Biosynthetic or synthetic degradable hernia mesh is the fastest growing segment of the hernia mesh market, reaching ~$95M in sales in 2017 with Bard controlling 54% of the US market, followed by Gore (30.4%), Novus Scientific (8.3%) and Ethicon (7.3%). While biosynthetic mesh may be used in any type of hernia repair, it is most commonly used in ventral hernia repair cases where there is an increased risk of bacterial infection. The reason biosynthetic meshes are used in infection prone cases is because non-degradable meshes colonized with bacteria are difficult to treat. Non-degradable meshes colonized with bacteria lead to persistent wound sepsis, enterocutaneous fistula, pain, and erosions. In 2017, there were more than 20k ventral hernia procedures performed with biosynthetic meshes in the US. While the biosynthetic mesh market is rapidly growing, >30% of patients treated with biosynthetic mesh will experience a ventral hernia recurrence within 10 years of their initial surgery, which will cost millions of dollars annually. The reason why so many ventral hernias recur despite the benefits of biosynthetic meshes is because biosynthetic hernia meshes lack an adequate soft tissue anchoring system. Without an adequate soft tissue anchoring system, biosynthetic meshes cannot resist applied mechanical forces and as a result meshes contract, migrate, and tear away from tissue. To meet this deficiency, we created a unique hernia mesh (termed the T-line Hernia Mesh) with a superior soft tissue anchoring system ~275% stronger than competing anchoring technologies. The 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 cases. Through this proposal, we will illustrate that a biosynthetic T-line Hernia Mesh will exhibit appropriate physical properties, mechanical performance, and 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 wall.
Aim 1. Partner with an experienced commercial manufacturer of biosynthetic hernia meshes to develop a copolymer material for manufacturing a biosynthetic T-line Hernia Mesh.
Aim 2. Produce a biosynthetic T-line Hernia Mesh from the superior monofilament from Aim 1 and demonstrate its enhanced anchoring system in cadavers and ensure it has the properties needed for FDA 510(k) clearance. At the completion of this proposal, we will have established manufacturing and performance proof points demonstrating a biosynthetic T-line Hernia Mesh is superior to market competitors. In a follow-on Phase II SBIR submission, we will complete validation & verification testing, ISO10993-Biological Evaluation of Medical Devices testing, and a chronic GLP swine study to complete FDA 510(k) clearance. Development 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 repair, breast reconstruction, and tendon reconstruction.
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 annually. Biosynthetic hernia mesh is commonly used in repairs but often fails because of inadequate soft tissue anchoring. DBMA, Inc. proposes to develop a biosynthetic T-line Hernia Mesh to overcome anchor point failure in infection prone wounds and prevent hernia recurrence and occurrence.
