NANOFIBER SOLUTIONS LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

PROJECT SUMMARYThe long term objective of this application is to bring a trachea patch to the market to treat tracheal stenosisor narrowing of the airwaywhich left untreated is a life threatening condition that affects both young children and adultsCurrentlyotolaryngologists have only two major options for treating tracheal stenosisOne is a complex surgical procedure known as slide tracheoplasty that few surgeons in the country are truly qualified to performThe other is to open the trachea wider and hold it open with a graft of rib cartilageBoth are difficulttime consuming procedures with potential complicationsWe have a U Spatent application submitted on a trachea patch biomaterial that overcomes the four major technical hurdles required to replace rib cartilage graftingmechanical integritysuturableresorbableandair tightThere is currently nothing on the market even remotely resembling the idea of a synthetic patch for tracheal stenosisWhile the academic tissue engineering community has focused primarily on regenerating an entire trachea with highly complex strategiesarguably leading to technology in search of an applicationwe have focused instead on identifying a specific patient indication with an unmet need and designed a technology to fill that voidCo inventors Weatherly and Detamore have worked together for a decadeand after preliminary studies inrabbits andsheepand partnering with Nanofiber Solutions intogether as a team we are at an inflection point where key refinements of the technology are crucial to moving forward to a Phase II SBIR project and then onward to the clinicThe chief hypothesis is that refinement within the device realm will improve airway opening relative to the original deviceWe have three parallel aims to test in a single in vivo study with rabbitseach testing a differentmore specific hypothesis regarding solutions to improve the technologyThe Specific Aims are to test the hypotheses that each of the following will improve airway openinga faster degrading polymera more favorable biomaterialcell interactionandan anti microbial peptideCompared to rib cartilage graftingour trachea patch holds the following advantagesNo surgery to remove rib tissuesaving operating room time and costand eliminating potential complication infection and morbidity at the rib siteattractive to patients and insurance companiesEasy to useas it isplug and playfor surgeons who perform rib cartilage graftingattractive to surgeonsNo biologics or drugs are requiredattractive to investors for FDA approvalFor several reasonswe focus initial clinical translation on the pediatric population with laryngotracheal stenosisIn the simplest termsour goal is to fix tracheas for kids around the world with narrowed airways to help them survive and breathe normally again PROJECT NARRATIVE The proposed technology will help surgeons to treat patients who have difficulty breathing due to narrowed airwaysa potentially life threatening conditionCurrentlysurgeons perform either a very complicated surgeryor they open front of the trachea with an incision and use rib cartilage to hold the trachea openThe technology is an off the shelf trachea patch that will replace the need to harvest rib cartilageallowing the patient to breathe normally without the need to harvest cartilage from the rib