Bioabsorbable Membranes for Prevention of Adhesions

DESCRIPTION (provided by applicant): Stonybrook Technology and Applied Research (STAR), Inc. is currently focused on the development of unique anti-adhesion nanostructured products in post-operative surgery. Adhesions are mainly induced from the trauma of surgery and can lead to serious complications, including pelvic pain, small bowel obstruction, female infertility, chronic debilitating pain and difficulty with future operations. Typically, a patient will often undergo surgery to remove adhesions, only to have them reform. It is a very costly problem, e.g., Medicare alone has paid $3.22 billion per year for the treatment of adhesion related complications in the 1990's. In this SBIR Phase II submission to the NIGMS, STAR is seeking 3 years of support to complete the development of two FDA-regulated anti-adhesion products: (1) unsupported membranes for abdominal surgery and (2) mesh supported membranes for hernia repair. The specific aims of this application are: 1. Thorough in vivo studies using rat and rabbit models to evaluate the proposed two anti-adhesion products. 2. Introduction of medicated alternatives and composition adjustments as contingency plans. 3. Development of mass production facility using multiple-jet electro-spinning technology to commercialize anti-adhesion products. Thus, in the Phase II project, the proposed tasks will deal mainly with the completion of: 1. In vivo studies using the objective rat model and the rabbit model to evaluate the anti-adhesion properties of two electro-spun non-medicated products based on a successful chemical composition. 2. Optimization of non-medicated anti-adhesion products by fine tuning of the PEG composition using in vitro and in vivo evaluations as a first contingency plan. 3. Optimization of medicated anti-adhesion products by determining the minimum effective dosage of Cefoxitin sodium for local delivery based on in vivo evaluation as a second contingency plan. 4. Development of scale-up instrumentation by the implementation of electro-blowing technology, robust linear fluid delivery system, uniform thickness production and system integration.