Tissue Bulking Agent

BioCure has demonstrated the usefulness of its PVA based fast crosslinking system in bulking the lower esophageal sphincter to treat gastroesophageal reflux disease (GERD) and urethral bulking to treat urinary incontinence. The liquid composition can be easily delivered into the desired site using a dual lumen catheter or a syringe, where it polymerizes into a permanent flexible hydrogel depot. The material has excellent biocompatibility.

:: Rationale

Tissue bulking agents are presently used for treating urinary incontinence and have been proposed for use in treating GERD. Collagen is commonly used and has the disadvantages that it migrates and is absorbed over time, requiring repeated injections. Moreover, some people have an allergic reaction to non-autologous collagen. The product concept is a bulking agent that comprises fast crosslinking prepolymers that can be delivered through standard means to form a bulking hydrogel at the site.

:: Technology Description

The bulking agent as developed so far is essentially the same as the LiquiGel™ liquid embolic agent. The formulation was adjusted to provide slower crosslinking to enable more accurate placement and molding of the material.

:: Results to Date

The composition was injected into the subcutaneous space of freshly excised pig bladders using separate syringes for the reductant and oxidant solutions placed into a syringe manifold. One or more mixers were placed between female and male diffusers. A 20 gauge by 3.5 inch needle was used for final delivery. The compositions injected easily into the subcutaneous space to show demonstrable bulking with limited tracking as the needle was withdrawn.

:: Patent Position

Issued patents for the fast crosslinking PVA hydrogel system. Patents pending for use of the PVA hydrogel system for tissue bulking and coating.

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