ABSTRACT An increased incidence of various pre-existing conditions like diabetes and hypertension, combined with systemic issues surrounding the quality of maternal health care provided, has resulted in a significant increase in the cesarean delivery rate in minority communities. These surgical procedures contribute to disparities in maternal health outcomes and postoperative complications, as C-sections increase the likelihood of pelvic adhesion formation. These adhesions are a leading cause of infertility, pain, and increased delivery time for subsequent births, and the disproportionate administration of these procedures in minority communities (i.e. these women are 33% more likely to undergo cesarean delivery) means these repercussions may be found more frequently in these populations. Current products for adhesion prevention are difficult to apply in gynecologic procedures and fail to properly address this severe surgical complication. Luna Labs’ patented AeroVeil technology, a two-component sprayable hydrogel, has been demonstrated effective in decreasing the incidence and severity of abdominal adhesion formation in rat and rabbit models. The proposed program will focus on transitioning product application from these abdominal adhesion models into wound healing and efficacy models of gynecologic applications to evaluate the safety and efficacy of product application in this space. Successful completion of these efforts will drive technology transition and regulatory approval to support the initiation of clinical trials with a commercial partner and reduce the needless surgical complications suffered by women in minority communities.

PROJECT NARRATIVE A two component sprayable hydrogel barrier that has been previously demonstrated to reduce abdominal adhesion formation will be investigated for the prevention of uterine adhesions following cesarean delivery. The implications of this study are significant as the rate of cesarean delivery now accounts for more than one third of live births, with a particularly high rate observed within minority communities. This Direct Phase II effort will target the demonstration of product safety and efficacy to support uterine healing while mitigating adverse scar or adhesion formation, improving postoperative outcomes for women at higher risk of maternal morbidity or mortality.