LUNA LABS USA LLC — Department of Health and Human Services SBIR Phase I: 300

Description

ABSTRACT Adhesion formation after intra-abdominal surgery poses a significant health risk, cited as a leading cause of small bowel obstruction and female infertility. Methods to prevent these adhesions are currently limited to barrier films, which are difficult to place and are often restricted to use preventing adhesions to the surgical incision site, leaving the bulk of the abdominal contents unprotected. These barrier products also fail to address the tissue response that causes most adhesions. This program will focus on the optimization of a low-cost, sprayable barrier that will flow around and adhere to the internal tissues of the abdominal cavity, providing protection from adhesions for all internal surfaces. This hydrogel will also deliver anti-inflammatory or fibrinolytic therapeutics to mitigate local biological responses responsible for adhesion formation. Luna Labs will optimize the product formulation using in vitro characterization before completing preliminary validation of efficacy in a rodent abdominal model of adhesion formation. These results will support a Phase II transition effort towards product commercialization and submission to the FDA.