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Cryolife, Inc. (CRY) Receives CE Mark for BioGlue Surgical Adhesive for European Market

Cryolife, Inc. (CRY), headquartered in both Atlanta, Georgia and San Mateo, California, processes and distributes implantable living human tissues for use in cardiac and vascular surgeries throughout the United States and Canada. The company recently announced the receipt of a CE Mark for the use of CryoLife’s BioGlue Surgical Adhesive for periosteal fixation following a brow lift. The CE Mark approval is a visible declaration by the manufacturer or representative that the equipment complies with all the requirements of the applicable European Union (EU) directives.

The adhesive will be distributed by the company’s partner, BioForm Medical, for use in approved cosmetic and reconstructive plastic surgery in the EU. The product will be marketed under the name “BioGlue Aesthetic™ Medical Adhesive.” CryoLife will be the exclusive supplier of BioGlue for all cosmetic and plastic surgery applications under the terms of the agreement with BioForm.

According to Steven Basta, chief executive officer of BioForm Medical, Inc., the adhesive will not be commercially launched in the EU until further clinical development is completed. The product will be available in Europe on a limited basis to early users who will help the company in the evaluation and development program. Basta believes the program will compliment the development program in the U.S., where the company is planning a study of the adhesive for use in plastic surgery.

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