SBIR Phase II: Novel size-changing, gadolinium-free contrast agent for magnetic resonance angiography

SBIR II 期：用于磁共振血管造影的新型尺寸变化、无钆造影剂

• 批准号: 2322379
• 负责人: Abhinav Sannidhi
• 金额: $ 99.97万
• 依托单位: NANOXORT LLC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2322379&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Novel; size

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will provide a tool for vascular imaging, an area of medicine with a large clinical need. The developed blood pool contrast agent (BPCA) has the potential to disrupt the current magnetic resonance angiography (MRA) contrast agent market because of its improved safety profile and enhanced imaging of the vascular system compared to current gadolinium-based contrast agents (GBCAs). The proposed technology has the potential to improve the diagnosis and safety of contrast-enhanced MRA. This creates a win-win-win scenario for everyone involved. For patients with vascular disease, this solution provides a safer alternative with a more accurate diagnosis that will allow doctors to prescribe safer, more effective treatments. For the patient’s family, it reduces financial and social burdens by enabling preventive treatment due to earlier disease detection. For radiologists, the clearer MRA images may lead to more accurate diagnoses. The product will be marketed to radiologists and medical institutions that perform MRA to diagnose vascular thrombosis, renal stenosis, and pediatric MRA.This Small Business Innovation Research (SBIR) Phase II project seeks to optimize an iron-based BPCA for use in MRA for the detection of vascular diseases. Contrast-enhanced MRA is a staple diagnostic procedure for imaging blood vessels. The market is currently dominated by gadolinium-based contrast agents (GBCAs) due to their excellent contrast enhancing effects; however, due to their potential toxicity, GBCAs are designed to be rapidly cleared, leaving only a short window for MRA image acquisition and resulting in suboptimal image quality of blood vessels. To address the need for a safer contrast agent able to provide enhanced vascular imaging, the Phase II project will optimize an iron-based contrast agent that will enable an extended imaging window for improved MRA resolution, but which is removed by kidney filtration. The research objectives include: (1) optimizing the minimum viable product to enable dose reduction and enhance the safety profile; (2) evaluating diagnostic imaging efficacy and toxicology; and (3) demonstrating a scale-up manufacturing process for the synthesis of the final formulation. This solution addresses the major points required to de-risk commercialization and bring the technology closer to the market.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）II期项目的更广泛的影响/商业潜力将为血管成像提供工具，该工具是临床需求巨大的医学领域。与当前基于Gadolinium的对比剂（GBCAS）相比，开发的血液池对比剂（BPCA）具有破坏当前磁共振血管造影（MRA）对比剂市场的潜力。提出的技术有可能改善对比度增强MRA的诊断和安全性。这为参与的每个人都创造了双赢的场景。对于血管疾病的患者，该解决方案提供了更安全的替代方法，并具有更准确的诊断，可以使医生保留安全，更有效的治疗方法。对于患者的家人，它可以通过较早的预防治疗来减少财务和社会伯恩斯。疾病检测。对于放射科医师，更清晰的MRA图像可能会导致更准确的诊断。该产品将销售给执行MRA以诊断血管血栓形成，肾脏狭窄和小儿MRA的放射性医师和医疗机构。这项小型企业创新研究（SBIR）II期项目旨在优化基于铁的BPCA，以用于MRA用于检测血管疾病。对比增强的MRA是用于成像血管的主食诊断程序。由于其出色的对比度增强效果，市场目前由基于Gadolinium的对比剂（GBCA）主导。但是，由于其潜在的毒性，GBCA被设计为快速清除，仅留下了一个简短的MRA图像获取窗口，并导致了血管的次优质量。为了满足能够提供增强型血管成像的更安全的对比剂的需求，II期项目将优化基于铁的对比剂，该对比剂将使扩展成像窗口能够改善MRA分辨率，但通过肾脏过滤去除。研究目标包括：（1）优化最小可行产品以减少剂量并增强安全性； （2）评估诊断成像效率和毒理学； （3）证明了最终公式合成的扩大制造过程。该解决方案解决了脱离风险商业化并使技术更接近市场所需的主要要点。该奖项反映了NSF的法定任务，并使用基金会的知识分子优点和更广泛的影响审查标准通过评估来诚实地获得支持。