Bioadhesive/Mesh Constructs for Incisional Hernia Prevention
Department of Health and Human Services
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Small Business Information
KENSEY NASH CORPORATION
735 Pennsylvania Dr, EXTON, PA, 19341-
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): Bioadhesive/Mesh Constructs for Incisional Hernia Prevention. Although many surgical procedures are now performed using laparoscopic techniques, a large number of abdominal surgeries still require a laparotomy. From 2%to 23% of laparotomy closures result in herniation of the abdominal incision, and an estimated 400,000 incisional hernia repairs are performed annually in the US. This healthcare burden becomes significantly amplified when considering that recurrence ratesafter initial hernia repair typically range from 20% to 25%. Mean hospital costs for incisional hernia repair are estimated to be between 10K and 15K, for a total of 4-6 Billion annually. If introduction of a reliable method for prophylaxis resulted ineven a 20% reduction in the incidence of incisional hernias, the savings in hospital costs alone would range from an estimated 800 Million to 1.2 Billion. Prevention of incisional hernias represents a significant unmet clinical need. Despite ongoing efforts to reduce the risk of herniation, the incidence of incisional hernias has remained relatively steady, and there is no consensus as to the best way to reduce this risk. Although no single approach has proven itself to be an effective hernia preventionstrategy, the majority of studies indicate that risk reduction is possible through better surgical materials and techniques. The goal of this Phase I proposal is to establish the feasibility of reinforcing the traditional suture closure of laparotomies byplacement of an adhesive-coated mesh in an on-lay position on the superficial fascia over the fascial incision. The adhesive coated meshes will be applied in a peel-and-stick manner over the continuous suture repair of the superficial fascia, thereby reinforcing this closure. The inspiration for the novel technology comes from the adhesive proteins secreted by marine mussels. Even in a wet, turbulent and saline environment, these adhesive proteins harden rapidly and enable marine mussels to anchor themselves to various surfaces. Nerites Corporation has developed a series of synthetic versions of these adhesive proteins that can take the form of a liquid that can be sprayed or painted onto tissue, or that can be cast into dry thin films or membranes that canbe used alone or in conjunction with synthetic or biologic meshes or scaffolds. This Phase I project will evaluate several adhesive/mesh formulations and characterize them based the performance metrics of strength, resorption, and biocompatibility. Feasibility of the approach will be demonstrated in a rodent model of incisional hernia. PUBLIC HEALTH RELEVANCE: Prevention of incisional hernias represents a significant unmet clinical need. Apart from the significant impact on patients' outcome and quality of life, around 4 B is spent annually in the US on incisional hernia repairs. If introduction of a reliable method for prophylaxis reduced the incidence of incisional hernias by even 20%, the savings in hospital costs alone would range from an estimated 800 million to 1.2 billion dollars and around 80,000 patients would benefit.
* information listed above is at the time of submission.