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Clinical trials to begin for new surgical adhesive

Article-Clinical trials to begin for new surgical adhesive

Atlanta — CryoLife Inc., based in Atlanta, and San Mateo, Calif.-based BioForm Medical Inc. have announced that the first patient has been enrolled in a clinical study evaluating BioGlue® Surgical Adhesive as a method of fixation in brow lifts, reports PRNewswire.

BioForm recently received permission from an FDA Investigational Device Exemption (IDE) to begin enrollment in a feasibility study to evaluate the safety and effectiveness of BioGlue for tissue fixation in brow-lift procedures.

According to the PRNewswire report, BioForm CEO Steven L. Basta says the trial will be “the first for a surgical adhesive as a fixation methodology for browplasty” and that if the product proves safe and effective, “the use of BioGlue may represent an attractive and less invasive alternative for physicians and patients compared to traditional methods of fixation.”

BioForm and CryoLife, a biomaterials, medical-device and tissue-processing company, entered into a licensing and distribution partnership in October 2006 for the development and marketing of the latter firm’s BioGlue Surgical Adhesive. BioForm is responsible for all clinical trials, regulatory filings and sales and marketing of BioGlue for cosmetic and plastic surgery applications. CryoLife remains the exclusive manufacturer of the product.

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