You are here

A Nitric Oxide Polymer Platform for the Prevention and Treatment of Infected Wounds

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI132094-01
Agency Tracking Number: R43AI132094
Amount: $255,827.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA16-302
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-04-01
Award End Date (Contract End Date): 2018-09-30
Small Business Information
950 DANBY RD STE 300
Ithaca, NY 14850-5714
United States
DUNS: 824978477
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (772) 267-0306
Business Contact
Phone: (607) 227-7522
Research Institution

This proposed SBIR research effort will lay the foundation for commercializing a new class of biomaterial for
the prevention and treatment of infected skin wounds thereby enhancing patient health through improved
patient outcome and reduced patient morbidity Specifically we will focus on evaluating and developing a
biomaterial comprised of a nitric oxide NO releasing based on a commonly used medical polymer Important
to the current application this polymer can be designed to releases NO at predefined levels and exhibits
excellent antibacterial and anti biofilm properties as evidenced by our preliminary data using both in vitro and
ex vivo biofilm models where it significantly outperforms commercially available wound care dressings
Through the completion of research and development tasks during the Phase I II efforts we will have compiled
a compelling data set that outlines the biocompatibility the efficacy and the mode of action of the NO releasing
polymer in infection management and wound healing that supports its entry into the FDAandapos s regulatory process
Nitric oxide releasing technologies offer a compelling alternative to standard antimicrobial treatments and
antibiotics currently used in to combat infection in wounds Our preliminary data clearly demonstrate the
potential clinical utility of the proposed NO releasing polyemr in addressing microbial infection in general and
more importantly prevention and treatment of microbial biofilms that plague chronic skin wounds An important
milestone for this Phase I project will be the development of prototype NO releasing topical formulations
that will serve as both a non antibiotic prophylactic treatment against microbial infection and as a
treatment for chronically infected wounds two unmet needs within the wound care field
Completion of the Phase I efforts will result in a compelling data set that outlines the efficacy and defines the
minimal requirements for product formulation in terms of topical application Together these studies will help in
the transition to broader Phase II studies designed to support entry of our product into the FDAandapos s regulatory
process iFyber will address the efficacy of the NO releasing technology through the Phase I aims and tasks
outlined below
AIM Develop a series of prototype topical formulation guided by an ex vivo dermal model system
Task Produce prototype NO releasing topical formulations Past Randamp D efforts have established
that point of care POC compounding is a plausible strategy for an NO based wound dressing that is
POC formulation s that are mixed just prior to applying to a wound Prototype formulations selection
will be guided by efficacy testing in the ex vivo model Task and subsequently in pilot in vivo studies
Task Conduct ex vivo dermal model testing for formulation selection The goal of this task is to
evaluate the efficacy of the prototype formulations from Task in an ex vivo porcine dermal model to
define suitable antimicrobial and anti biofilm semi solid dressings for wounds A main goal in this task
will be to down select formulations for pilot animal studies Tasks and
AIM Guide prototype development through pre clinical pilot studies
Task Conduct in vivo testing on selected formulations Most promising formulations identified
through Task will be evaluated in two pilot in vivo studies conducted in the laboratory of Dr Steven
Davis at the University of Miami These studies will establish efficacy in biofilm prevention study and
reduction in an existing biofilm associated infection study and results of these studies will help to
further down select formulations for future Phase II development
Task Determine the baseline in vivo biocompatibility profile of the NO releasing polymer In
addition to assessing infection prevention and anti biofilm efficacy the effects of candidate formulations
on non infected wounds will also be assessed with respect to the wound healing process specifically
inflammatory response erythema re epithelialization granulation tissue formation and initial molecular
screens for healing and inflammatory processes Project Narrative
Acute wounds as well as chronic slow healing wounds are aggravated by relentless microbial
infections that promote remarkable tolerance to classical anti infectious treatments including systemic and
topical antibiotics and general topical biocides The current SBIR research effort aims to advance the
development of a new class of biomaterial for the prevention and treatment of both acute and chronic wound
infections to improve treatment and patient health with improved outcomes

* Information listed above is at the time of submission. *

US Flag An Official Website of the United States Government