SPINAL SINGULARITY, INC. — Department of Health and Human Services SBIR Phase II: 300

Description

PROJECT SUMMARY ABSTRACT The primary objectives of this SBIR Phase II project are to evaluate the safetyeffectivenessand user satisfaction of the Connected Catheter SystemCCSpinal Singularity developed the CC as a fully internalwirelessly controlled urinary prosthesis designed to dramatically improve quality of life for males with urinary retention disorders and to ultimately lower the incidence of catheter associated medical complications such as urinary tract infectionsUTIsand genito urinary traumaThe CC resides fully internally to the male lower urinary tractLUTwith its distal end in the mid penile urethrafor an extended service life of up todaysThe distal Catheter tip incorporates a magnetic valve pump that enables the bladder to fill naturally and the user to control voiding using a hand held wireless controllerBy residing fully within the body and enabling users to empty their bladders comfortably and conveniently without frequent catheterization or external drainage apparatusthe CC holds the potential both to significantly improve urologic quality of life for its users and to reduce the rates and medical expenses of associated clinical complicationsincluding UTI and traumaFurthermorethe CC may significantly reduce the ongoing cost of supplies compared to clean intermittent catheterizationIn this Phase II projectthe CC system will first undergo a battery of preclinical design verification and validation testingThen the CC will be used in up tousers in a clinical study designed to examine feasibility and safetyThis single arm study features three months of monitoring of CC use and will establish the clinical safety and feasibility of the CCWe expect that the CC will be easy to use and will improve user satisfaction scores in quality of life and the CC user surveyThis project will provide some of the data necessary to support the subsequent regulatory submission of the CC for market clearance in the US and lay the groundwork for a more extensive clinical trial in a Phase IIbThe end goal is to make this superior bladder management technology available to millions of men who rely on urinary catheterization PROJECT NARRATIVE The Connected Catheter SystemCCis catheter designed for male chronic catheter users with neurogenic bladderThe CC enables users to void without multiple catheter insertionsand without external tubes hanging from the bodygiving users more independence over their urinary habitsThe goals of this Phase II clinical feasibility are to perform final device validation and verification studies and demonstrate that the CC works effectively in up tochronic catheter usersThis study lays a foundation for a larger Phase IIb study where Spinal Singularity will assess urinary tract infection rates in CC users compared to other catheterization methodse gchronic intermittent catheterization and Foley catheter users