In the proposed phase II NIH STTR funding opportunity (PA-12-089), LodeSpin Labs (LSL) is developing a magnetic nanoparticle tracer for use in Magnetic Particle Imaging (MPI), a disruptive new medical imaging technology currently being developed as a safe, effective and quantitative alternative to existing cardiac imaging technologies like CT and MRI. MPI is a promising safer alternative to current CT angiography procedures;it uses safe magnetic fields (no ionizing radiation) and safe iron oxide nanoparticle tracers. Unlike MRI, it offers real-time imaging that is quantitative and has potential for sub-mm spatial resolution. MPI shows tremendous potential as a safe clinical imaging procedure for diagnosis and treatment of cardiovascular disease (#1 cause of deaths in the US), and opens doors to novel molecular imaging applications. However, it remains under development largely due to the unavailability of suitable tracers. While iron oxide nanoparticle tracers exist, having been developed for MRI as well as for iron replacement in CKD patients (Feraheme), LSL's tracer is the first, and only, tracer to be designed specifically for MPI. Furthermore, there is unanimous agreement in the industrial and academic research community developing MPI hardware that LSL tracers provide superior MPI imaging performance, which will enable MPI's clinical and commercial potential. Therefore, LSL has a significant opportunity to be the first provider of high-performing MPI tracers in the emerging pre-clinical MPI market and future clinical market. In Phase II, UW and LSL, in partnership with industrial giants Bruker BioSpin and Philips Medical Systems, will demonstrate real-time in vivo imaging in phantoms and live animals. LSL has further strengthened its team by including Dr. Steven Conolly, as an imaging scientist consultant, and Dr. Julian Simon, as a conjugation and medicinal chemistry consultant. LSL will also pursue pilot toxicology studies that will demonstrate tracer safety to future investors and enable joint ventures that will ultimately fund future regulatory studies. In Phase I our efforts to develop optimized tracers, and strategic partnerships with Philips Medical Systems (Limited Evaluation License) and Dr. Conolly's group at UC-Berkley (Material Transfer Agreement) have positioned the LSL team as pioneers in MPI tracer technology. There is unanimous agreement in the MPI community that LSL tracers outperform any iron oxide formulation currently in the market. Thus, we envision our tracers as truly enabling MPI in achieving its clinical and commercial potential. In Phase II, LSL's immediate goals are to demonstrate our tracer's superior performance in phantom and in vivo imaging, targeting sub-mm resolution (SA1) in both time- and frequency-domain image reconstruction methods, further enhance tracer performance to compete with current standards in x-ray CA procedures (SA2), and assess tracer safety in pilot toxicology studies in mice (SA3).

Public Health Relevance

Medical imaging is a crucial technique used by clinicians for diagnosing diseases and determining the correct treatment options for patients. In this project, we will develop magnetic nanoparticle tracers for a new and emerging imaging technology called Magnetic Particle Imaging (MPI), with a specific focus on cardiovascular angiography. MPI can produce real-time, quantitative 3-D images and our novel tracer technology, specifically tailored for MPI, will enable the technology to transform from a scientifically niche technique t a widely used clinical imaging procedure for diagnosis and treatment, initially focusing on cardiovascular disease, and subsequently on molecular imaging, and related research.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
5R42EB013520-03
Application #
8710215
Study Section
Special Emphasis Panel (ZRG1-SBIB-T (10))
Program Officer
Liu, Christina
Project Start
2011-08-04
Project End
2015-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
3
Fiscal Year
2014
Total Cost
$548,506
Indirect Cost
Name
Lodespin Labs, LLC
Department
Type
DUNS #
962761842
City
Seattle
State
WA
Country
United States
Zip Code
98103
Arami, Hamed; Krishnan, Kannan M (2014) Intracellular performance of tailored nanoparticle tracers in magnetic particle imaging. J Appl Phys 115:17B306