SBIR Phase I: Development of a Novel, Sprayable, Large Volume Hydrogel Delivery System Platform

SBIR 第一阶段：开发新型、可喷雾、大容量水凝胶输送系统平台

• 批准号: 2304462
• 负责人: Greg Grover
• 金额: $ 27.5万
• 依托单位: KARIOS TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2304462&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Novel; Sprayable

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a simplified system for applying compound in situ to form biomaterials during surgical procedures. Controlled biomaterial applications pose significant potential surgical advantages including for anti-adhesion, tissue sealant, and drug delivery purposes. The proposed platform will enable procedural consistency to provide new and improved ways to manage bleeding and reduce scar tissue formation during surgical procedures. This product aims to gain a share of the $1.5 billion adhesion prevention market and $1.2 billion hemostat market, and enable eventual site-specific delivery cells and drugs, depending on the biomaterial delivered. This Small Business Innovation Research (SBIR) Phase I project will develop a ready-to-use, large volume delivery system for in situ forming biomaterials. The scope of activities includes transferring a novel, proprietary, in situ biomaterial with applicability as a tissue sealant, scar tissue reductant, and drug/cell delivery vehicle, into a novel single use applicator. The prepackaged delivery system will formulate the suspended biomaterial with the resuspension solution using an internal mechanical mechanism which delivers the biomaterial in a controlled aerosolized manner suitable for clinical use. This Phase 1 project aims to complete and validate prototypes with lyophilized biomaterials within good manufacturing practices, engineer the design of the syringe barrel and delivery tips/nozzles, and complete laboratory validation in a manner suitable for first in human use.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.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是一个简化的系统，用于在外科手术过程中原位应用化合物形成生物材料。受控生物材料的应用具有显着的潜在手术优势，包括用于防粘连、组织密封剂和药物输送目的。拟议的平台将实现程序的一致性，以提供新的和改进的方法来管理手术过程中的出血并减少疤痕组织的形成。该产品旨在获得 15 亿美元的粘连预防市场和 12 亿美元的止血剂市场的份额，并最终实现特定位点的细胞和药物递送，具体取决于递送的生物材料。该小型企业创新研究 (SBIR) 第一阶段项目将开发一种即用型大容量输送系统，用于原位成型生物材料。活动范围包括将可用作组织密封剂、疤痕组织减少剂和药物/细胞输送载体的新型专有原位生物材料转移到新型一次性涂抹器中。预包装的递送系统将使用内部机械机构将悬浮的生物材料与重悬溶液一起配制，该机械机构以适合临床使用的受控雾化方式递送生物材料。 该第一阶段项目旨在按照良好的制造规范完成和验证冻干生物材料原型，设计注射器筒和输送尖端/喷嘴的设计，并以适合首次用于人类的方式完成实验室验证。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。