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U.S. BIOMATERIALS/BIOMATRIX PREPARING IDE FOR UROGLAS

This article was originally published in The Gray Sheet

Executive Summary

U.S. BIOMATERIALS/BIOMATRIX PREPARING IDE FOR UROGLAS, an injectable product for urinary incontinence that combines U.S. Biomaterials' Bioglass "bioactive ceramic" material with Biomatrix' hylan hyaluronan derivative. The investigational device exemption will seek FDA approval to study the device in patients at the University of Florida, where institutional review board approval has been obtained, and possibly other centers. Use of the device involves a series of injections during the course of one day into the neck of the bladder. The injections, according to U.S. Biomaterials, augment the existing soft tissue in the urethra, allowing the sphincter to operate with greater efficiency and less effort. UroGlas is the first product being studied under a recently- signed multi-year collaborative agreement between the two companies to develop therapeutic injectable products combining Biomatrix' "proprietary hylan or other hyaluronan derivatives with U.S. Biomaterials' Bioglass or other bioactive ceramics," according to a July 28 joint release. Bioglass is a synthetic material that, according to U.S. Biomaterials, can bond to both bone and soft tissue. A chemically modified form of hyaluronan, defined as a "polysaccharide present in the intercellular matrix of nearly all connective tissues," Hylan serves as the delivery vehicle for Bioglass. Commenting on the agreement, Biomatrix President and Chief Operating Officer George Oram said: "The combination of these highly biocompatible biomaterials presents a number of interesting possibilities...We may be able to develop implants with infinite residence times which cause no tissue reaction." U.S. Biomaterials President and Chief Executive Officer Bruce Hegstad added that "these products may prove effective in the repair of tissues or as bonding agents in the dental, musculoskeletal and urological fields, and also hold promise as delivery systems for various growth factors and therapeutic agents." Privately held U.S. Biomaterials currently markets two Bioglass-based products: ERMI, an endosseous ridge maintenance implant, and MEP, a middle ear prosthesis. The Timonium, Maryland company also is awaiting clearance of PerioGlas, a BioGlass product for filling the gap between bone and soft tissue in periodontal disease. Biomatrix, based in Ridgefield, New Jersey," develops advanced biomaterials for use in therapeutic medical applications and skin care products based on proprietary hylan technology," the release states.

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