SBIR-STTR Award

Scars form after tendon injury. It binds the tendon and prevents it from gliding freely, resulting in diminished movement in a high percentage of patients. Prophylactic application of an agent that inhibits adhesion formation would improve the outcome of these patients. We have developed a series of proprietary materials that inhibit scar formation. The purpose of the research is to develop a chicken model and to test ASCON-T, one such scar inhibiting aaent. The chicken is chosen as a preclinical model because the movement of a chicken foot mimics the movement of the human hand. Specifically, the investigators will develop a reproducible model for injury of and immobilization of the tendon. They will develop test methods for evaluating the resulting scar. Once this model is developed in Phase 1, they will test ASCON-T for safety and efficacy in Phase 11.Awardee's statement of the potential commercial applications of the research:Of the 90,000 people that require hand surgery in the U.S., 36,000 patients may require repeat surgeries. The prophylactic application of ADCON-T after the surgical repair of tendons lacerations will save the health care system about $33 million.National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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. PROPOSED COMMERCIAL APPLICATION: 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 .

Thesaurus Terms:
adhesion, biomaterial development /preparation, female reproductive system disorder, polymer, postoperative complication disease model, female reproductive system surgery, method development, model design /development, protein purification, uterus laboratory rabbitNational Institute for Nursing Research (NINR)