GEL4MED, INC. — Department of Health and Human Services SBIR Phase I: 300

Description

<p>DESCRIPTION provided by applicant The goal of this Phase I SBIR proposal is to test the feasibility of an antimicrobial tissue scaffolding hydrogel matrix in eliminating infecting bacteril pathogens and promoting wound regeneration Preventing and treating wound infections and regeneration are becoming less effective due to the rapid rise in Multi drug Resistant Organisms MDRO A recent study by Pada et al reported that patients with MRSA infected wounds were times more likely to die during their hospitalization had times longer hospitalization and incurred times higher hospitalization costs when compared to patients without infection Patients who do survive MRSA multidrug resistant Staphylococcus aureus often spend months in the hospital and endure repeated surgeries to cut out infected tissue In of staph infections were MRSA By the number had climbed to and now is over and still rising The proposed product will treat wounds by both i preventing infection through a unique mechanism of action that is broad spectrum antibacterial and it will promote tissue regeneration by providing cell attachment sites within the scaffolding matrix Additionally the gel formulation of the proposed product allows it to be flowable and conform to unique wound shapes and depths easily so it can be administered quickly by any healthcare professional To establish the feasibility we propose the following two specific aims Specific aim Demonstrate the therapeutic in vivo efficacy of the product to eliminate infection from a wound in a mouse model infected with Staphylococcus aureus S aureus Milestones Show elimination of S aureus from wounds to or below as quantified by bacterial titers Specific aim Demonstrate the in vivo efficacy of the hydrogel to promote healing of full thickness dorsal excisional wounds in swine Milestones Show accelerated wound healing by day In SBIR Phase II we will validate the hydrogel in an infected wound healing swine model establish GMP manufacturing and execute GLP studies in preparation for our FDA submission PUBLIC HEALTH RELEVANCE The proposed product is a flowable antimicrobial skin scaffolding matrix that will both promote regrowth of patient tissue to close a wound while eliminating bacteria through direct cell membrane disruption The product is designed to incorporate three major benefits in one material void filling scaffold cell compatibility and brod spectrum antimicrobial effects all of which are crucial for wound closure The product is easy to administer as an in topical skin substitute This product could mitigate the amputations million infections and deaths associated with poor wound closure and antibiotic resistance annually</p>