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February 19, 2018 Issue



Q&A with Elizabeth Mirowski, CEO of QalibreMD bringing to market Quantitative MRI Products that provide Numbers for an Anatomical Image much like Blood enabling Better Patient Outcomes



Elizabeth Mirowski

Chief Executive Officer




Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – February 19, 2018


CEOCFO: Ms. Mirowski, the first thing I see on the QalibreMD website is “Impeccable Standards for Quantitative Patient Imaging.” Would you tell us more?

Dr. Mirowski: We provide standards for medical imaging, specifically MRI. The standards go into an MRI machine and they allow you to determine how much error is reading off that machine on a day-to-day basis, and allow you to determine differences between MRI scanner manufacturers. For example, if you have a software or hardware upgrade you can determine how much that has affected the information coming from the MRI. I think most of us believe that MRIs are the best in diagnostic imaging that is out there and that to a certain extent is true but what we do not realize is it is giving an image of what the body looks like inside and that is about all. Therefore, if we see a tumor or some type of anomaly we will see it as an oddly shaped lesion in the body and then we will subsequently test it using biopsies and histology. However, there is a lot more information we can get out of that MRI and that information could be linked to what type of cell irregularity is present, and identify if a suspicious tumor is benign or cancerous. When you correlate that data together now you can imagine a much faster assessment of what is going on in your body.


CEOCFO: How much deviation should one expect from a piece of equipment?

Dr. Mirowski: Our product has shown that you can get as much as a 40% difference between readings on different scanners. How does this affect the end result? Let me give an example. At our recent open house, we had a guest mention they get a yearly MRI scan to monitor a suspicious lesion. It turned out that they had changed insurance companies and had to get their yearly scan at a different facility. The report came back that the lesion size had grown by three times. That in effect was not the case for what was going on in the body, in fact it was it was an artifact coming from the MRI scanner.


CEOCFO: Do people in the industry typically know that they should expect a certain brand to be off by a certain amount, or is it the individual piece of equipment that makes a difference?

Dr. Mirowski: It is more the individual piece of equipment because there are a lot of different ways that you can acquire the data. If you can imagine, and this is an old reference, I had a stereo system with an equalizer with all the different frequencies and I could tune all of them to make the sound come out sounding different. Well that, in essence, is sort of the same thing that you can do with an MRI. You can actually tweak it to paint a slightly different image. I am not a medical doctor or a radiologist; but even to me it is obvious that you can see a huge difference between two images taken with different acquisition parameters. Whether or not the specific protocol is getting the true answer is unknown until you actually put a standard in the MRI, and if you are not getting the correct numbers out then your protocol is failing and you should not be using it.


CEOCFO: What is the technology and how do you measure?

Dr. Mirowski: It is a physical device that is tailored for different types of imaging so it could fit into a head coil, specific to imaging the brain, it could fit into a breast coil specific to breast imaging, or it could be a human torso that allows you to image the prostate. We have different form factors that test each type of coil used with MRI. The coil is basically what sends the signal back and gets you the image that you see. What is in the product is a variety of different solutions that mimic tissue parameters you measure with an MRI. For example, our most complicated product has over 300 different features and forty-two different solutions. Those solutions are referenced back to the National Institute of Standards and Technology. When it is scanned in an MRI, the numbers obtained are compared to the referenced values and an error reading is reported. So if you expect to get a T1 of 350 milliseconds and you measure 400 milliseconds from your scanner, you report an error of 15%, which can significantly impact the image data.


CEOCFO: Would someone looking at your equipment see a print-out of twenty or thirty items or will they just see overall it is operating as it should be? What is somebody reading and how often might they read it?

Dr. Mirowski: Ideally you would be scanning these daily because people are developing protocols to be able to see the changes in volume as a result of taking a therapeutic remedy for cancer or MS. This generates a lot of data, so we are developing a software program that uses computer vision to process the data, specifically finding the regions of interest, calculating what the number is there and comparing it to a chart that says this is what it should be. Then it outputs an error report of parameters that are out of specifications.  For example, if it should be less than 4% deviation, but it is more than 4%, then we would flag it and say you cannot scan that particular protocol for a day, you need to get it the machine serviced. In some cases there might be ways to deal with this error and say for any AI or Deep Learning algorithms that are mining radiological data, this is your error for that day that is coming from the machine itself. It enables other products that look at patient data to have some baseline for comparison.


CEOCFO: How common is it that people are paying enough attention?

Dr. Mirowski: Right now our target market is the research market and we are poising our product for use in routine clinical settings. One of the things that the product enables is testing to make sure you get the right answer so if you developed new MRI technique that takes the scan time from 45 minutes down to 5 minutes, then you need to prove that it is getting the correct answers. These protocols are in the process of being vetted to determine how they can be applied to the clinical diagnostic market. Ideally our products would be used on every scanner to prevent unnecessary repeat scans today, but in the future when big data starts coming down the pipeline, if you do not have anything to compare to ground truth, you can have garbage in and garbage out and you cannot mine previous data even though there is plenty of it there.


CEOCFO: Should the consumer know they might want to go to a facility if given a choice that has higher standards?

Dr. Mirowski: At this point, we are at the top research institutions and hospitals and in the world. They are aware and are definitely in the process of implementing our technology to be able to have this standardization. We are looking to work with payer or health systems that have many different machines where people can get their MRI scan on a different machine each year. Ultimately we want to get onto their radar because that is who is going to be able to drive whether or not these standards are adopted widely.


CEOCFO: What is the competitive landscape?

Dr. Mirowski: We are a spinoff of High Precision Devices, a custom instrumentation, design engineering and manufacturing company. Our parent company designed and manufactured the initial vibration isolation platforms used to detect gravitational from space. The scientists heading this research were recently awarded the Nobel prize in physics. My point here is that precision and quality is our nature. What has been out there in the world are phantoms and they are meant to mimic human anatomy and human tissue but not to the extent that they would provide a ground truth, like the “zero” of a scale, that you could then compare different sites to each other. The precision and accuracy needed to achieve such a product is not trivial.


CEOCFO: How do you as CEO handle the business side?

Dr. Mirowski: Since this is a new trajectory for MRI, it requires some strategy to determine the best commercialization pathway. I spend much of my time working on developing relationships with various industry partners and fundraising to be able to execute our strategy.  Part of our goal now is to take our product and make it widely adoptable so you could put our device into the MRI and you would be able to scan it overnight and generate a report to be used for seamless accreditation. We are in the process of completing the development of that full package as QA/QC service contract and we are working to obtain NIH funds to do so. We have partners already that are lined up to do work with us on these efforts. Once we can have a seamless product that is very easy for MRI techs to use, I think that is when we will be poised for widespread adoption.


CEOCFO: Do you have enough funds for the time being or are you looking for investment?

Dr. Mirowski: We are in the process of looking for accredited investors, which I feel is a full-time job for any start-up. We do have a lot of interest in what our technology enables. To get to where we are at, we have put in some of our own internal funds from the parent company. We have managed to float some of this through SBIR (Small Business Innovation Research) grants. The rest of it is through revenues, we have already done over three quarters of a million in sales just through our research market so we just want to ramp this up faster and be able to get these use-cases developed and underway and it always requires money.


CEOCFO: How do you test your equipment once it is in use?

Dr. Mirowski: Our products have proven shelf life up to five years but we are not pushing that. For clinical applications, we exchange ours every year. We test the solutions before we send them out and when they come back we can make samples of them and retest to make sure they stay the same. Also, we can monitor the product through the software and if we see a sudden and very large change that is suspect we will call back the item and test it; we have that capability to monitor.


CEOCFO: What surprised you throughout the process?

Dr. Mirowski: What surprised me most is you cannot compare MRI data over time, yet people are using it to do so. It’s surprising to almost everyone I say this to. Originally we were digging into this technology because imagine if instead of getting a mammogram and then a biopsy and a lumpectomy, you could just hop into an MRI and determine that there is a lump, it is cancerous tissue so now we are going to give you chemotherapy, image the size reduction of the tumor and then just aspirate the rest of the tumor through a needle so you do not have to have a lumpectomy. That was the original motivation, to look at what we can do to reduce the morbidity time of patients and be able to reduce cost in the healthcare process altogether. But then as I was talking to more people about what we were doing, I was learning more and more that you cannot compare data over time on the MRI. So if you have a graft put in your knee when you are 43 and then they look at it when you are 53, they may or may not see it and they make a judgment call that they cannot see it so it must have come off and they open your knee and find out the graft is still there. These are stories that have come to me from people and when I tell them what I do it just surprises me that somebody often has a story that corroborates that issue.


CEOCFO: How do you stand out at events like the Biotech Showcase?

Dr. Mirowski: I’m not sure, but when we educate people about how much variation there is in MRI and what negative results that produces, we get a lot of activity in discussions. We really think our product offering will disrupt medical imaging as we know it.


CEOCFO: Why pay attention to QalibreMD?

Dr. Mirowski: We are doing something that one would love to say is exciting, but standards are not exciting, and they are something that is absolutely essential for big data science, AI or any doctor or radiologist to provide excellent healthcare. You have to have very stable quality ground true standards that allow your MRI techs in your facilities to implement them extremely easily. Our big game-changer is our products can transform MRI images from just an anatomical image to an image with numbers much like blood analytics, where certain numbers are associated with healthy or unhealthy tissue. Our value-add is we provide an assessment of the error coming from the MRI machine, which makes patient image data more accurate and has facilitated the development of faster and more accurate MRI scans.


“Our big game-changer is our products can transform MRI images from just an anatomical image to an image with numbers much like blood analytics, where certain numbers are associated with healthy or unhealthy tissue. Our value-add is we provide an assessment of the error coming from the MRI machine, which makes patient image data more accurate and has facilitated the development of faster and more accurate MRI scans.”- Elizabeth Mirowski





Maddie Evenson







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