INTEGRA(R) Artificial Skin is a bilayer system that enables the replacement of injured skin with functional autologous tissue. This project is the logical next step in the perfection of this tissue engineered product. Following clinical trials and commercial introduction, we have been able to identify its strengths and weaknesses in the clinical setting. The strengths of this product include rapid physiological recovery during acute treatment, minimal donor site morbidity, and excellent functional outcome characterized by an absence of scarring. The weaknesses include a higher incidence of postoperative complications than for conventional autograft. Our hypothesis is that the advantage of autograft is due to endothelial cells from the vasculature in autograft. which allow the autograft to rapidly revascularize. Therefore, we postulate that the incidence of postoperative complications for Artificial Skin can be reduced by accelerating angiogenesis by our peptide enhancement technology. Peptide Enhanced Artificial Skin can be expected to promote a speedier rate of wound healing, which should result in a decreased incidence of complications, principally those arising from infection and mechanical dislodgment. In addition, we anticipate an improved cosmetic and functional outcome. In Phase I we will develop prototypes and demonstrate their biocompatibility and efficacy in animal models.
If this SBIR program is successful Integra LifeSciences Corporation is committed to manufacturing the Peptide Enhanced Artificial Skin and marketing it worldwide for burns and reconstructive surgery. Future applications may include chronic wounds. Potential Markets are over $800,000,000 per year. Sales of over $10,000,000 are projected within 2 years of introduction.
