# Chitosan Endoluminal Hemostatic Dressing

> **NIH NIH R42** · TRICOL BIOMEDICAL, INC. · 2021 · $853,858

## Abstract

Abstract
 Post-operative bleeding remains the major complication of transurethral and open prostatic surgical
procedures. Prolonged bleeding from these procedures causes delayed healing and longer hospitalization
which significantly increases the cost of patient care. Moreover, prolonged urethral catheterization due to
significant post-operative hematuria is one of the major causes of discomfort and increases the morbidity to the
patients after prostatic surgery. Our goal is to develop an advanced hemostatic urinary catheter device (HUCD)
assembly to control and prevent prostatic bleeding via transurethral application enabling significant reduction in
catheter indwelling time and providing for reduced length of hospital stay following prostatic surgery. In our
Phase II study we successfully developed a chitosan endoluminal hemostatic dressing (CEHD) that used a
standard Foley catheter for delivery. CEHD success in preclinical testing was demonstrated by i) 75%
hemostatic efficacy at 3 minutes in fullly stopping bleeding in a swine splenic capsular stripping model; ii)
deliverability in the swine bladder neck model, iii) 100% urethra patency, iv) prolonged dressing to wet tissue
adherence (> 48 hours), iv) compliance of the dressing with the urinary tissue, v) 100% removal of the dressing
in less than 168 hours by dissolution or flushing; and vi) non-inferiority to TURP hemostasis standard of care.
 The Phase IIB study will address Foley catheter delivery limitations in the Phase II study by 1)
development, to design lock, acceptance & verification of a hemostatic urinary catheter device (HUCD)
composed of an advanced balloon catheter with removable sheath (BCRS) and CEHD; 2) demonstrate design-
locked HUCD manufacturability (3 Lots), stability, sterility, biocompatibility, safety and efficacy to support an
IDE submission for Phase 1 clinical investigation.

## Key facts

- **NIH application ID:** 10256107
- **Project number:** 2R42DK078400-05
- **Recipient organization:** TRICOL BIOMEDICAL, INC.
- **Principal Investigator:** Simon John McCarthy
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $853,858
- **Award type:** 2
- **Project period:** 2009-09-21 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10256107

## Citation

> US National Institutes of Health, RePORTER application 10256107, Chitosan Endoluminal Hemostatic Dressing (2R42DK078400-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10256107. Licensed CC0.

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