A Biosynthetic Degradable Textile for Soft Tissue Reconstruction

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ABSTRACT Laparotomy patients are plagued with ventral hernias occurring and recurring in up to 30% of cases. Hernia occurrence and recurrence is caused by anchor point failure of both permanent and degradable mesh (i.e. suture, tacks, and screws cheese-wire through mesh and tissue, resulting in mesh migration and/or contraction). Simply, hernias occur or recur where mesh is not adequately anchored to tissue and migrates or contracts. It is rare for moderate to heavy weight meshes to rip allowing hernias to occur through the torn mesh or for hernias to occur between intact mesh anchor points. Biosynthetic hernia mesh (i.e. a synthetic hernia mesh made from a biodegradable polymer) is the fastest growing segment of the hernia mesh market with ~$95M in sales in 2017. Moreover, several recent long-term occurrence (prevention) and recurrence (treatment) outcome studies have illustrated that newer degradable biosynthetic meshes, including Bio-A, Phasix, and TIGR mesh, promote tissue regeneration and are equivalent in performance and safety to permanent mesh and superior to xenografts and allografts. However, despite emerging data in support of biosynthetic mesh over permanent mesh and the gradual growth of biosynthetic mesh in the market place, biosynthetic meshes suffer from the same occurrence and recurrence problems as permanent mesh – both types of meshes lack an adequate soft tissue anchoring system. While anchor point failure has unquestionably been recognized for decades as the most common cause of ventral hernia recurrence, there are no mesh anchoring systems on the market designed to address this problem. Sutures (or tacks, screws, or glue) are simply insufficient. A better anchoring system is sorely needed. To meet this need, Deep Blue Medical Advances, Inc. (DBMA) has engineered a patented T-Line® Hernia Mesh anchoring system for use in open and laparoscopic repair and demonstrated the benefits with a permanent polypropylene mesh. DBMA has successfully completed Phase I goals selecting a biodegradable copolymer with appropriate mechanical properties and degradation rate to promote healing. The novel biosynthetic T-line Hernia Mesh design has >250% greater anchoring strength compared to leading products on the market. In this Phase II SBIR grant, we will complete major milestones for FDA 510(k) clearance of the class II biosynthetic T-Line Hernia Mesh. It is evident from the medical literature, market reports, online webinars and podcasts, corpus of recent presentations at hernia meetings, and guidance from our world-class scientific advisory board that biosynthetic hernia meshes are rapidly gaining favor in the marketplace and that the biosynthetic T-Line Hernia Mesh, with its surgeon-friendly, physiologically designed, superior anchoring system will have a transformative impact in surgical care.