SBIR Phase I: Development of an Injectable Shear Thinning Biomaterial for the Treatment of Aneurysms

SBIR 第一阶段：开发用于治疗动脉瘤的可注射剪切稀化生物材料

• 批准号: 2012224
• 负责人: Ehsan Jabbarzadeh
• 金额: $ 22.5万
• 依托单位: OBSIDIO, INC.
• 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: 2020-07-01 至 2021-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2012224&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Injectable; Shear

The broader impact of this Small Business Innovation Research (SBIR) Phase I project lies in the development of an innovative universal embolization biomaterial for the treatment of aneurysms with the goal of stopping undesired blood flow through vessels anywhere in the body. Recent reports estimate aneurysm incidence of 6 million in the US alone. The mortality rate for aneurysm rupture alone are over 50%; 66% of those who survive a rupture suffer from major disabilities. Current benchmark treatments for aneurysms include coil embolization, in which trained radiologists push long metal wires with a coiled shape into the vessel until they are packed densely to slow and clot blood flow. While treatment options exist, most suffer from difficulty in administration, high treatment failure rate, and high cost. The proposed novel shear-thinning biomaterial (STB) technology offers an easy-to-use, cheaper and safer alternative to treat aneurysms. This approach has the potential to reduce procedure time, decrease radiation exposure, reduce world-wide morbidity and mortality, and provide access to a broad range of hospitals. The proposed project will generate the required data for a development of a robust, minimally invasive, and biocompatible STB product for treatment of aneurysms. In Objective 1, we will demonstrate STB off-the-shelf readiness, including stability over an adequate shelf life in a premixed, ready-to-use formulation, and biocompatibility through the ISO-10993 framework. These studies will demonstrate STB safety. In Objective 2, we will conduct preclinical toxicological and performance testing to demonstrate the durability, safety and efficacy of the STB embolic agent using a canine saccular aneurysm (SA) animal model to demonstrate biocompatibility of optimized STBs and successful delivery. Benchmarks include stoppage of blood flow and absence of recanalization within the aneurysm sac in a 60-day follow up time period. Other parameters to be studied include inflammation rates, proper adhesion, and immobility of the material upon exposure to the blood stream, with the goal of successful (95%) exclusion from the circulation up to 60-day post embolization with epithelization along the lumen interface.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.

这项小型企业创新研究（SBIR）I阶段项目的更广泛影响在于开发创新的通用栓塞生物材料来治疗动脉瘤，目的是阻止不需要的血液流经人体任何地方的血管。最近的报告估计，仅在美国，动脉瘤的发病率为600万。动脉瘤破裂的死亡率超过50％；幸存下来的人中有66％因主要残疾而遭受破裂。当前针对动脉瘤的基准处理包括线圈栓塞，其中训练有素的放射线医生将长的金属线推入容器中，直到它们被密集地挤满以缓慢而凝结的血液流动为止。尽管存在治疗方案，但大多数人都在管理困难，高治疗失败率和高成本中遭受困难。拟议的新型剪切稀薄的生物材料（STB）技术为治疗动脉瘤提供了易于使用，更便宜，更安全的替代方案。这种方法有可能减少程序时间，减少辐射暴露，降低世界范围内的发病率和死亡率，并提供进入广泛医院的机会。拟议的项目将生成所需的数据，以开发可靠的，微创和生物相容性的STB产品，以治疗动脉瘤。在目标1中，我们将展示STB现成的准备就绪，包括在预处理，即用的配方中稳定在适当的保质期和通过ISO-10993框架中的生物相容性。这些研究将证明STB安全性。在目标2中，我们将进行临床前毒理学和性能测试，以证明使用犬Saccular动脉瘤（SA）动物模型的STB栓塞剂的耐用性，安全性和功效，以证明优化的STB和成功递送的生物相容性。基准包括在60天的随访时间内停止血液流量和动脉瘤囊内的重新定性。要研究的其他参数包括炎症率，适当的粘附和暴露于血液流的材料，其目的是成功（95％）排除在循环后至60天的栓塞后，并沿着管腔界面上的上皮化，这是NSF的法定任务，反映了通过评估的范围的范围，这一奖项被认为是构成的范围。