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

Description

Two million laparotomies are performed annually in the U Swith ventral hernia being a frequent complication inof patients and costing as much as $billion annuallyThe ten year ventral hernia recurrence rate is reportedlywithout hernia mesh andwhen a mesh is added to the repair and these numbers underestimate recurrence rates in the rapidly growing morbidly obese population in the USIn Junein the Lanceta landmark paper concludedand other recent investigations concurredthat onlay mesh reinforcement after primary laparotomy significantly prevented hernia formation in patients with BMI andgtor patients undergoing AAA repairHoweverin ventral hernia repairhernia mesh frequently fails at the suturemeshtissue interface because suturecheesewiresor slicesthrough mesh or tissueGiven 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 herniamassive growth opportunities now exist in the hernia mesh market for hernia mesh does not lead tocheesewiringDeep Blue Medical AdvancesDBMAInchas developed the Tline hernia meshwhich contains seamless uninterrupted extensions continuous with the mesh body that areX the surface area of standard sutureThe extensions are sewn into fasciaexactly as sutures would be sewnand the T line hernia mesh remains anchored to fascia at forcesgreater than the maximum force exerted on the abdominal wallN cmwhere suture fails atN cmIn Phase Iwe successfully demonstrated that the T line mesh passed in vitro physicomechanical testing by FDA standards and that the mesh wasstronger than predicate technologies when tested in swine modelsIn Phase IIwe outline three aims focused on optimizing the mesh per the recommendations of surgeons and conducting studies required by the FDA forkapprovalTaskComplete needle attachments to the mesh according to USP standardsYearQTaskComplete packaging and sterility testing to FDA standardsYearQTaskComplete verification and validation studies and prepare akpackage for FDA submissionYearQYearQBased on the simplicity of our designcompelling preliminary dataand clear path to marketthis innovative solution promises to drastically reduce and prevent hernias and save the healthcare industry billions of dollars per yearBeyond hernia repairthe T line Mesh could also significantly enhance soft tissue repairwhere large wounds following traumaradiationand oncologic resection are major unsolved surgical problems desperately in need of a device to manage the high tension Project Narrative 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 annuallyHernia mesh and suture are commonly used in repairs but they often fail because of mechanical stressDBMAIncproposes to develop a novel hernia mesh to overcome the most common mechanical failure modes of mesh and suture