Phase II year
2021
(last award dollars: 2023)
Phase II Amount
$2,051,654
The primary objectives of this Phase II SBIR Proposal are to develop the UroMonitor (UM) with an ISO-13485certified manufacturer and evaluate the safety and feasibility of the UM in a Clinical Feasibility Study.Urodynamics evaluations are conducted to aid in diagnosis and treatment of patients with Lower Urinary TractSymptoms (LUTS). This evaluation measures the pressure and volume in the bladder to characterize bladderperformance and inform decisions regarding the appropriate course of treatment. In many cases, Urodynamicsevaluations fail to reproduce patient symptoms, which limit effectiveness. One major reason this occurs isbecause the test requires patients to remain static and artificially fill their bladders using catheters. Bright Urohas developed a method to conduct Ambulatory Urodynamic Monitoring that is wireless and catheter-free. Weare confident this will result in more accurate, more comprehensive evaluations that improve outcomes forpatients, clinicians and payers.Bright Uro has developed the UM as a wireless sensing platform for extended urological monitoring in the homeenvironment. The UM can remain in the bladder for up to 7 days and record pressure and volume. Whensynthesized with a Voiding Diary, Uroflowmetry, and other physiological data, the UM will provide the mostcomprehensive Urodynamic report available to clinicians. The UM system leverages promising clinical resultsfrom a First in Woman clinical study recently completed at the Cleveland Clinic. This lays the foundation for ourproposed Clinical Feasibility Study where we will evaluate the safety and feasibility of the UM for an extendedperiod in the home setting.Data collected from this study will provide valuable insight and inform future clinical studies. If successful, theUM will be postured for follow-on studies including a potential Phase IIB application and a larger pivotal studywith greater statistical power. Our goal is to bring the UM to market where it could revolutionize the wayUrodynamics evaluations are conducted and significantly improve outcomes for patients, clinicians, and payers.
Public Health Relevance Statement: PROJECT NARRATIVE
We have recently developed a wireless, catheter-free method of ambulatory urodynamic monitoring for extended
periods of observation in the home environment. Due to recent technological developments, this will be the first
time anyone has collected a comprehensive dataset of bladder performance including Pressure, Volume, Voiding
Diary, Uroflowmetry, and other physiological data (from a smartwatch) in a synchronized manner for an extended
period in the home environment (4-7 days). In the proposed Phase II application, we will update the UroMonitor
(UM) design, complete necessary testing of the UM for clinical use, and manufacture UM devices in sufficient
inventory for use in a clinical feasibility study. Data collected from 40 patients in a Clinical Feasibility Study will
offer meaningful insight and critical knowledge to inform future clinical studies and support eventual FDA
regulatory submission. If successful, the UM could offer actionable insights that have never been available for
Urologists and change the way patients with Lower Urinary Tract Symptoms are diagnosed.
Project Terms:
