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

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.