Lodespin Targets Opportunity in Next-Generation Medical Imaging

A new University of Washington spin-off company, Lodespin Labs, is emerging as a key player in the development of what could be the next big advance in medical imaging technology – magnetic particle imaging (MPI). It capitalizes on the magnetic properties of nanoscale iron oxide particles that can be injected into the bloodstream for real-time imaging of coronary blood flow and other heart functions.

Lodespin is the creation of
Kannan Krishnan, professor of materials science and engineering, and two of his graduate students, Matt Ferguson and Amit Khandhar. Ferguson completed his MSE doctorate this past winter and was selected by the UW Center for Commercialization (C4C) to receive funding as a Commercialization Postdoctoral Fellow to continue his work toward spinning out the company. C4C has filed patent protection for the team’s nanoparticle tracers and helped LodeSpin secure crucial grant funding to advance its technology.

The Missing Link for MPI
Royal Philips Electronics began developing the hardware for MPI about ten years ago, believing it has the potential for high-resolution, real-time, three-dimensional imaging that could offer a great diagnostic leap beyond current magnetic resonance imaging (MRI) technology. The biggest remaining hurdle for Philips is not developing the imaging machine, but access to tracer particles that could achieve the desired imaging quality for effective diagnostics of cardiovascular disease and other conditions. The commercial tracer Philips initially used for testing had been designed for MRI, had not been optimized for MPI standards, and produced an extremely weak magnetic signal when scanned in an MPI machine.

That caught the attention of Krishnan, an internationally recognized expert in developing magnetic particles and tracers for diagnostics and imaging. He passed the information along to Ferguson, then a new doctoral student looking for a research focus.

“I thought we could develop a much better tracer, which is a physics and chemistry problem. Matt had a background in physics and the ability to significantly advance this project,” Krishnan said.

Lab Bench Neighbors Become Entrepreneurs
In Krishnan’s lab, Ferguson worked side-by-side with Khandhar, whose research focused on a parallel project on magnetic particle hyperthermia. They joined forces and in March 2010 presented an abstract on their work at the first international meeting on MPI, held in Germany and organized by Philips and Bruker Biospin, its collaborating German partner for developing preclinical MPI scanners.

“We received exceptionally positive comments about our work and we clearly had the best particles for MPI. I came back to the UW thinking ‘This project has legs, let’s do something with it,’” said Ferguson.

An international professional colleague also encouraged Krishnan to start a company, his first venture into entrepreneurship. The team chose the name Lodespin Labs, a hybrid derived from “lodestone,” the common name for magnetite, a naturally magnetized mineral, and “spin,” a fundamental property of electrons and elementary particles responsible for magnetism. They applied for a state business license in June 2010, and in late fall turned to C4C for help with next steps.

C4C Fast Tracks Lodespin
The Lodespin team began meeting regularly with technology manager Mike Clarke and other C4C specialists including patent agent John Tolomei, commercialization gap funding manager Jeannette Ennis, and two entrepreneurs-in-residence (EIR): initially Terri Butler and now Chris Wood.

A first order of business was protecting the team’s intellectual property by filing a patent application on the nanoparticle tracers and the process for creating and coating them. An international patent is pending, which the team expects to nationalize in the US and several foreign jurisdictions.

With Mike Clarke’s encouragement and coaching from Terri Butler, Ferguson and Khandhar entered the April 2011 Business Plan Competition sponsored by the Foster School Center for Innovation and Entrepreneurship. They teamed up with Garrett Leischner, a UW MBA candidate who was a C4C intern helping the team research market opportunities. They refined the Lodespin business plan, presented to local investors judging the competition, tied for third place, and won $5,000.

Also with Clarke’s assistance, the team applied for and won a $50,000 award in 2011 from C4C’s Commercialization Gap Fund program to evaluate the biodistribution of iron oxide particles in the blood and key organs and assess their general safety for clinical use. Jeanette Ennis guided LodeSpin through a successful application for a Phase I Small Business Technology Transfer (STTR) award, a one-year $250,000 grant that will conclude in August 2013. This funding is supporting research on particle refinement and expansion of Lodespin’s interactions with Philips and other potential collaborators. In addition, she helped the team secure a National Science Foundation Phase I Small Business Innovation Research (SBIR) six-month award for $150,000, which the team is now using to improve the performance of the MPI tracers. They have applied for a Phase II STTR grant from the National Institutes of Health to continue long-term safety studies required for approval for human clinical use, and will apply for a Phase II SBIR in 2013.

“Our team at C4C has been absolutely superb, and we can’t say enough good things about Mike. He has been fabulous,” Krishnan said. “Once we engaged with C4C, plans for our company started to move fast. The C4C team is responsive and proactive and has provided excellent guidance at every stage. When I give talks on our research and company, whether on campus or anywhere in the world, I always mention how lucky we are to have C4C at the UW.”

Lodespin’s Particles Dramatically Improve MPI
An MPI scanner images the spatial distribution of superparamagnetic nanoparticles injected into the bloodstream by detecting their signal response to the machine’s oscillating magnetic field. Lodespin’s particles provide a signal thirty times stronger than other particles now available for MPI, and they have achieved excellent uniformity of particle size and control over behavior, a challenging feat of nanoparticle engineering and optimization.

Just as critical, testing to date shows the particles are safe for use in clinical diagnostics. Current tracers for diagnostic imaging contain iodine or gadolinium, which are both toxic to patients with chronic kidney disease. Iron oxide nanoparticles are cleared through the liver, not the kidneys, and are generally considered benign since iron is a natural component of the hemoglobin in the blood.

Significant Market Potential
Lodespin has just entered an agreement with the Cardiovascular Institute of Spain for use of its tracers in a preclinical machine that will be tested on animal models, and also plans to conduct cooperative research with Johns Hopkins University. Even though a new start-up, Lodespin has attracted attention from Philips, an industry giant. Lodespin is aiming to be the principal supplier of tracer particles to users of the machines produced by Philips and Bruker Biospin.

“We have a symbiotic relationship with Philips,” Krishnan said. “They can’t perfect their scanner without high-quality tracers, and we are depending on development and commercialization of the hardware to develop the market for our tracers.”

That market could be huge. Diagnostic angiography is a common procedure and current tracers cost about $100 to $150 per dose, representing about a $2.5 billion business in the US alone. Human clinical use of MPI is anticipated in five to ten years, and the Lodespin team sees other future applications as a tumor marker for cancer diagnostics.

The industry and entrepreneurial experience of EIRs Butler and Wood has offered essential perspectives on what it takes to establish and build a successful business focused on the market and customers’ needs. They also helped the Lodespin team make valuable connections in the biotechnology and investment sectors. From his 25-year perspective in the medical imaging industry, EIR Chris Wood has confidence the Lodespin team has the ability and motivation to commercialize their tracer technology, particularly given their collaboration with an advocate like Philips.

“If MPI enters the market for cardiovascular diagnostics, a new tool will be unleashed and medicine will find many other applications for it,” Wood said. “With potential for uses in both cardiovascular disease and cancer, you have two killer apps. The sky is the limit for MPI and Lodespin’s tracer.”