Deep Blue Medical Advances, Inc. — Department of Health and Human Services SBIR Phase I: 300

Description

AbstractBiosynthetic or synthetic degradable hernia mesh is the fastest growing segment of the hernia mesh marketreaching$M in sales inwith Bard controllingof the US marketfollowed by GoreNovus Scientificand EthiconWhile biosynthetic mesh may be used in any type of hernia repairit is most commonly used in ventral hernia repair cases where there is an increased risk of bacterial infectionThe reason biosynthetic meshes are used in infection prone cases is because non degradable meshes colonized with bacteria are difficult to treatNon degradable meshes colonized with bacteria lead to persistent wound sepsisenterocutaneous fistulapainand erosionsInthere were more thank ventral hernia procedures performed with biosynthetic meshes in the USWhile the biosynthetic mesh market is rapidly growingandgtof patients treated with biosynthetic mesh will experience a ventral hernia recurrence withinyears of their initial surgerywhich will cost millions of dollars annuallyThe reason why so many ventral hernias recur despite the benefits of biosynthetic meshes is because biosynthetic hernia meshes lack an adequate soft tissue anchoring systemWithout an adequate soft tissue anchoring systembiosynthetic meshes cannot resist applied mechanical forces and as a result meshes contractmigrateand tear away from tissueTo meet this deficiencywe created a unique hernia meshtermed the T line Hernia Meshwith a superior soft tissue anchoring systemstronger than competing anchoring technologiesThe purpose of this project is to work with a leading commercial manufacturer of biosynthetic meshes to develop a superior performing biosynthetic T line Hernia Mesh to improve outcomes in infection prone ventral hernia casesThrough this proposalwe will illustrate that a biosynthetic T line Hernia Mesh will exhibit appropriate physical propertiesmechanical performanceand degradation rates to outperform predicate biosynthetic meshes and that the T line Hernia Mesh will uniquely remain anchored to cadaver fascia at forces exceeding the maximum amount of force on the abdominal wallAimPartner with an experienced commercial manufacturer of biosynthetic hernia meshes to develop a copolymer material for manufacturing a biosynthetic T line Hernia MeshAimProduce a biosynthetic T line Hernia Mesh from the superior monofilament from Aimand demonstrate its enhanced anchoring system in cadavers and ensure it has the properties needed for FDAkclearanceAt the completion of this proposalwe will have established manufacturing and performance proof points demonstrating a biosynthetic T line Hernia Mesh is superior to market competitorsIn a follow on Phase II SBIR submissionwe will complete validation andampverification testingISOBiological Evaluation of Medical Devices testingand a chronic GLP swine study to complete FDAkclearanceDevelopment of the biosynthetic T line Hernia Mesh with enhanced anchoring is urgently needed in the field of hernia and has broader implications in the fields of chronic wound repairbreast reconstructionand tendon reconstruction Project Narrative Hernia occurrence and recurrence in infection prone wounds is a major medical problem that affects tens of thousands of patients per year in the United States and costs billions of dollars annuallyBiosynthetic hernia mesh is commonly used in repairs but often fails because of inadequate soft tissue anchoringDBMAIncproposes to develop a biosynthetic T line Hernia Mesh to overcome anchor point failure in infection prone wounds and prevent hernia recurrence and occurrence