Collagen-based tissue guidance biofabric for treatment of stress urinary incontinence

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Innovation in approaches for soft tissue repair and support involving connective tissue laxity are needed for many clinical applications. These include developing improved treatments for female pelvic floor disorders, ab- dominal surgical repair (hernia), orthopedic applications for tendon and ligament repairs. Some of these disorders, such as stress urinary incontinence (SUI) in women, pelvic organ prolapse (POP) and hernia repair, are treated by using synthetics such as polypropylene mesh as the standard of care. Nonetheless there is a high reported incidence of complications relating to the implantation of polypropylene mesh in pelvic floor disorders. Other biomaterials, such as decellularized allografts or xenografts, lack porosity to accommodate tissue integration; thus, their physical properties diminish over time, resulting in functional failure. There is, therefore, a strong clinical need to develop innovative soft-tissue repair and support products to treat these life-altering conditions in women and such products would also impact hernia, orthopedic repairs, and other fields as well. CollaMedix is developing new implantable medical devices based on pure collagen threads formed by a novel, patented electrochemical compaction process. Medical-grade solubilized bovine Type I collagen is electrocompacted into threads that are among the most dense and strongest forms of reconstituted collagen. Therefore, these threads can be woven or filament-wound into complex shapes to make a biofabric (CollaFabric™) to form a wide variety of bioabsorbable implants that have ample porosity for tissue ingrowth and rapid integration. CollaFabric produces a new tissue growth response in the body while it is being broken down; thus, it performs better than synthetic plastic implants, while avoiding negative side effects, including extrusion, erosion, and chronic inflammation. CollaMedix and co-inventors at Case Western Reserve University have conducted extensive preliminary biocompatibility studies on CollaFabric in rats, rabbits, and recently on sheep, that showed excellent tissue integration and strength even at 6 months. The first family of products produced from CollaFabric will be for the treatment of SUI and POP in women, followed by products for other applications. The aim of this project is to complete the development of a SUI treatment for women based on CollaFabric. The proposed activities and data collection are based on direct feedback from FDA. The design of existing CollaFabric prototypes will be optimized and the design frozen. The design will then be verified and validated, including packaging validation, sterilization validation, biocompatibility testing, and in vivo implant testing, with comparison to an existing predicate, in a 6-month sheep study. The end result of this work will be an FDA 510(k) application.