SBIR Phase I: Development of a bioabsorbable tissue adhesive

SBIR 第一阶段：生物可吸收组织粘合剂的开发

• 批准号: 1937713
• 负责人: RAO BEZWADA
• 金额: $ 22.5万
• 依托单位: BEZWADA BIOMEDICAL LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2021-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1937713&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; bioabsorbable; tissue

The broader impact/commercial potential of this SBIR Phase I project will advance the development of a bioabsorbable tissue sealant for use in the closure of internal surgical site wounds. Wound care is associated with significant healthcare and economic costs. Surgical wounds account for the majority of acute wounds, as there are over 100 million surgical incisions a year globally, where approximately 80% require a closure product. Improper or ineffective closure of surgical wounds can result in a number of complications, including infection, scarring, improper healing, and blood loss. Currently available products for use in closing internal surgical wounds are often limited in their effectiveness due to low versatility, safety concerns, and slow curing times. An ideal tissue adhesive would provide sufficient strength and be bioabsorbable, thus providing for effective wound closure for internal and external applications. Bezwada Biomedical seeks to meet this unmet need through the development of a polyurethane-based adhesive for internal surgical wounds that is biodegradable, easy to use, and biocompatible. Successful commercialization of this technology will provide clinicians and surgeons with an effective and versatile wound closure product for surgical applications, thus decreasing the likelihood of complications that significantly impact patient outcomes and increase the costs of care.This Small Business Innovation Research (SBIR) Phase I project will develop a polyurethane-based tissue adhesive incorporating hydrolyzable linkage bridging using safe and biocompatible compounds through an innovative chemistry approach. The hydrolyzable feature differentiates the technology from existing absorbable polyurethanes and is the result of highly reactive aromatic isocyanates with a hydrolyzable link connecting the aromatic rings, allowing for safe and tunable degradation. The overall goal of the proposed program is to identify a single lead polyurethane formulation with two Technical Objectives: 1) synthesis of monomers and development of formulations; 2) assessment for physical, mechanical, functional, biocompatibility, and ease-of-use properties to identify the optimal formulation.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这一SBIR第一阶段项目的广泛影响/商业潜力将推动可生物吸收组织密封剂的开发，用于封闭手术内伤口。伤口护理与巨大的医疗保健和经济成本有关。手术伤口占急性伤口的大部分，因为全球每年有超过1亿个手术切口，其中约80%需要闭合产品。手术伤口闭合不当或无效会导致许多并发症，包括感染、疤痕形成、愈合不当和失血。目前可用于封闭内外科伤口的产品由于通用性低、安全性问题和治愈时间较慢而其有效性往往受到限制。理想的组织粘合剂将提供足够的强度和生物可吸收，从而为内部和外部应用提供有效的伤口封闭。Bezwada Biomedical寻求通过开发一种可生物降解、易于使用和生物兼容的内外科伤口用聚氨酯粘合剂来满足这一未得到满足的需求。这项技术的成功商业化将为临床医生和外科医生提供一种用于外科应用的有效和多功能的伤口闭合产品，从而减少严重影响患者预后和增加护理成本的并发症的可能性。这项小型企业创新研究(SBIR)第一阶段项目将通过创新的化学方法开发一种基于聚氨酯的组织粘合剂，使用安全和生物相容的化合物进行可水解连接桥接。可水解性特征使该技术有别于现有的可吸收聚氨酯，是高活性芳香族异氰酸酯与连接芳香环的可水解链的结果，允许安全和可调节的降解。拟议计划的总体目标是确定具有两个技术目标的单一含铅聚氨酯配方：1)单体的合成和配方的开发；2)物理、机械、功能、生物兼容性和易用性的评估，以确定最佳配方。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。