CryoLife Inc and BioForm Medical Inc have received a CE Mark for the use of CryoLife’s BioGlue Surgical Adhesive for periosteal fixation following endoscopic browplasty or brow lift. The CE Mark approval allows the product to be marketed in the European Community (EU).
BioGlue will be distributed by BioForm Medical for use in approved aesthetic and reconstructive plastic surgery in the EU, under the name "BioGlue Aesthetic™ Medical Adhesive." Under the terms of the agreement, CryoLife is the exclusive supplier of BioGlue for all aesthetic and plastic surgery applications, and BioForm is responsible for all clinical trials and regulatory filings, and for sales and marketing of BioGlue in 12 EU countries.
"BioGlue has many potential applications in aesthetic surgery, and we are particularly excited about its promise in brow lift surgery," said Steven Basta, CEO at BioForm Medical. "This is an important step in our overall development strategy to evaluate the use of BioGlue as a quick and easy-to-use fixation method in plastic surgery. The CE Mark will enable us to accelerate development and evaluation of BioGlue applications with European physicians."
According to Basta, BioGlue will not commercially launch in the EU until further clinical development is completed, but the product will be available in Europe on a limited basis to early users who will help in the evaluation and development program.
"This program will complement the development program in the US, where we are advancing toward a planned US pivotal study of BioGlue for use in browplasties," says Basta.
[Medical News Today, June 11, 2008]