Postoperative adhesion formation between pelvic structures is a significant cause of lower abdominal pain and infertility. Prophylactic use of an adhesion adjuvant that inhibits formation of gynecological adhesions would greatly improve the outcome of these patients. We have developed a series of proprietary formulations that inhibit adhesion formation. The purpose of the Phase I research is to evaluate the safety and effectiveness of our candidate product. Specifically, the investigators will develop a reproducible rabbit uterine horn adhesion model and then use the model to evaluate the safety and effectiveness of our candidate product. The effect of multiple treatment applications will be evaluated as additional safety information. Successful outcome of the phase I will lead to extensive regulatory preclinical testing of our candidate product.
Annually over 700,000 patients undergoing a gynecological procedure develop surgical adhesions. They frequently suffer complications such as pain and infertility as a result of the adhesions, which may be so severe that they require a second operation to remove the adhesions. The total cost for adhesion removal is close to $1.2 billion a year. Development of an effective product to inhibit surgical adhesions will be of significant value .
