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

> **NIH NIH R44** · COLLAMEDIX INC. · 2021 · $1,273,884

## Abstract

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.

## Key facts

- **NIH application ID:** 10145752
- **Project number:** 5R44HD102241-02
- **Recipient organization:** COLLAMEDIX INC.
- **Principal Investigator:** Subba Shankar
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,273,884
- **Award type:** 5
- **Project period:** 2020-04-15 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10145752

## Citation

> US National Institutes of Health, RePORTER application 10145752, Collagen-based tissue guidance biofabric for treatment of stress urinary incontinence (5R44HD102241-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10145752. Licensed CC0.

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