We have licensed BioGlue® Surgical Adhesive, from CryoLife, Inc., and have exclusive U.S., Canadian and European distribution rights for aesthetics applications of BioGlue surgical adhesive. BioGlue surgical adhesive that was approved by the FDA in 2001 as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels, and it is approved in Canada and the European Union for various cardiovascular, vascular, pulmonary and general surgical applications. BioGlue surgical adhesive is a sealant that is made of a bovine serum albumin, a cow protein, and a chemical called glutaraldehyde. BioGlue surgical adhesive has been sold commercially since 2001 in the United States and internationally since 1997, and has been used successfully and safely in over 500,000 procedures.
BioGlue surgical adhesive takes seconds to apply and to create a durable mechanical bond, with full adhesion within minutes. BioGlue surgical adhesive offers durability of fixation and the requisite tensile strength for facial aesthetic applications that other glues have not been able to achieve. We believe that BioGlue may offer an attractive alternative to conventional fixation methods, which involve drilling into the skull for fixation, either with resorbable screws, posts or other suspension methods.
In June 2007, pursuant to an investigational device exemption, or IDE, we began to enroll patients in a feasibility study to evaluate the safety and effectiveness of BioGlue surgical adhesive as a method for tissue fixation in patients undergoing browplasty, or forehead lift, procedures, and enrollment is ongoing. BioGlue surgical adhesive is a Class III medical device, subject to the medical device regulatory approval pathway.
We are evaluating clinical, regulatory and commercialization strategies for additional indications in the United States, Canada and the European Union, including procedures where an adhesive may be applicable, such as mid-face lifts, nose and eyelid surgeries and other cosmetic surgeries.
For more information about BioGlue surgical adhesive, please go to BioGlue. (This link will take you to the CryoLife website)
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