm Medical products. In 1996, human clinical studies using technology underlying BioForm's Medical products were initiated for the treatment of stress urinary incontinence (SUI). In 2000, we expanded clinical testing in humans to vesicoureteral reflux (VUR) disease.
In 2001, BioForm Medical initiated the commercialization phase of its products worldwide, with the first FDA 510(k) clearance of Coaptite for use as a tissue marker, and CE Mark authorization of COAPTITE implant for VUR and SUI.
Subsequent clearances followed including the 510(k) clearance of RADIESSE® dermal filler for vocal fold insufficiency and craniofacial augmentation and various worldwide clearances for Radiesse for facial soft tissue augmentation.
In 2003, BioForm Medical expanded operations from its facility in Wisconsin with the addition of corporate headquarters in San Mateo, CA. This expansion followed in 2004 with the incorporation of a European subsidiary in The Netherlands to manage a growing European presence.
In July 2004, Radiance FN was renamed RADIESSE. This product name change is the first step in BioForm Medical's plan to offer several future products under the RADIESSE family brand that are specifically designed to meet the needs of patients and physicians.
In April 2006, BioForm Medical partnered with Boston Scientific Corporation to commercialize COAPTITE implant for the treatment of stress urinary incontinence due to intrinsic sphincter deficiency (ISD) in adult females.
In December 2006, RADIESSE® dermal filler was approved for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also approved for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
In May 2007, BioForm Medical entered into a license agreement with Chemische Fabrik KREUSSLER & Co. GmbH for the exclusive U.S. distribution rights for Aethoxysklerol® sclerosing agent, a leading varicose vein treatment currently sold outside of the United States. AETHOXYSKLEROL® sclerosing agent is not approved for sale in the United States and is currently in a Phase III clinical trial.
In June 2007, BioForm Medical received IDE approval from the FDA to initiate enrollment of patients in an early stage human trial evaluating BioGlue® Surgical Adhesive as a less invasive alternative for tissue fixation in browplasty procedures (brow lifts)
BioForm Medical continues to build a rich product pipeline to serve its customers through internal research & development and external product acquisitions.