ECM BIOSURGERY, INC — Department of Health and Human Services SBIR Phase I: 200

Description

DESCRIPTION provided by applicant Chronic wounds contribute to lower extremity amputations and in the diabetic population have a incidence rate These wounds cost the US $ B per year Current treatment strategies are implemented after a wound has persisted over weeks and usually rely on some type of skin substitute composed of extracellular matrix components These efforts produce marginal results increase in closure rates compared with saline dressings alone and more effective products are needed in the clinic SOLUTION ECM Technologies LLC is a start up company that seeks to commercialize technology garnered from the study of bacterial host interactions from the laboratory of Dr Hook in the Texas Aandamp M Health Science Center The mission of ECM Technologies is to utilize bacterial proteins to augment current biomaterials Our licensed technology and the science behind our product development is described below and contribute to wound healing by increasing fibroblast proliferation and adhesion increasing angiogenesis and migration of endothelial cells and increasing keratinocyte adhesion and migration all through binding a collagen ligand To increase the potential for integrin mediated wound closure we have discovered and characterized a bacterial collagen mimetic protein that allows for the introduction of and integrin binding sites and is more thermally stable than collagen type I termed Designer Collagen Incorporation of Designer Collagen into poly ethylene glycol PEG hydrogels has provided a network with three dimensional D properties that maintains the cell instructive cues of Designer Collagen where cells adhere migrate and proliferate on the otherwise inert PEG material We seek to commercialize Designer Collagen microspheres for use in chronic wounds Designer Collagen enables recombinant purification which offers batch to batch consistency and eliminates the need for animal derived materials and PEG PAE offers a highly tunable system for desired degradation absorption and mechanical properties Designer Collagen microspheres constitute a gel like dressing that will conform to atypical wound shapes and depths while offering immediate protection from potential infection Aim Fabricate a topical bioactive microsphere hydrogel dressing based on Designer Collagen Aim Evaluate the Designer Collagen microspheres in a diabetic mouse model of impaired wound healing After achieving these aims we will have established proof of concept data for Designer Collagen microspheres for use as a chronic wound dressing Continuation of this project in a Phase II project is desired to achieve additional animal work approach the FDA and to devise a GMP production plan PUBLIC HEALTH RELEVANCE Since chronic wounds are common to individuals with diabetes of the US population and costs the US billions each year effective inexpensive treatment options are needed Currently a andapos wait and seeandapos approach is used by clinicians since expensive therapies do not have high wound closure rates offering a increase in comparison to moist dressings alone ECM Technologies development of a Designer Collagen microsphere dressing which offers advantages in optimization of wound healing mechanisms tunable mechanical properties deposition into amorphous wounds and immediate barrier protection is greatly needed in the clinic