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Frost & Sullivan Recognizes Cohera Medical, Inc.® for Developing TissuGlu®, Its Pioneering Surgical Adhesive That Is Strong, Easy-To-Use, Biocompatible and Resorbable
Date:1/25/2011

tive complication rate from 15 to 52 percent – the formation of seroma being the most likely complication. Usual methods to combat seroma formation include the placement of closed suction drains, use of compression garments around the tissue, use of progressive tension sutures, and use of fibrin sealants to reduce fluid accumulation. However, most of these methods can lead to further complications such as leakage from drain sites, skin necrosis and inconsistent adhesion.

Using TissuGlu not only reduces the fluid drainage that can lead to formation of seroma but also reduces the need for post-surgical drains. The adhesive is molecularly designed to bond biological tissue in the presence of moisture, and then later degrade by hydrolysis into benign components. This is a key criterion in determining the biocompatibility of an internally used adhesive. In contrast, cyanoacrylates – the widely used adhesive in medical applications – has been restricted to just topical use, because it yields formaldehyde as a result of hydrolytic degradation of the polymer main chain.

According to the most recent preclinical testing data, TissuGlu has prevented the formation of seroma in an animal model of abdominoplasty. In-vivo studies have also shown that TissuGlu is biodegradable and safe for internal use. The adhesive passed all biocompatibility tests to establish safety prior to human clinical trials. In particular, a 13-week sub-chronic toxicity study found TissuGlu® to be a non-irritant, comparable to saline. A human feasibility trial demonstrating the safety of the adhesive material was just completed for the abdominoplasty indication in Germany.

Apart from the adhesive being effective in minimizing post-operative wound drainage, histological analysis of the tissue samples from the pre-clinical study showed no signs of inflammation or foreign body reaction associated with the adhesive. The lysine-derived urethane works to reduce fluid a
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SOURCE Cohera Medical, Inc.
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