ABSTRACT The prevalence of stress urinary incontinence (SUI) in women is 22% in ages 45-64 years, and up to 41% in women over 80 years old. Synthetic polypropylene mesh slings are the current standard of care treatment, and the market for these devices is over $400M/year. However, complications rates, including chronic pain, extrusion, and erosion, range from 5-15%. There have been numerous class-action lawsuits against manufacturers, a pause on SUI sling sales in the UK and New Zealand, and many patients are hesitant or unwilling to receive these implants. Therefore, there is a strong clinical need to develop new implants to treat this debilitating and life-altering condition in women. CollaMedix’s patented electrochemical compaction fabrication process transforms solutions of medical-grade bovine Type I collagen into continuous-length threads on spools that are among the densest and strongest forms of reconstituted collagen. Collagen molecules are strictly aligned in parallel to the long axis of threads, mimicking the native topography of ligament-like tissues. When implanted in vivo, host collagen deposited throughout scaffolds made from these threads is also aligned, indicating that the threads act as a template, resulting in an ordered tissue structure, not a randomly oriented scar. The collagen threads are resorbed and remodeled over time as a strong, ligamentous tissue grows through the scaffold. Based on this technology, CollaMedix has developed a tape-shaped, pure-collagen product for SUI treatment, CollaSling™, composed of braided pure-collagen threads. CollaSling is implanted in the same manner as standard SUI slings and imparts less inflammation than polypropylene over time, as shown in long-term sheep studies. We have completed the product design and high-risk verification and validation (V&V) studies required for FDA submission, including the full biocompatibility test suite, large animal implant study, and sterilization method development for the CollaSling. The aims of this study are to complete the validation work and protocol development needed to submit an Investigational Device Exemption (IDE) to the FDA for the CollaSling and, once the IDE is approved, to initiate and complete a 20-participant Phase I safety pilot clinical study. The pilot study will be conducted at three hospital centers: Duke University Hospital, Cleveland Clinic, and MetroHealth. Women with SUI who volunteer for the study will be implanted with CollaSlings using standard surgical techniques and followed carefully. An interim safety analysis based on adverse event rates will be conducted at 3-months post-surgery, and all participants will be followed for a minimum of one year to assess CollaSling safety and efficacy by comparing objective measures of continence and patient-reported outcomes to previous studies on SUI slings. Successful completion of this pilot, first-in-human trial of the CollaSling will allow the project to move forward to a Phase II pivot...