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

PHMB 浸渍的脱细胞生物移植物用于治疗三度烧伤

• 批准号: 10338915
• 负责人: Nicholas Pashos
• 金额: $ 5.2万
• 依托单位: BIOAESTHETICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-18 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10338915
• 关键词: Affect; Anti-Infective Agents; Antibiotics; Biological; Burn injury; Cessation of life; Clinical; Contracts; Drug resistance; Ecosystem; Enrollment; Goals; Grant; Health; Health Care Costs; Hospitalization; Hospitals; Infection; Infection prevention; Injury; Innovation Corps; Insurance Carriers; Legal patent; Length of Stay; Link; Medical; Operative Surgical Procedures; Patients; Pharmaceutical Preparations; Phase; Polymers; Price; Quality of life; Recovery of Function; Reporting; Risk; Site; Small Business Technology Transfer Research; Technology; Testing; Time; Tissue Grafts; Tissues; Training; Treatment Cost; United States National Institutes of Health; Work; antimicrobial; burn therapy; burn wound; commercialization; healing; health care service utilization; improved; in vivo; innovation; novel; pathogen; preference; programs; reconstruction; regenerative; scaffold; severe burns; third degree burn; wound; wound closure; wound healing

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.

项目概要 BioAesthetics 正在开发一种新型脱细胞移植物，以改善烧伤伤口的愈合。我们的专利- 正在等待的载药、聚合物整合的脱细胞生物移植物（PCT/US19/25306）将作为 阻挡病原体，在愈合过程中向伤口部位输送抗感染药物，并提供 最佳的再生支架。这将允许单阶段伤口重建，而无需 需要额外的患者来源的组织，全层烧伤（例如，二度和三度烧伤） 烧伤）。我们的谓词 STTR 第一阶段拨款旨在提供我们的概念证明 移植物能够促进伤口愈合并预防体内烧伤伤口的感染。 该提案的目标是参加 NIH I-corps 计划，这将有助于 BioAesthetics 验证客户需求并将该技术商业化。我们在 NIH I-corps 中的目标 计划的目的是了解组织移植物使用周围更大的生态系统，包括临床医生 烧伤治疗中的产品偏好、医院的定价和报销 保险公司网络和抗菌药物的使用。在美国，需要治疗的烧伤影响了近 每年影响 50 万人，导致约 4 万人住院，3,400 人死亡。一个 2010 年医疗保健成本和利用项目简介报告称花费了大约 $1.5B 在美国，因烧伤相关的伤害，还有与失业相关的额外 5B 美元。临床上很多 烧伤治疗存在相关挑战，包括感染、伤口闭合时间和愈合时间 功能恢复，这可能导致住院时间长、治疗费用高以及增加 感染耐药性感染的风险。识别新颖、 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快速治愈感染的烧伤伤口，减少对 抗生素，不需要额外的手术，提高患者的生活质量。