# Characterization of the Effect of an ECM Based Adhesion Barrier on Healing of Bowel Anastomoses

> **NIH NIH R43** · TYBR HEALTH, INC. · 2021 · $255,991

## Abstract

Project Summary
Over 7 million abdominal and pelvic operations are performed each year in the US and adhesions—the leading
cause of post-operative morbidity—form in nearly 90% of patients following these surgeries. Adhesions are
bands of scar tissue that contribute to the manifestation of myriad life-long complications (e.g., chronic pelvic
pain, small bowel obstruction, and infertility) and the annual healthcare burden exceeds $2.5 billion, but current
options to mitigate adhesion formation are limited and flawed. Based on nearly a decade of research, we have
developed a sprayable adhesion barrier derived from extracellular matrix (ECM Spray), which serves as a
mechanical barrier that elicits a healing response from the patient’s own body to prevent adhesions and regulate
tissue repair. The ECM Spray is thermally responsive and forms a thin film hydrogel over the tissue where it’s
applied and prevents adhesions by acting as a mechanical barrier between adjacent tissues. In two separate
pre-clinical studies using validated small and large animal models, post-operative application of ECM Spray has
resulted in >75% reduction in adhesion incidence and tenacity. A major limitation of currently available adhesion
barriers is that they are contraindicated for use in procedures that involve a bowel resection and re-connection
(i.e., bowel anastomosis) because the adhesion barriers have been shown to inhibit healing which can cause
leakage. Interestingly, we’ve shown that when applied to surgically injured peritoneum, ECM Spray acts as a
scaffold to support re-epithelialization and healing of the peritoneum. However, it is unknown how ECM Spray
will interact with more complex wound healing processes which occur in intestinal anastomosis procedures.
Therefore, the objective of the present study is to determine the efficacy of ECM Spray’s for preventing
adhesions while safely maintaining bowel healing following anastomosis procedures. In Aim 1, we will determine
the efficacy of ECM Spray on adhesion prevention and characterize the effect of ECM Spray on intestinal healing.
In Aim 2, we will determine whether ECM Spray may promote anastomotic healing in a high-risk model of
intestinal repair. Results of the proposed work will lead to a key research and development milestone necessary
for establishing safety and efficacy of ECM Spray for use in abdominal and pelvic operations and increase the
technological and commercial potential of ECM Spray. In addition, if we show potential for ECM Spray to limit
anastomotic leaks, this will broaden the scope for use and dramatically increase the patient and clinical impact,
as well as encourage surgeon adoption in colorectal surgeries.

## Key facts

- **NIH application ID:** 10325229
- **Project number:** 1R43DK127897-01A1
- **Recipient organization:** TYBR HEALTH, INC.
- **Principal Investigator:** Timothy Joseph Keane
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $255,991
- **Award type:** 1
- **Project period:** 2021-08-11 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325229

## Citation

> US National Institutes of Health, RePORTER application 10325229, Characterization of the Effect of an ECM Based Adhesion Barrier on Healing of Bowel Anastomoses (1R43DK127897-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10325229. Licensed CC0.

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