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Winston-Salem, NC, United States

Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 999.66K | Year: 2015

Burn injuries, particularly those to the face, present a number of functional and psychological challenges that arise from scarring and related contracture. A major goal of trauma and burn surgeons is to prevent scarring and improve grafting technologies given the complexity of facial topography. This project seeks to optimize and finalize a prototype of a 3D printed keratin facemask capable of delivering drugs capable of inhibiting scar formation. This will be accomplished by first optimizing the formulation through a series of in vitro tests, screening optimized formulations in a small thermal burn wound model in pigs, and confirming efficacy of the selected construct in a large thermal burn wound model in pigs. Additionally, a facemask prototype will be printed, and storage parameters will be determined. The resulting construct will be able to act as a long-term primary burn wound dressing that delivers a drug to prevent scarring as it naturally degrades, reducing the need for full, painful dressing changes and the risk of scarring and contracture in our Wounded Warriors.

Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 1000.00K | Year: 2015

Currently, no commercial products exist for the repair of large injuries to muscle, particularly volumetric muscle loss (VML). In Phase I of this project, data demonstrated that keratin biomaterials can provide temporal release of growth factors while maintaining cell viability in vitro and in vivo. In Phase II, the biomaterial formulation was optimized for spatio-

Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 999.30K | Year: 2014

No currently available burn product has shown efficacy in substantially decreasing wound healing time and preventing scar formation. The goals of this Phase II proposal are to expand on the results obtained in the Phase I study that showed that (1) halofuginone inhibited collagen-mediated contracture in dermal fibroblasts and (2) the presence of the keratin in the KeraStat burn product results in an attenuation of the cellular injury response following UVB irradiation. The proposed Phase II project will test two potential solutions (KeraStat and Halogel) to determine their efficacy in reducing time to wound closure and decreasing scarring in a porcine burn healing and scarring model. Following this in vivo efficacy testing, we will further expand to test the efficacy of KeraStat for reducing time to wound closure and for scar prevention in an investigator-initiated 60 patient human clinical trial in partial thickness burn patients. Together, these studies will allow KeraNetics to market and sell the KeraStat product to both the Department of Defense and to civilian burn centers to treat patients and Soldiers with debilitating burn wounds and scars.

Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase I | Award Amount: 149.99K | Year: 2014

With the advent of improved body armor and vehicles and the enemy"s use of the improved explosion device (IED) in the most recent conflicts, blast injuries and related burns to the face have become more and more common among our Wounded Warriors. Pathological scarring, which often results in contracture, tends to be more prevalent in these burn cases due to the traumatic nature of the IED injury. The specialized care, rehabilitation, and reconstructive surgery required for these injuries results in significant degradation of quality of life for facial burn victims. The aim of this proposed project is to conduct a proof of concept for an innovative 3D printed halofuginone eluding keratin-based wound dressing that could potentially improve healing rates and reduce scarring and contracture in our burned Wounded Warriors. The proposed dressing will be formulated and tested for mechanical properties and drug delivery capabilities. It will then be tested in vitro for treatment of wound contracture. In the potential Phase II follow-on project, a full prototype of the dressing would be constructed, and efficacy would be tested in a porcine burn model.

Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 1000.00K | Year: 2012

Skeletal muscle injury is a significant challenge to warfighters due to the severity of the injuries often caused by Improvised Explosive Devices. Currently, there are few viable clinical treatment options for these types of injuries. Keratin hydrogels offer a solution to these challenges as carriers of cells and growth factors. Human epithelial keratins are the major structural proteins in cells and form a cytoplasmic network of intermediate filaments. Human hair keratins are genetically similar to epithelial keratins and their intrinsic characteristics make them unique candidates for biomaterial-based carriers of growth factors and cells. In the Phase I project, we showed that keratin hydrogels provide sustained release of growth factors and maintain cell viability in vivo. This Phase II proposal will build on these findings and move toward a product that facilitates skeletal muscle regeneration. The Phase II objectives are to optimize formulations of keratin for delivery of cells and supporting growth factors (FGF and IGF-1), to test the safety and immunogenicity of these formulations, and to assess the functional muscle recovery in two rodent models of muscle loss. Completion of the Phase II objectives will yield a keratin hydrogel formulation optimized for in vivo regeneration of injured skeletal muscle.

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