PHMB-Impregnated Acellular Biologic Grafts for Treatment of Third-Degree Burns

项目摘要 BioAesthetics正在开发一种新型的无细胞移植物，用于改善烧伤伤口愈合。我们的专利- 一种待审的载药的、聚合物整合的脱细胞生物移植物（PCT/US 19/25306）将作为 对病原体的屏障，在愈合期间将抗感染药递送到伤口部位，并提供 最佳再生支架这将允许单阶段伤口重建， 需要额外的患者来源的组织，全层烧伤（例如，二级和三级 烧伤）。我们的同品种STTR第1阶段赠款旨在提供概念验证， 移植物能够在体内促进伤口愈合和预防烧伤伤口的感染。 该提案的目标是加入NIH I-corps计划，这将有助于生物美学 验证客户需求并将该技术商业化。我们在国家卫生研究院的目标 该计划旨在了解围绕组织移植物使用的更大生态系统，包括临床医生 烧伤治疗中的产品偏好、定价和通过医院报销， 保险公司网络和抗菌药物的使用。在美国，需要治疗的烧伤几乎 每年有50万人死亡，造成约4万人住院治疗，3,400人死亡。一 2010年医疗保健成本和利用项目简报报告称， 在美国，与烧伤有关的伤害，另外50亿美元与失业有关。许多临床 存在与烧伤治疗相关的挑战，包括感染、伤口闭合的时间和 功能恢复，这可能导致住院时间长，治疗费用高， 感染抗药性感染的风险。有一个显著的未满足的需求， 安全治疗严重烧伤患者的创新方法。我们相信我们的 增强的脱细胞移植物将能够迅速愈合感染的烧伤创面，减少对 抗生素，不需要额外的手术，并改善患者的生活质量。

PROJECT SUMMARY BioAesthetics is developing a novel acellular graft for improved burn wound healing. Our patent- pending drug-loaded, polymer-integrated acellular biologic graft (PCT/US19/25306) will act as a barrier to pathogens, deliver anti-infectives to the wound site during healing, and provide an optimal regenerative scaffold. This will allow for a single-stage wound reconstruction, without the need for additional patient-derived tissue, of full-thickness burns (e.g., second- and third-degree burns). Our predicate STTR Phase 1 grant is geared towards providing proof-of-concept that our grafts are capable of promoting wound healing and preventing infection in burn wounds in vivo. The goal of this proposal is to enroll in the NIH I-corps program, which will help BioAesthetics validate customer needs and commercialize this technology. Our objective within the NIH I-corps program is to understand the larger ecosystem surrounding tissue graft use, including clinician product preference in treatment of burns, pricing and reimbursement through hospitals and insurer networks, and antimicrobial use. In the US, burns requiring medical treatment affect nearly 500,000 people each year, causing approximately 40,000 hospitalizations and 3,400 deaths. A 2010 Healthcare Cost and Utilization Project brief reported that approximately $1.5B was spent in the US on burn-related injuries, with an additional $5B linked to lost work. Many clinical challenges exist related to burn treatment including infection, time to wound closure, and time to functional recovery, which can result in long hospital stays, high treatment costs, and an increased risk of contracting a drug-resistant infection. There is a significant unmet need to identify novel, innovative approaches to safely treat patients with serious burn wounds. We believe that our enhanced acellular graft will be able to rapidly heal infected burn wounds, reduce the need for antibiotics, not require additional surgeries, and improve patient quality of life.