Two million laparotomies are performed annually in the U.S., with ventral hernia being a frequent complication in 10-30% of patients and costing as much as $6 billion annually. The ten year ventral hernia recurrence rate is reportedly 63% without hernia mesh and 32% when a mesh is added to the repair and these numbers underestimate recurrence rates in the rapidly growing morbidly obese population in the US. In June 2017 in the Lancet, a landmark paper concluded (and other recent investigations concurred) that onlay mesh reinforcement after primary laparotomy significantly prevented hernia formation in patients with BMI >27 or patients undergoing AAA repair. However, in ventral hernia repair, hernia mesh frequently fails at the suture / mesh / tissue interface because suture ?cheesewires,? or slices, through mesh or tissue. Given the fact that there are millions of laparotomies performed per year in the US and that many patients undergoing laparotomy are high risk for developing hernia, massive growth opportunities now exist in the hernia mesh market for hernia mesh does not lead to ?cheesewiring?, Deep Blue Medical Advances (DBMA, Inc.) has developed the T- line hernia mesh, which contains seamless uninterrupted extensions continuous with the mesh body that are 15X the surface area of standard suture. The extensions are sewn into fascia, exactly as sutures would be sewn, and the T-line hernia mesh remains anchored to fascia at forces 300% greater than the maximum force exerted on the abdominal wall (16N/cm), where suture fails at 6-12N/cm. In Phase I, we successfully demonstrated that the T-line mesh passed in vitro physicomechanical testing by FDA standards and that the mesh was 300% stronger than predicate technologies when tested in swine models. In Phase II, we outline three aims focused on optimizing the mesh per the recommendations of surgeons and conducting studies required by the FDA for 510(k) approval. Task 1. Complete needle attachments to the mesh according to USP standards (Year 1, Q1-2). Task 2. Complete packaging and sterility testing to FDA standards. (Year 1, Q2-3) Task 3. Complete verification and validation studies and prepare a 510(k) package for FDA submission. (Year 1 Q1-4, Year 2 Q1-3) Based on the simplicity of our design, compelling preliminary data, and clear path to market, this innovative solution promises to drastically reduce and prevent hernias and save the healthcare industry billions of dollars per year. Beyond hernia repair, the T-line Mesh could also significantly enhance soft tissue repair, where large wounds following trauma, radiation, and oncologic resection are major unsolved surgical problems desperately in need of a device to manage the high tension.
Hernia occurrence and recurrence is a major medical problem that affects hundreds of thousands of patients per year in the United States and costs billions of dollars annually. Hernia mesh and suture are commonly used in repairs but they often fail because of mechanical stress. DBMA, Inc. proposes to develop a novel hernia mesh to overcome the most common mechanical failure modes of mesh and suture.
