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

Description

DESCRIPTION provided by applicant The long term objective of this application is to bring a trachea patch to the market to treat tracheal stenosis or narrowing of the airway which left untreated is a life threatening condition that affects both young children and adults Currently otolaryngologists have only two major options for treating tracheal stenosis One is a complex surgical procedure known as slide tracheoplasty that few surgeons in the country are truly qualified to perform The other is to open the trachea wider and hold it open with a graft of rib cartilage Both are difficult time consuming procedures with potential complications We have a U S patent application submitted on a trachea patch biomaterial that overcomes the four major technical hurdles required to replace rib cartilage grafting mechanical integrity suturable resorbable and air tight There is currently nothing on the market even remotely resembling the idea of a synthetic patch for tracheal stenosis While the academic tissue engineering community has focused primarily on regenerating an entire trachea with highly complex strategies arguably leading to technology in search of an application we have focused instead on identifying a specific patient indication with an unmet need and designed a technology to fill that void Co investigators Weatherly and Detamore have worked together for nearly a decade and after preliminary studies in rabbits and partnering with Nanofiber Solutions in together as a team we are at an inflection point where a large animal study is necessary to translate the technology to the clinic Therefore the current Phase I SBIR project is highly focused with a single Specific Aim To demonstrate proof of concept safety with engineered trachea patches to repair induced defects in sheep tracheas We will test the hypothesis that covering induced trachea defects with our engineered trachea patches will allow sheep to survive with minimal tracheal stenosis Completion of the Phase I project will strategically position us to incorporate FDA guidance and embark on a full scale efficacy study in sheep in a Phase II SBIR that will allow us to proceed to the clinic Compared to rib cartilage grafting our trachea patch holds the following advantages No surgery to remove rib tissue saving operating room time and cost and eliminating potential complication infection and morbidity at the rib site attractive to patients and insurance companies Easy to use as it i andquot plug and playandquot for surgeons who perform rib cartilage grafting attractive to surgeons No biologics or drugs are required attractive to investors for FDA approval For several reasons we focus initial clinical translation on the pediatric population with laryngotracheal stenosis In the simplest terms our goal is to fix tracheas for kids around the world with narrowed airways to help them survive and breathe normally again PUBLIC HEALTH RELEVANCE The proposed technology will help surgeons to treat patients who have difficulty breathing due to narrowed airways a potentially life threatening condition Currently surgeons perform either a very complicated surgery or they open front of the trachea with an incision and use rib cartilage to hold the trachea open The technology is an off the shelf trachea patch that will replace the need to harvest rib cartilage allowing the patient to breathe normally without the need to harvest cartilage from the rib