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Evaluation of extracellular matrix gel for adhesion prevention and tissue healing intendon surgery

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AR079966-01A1
Agency Tracking Number: R43AR079966
Amount: $256,573.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAMS
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-19
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
 (713) 248-5635
Business Contact
Phone: (713) 248-5635
Research Institution

Project SummaryApproximately 32M musculoskeletal injuries in the US cost nearly $322B annually (1). The high economic
burden is due in part to post-operative scar formation (i.e., adhesions), which is the leading cause of disability
following tendon surgery (4, 5). We are developing a sprayable adhesion barrier derived from extracellular matrix
(ECM Spray), which serves as a mechanical barrier and elicits a healing response from the patient’s own body
to prevent adhesions from forming. Around 1.5M patients suffer flexor tendon injuries each year and as many as
30-40% of these individuals will subsequently have limited range of motion due to adhesions (6). Current options
to mitigate adhesions are limited and flawed, and there is an unmet need for a technology which can safely and
effectively prevent adhesion formation to maintain normal joint function after tendon injury. ECM Spray is
thermally responsive, forming a thin film hydrogel over the tissue where applied and prevents adhesions by
acting as a mechanical barrier between adjacent tissues. Application of ECM Spray as the last step of a surgical
procedure resulted in rt70% reduction on post-operative adhesions in abdominal and pelvic animal models of
adhesion formation. A major limitation of currently available orthopedic tendon protectors / adhesion barriers is
that they are bulky sheets unable to conform to the region of the repaired flexor tendon and therefore impair
tendon movement / gliding. Newer thin sheet products are available, but surgeons describe them as performing
like “wet toilet paper” because they disintegrate upon hydration. ECM Spray is applied as a liquid, rather than a
sheet, to conform to the repaired flexor tendon and surrounding flexor tendon sheath. Past attempts at
developing sprayable adhesion barriers have been unsuccessful, in part because of impaired tissue healing after
application. While it remains unknown what impact ECM Spray will have upon tendon healing, we have shown
that ECM Spray acts as an inductive scaffold to support constitutive repair of the peritoneum. Based upon these
data, the objective of the present study is to determine ECM Spray’s safety, efficacy, and usability in orthopedic
surgery following flexor tendon injury. In Aim 1, we will characterize tenocyte cellular response to ECM Spray,
which will determine if ECM is biocompatible and supportive of tenocyte and synoviocyte growth. In Aim 2, we
will determine if ECM Spray effective for reducing tendon adhesion formation without compromising the
biomechanics of healing tendons. In Aim 3, we will demonstrate usability in human anatomy, which is critical to
surgeon adoption and commercialization. Results from this safe-by-design approach will lead to key research
and development milestones necessary for use of ECM Spray in orthopedic surgery and could ultimately improve
the lives of the millions affected each year by adhesion-related morbidity.

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

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