SBIR-STTR Award

The company will use a new class of information rich, non-immunogenic, animal derived, biomaterials to develop prostheses for accelerating the healing of soft tissue injuries. There will be two products: 1) a wound dressing for external injuries and ulcerations and 2) a skin replacement for burns, avulsions and other injuries. Biomaterials which will be used for development of the products are now in pilot production. They are called ADMAT (Animal Derived extracellular MATrix) which is combined with a biopolymer scaffold, NATPOL (NATural bioPOLymer). These NATPOLs will be spun and woven to produce a structurally stronger base than conventional matrixes. The materials will be used to constitute Dermal Equivalents (DE) which will be suitable for wound dressings and which also serve as the dermal component of replacement skin or Skin Equivalents (SE). The development of DEs and SEs, with and without ADMAT, will be tested in vitro. In Phase 2, the tissues will be grafted 1) to outbred mice using cultured murine cells; 2) to nude or SKID mice using cultivated human skin; and 3) to a rat burn model. Observations of grafts and animals, measurements of tenacity, resistance to enzymatic breakdown, histology and immunocytochemistry will be the principal tools for data gathering

In the course of Phase I of the SBIR, and for many years before, we have been interested in the design and fabrication of engineered skin replacements able to induce organ regeneration of which we believe the skin is capable. In Phase I we developed and characterized a new class of skin-specific biomaterials (NATPOL TM Collagen), scaffold fabrication technologies, and growth factor-cytokine complexes (ADMAT TM Growth Factor Cytokine Microparticulates). We hypothesize that novel fiber-based tissue scaffolds fabricated from the collagens isolated from the developing skin of the fetal pig enriched with a complex of growth factor-cytokines found in fetal skin can provide the developmental tissue building signals to modulate cellular remodelling of the skin replacement prosthesis. The cells populating the tissue scaffolds are cultivated allogeneic skin cells and/or responding host cells which speed integration of the information-rich scaffold into the host tissue. Promising skin prothesis designs developed in Phase I, ready for evaluation in Phase II, are an acellular would dressing, DressSkin TM, and a cell seeded living skin equivalent, LiveSkin TM, both for treatment of ulcerations, burns, avulsion and other major injuries as well as for skin donor sites and replacement of skin removed because of disease. We proposed to systematically evaluate in animal experiments skin prosthesis efficacy as a function of the scaffolding design, use of skin-specific growth factor-cytokine complexes, and the specific derm cell population seeded into the living skin equivalent. PROPOSED COMMERCIAL APPLICATION We propose to produce a wound dressing and a skin replacement. The market potential exceeds 1 billion dollars