# Feasibility, Pilot, and Communication studies towards Translation of Aurie Reusable Catheter System into Clinical Practice.

> **NIH NIH R44** · CATHBUDDY, INC. · 2024 · $404,988

## Abstract

Enter the text here that is the new abstract information for your application. This section must be no
longer than 30 lines of text.
600,000 people in the US rely on intermittent catheterization (IC) for bladder emptying,
but current IC products not adequately meet users’ needs. CathBuddy, Inc. has
developed a novel IC system that is safely reusable, with an automated, validated
method to clean, disinfect and lubricate catheters for re-use. The objective of this SBIR
Phase II project is to modify the design of the 16” Aurie Reusable Catheter System
(developed first due to increased technical difficulty and use by both male and female
IC users) to a 6” system (preferable for many female IC users and needed to enhance
widespread appeal and recruitment for clinical studies). Patients with neurogenic
bladder (NB) are often unable to void spontaneously and require self-administered IC
multiple times each day. Current guidelines recommend the use of a new single-use
catheter with each catheterization, a practice adopted to reduce infection risk, although
IC still contributes to a 50% annual complicated urinary tract infection risk. No-touch
catheters reduce this infection risk by 44.5% with features including introducer tips and
insertion sleeves that reduce the likelihood of contact contamination, but they are often
prohibitively expensive on a per-use basis and only 5% of the user population can
access them. These factors have led to CathBuddy, Inc.’s development of a safely
reusable no-touch urinary catheterization system that alleviates many of the
documented obstacles in IC with a specific focus on human factors and ease-of-use
through a no-touch design. By incorporating a personal portable washer-disinfecting
carrying case for use by the individual into this novel catheterization system, the notouch
catheters can be safely reused on-the-go, and per-use costs drop dramatically. In
addition, plastic waste from catheterization can be reduced by up to 85%. In this Phase
II project, 1) the existing 16” system will be modified to incorporate 6” catheterspecific
design requirements. Modification of the 16” system will require first
evaluating the decrease in fluid volume requirements between the two catheter lengths;
this will be translated into smaller supply needs, smaller batteries (for onboard pumps),
and a smaller overall footprint. This effort will culminate in the development of an
alpha prototype of the female system that can be used in future efforts for FDArequired
Verification and Validation testing.

## Key facts

- **NIH application ID:** 10920608
- **Project number:** 1R44DK139913-01
- **Recipient organization:** CATHBUDDY, INC.
- **Principal Investigator:** Souvik Paul
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $404,988
- **Award type:** 1
- **Project period:** 2024-05-15 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10920608

## Citation

> US National Institutes of Health, RePORTER application 10920608, Feasibility, Pilot, and Communication studies towards Translation of Aurie Reusable Catheter System into Clinical Practice. (1R44DK139913-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10920608. Licensed CC0.

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