Heath Fletcher (00:13)
Hello again, welcome to the Healthy Enterprise podcast. If you're returning listener, again, thank you for joining me. And if you are new to the podcast, then welcome and I hope you enjoy it. My guest today is David Georges. He has been a global business leader in breast imaging for the past 25 years and has contributed to the introduction of a range of innovations such as mammography, breast biopsy and computer aided detection.
Today, David is the North American president for Koning Health. And we're gonna learn about the BreastCT device that they are bringing to the marketplace and changing the industry. So ⁓ let's have a chat with David. So David, welcome to this episode. I really appreciate you ⁓ spending some time with me here this morning. So. ⁓
David Georges (00:50)
to change.
Thank you. Nice to be here.
Heath Fletcher (01:09)
Awesome. I'd like to start off by giving you an opportunity to kind of introduce yourself to listeners and give us a bit of the background on where you came from and what got you into this healthcare space and and eventually that'll lead us into coning and we can talk more about
David Georges (01:26)
sure, that'd be great. ⁓ Actually this represents my 40th year in the breast detection industry on the equipment side. I have been involved in five different technology launches in that time period, all focused on early stage breast cancer detection. ⁓ It brought me to ⁓ Dr. Roland Neng, the founder of Koning, while he was at the University of Rochester finishing
the research and development on the first cone beam breast CT product that we have since ⁓ acquired. Our FDA PMA clearance, ⁓ AMA recognition by way of CPT codes for reimbursement, accreditation recognized by the CMS, Medicare Medicaid ⁓ facility, and we are well on our way.
to launching the product after multiple revisions over the last 12 years. So ⁓ we're here as a real commercial product, installing routinely with a very nice little backlog of devices being built.
Heath Fletcher (02:36)
Okay, so what drew you to this market? Like what was the initial, ⁓ you know, what motivated you to enter this market or this space of all the healthcare opportunities and technology opportunities out there?
David Georges (02:49)
⁓
well, I originally, I, when I entered into the X-ray industry, I looked at all the expert X-ray emitting devices, ⁓ was closely affiliated with the distributor across multiple lines and became very interested in what was happening around the globe with women in over 30 and many times over the age of 40 that were showing this increased rate of early stage breast cancer.
And it was very difficult to detect in the initial phases of when I entered into the business. We were still using wet film and chemistry. The technology for detecting small cancers was not very advanced. And I just grew very ⁓ interested and very close to the industry and continued to work using my x-ray background to enhance and find different methods and different modalities from which to
help radiologists find breast cancers at their earliest possible stage because we all knew at the time that if I found it early, stage one, there's a 98 % cure rate. When we think about women suffering from breast cancer for years and years, that is primarily based on the fact that we just didn't have the capability or the technical capability to discover it at an early enough stage, which means most likely it had metastasized and impacted other organs of the body and.
and the outcomes then were very poor. So it really became a personal ⁓ involvement in the industry to see if there were things that if you just flush them out through the advanced engineering within the imaging industry, could you actually help physicians improve the outcomes of finding breast cancer at an earlier stage?
Heath Fletcher (04:37)
And so then you ran into the CEO of Koning and
David Georges (04:41)
Yes, actually I was introduced ⁓ to Dr. Roland Ng and we made an agreement to get together and take a look at what he was doing at the university. And it was the first time that anybody had been able to manage the ability to acquire an image of the breast and display that image in true isotropic three-dimensional format. Prior to that, a mammogram is a two-dimensional image.
of a three-dimensional body part. And we were only actually able to identify the abnormalities on a single axis. And with an isotropic data set moving away from two-dimensional imaging, which mammography has been for well over 40 years, ⁓ we now have the ability to interrogate that breast tissue from any angle and at any slice thickness.
And that's because we borrowed some of the basic technology that had been used in whole body CT scanning that has been the basis of cancer detection in the head, or abdomen for 30 to 40 years. So we borrowed some of that advanced technology, integrated it into our breast CT device, giving the radiologist an opportunity to have more tools with a more complex and more comprehensive opportunity to interrogate the breast tissue.
Since then, the users are seeing things that they've really never seen before during a scan. At the same time though, Heath, what we discovered was we could achieve this without the need to compress the breast, which is very common in mammography today. The breast is uncomfortably positioned between two plates. There's approximately 20 pounds of pressure put against the breast tissue, not very comfortable for most women.
But it did give that two-dimensional image an opportunity to flatten the breast tissue so that the x-ray photons could penetrate more effectively. And it helps, ⁓ but it's not comfortable. And many women are not very compliant to obtaining their recommended annual mammogram because they just can't tolerate the discomfort or even the pain of compression. that... It has been.
Heath Fletcher (06:57)
It's definitely been a barrier.
David Georges (07:00)
You know, we did a small ⁓ investigation on what that really meant because there are many people who say, I get my annual mammogram. I'm not happy with it. I don't like it, but I have to go anyway. It's just something that I should do. Well, the MQSA, which is the quality metric for breast imaging centers around America, ⁓ they claim that there are 39 million screening mammograms offered every year or achieved every year.
in the over 8,600 MQSA certified facilities. But unfortunately, when you measure that against the population of patients in the United States at age 40 and above, which is the baseline age that people are recommended to have their annual mammogram, there's 84 million women in that population base. So that tells us that the compliance rate is, there's 54 % of women who are just not achieving their annual recommended mammogram.
And if we look at the top, yeah, it is astonishing. But when we, when we look at the top two or three issues, one of them is the discomfort from compression. And the other is a lack of confidence that the two dimensional imaging is actually going to give them a clear, identifiable understanding of the condition of the rest tissue. ⁓ and I think that is what led to many of the advocacy efforts that have been going on for the last several years in informing women.
of what their breast density is becomes a very important factor in understanding whether your mammogram was clear and concise or whether your mammogram is indeterminate due to the dense nature of your breast. ⁓ So today you are ⁓ supposed to be receiving a lay letter directly to the patient explaining that the radiologist read your screening mammogram.
They found that your density may obscure some of the detection capabilities and perhaps supplemental imaging would be recommended. And that's going out to about 50 % of those patients who are in that annual category, that 39 million that I mentioned previously. ⁓ So it's an issue and we need to find ways to do a better job on dense breast tissue. And we have many processes that are in place today. Contrast enhanced mammography is
becoming very popular. MRI imaging of the breast has also been around for many years, has a very, very high sensitivity and a very high cancer detection rate. But an MRI is expensive. It's pretty time consuming. It's not very comfortable for the patient. So we are looking for alternatives. And to get rid of compression was one of our primary objectives. Then to create this isotropic 3D data set gives us an opportunity to be more.
comprehensive in the way that we interrogate the breast tissue. And then doing all of this at the same dose as a mammogram became paramount because we didn't want to have a dose premium ⁓ in doing a breast CT. So we worked very, very hard to hold the dose down to the same level as a mammogram. And we have accomplished that. And I think those are the three factors that bring this technology to the attention of radiologists and facilities who perform.
breast cancer detection services. That's where we're at.
Heath Fletcher (10:23)
Yeah, I'm glad you brought that up too, because the CT scan was something that people were a little bit timid of because people tend to think it's a higher dose of radiation, but you've already addressed the fact that you actually keep it the same as a typical mammogram or slightly less even from what I've heard as well.
David Georges (10:43)
In some cases, that can be exactly ⁓ how the final outcome or the final measurement of dose is. But at the end of the day, maintaining our requirement to stay within the FDA requirements was our core objective, and we've met that objective. ⁓ And we're very proud of the fact that we're able to mimic the same technique, radiation technique, as a mammogram, meaning 49 kVp within a very low mass range.
still being able to create that isotropic 3D data set and present those new tools to the radiologist.
Heath Fletcher (11:20)
Okay, so let's look back a little bit. So when you got to Koning, ⁓ where was the company at at that stage? Where what part of development were you? Business development? Were you in?
David Georges (11:29)
It was very close to getting ⁓ our first FDA PMA clearance, ⁓ giving us the opportunity to continue working on the device and commercializing the device. We went through a couple of iterations of the device. We wanted to ⁓ reduce the size, reduce the power consumption. We wanted to make sure the device would fit into a routine mammographic room, or at least the average size mammographic room, or prone stereotactic biopsy room.
two common devices that were in the mammography clinics at that time, and that it connected to the same power that was already in the building used either for a previous mammogram machine or a previous stereotactic biopsy device. Those were kind of the key issues in relationship to commercializing the product. We had to get it in through standard doors, 36 inch wide doors. We had to be able to use the exact same room size that was there. Otherwise the facility would have
an extraordinary expense in either moving walls or doors or that sort of thing. And we didn't want that to happen. We wanted it to literally be take an old device out, put our new device in, connect it to the power and start training. And that's what we've been able to achieve. I think our installation time is about a day and a half before we call in the physicist to imagine the X-ray tube and start training the technologist how to use the device.
Heath Fletcher (12:51)
incredible. Yeah. So in and out the old machines done, comes the new one and you're you're changing changing the way mammograms are done instantly and that's done at clinic level ⁓ or hospitals. It's it's in all in virtually any facility, right?
David Georges (13:08)
Yeah, any facility that is either interested in doing breast imaging and starting their journey with breast CT has been very popular for us in some of our first few installations. Since then, we've grown to putting them into independent diagnostic testing facilities and even some hospitals that have a more complex requirement ⁓ within the standards of care, but are very interested in moving the innovation along and making this available to patients who either one don't comply
with the current recommendations or that they want to set up a supplemental imaging program and introduce contrast enhanced imaging by way of REST CT.
Heath Fletcher (13:48)
So you go, you arrive at Koning, and then the company gets to ⁓ a place where many startups want to reach. It's an exciting place to get to that point where you can actually go to market, right? ⁓ So that must have been quite a feeling and quite an experience for you. ⁓ I don't think it's your first time that you've done that, ⁓ which I think is why you were brought into this role, because that's your sweet spot. That's where your skill set is, right?
David Georges (14:18)
Well, primarily, yes. And the concept behind that was to make sure that we had a solid foundation of where the standard of care was at the point in time that we started our commercialization, because we have to be able to integrate into an environment that is utilizing standard of care, which would be compressional mammography and either the screening or the diagnostic capacity. And then...
to help them move from one modality to the next and to do so ⁓ one step at a time and to make sure that the radiologist conversion to breast CT is solid to make sure that the technologists are doing what they need to do and that there's an understanding of the patient response on how this is going to move forward in utilization by driving the awareness that the technology exists, that it is FDA cleared, that it can be used in
multiple configurations. And that was the challenge. It's getting over that first layer of introduction ⁓ by raising the awareness, comparing it to the current state, and then having the facility find the value proposition to move forward with this technology, in part, not necessarily in whole. This is not a wholesale transformation. We never expected it to be. But as more and more people get interested, they want to add it. They want
They want to perform a lot of self-discovery on what is the utilization, the feature sets, and how do I use it? How does it compare to my standard that I'm used to looking at today? And many other components as far as ⁓ getting up and running into the REST CT environment.
Heath Fletcher (16:00)
When you look back on your career, what aspects or what did you draw from when you got to this stage at Coney? What did you draw from that helped you ⁓ achieve the goals and the success that you wanted in this experience?
David Georges (16:19)
Sure, and as most people know, when we innovate, we also create an environment where any of the users will ask very well positioned questions. How does it compare to what I'm used to? What is it going to do for the facility? Is it going to require any more of my time or will it require less of my time? In particular, the radiologist that was reading.
This is the key concerns that people have. ⁓ Insurability, reimbursement from insurance, acceptance by the societies. These are all the milestones that are necessary for widespread adoption. And they come, but they come slow and they come with proof. We have over 160 peer-reviewed publications that are available to be read on various studies that have been done on various features of this technology. That's helpful.
in building the credibility of the device. ⁓ Of course, the FDA clearance, the AMA recognition by way of CPT codes, accreditation by a nationally known accreditation body, all of these things are necessary for any innovation to move within medicine. Medicine is very conservative, rightfully so. And in order for them to feel comfortable shifting from one standard of care to perhaps the new standard of care or the up and coming standard of care,
There's a little risk involved that we understand. So it's a lengthy process. You have to be patient, you have to be understanding, but you have to also provide that education. So physician training, technologist training, facility enhancement, what does it do and how does it work? I mean, these are the things that we are forced to do at this early stage of our launch.
Heath Fletcher (18:11)
I mean, anytime you're trying to create change, there's resistance to a certain extent because things, you know, well, they're working fine now. What's wrong with what we're doing? But I think taking, like you've said, is taking more of a holistic approach where you're looking at all the variables and how do we, how do we implement this, this new way of doing things with the least amount of impact.
on the people that are actually going to be delivering this to the end user, to the patient, right? So by really looking at it from a 10,000 foot approach, you're actually seeing how if we do this, we'll disrupt that. And if we hit this, then it'll knock this over. And it sounds like you had an approach where that was critical in the success of making this accepted and embraced by the community.
David Georges (18:39)
Exactly.
And we're still working on that and we will be working on that for years. The adoption cycles change from one facility to the next. And we just have to be patient and understand what their tolerance rate is and how they move from one technology to the next. It's nothing that's unusual in medicine. It's just something that takes a very specific process in order to make all stakeholders comfortable with the ultimate transition or conversion to the latest technology.
Heath Fletcher (19:33)
And it seems like the industry is getting a wall of change too, right? Because it's being hit from all different angles, whether you're talking about AI technology or administrative changes or so. mean, there's a lot of change happening in the industry as a whole. you know, but these, this type of change is probably something that people have been waiting for for a very long time. think the old process of mammogram, I think is over 60 years old, correct?
Yeah. And very outdated. ⁓ amazing. So where are where is Coning at now? You are you've gone to market and what's the what's the what's the vision now?
David Georges (20:03)
Correct.
Well, I think that the vision is to continue to be focused on the market, but we are focused on a global market. ⁓ Our domestic market is certainly our primary market, ⁓ but the European market, the Middle Eastern market, the Southeast Asia market, Australia, they all have different levels of acceptability within new technology. ⁓
been pleased to report that we have multiple units in healthcare facilities in China operating for several years. We have a new facility in Australia that is operating. They're finding great results. The Middle East, we just turned over the first unit into UAE in Dubai. They're finding in that particular culture, the ability for a patient to position themselves without the assistance of a technologist. Nobody's touching them.
It's a very significant interest in many communities. And then in our domestic market, it's a matter of continued education, getting out there, attending the conferences, speaking about the technology, helping to move the awareness and the understanding of the value proposition. And I think in the last 18 months, we've done very well. We've installed approximately 15 systems here domestically. We have about 40 on a global basis.
We have a significant backlog currently and a very, very healthy pipeline of those who are working toward getting an approved budget to purchase systems from Koning. So I think the future is bright. I think that we see the ⁓ initial uptake of this technology in a very positive light. And I think it's going to start paying off. Perhaps I would estimate that 2026 is our inflection point for real. ⁓
By then we should have about 30 or 40 systems installed domestically. There should be enough industry communication and chatter amongst the users to continue to build the awareness and the adoption of breast-seating.
Heath Fletcher (22:28)
Yeah, well, certainly the people that I've talked to have, you know, when they hear about this, that it's, it's, it's actually very mind blowing for a lot of people that think, wow, this is, this is actually happening now. I mean, my wife, for example, I was telling her about it. And she said, Wow, why is this taken so long to get this? Like, it's ridiculous how awful the experiences. In fact, I think they say things that must, the whole process must have been invented by a man because of
would never have put themselves through that process. I'm sure you've heard that term before, but ⁓ I mean, it is being embraced by the end user. And I think probably that is that part of getting the message out is telling the end user, hey, this is what we have available. And then the power of that where, you know, they're going to their doctor saying, this is what I want.
David Georges (23:22)
Yeah, I think that that helps. ⁓ And on the other hand, although we have a very strong social presence and women are very excited and we announced centers that are going to be bringing product to the market, they put an advanced signup sheet and those signup sheets fill pretty quickly of women that say, call me when you can schedule an exam for me. I'd much rather do this. But at the same time, it is imperative that we focus
on the radiology community and the surgical community, those that specialize in breast cancer detection and breast cancer treatment. They are the ones who will be utilizing the machine. They are the ones who will be learning how to maximize its capacity. And then when we speak to the administration of facilities, we simply position this as another or new portal of entry to service patients potentially you don't currently service.
because they want to come to you because you're offering a non-compression option. And at the same time, the radiologist has the advantage of looking at a true isotropic 3D data set and doing so in a very efficient manner by comparison to the current methodology that's used to take a patient from a screening mammogram, which we don't have that asymptomatic screening indication yet, but we're working on it right now, to a diagnostic mammogram.
would perhaps say confirmatory ultrasound, a biopsy. If the pathology comes back positive, they typically would go to an MRI for understanding either multifocal disease or contralateral disease. All of those steps can be consolidated now into a single step of doing a diagnostic breast CT with contrast. And then if something is found, they move to biopsy and that journey, the detection journey is over much more efficiently and much more effectively.
So ⁓ I think that this is really what's going to draw the attention of the facilities that are performing these services is that it just becomes so much more efficient. Our scan time is seven seconds abreast and they're done. ⁓ So it's very, very fast, very efficient process. No callbacks for additional views. mean, this is just a significant change in the workflow metrics that are in place in many facilities today.
Heath Fletcher (25:46)
And probably that's the end. It's a 360 image, right?
David Georges (25:50)
Yes, yeah, we rotate our x-ray tube and detector completely around the breast. takes seven seconds. And that's what creates that isotropic data set that allows us to see the breast in true 3D and to do some things that are common in CT, like co-registration of findings in multiple planes, ⁓ multi-planar reconstruction, MIP imaging, all of the things that are common in advanced diagnostic modalities are now built into this dedicated breast scanner.
Heath Fletcher (26:19)
Right. And that, he's the existing mammogram is to do obtain that type of image. It's multiple, multiple pictures, right? Multiple, ⁓ images that are spliced together, right?
David Georges (26:29)
Yes. Yes,
typically there's an MLO and a CC view of each breast. That starts in the screening environment. And then if additional imaging is needed, they move the patient to a diagnostic and they can do multiple additional images to clarify what they may have seen on the screening. And it goes from there. That's a lot of process. If it's accumulated the dose, it's relatively significant dose when you compare it.
to breast CT, which is a single mutation. So if we're on par with dose and we've reduced the number of connections to that patient, then we're getting to the net result a lot faster. And we're moving the patient through the process much more efficiently.
Heath Fletcher (27:18)
What resistance have you seen, if any?
David Georges (27:21)
Well, I don't think there's imaging resistance. I think there is modality resistance because it is so new and it's understandable. We have the most highly regulated subset of imaging in the breast imaging sector across all imaging modalities. It's the most highly regulated subset. So we have to be mindful that we're working in an environment that needs significant confidence.
even proof that to transition a patient from a mammogram to a ⁓ diagnostic CT will have the clinical value and of course the support of the radiologist to stand against any potential ⁓ concern that there might be about utilizing this instead of what has been for the last 40 years standard of care. And they're utilizing the device as the standard of care.
And I have a tendency to look at it and say, well, I think the outcome should be the standard of care. How quickly do we detect the cancer and how quickly do we get that patient to treatment? I hope in the future will be the standard of care instead of focusing on just a modality as the standard of care.
Heath Fletcher (28:37)
And on top of that, this device also allows for a ⁓ smoother and easier ⁓ biopsy process too, isn't that right?
David Georges (28:47)
Well, does. When
we've compared our breast CT guided biopsy to the standard stereotactic biopsy, and there's two types of biopsies, ultrasound guided and stereotactic. ⁓ Stereotactic biopsy is an x-ray emitting biopsy ⁓ device just like ours, except we do much less imaging. So we are now claiming that there is 50 to 60 % lower dose to do a breast CT biopsy than there is to do a stereotactic biopsy. wow.
And although the dose from both are relatively low, mean, dose is dose. We should all be conscious of what radiation dose we're putting the patient through. ⁓ And in our particular case, it just ended up to require less imaging. the accumulated average dose is significantly lower.
Heath Fletcher (29:34)
And again, less invasive.
David Georges (29:37)
Well, I think it's pretty much the same invasive procedure. mean, we are identifying the area of interest. We are localizing that area. We're harvesting samples. They're being sent off to the cytopathologist for interpretation. So ⁓ the process is very similar. It's just lower dose and it takes a little less time.
Heath Fletcher (30:01)
Okay, well those are two good things. Yeah, absolutely. ⁓ So I want to ask you about when you entered going back again to when you first started at Coining when you entered the the company, and of course you were at this pivotal point in business development, what did you how did you kind of take that role and lead that company? What and what
David Georges (30:02)
Yes, absolutely.
Heath Fletcher (30:28)
What did you lean on as a foundation, as a leader in Coney?
David Georges (30:33)
Well, I think understanding the industry ⁓ at a very finite level, the breast imaging industry, ⁓ finding that connectivity of moving a device into an environment that would resonate with the users, in particular the radiologist and the technologist and the facility managers. ⁓ It was a repeat of several other technologies that had launched.
But I think for the first time, this technology spoke at a much higher volume ⁓ to all stakeholders because of the feature set of no compression, true 3D imaging, low dose, ⁓ very easy on the patient, a very fast and efficient mechanism. I mean, it was in a situation where they said, which one attracts you the most? Is it the no compression? Well, if you're talking to the patient, obviously.
But if talking to the reading radiologist, was, do I have to spend any more time reading this than I do a mammogram? And do I have better comprehensive data than I do in a mammogram? And how do I generalize what will be the value proposition for my day and my routine, which are great questions. And now the most frequently asked question, once they get accustomed to the fact that breast CT is real, alive and well and available,
is AI ⁓ going to be available to help me interpret these data sets? And ⁓ of course, AI ⁓ is the buzzword of the decade. And frankly, I'm happy to report that we do use an AI algorithm to create our reprocessed images. And it's really helped in not only expediently, but effectively creating the image data set that gets sent to the radiologist. ⁓
Heath Fletcher (32:09)
and it's everywhere.
David Georges (32:28)
with some of that machine learning that's integrated into that reprocessing algorithm. On the other hand, as far as interpreting images, that will be a significant demand when the device is FDA cleared for asymptomatic screening. And that's when AI will fall into the mainstream for breast CT. And of course, we're working on that right now. So that when in...
when the indication for use is cleared by the FDA, shortly behind that, we will have an AI algorithm to help the radiologist take a look at images through the lens of AI, as well as through the human lens of the trained radiologist, and compare what do they see. ⁓ We think it'll be helpful. Yeah. And I think it's necessary when you look at the trajectory of what's going on in AI everywhere else in the energy. Absolutely.
Heath Fletcher (33:24)
⁓ Yeah, it's definitely taken the, well, it's taken everything by storm. ⁓ It doesn't matter what industry you're talking to, AI is playing a role somewhere in the line of ⁓ business and production. ⁓ What about ⁓ characteristics of yourself or in your leadership role? What do you find ⁓ is the most...
some of the most important aspects of guiding a company ⁓ through a stage of development like that or through any kind of ⁓ state of change and advancement.
David Georges (34:04)
Well, and I think the number one goal from my perspective was to create that commercial viability and to make sure that the device, we certainly knew the device was engineered extremely well. Then we had to reset and create a device that would fit into the world it was intended to serve. That was step one. And so some... ⁓
Heath Fletcher (34:19)
Mm.
David Georges (34:30)
additional engineering, some additional change, both cosmetics as well as in speed and size and power. All those things had to be changed to accommodate the part of the industry that it was going to be going into. So that was more or less job one. And then it was the grueling task of introduction to the industry, getting out into the industry and saying, we've gone through all of the
all of the things that we needed to. We've hit all of those strong points on development, on viability, on ⁓ service ⁓ uptime, on regulatory, all of the things that were done that said, okay, now let's go. Let's go talk to people. Let's go show our device. We got involved in industry conferences. We went out and communicated with those who have been involved in my career previously with previous technologies. ⁓
And it was, you know, a natural move in the right direction. And then of course, broadening your sales and distribution market and working on training those people that have touch points within the industry with administrations and with radiologists and facility managers to help them communicate the value of this technology. So you somewhat become a technical sales associate to people who are
communicating with facilities that want a deeper dive into the technology. ⁓ the sales training ⁓ that is very much a part of what I do on a daily basis to try to convey what I've learned in the development of this technology and how to consolidate that into a clear and concise presentation for those who would be interested in learning more. I think those are the key things that were part of my responsibility when I came into the company.
Heath Fletcher (36:25)
Mm-hmm and a heavy education component and is in this process, right?
David Georges (36:30)
Absolutely, yeah.
You have to take what you learn and then put it into an environment that is going to be presentable and that is backed up with ⁓ good references ⁓ to make the presentation credible. ⁓ You're announcing the fact that there's a technology that it's worthy of their time to take a look and become educated.
Heath Fletcher (36:55)
Yeah, I like what you said about, you know, really getting the radiologist to understand that it's important that they understand that this is a better way to do things. I mean, it's easy to say, oh, well, it's more comfortable and less time consuming and great. The end user will always want anything easier, simpler, less time consuming, anything like that, more comfortable, but to have them understand how much better the scan is and how much better they can do their job.
is probably quite critical.
David Georges (37:27)
And I think that's a key point because at the end of the day, our number one customer is the radiologist that's going to be sitting down and reading these images. It's their responsibility to understand what is the morphologic representation of an area of interest by comparison to what they were used to seeing in a mammogram machine or in an MRI machine. And this became key. And it's also the comparative that they need in order to gain the comfort.
they'll never gain the comfort from a publication or a brochure. They're going to, that's going to raise the awareness, but they're going to have to go through a fair amount of self discovery where once they see the images or go through the physician training and we're comparing it to the current state, which would be the mammogram or the MRI. And we show what is the variable between using breast CT and either of those other two modalities.
it becomes clear that there are some aha moments in that training that you can pick up and they'll go, now I see how you're doing this, or this is very interesting. I like what I see here ⁓ because the resolution and the ability to pick out abnormalities is very straightforward. Not that it's simple. I'm not underestimating the power of a radiologist to see things that people like you and I normally cannot see.
But they're quite talented in that regard. But am I able to provide the clarity that they demand and that they deserve to see? And I think that's going to come from them going through 25 or 50 sets of images, gaining that confidence level. ⁓ And we just have to be aware that that's what it's going to take and that there is no risk for them from a medical legal perspective.
there is something BreastCT would miss that a mammogram would not. That's something that we've proven over and over again, that at least you are going to get equivalence with a more comprehensive data set, if not superiority in many, many cases. And it also gives them a very simple platform to introduce the utilization of contrast-enhanced BreastCT, which is, I'm sure...
going to gain in popularity over the next many, years, I think that most comprehensive breast imaging centers will all be doing some form of contrast enhanced ⁓ x-ray based imaging, whether it be contrast enhanced mammography or contrast enhanced breast CT.
Heath Fletcher (39:59)
⁓ I think the word you said is confidence. That's critical, I think, for the radiologists and doctors to say, ⁓ yeah, I am confident in what I am seeing now. And if you can get them to that stage faster and with more clarity, obviously that's beneficial for them. ⁓
David Georges (40:11)
Yes.
parent
that we project that we understand that and and that brings us together with the user. Right. It is their eyes that are going to look at this image and it is their eyes that are going to judge if this image is suitable for their requirements and we just have to be patient and provide them with the data and give them the examples and then eventually they get into it and they begin to see it and they begin to adjust.
And it's not a big adjustment. We're using the same x-ray tube and a very similar detector that what we use in mammography, which means the presentation of breast tissue will be very similar to what they see in mammography, just a more comprehensive data set.
Heath Fletcher (41:05)
And once they see it, they can't unsee it. Once they see that, I'm sure once they see the difference, it's almost like there's no way of going back at that point.
David Georges (41:17)
We've heard that and I can't say that there's been a 100 % transition in any single breast imaging center in America yet. But I think we have a ways to go, but I can see that as we make these steps forward, that they're going to begin to gravitate more and more to the patients on breast CT than they will looking back and saying, you know, I'm kind of releasing my umbilical cord to the diagnostic mammogram.
because I so much appreciate what I'm seeing on the diagnostic breast CT. ⁓ I think that is just where we're at at the moment. And as more and more pick up on it, as more and more of them enter into our physician training environments, I think they're gonna come away with a better understanding and a better appreciation. But you know, that's very normal. When we went from full field digital mammography to digital breast tomosynthesis,
Most radiologists took a weekend course. They learned about what the difference is between MAMO and DBT. And we're in the position to have to do the exact same thing. And we're doing that now. And they're walking away after looking at about a hundred cases and they're going, I get it. I get it. This is really quite unique. I like the tools and I like the fact that I get to see one breast and I'm manipulating the image instead of manipulating the breast. Right. Yeah. So it makes a great
Heath Fletcher (42:39)
That's a critical definition, a description that I haven't heard actually. yeah, that makes it very, I mean, only people who actually have been through the physical process understand what you mean by that. But now that you explained it, it's like, ⁓ I see that. Yeah. Okay. That's interesting. I mean, even the mammogram probably had resistance when they first brought it on board and someone brought that machine.
David Georges (43:00)
It did.
I will tell you that I was there at the beginning, with xerography moving to film screen mammography and digital mammography. ⁓ It was very interesting watching the transitionary, the bell curve of acceptance. ⁓ And it happened in each and every one of them and it will continue to happen. It's a natural occurrence with ⁓ anybody that's moving from
being expert at one technology to moving over to a new and innovative technology.
Heath Fletcher (43:34)
Right. So
interesting for you to have been part of that, that transformation over the last few decades to be where you're at today. And now bringing this, this completely new technology to that space must be pretty, ⁓ I must feel pretty good.
David Georges (43:53)
Well, it's exciting, but all of the transitions I've gone through are exciting because they're moving the science one step closer to being better and better. ⁓ And that's what keeps us moving. That's what keeps driving this is that if it does become better, if it does produce better outcomes, if it creates new efficiencies, then you're winning step by step. And that's why the scientists are working so hard at moving technology forward.
And it's never moved forward at a more ⁓ rapid pace than it is right now. ⁓
Heath Fletcher (44:27)
pace is moving so fast. And so the other sciences too. Is that your advice to people who are, you know, entering, you know, the industry, ⁓ not necessarily specifically breast imaging, but into healthcare or tech or bio, you know, when they're stepping out of school and looking at where to, where to set their sights on, what would you advise someone moving in or maybe even changing careers right now as to how to, ⁓
were to how to guide themselves.
David Georges (44:58)
Yeah, I think that ⁓ if we break it down into a couple of components, one would be the engineering side. If they had an interest in engineering, whether it was software engineering or hardware engineering, you know, it really doesn't matter. ⁓ There is a need for good, fresh engineering ⁓ view of the world. And, you know, we've hired several young engineers from Georgia Tech University. We're near Atlanta, near the campus of Georgia Tech.
And these young engineers come in with a fresh mind and a clear outlook. ⁓ They have no boundaries. They're very hard workers and they see, they see the science, they see the engineering challenges and they dive in and make it happen. mean, everything from people coming to us that already understand how to operate a 3D printer. Right. You know, how to create a hardware interface that is ⁓ exceptional in
assisting the device to move forward. And of course, software, it's always about the software. So from an engineering component, there will be no lack of requirement to continue to look to good engineering minds that want to build up a career in medicine, in science and medicine. If from the administration side, if you were looking at the distribution and sales,
Well, my gosh, I mean, between AI and new imaging modalities, the list is almost endless. And if you were interested in representing products or in the medical industry, ⁓ absolutely, you would be doing yourself a great favor to take a look at what's up and coming and what is the sales process? What experience do you need? What skill sets do you need in order to take the message?
from the engineers and the science lab into the end user. You are that conduit. And it requires a certain amount of intellect. It requires a certain amount of understanding on both ends of the spectrum. And if you can do that, you will be extremely successful in presenting these products. So ⁓ yeah, I think the opportunity is extraordinary, quite frankly. And I think it's going to continue to grow.
Heath Fletcher (47:17)
How about mentorship? Did you tap into mentorship over the years as in your career?
David Georges (47:21)
Well, ⁓ I think from a standpoint of training technology to the representatives has always been something that I've been greatly interested in. think I've done a fairly decent job of bringing technology into the ⁓ sales and distribution world. So mentoring these people that are either, their careers are evolving around imaging or they are new to that field.
This is still brand new technology. It still has to have an understanding of what makes this technology unique by comparison to what is in use today. So yeah, think mentoring, ⁓ we've got some great engineering mentors within our group. ⁓ I think that myself and a couple of folks also that I work with on a daily basis are great mentors through our distribution and sales environment. I think that making sure that they understand the technology.
that they're accurate in their claims and presentations will always be accepted and appreciated by those that they're speaking to, whether it's administration, whether it's clinical or the physicians. ⁓ I think that, you know, we've come into a world where you don't know whether or not you believe what you see on social media or not. And we do need to make sure that when we have the ability to communicate with people that we are
very accurate and that we have very ⁓ understanding of where their current world is. And if you can gain agreement that their current world has certain limitations and that your device can help remove some of those limitations, ⁓ you probably have a person that is going to answer the question by simply saying, well, tell me more. And isn't that running where we want to be? Just tell me.
Heath Fletcher (49:12)
That's
where we want to be. Tell me more. exactly. Now, ⁓ one last thing I want to ask you about, about the device is that there is a social component in the sense that this is device is can also be mobilized. Yes. So a mobile unit that could be taken to remote areas, ⁓ maybe underdeveloped countries and create that accessibility that right now doesn't exist.
David Georges (49:42)
There are methods in place today where mobile mammography has been very, very popular. so in so doing, the question became, would you be able to adapt breast CT to the same mobile environment? And the answer is yes, we have done so. We have ⁓ four different mobile configurations, ⁓ three of which are on the road.
⁓ being utilized for corporate scan days or for demonstrations to facility, larger facilities that have a large cohort of people involved in making decisions. ⁓ It's been phenomenally successful to demonstrate and to also scan. So, Koning owns a mobile unit that we lend out frequently.
⁓ and then there are private centers that have mobile units that are deploying them throughout their geography. So it is very mobile and it is standing, ⁓ the rigors of being mobile very well. I mean, it's, it's a very robust piece of equipment and it will stand. As a matter of fact, recently we have been working with the government in Manitoba to have a mobile unit to reach out into.
the ⁓ into the Native American population where the medical facilities are few and far between. And especially in that region. I think that we're looking at doing something with them ⁓ in 2026. ⁓ And that will set a stage for, you know, replica.
Heath Fletcher (51:12)
Very few.
When you said corporate, you said like bringing down location for a corporate. So what does that?
David Georges (51:36)
Well,
did a, the larger industrial groups are oftentimes self-insured ⁓ and they'll have a consolidator or an underwriter that is helping them with their employee insurance benefits. And they have become very focused in warding off ⁓ sickness and warding off diseases. And they'll have testing labs.
in ⁓ the assembly facilities or in the industrial complex that they're in. And they give their employees an opportunity to go in and get ⁓ a test of some kind ⁓ and to make sure that they stay current in any of their basic healthcare ⁓ needs. the driver of that was if they stay healthy, they stay involved in their employment and they help their employer by doing their job. So ⁓ one of our ⁓
Heath Fletcher (52:06)
⁓ interesting.
David Georges (52:31)
partnerships that we have, ⁓ wanted to do a scan day and they wanted to do it at their assembly plant. So we drove our mobile van into their parking lot and they had their employees who were over 40 sign up to come in and be scanned under the guise of their medical environment. And ⁓ we were able to scan 60 patients in a day ⁓ within about a six hour day. And it worked out beautifully.
We've been invited back a couple of times. Wow. Yeah. And they drive this as a benefit. we were thrilled because in that day, that was 60 women who never knew what a breast CT was. And now they do. And they've said, my gosh, I'll never do anything else. And I will make sure I get this done routinely.
Heath Fletcher (53:03)
That's incredible.
There's the shift. In ⁓ six hours you had 60 people that shifted their whole perspective on experience that they didn't know that there was another way to do it.
David Georges (53:34)
Frankly,
those were patients who typically don't take the time to obtain their annual recommended ⁓ exam, regardless of what the exam is. In this case, it just happened to be a breast exam.
Heath Fletcher (53:50)
incredible. Wow.
Wow. We could talk forever about this stuff. This is really exciting. I'm excited for you. I'm excited for coning and ⁓ yeah. Do you have any ⁓ last thoughts or ⁓ or nuggets for for anybody out there or something we didn't cover that you'd like to mention?
David Georges (54:08)
Well, I think that our next big challenge is working with the early adopters to communicate with their payer representatives so that the payer of insurances can understand that we are at a bit of a transition period. Payers are suffering with low compliance, which means they are going to be paying for treatment at later stages.
when the outcomes are worse and when the costs are multiple times higher. The American Cancer Society in October of 24 published the difference in the cost of treatment between a stage one, two, three and four of breast cancer treatment. And the difference between treating a stage one and the difference in treating a stage four, 37 times higher to treat a stage four and the outcomes are worse.
So they're paying more money, they're getting worse outcomes. And that simply would tell you, if you were looking at that from a healthcare economics lens, you would say, then what it means is we should be driving earlier and earlier detection. Because I don't think that we have found a cure for breast cancer yet. However, if we can find the breast cancer at the earliest stage, even stage one, which is a difficult task, but can be done with proper interrogation and proper exams.
then the cost of treatment and the outcome is significantly better. Essentially, everybody wins. The payer wins, the patient wins, the provider of services is going to win. ⁓ It's one of the few things I've found in medicine where everybody benefits. I think it's now just a matter of continuing to push the level of awareness and how to integrate this.
if the insurance industry will begin to watch carefully and understand what's going on. And by the way, I've had some wonderful conversations with chief medical officers and CEOs of some of the large private payer plans throughout various states. ⁓ They're beginning to get it. They're beginning to understand that this is something that is gonna benefit them. It's not just adding another exam. It's actually going to replace several exams.
So on the onset, it could be a big cost savings, but at the back end is when they're going to get their real savings.
Heath Fletcher (56:34)
Very exciting. Very exciting. Well, congratulations. The road ahead ⁓ is not paved with gold at the moment, but you guys are on the way to changing that industry immensely. Yeah. Yeah. If people want to reach out and connect and find more about this, where should they go, David?
David Georges (56:37)
I think so too.
Well, we hope so. That's the goal.
CorningHealth.com.
Heath Fletcher (57:02)
Okay. And you're on link. Yeah. ⁓ thank you for your time today. I really appreciate you sharing your story and, ⁓ talking about what Coney is doing. This device is, is, is going to make, it's going to make people's lives a lot better. So thank you for sharing your time with me today. I really appreciate that.
David Georges (57:04)
website. ⁓
Thank
you, Heath. My pleasure. Thank you. Take care.
Heath Fletcher (57:23)
Alright, we'll talk again soon, I hope.
Such a privilege to be able to chat with David today. I ⁓ feel very inspired coming from that conversation about his career and how you can tell how invested and how much knowledge he has after decades of being in a particular industry and having seen so many transitions and changes and innovations and ⁓ disruptions over the decades in his career.
in the breast imaging ⁓ industry and to be part of a company that is bringing to the marketplace a brand new device and to be part of something that is going to make such an impact on women and how they not only perceive but actually experience the process of a breast examination and if to be able to ⁓ prevent
further advancement of the disease and to have early detection is an incredible, is an incredible accomplishment. So very excited for Koning Health and what is coming for them and for all women who have now an option moving forward. So thank you for listening. It was a great episode and I hope you come back. Stay healthy and we'll talk again soon.