# Validation of a Neurogenic Bladder Management Solution to Promote Independence and Reduce Long-Term Morbidity for Patients Unable to Perform Intermittent Catheterization

> **NIH NIH R44** · CRM MEDICAL DEVICES, INC. · 2023 · $775,342

## Abstract

PROJECT SUMMARY/ABSTRACT
The primary objectives of this SBIR Phase II project are to verify the surgical approach for
device placement, finalize device design, and complete Design Validation and Verification
testing to support 510k submission for the EZ-SP device. CRM Medical Devices developed the
EZ-SP catheter as a bladder drainage system for those who cannot volitionally void, with a
specific emphasis on assisting those with neurologic disease who have difficulties draining their
bladder via clean intermittent catheterization (CIC), the act of placing a catheter through their
urethra into the bladder for urinary drainage. Unfortunately, hundreds of thousands of men and
women in the United States struggle to perform CIC due to either poor upper extremity motor
function or difficulty accessing their urethra (most females). The EZ-SP device is a modified
form-fitting catheter that spans from the bladder to the skin level of the lower abdomen and is
initially placed via a simple, reversible, minimally invasive, 15-minute surgical procedure. By
residing on the lower abdomen, the EZ-SP can be easily accessed while in a wheelchair and
does not require time-consuming transfer to a commode or bed. It also reduces the social
stigma that comes with indwelling catheter use, where a bladder drainage tube is always
attached to a collection bag of urine and obviates the need for urethral catheterization, which
can be traumatic. Simply, the EZ-SP catheter has a continence valve within it that can be
mechanically opened for drainage when appropriate. To drain the bladder, a user attaches a
“magnetic click connector” (that requires minimal UE motor function to connect) to a mechanical
pump that removes urine from the bladder in a timely fashion and is then disconnected until the
bladder is full again. After initial placement, subsequent monthly EZ-SP changes can be
performed in an outpatient setting by simply deflating the retention balloon of the existing EZ-SP
device, removing the device, and placing a new EZ-SP catheter through the existing scar tract
from skin to bladder without further surgical intervention. In this Phase II project, we expect to
complete the necessary testing to support the subsequent regulatory submission of the EZ-SP
via a 510k process for market clearance in the United States and lay the groundwork for a
clinical trial in a Phase IIb study. The end goal is to make this superior bladder management
technology available to hundreds of thousands of men and women (regardless of upper
extremity motor function) who rely on urinary catheterization.

## Key facts

- **NIH application ID:** 10691472
- **Project number:** 5R44DK127580-03
- **Recipient organization:** CRM MEDICAL DEVICES, INC.
- **Principal Investigator:** Christopher Elliott
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $775,342
- **Award type:** 5
- **Project period:** 2020-09-20 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10691472

## Citation

> US National Institutes of Health, RePORTER application 10691472, Validation of a Neurogenic Bladder Management Solution to Promote Independence and Reduce Long-Term Morbidity for Patients Unable to Perform Intermittent Catheterization (5R44DK127580-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10691472. Licensed CC0.

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