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Improving the safety and effectiveness of adhesion prevention following colorectal procedures with high risk of cancer or infection

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43DK133012-01A1
Agency Tracking Number: R43DK133012
Amount: $269,911.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-30
Award End Date (Contract End Date): 2023-08-31
Small Business Information
Houston, TX 77021-2041
United States
DUNS: 117403833
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (814) 598-3998
Business Contact
Phone: (713) 248-5635
Research Institution

Project Summary
The leading cause of long-term post-operative morbidity is adhesions—which form in nearly 95% of patients
following surgery. Adhesions are bands of scar tissue that contribute to the manifestation of myriad life-long
complications (e.g. small bowel obstruction, infertility, and chronic pain). The annual healthcare burden from
adhesions exceeds $3 billion, but options to mitigate adhesion formation are limited and flawed. Among all
abdominal surgeries, the highest rate of adhesion-related complications occurs in colorectal surgery. While
pathologies caused by adhesions may take months or even years to manifest clinically, colorectal surgery is also
often complicated by infection (e.g., abscess formation or sepsis) and cancer tumorigenesis. The objective of
this proposal is to determine the effect of our newly developed sprayable hydrogel technology for adhesion
prevention in colorectal surgery within high risk surgical environments contaminated by bacteria or cancer cells.
TYBR’s expertise in biomaterial development and fluid dynamics has informed the development of 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 (upon contact with tissue) forms a thin film hydrogel to prevent adhesions between
adjacent tissues by acting as a mechanical barrier. ECM Spray has proven to be rt75% effective at reducing the
incidence and tenacity of adhesions in well-accepted small and large animal surgical models. These promising,
data show effective adhesion reduction with ECM Spray where sterility is maintained, but it is unknown how ECM
Spray will perform in contaminated surgeries—an at risk patient population without an effective therapy because
competitor products are largely contraindicated for use in contaminated surgeries. Infection risk is a key
translational challenge for adhesion barriers, which has been highlighted by past failed products, including
Intergel which was removed from the market after over 100 reports of infection problems, including 3 deaths.
Therefore, the objective of the present study is to determine if ECM Spray will prevent adhesion formation
without increasing risk of tumorigenesis or abdominal abscess in a contaminated surgeries. In Aim 1, we will
determine the effect of ECM Spray on bacterial growth. In Aim 2, we will determine the effect of ECM Spray on
cancer tumorigenesis. Results of the proposed work will directly lead to a key research and development
milestone towards commercialization. These results will be presented to the FDA to establish safety and efficacy
of ECM Spray for use in tumor resection surgeries and non-sterile surgeries and increase the technological and
commercial potential of ECM Spray. In addition, if we show potential for ECM Spray to reduce infection, this will
broaden the scope for use and dramatically increase the patient and clinical impact, as well as encourage
surgeon adoption in surgeries with a contaminated field.

* Information listed above is at the time of submission. *

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