Beginning in 1976, the FDA created two separate paths for medical device approvals.

Those that are substantially equivalent to an existing technology are eligible to receive a 510k approval, a (relatively) short process. All others, particularly new technologies, must go through the Pre-Market Approval (PMA) process and require clinical trials. This dichotomy creates a bias in medical device development towards incrementalism, especially for startups where FDA approval is the biggest factor in their survival and path to success.

This bias is further entrenched by the startup fundraising processes wherein VCs will often require FDA approval before investing or make it a leading factor in diligence. As a result, many new devices take an existing test and make it faster or take a process done by humans and automate it. These incremental advancements save lives and money, but they don’t bring step changes to diagnostics and medicine.

Among a myriad of other reasons, this helps explain why there hasn’t been a new imaging modality since Magnetic resonance imaging (MRI) was developed in the 1980s. In fact, after the FDA created separate paths for PMA vs. 510k approval, MRI was the first technology required to go through the PMA process. This led more than a dozen MRI companies and their trade association to sue the FDA to try, unsuccessfully, to reverse this decision.

Despite all these factors, new Celesta portfolio company Magnetic Insight is eschewing the incremental approach by developing an entirely new medical imaging modality offering the potential of rapid, seismic improvements in patient diagnosis and care. Today the company announced their Series B raise, led by Celesta, with participation from Alumni Ventures Group, Gaingels, and others.

Magnetic Insight’s core product is a magnetic particle imager (MPI). Legacy imaging techniques, such as computerized tomography scan (CT) or MRI, provide a static snapshot of structural systems in the body. Nuclear medicine, meanwhile, is able to monitor metabolic activity.

While these techniques remain important aspects of patient care, for many treatment regimens – such as patients undergoing immunotherapy – changes seen in a CT or MRI scan are often lagging indicators. They show what has already happened. What if we could monitor what is happening?

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Creating a new medical imaging modality is no small feat. It requires scaling the technology from mice to clinical applications in humans, while simultaneously supporting preclinical work that develops clinical use cases, and building knowledge and support with key opinion leaders and patient advocacy groups. We are confident that Magnetic Insight is up to this task.

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This is precisely the potential of magnetic particle imaging (MPI), which images cell activity. Cellular imaging allows clinicians for the first time to track treatments and patient biological responses in real-time. Now a treatment such as cell therapy, and the patient’s reaction to the treatment, e.g. potential brain inflammation, can be monitored and adjusted immediately.

MPI achieves this by applying a magnetic field to magnetized nanoparticles and using a directed “selection field” to localize the nanoparticles. The received signal is then converted into an image showing the location and intensity of the magnetic nanoparticles, which is typically then overlaid on a structural image like a CT or MRI. The nanoparticles used today are FDA-approved iron-oxide tracers that are actually safer for patients than MRI contrast or radioactive PET tracers. However, there are also custom nanoparticles currently in development by Magnetic Insight and others that could improve the image quality and capabilities of MPI.

While the full applications and capabilities of MPI are likely not yet known, there is particular promise in using MPI to image immunotherapy treatments. There are nearly 100 immunotherapy drugs approved for treatment of cancer and thousands more in development, yet existing imaging techniques are unable to determine quickly if an immunotherapy regimen is working within a solid tumor. These treatments can be astronomically expensive for patients – more than six figures for a single treatment regimen. Patients deserve the ability to track whether the therapy is reaching the targeted tumor, how their body’s immune system is responding, and to expect treatment decisions that are rapid, precise, and iterative. MPI has the capability to do exactly this.

Creating a new medical imaging modality is no small feat. It requires scaling the technology from mice to clinical applications in humans, while simultaneously supporting preclinical work that develops clinical use cases, and building knowledge and support with key opinion leaders and patient advocacy groups. We are confident that Magnetic Insight is up to this task.

The Magnetic Insight team and Co-Founder Steve Conolly’s lab at UC Berkeley are broadly recognized as the engine driving MPI forward. They have already proven the technology at the pre-clinical stage and have many systems installed globally at research centers and universities, including Johns Hopkins and Stanford. These preclinical partners, along with the NIH, are working to create the conditions necessary for an ecosystem to develop around MPI. Finally, both as a clinical workflow and via its software components, MPI integrates with existing imaging modalities, making it additive rather than competitive with existing imaging techniques.

With this series B investment, Magnetic Insight will build and test their first clinical-scale MPI machines and prepare the market for broad MPI adoption.

On behalf of the Celesta team, we are thrilled to support them on this important journey.