Martin Burns, the CEO of Bruin Biometrics in Los Angeles California, talks about a scanner that can detect bedsores, or pressures ulcers, before people can even see them.
Interview conducted by Ivanhoe Broadcast News in October 2016.
Why are you doing what you are doing?
Burns: It’s a real labor of love, it’s a labor of science, it’s the labor of really having the patient interest at heart. The reason we do this is because we spotted that in the medical industry there are conditions that patients develop that are very avoidable if you can detect them early. You hear that argument with cancer all the time. But, we’ve taken a series of disease states that have very deficient diagnostics standards. I think about bedsores, otherwise known as pressure ulcers, diabetic foot ulcers, osteoarthritis, the early stages of osteoarthritis, the early stages of deterioration of artificial hip and knee implants; and what we thought is there has to be a way of trying to solve these really big problems through the use of this technology. If we could provide a better diagnostic to clinicians, better meaning more certain and earlier, then what can happen is the clinicians can intervene on those patients and avoid the traditional trajectory of the disease state. Sure enough, what we found is when you take this into clinical practice, we discovered that pressure ulcers, in most cases, are perfectly avoidable. By intervening early on the right patient, you keep the skin intact.
How does that work?
Burns: It’s a fascinating piece of equipment. The way it works is just great. Think about the last time you hit your hand with a hammer. The very first thing that happens is the tissue inflames, it gets swollen which is referred to as the inflammatory response. With all our technologies we have to start with an understanding of the fundamental biology and the understanding of the physiology. The pressure ulcer is a wound. All wounds go through the inflammatory phase. This great information in the inflammatory phase can be measured by the SEM Scanner. The idea here is that when your tissue swells up in the presence of an injury you get moisture and what we try and do is we measure that moisture over the areas where you are developing a pressure ulcer. The way it works, is the lower sensor at the end here, this is actually derived from Sensor technology that came off of the Mars Rover. The higher the amounts of moisture at the area underneath the skin, the higher the value; the lower amounts of moisture, the lower the value. What happens is you take readings very, very fast the device I’ll use it on my hand here and the device will take a reading in less than a second and we’ll see the numerical value on there. That’s a very low number. During our clinical trial, we’ve taken a series of readings over sites at risk for developing an ulcer. We can give you a calculation that would say that patient has tissue that’s comprised and this patient is perfectly healthy. The advantage is massive. Because what we are able to do is even with tissue that’s not reddened at the skin surface and visually damaged, what we can do with the SEM Scanner is we can give clinicians about four days’ lead time of the presence of damage. So, if damage occurs on any skin surface, we can’t see it, but this scanner can.
When it happens early enough that you can turn the patient, reposition the patient, that’s what the person at the nursing home would do?
Burns: Absolutely, you have the whole clinical goal in all of this is to keep the skin intact. So the interventions are designed around keeping the skin intact. The most common one is the one you have already pointed out which, what is called pressure relief. You are trying to alleviate the pressure. The way you do that is you obviously get the patient to turn around enough to heal. You get the patient off the particular area, which is the lower part of the back and you rotate them over and you do that with a degree of frequency that allows the patient tissue to recover. What happens is the blood circulates in the area again and brings oxygen with it and allows the tissue to rejuvenate.
Is it just in the UK that you said that it’s approved?
Burns: Actually, it’s approved for use in the European Union and Canada. The UK, Ireland, Canada, Spain and Portugal are the markets we are in currently. We are looking at other areas to expand.
What kind of impact has it made there, how long has it been there?
Burns: Let me pick the UK as the example because that’s where we have been in the market the most. In the UK there’s data that just came out from several thousand patients scanned that we have data for; way more patients have been scanned where we don’t have data for but that’s okay, we’ve picked up all the data that we can for patients who have been scanned and what we found is in the aggregate that care settings that used the scanner as part of their overall care protocol managed to get their incidence right and in other words the number of new pressure ulcers that developed within their care setting down to less than one percent; and in often cases close to zero or zero. Multiple places actually got a zero rate of pressure ulcers when they deploy the scanner into the care; phenomenal results.
Without it, how frequent is the problem?
Burns: In each of those care settings, they reported individual rates of incidence anywhere from three to twelve percent, so it’s a very dramatic difference. Now, I would just qualify this by saying the SEM Scanner is only one part of the solution. We are trying to give nurses the information that they need to be more effective. They are being effective already today, but with this information acting on data that says that a patient has damage and you can’t see it, so act on it now. It gives them tremendous power, tremendous power, and when they act on it, it gives them the most tremendous power that nurses achieve when they use it.
Here in the US?
Burns: Yes, it’s a familiar process to those in the medical technology areas. Those outside of it look at it and think, what is this process? The Food and Drug Administration allows us to market the product within the US. We have a very collaborative relationship with the FDA, meaning that we actually go and solicit their advice about how we should design trials, what kind of data they need, how we meet their regulations and then we follow that incredibly closely. We have done that now very consistently for the last number of years and I’m really pleased to say that we are in the final trial and we just hit our point where we just can do what’s referred to as in-term analysis, meaning we got about half way through the trial, we can analyze the data and look at the quality of the results. If the results are what we expect them to be, we will file with the FDA soon.
What’s the future? What’s the marketing? How do you do that?
Burns: As you can imagine, we are a technology-driven company so we don’t stop with just this. We’ve already got next generations of this SEM Scanner lined up in terms of additional features we want to add on to it. It’s also not just about the product, it’s about the effect you can have, the impact you can have in clinical practice. Our goal is not to just deliver the technology but actually to help healthcare systems take cost out of their overall cost system. What that means is that when you think about what’s happening to our healthcare planners today, we are all getting our announcements about five, ten, fifteen hundred percent increases in those plan costs. There’s a huge burden about other healthcare, what we want to try and do and we have demonstrated that you can actually do this is to take very substantial cost out of the system. Let me give you an example. Pressure ulcers cost us in the US, including Medicare and Medicaid, an estimated $11 to $15 billion a year. About 60,000 Americans die each year from complications due to pressure ulcers. Nearly three million patients in the US get pressure ulcers every year. With the test results we have had in the UK, where you are getting incidence rates down to below one percent, what we are finding is we are actually able to genuinely save money, have fewer beds being ordered, have fewer dressings being used, and have fewer antimicrobials being demanded because you are keeping the skin intact. Then, it’s wonderful for nurses. This releases their time back into other types of practice away from treating the pressure ulcer which is what they are doing today. It’s a huge release of nursing time back into the system again for them to look at patients differently. So it’s a wonderful solution.
You’ll be able to take one home?
Burns: Yes, ultimately, we actually want to be able to have people to take it home, because patients are increasingly are being cared for at home now. The reality is that we are focusing on acute care. So, you think of the general hospital, long term acute care settings, the unskilled nursing facilities and then, of course, nursing homes. With those settings covered, we will substantially cover the broadest and biggest part of the pressure ulcer problem.
What will that cost?
Burns: The SEM Scanner is referred to as a cost-saving device. What we found is that within about seventeen days of deployment, the device pays for itself, and then you get cost release back again, this cost saving. Think about it as if you have a wound care budget and our argument is, don’t spend it. Just keep it and release it back into some other use. That doesn’t mean it’s free but it’s very nearly free. The way we price this is on a per-patient-per-day basis. In the UK, it works out to £1 per-person-per-day. In the US, it’s about $1.20 per-patient-per-day.
Where did you get the technology?
Burns: We have been extremely fortunate through the development of all our devices and have a tremendous relationship with UCLA. Our relationship expanded into two sides of the campus. On the one hand, into the Davis Geffen School of Medicine and the School of Nursing. The SEM Scanner, for example, was developed by Professor Barbara Bates-Jensen, who literally wrote the book on wound care, which all the nurses around the country are taught about wound care. Once she found that there’s no reliable technology to be able to measure changes in tissue damage, she went to the School of Engineering and specifically, the Weiner’s Health Institute. She said, “Look, can you build me something please?” Professor William Kaiser and his colleague Professor Majid Sarrafzadeh jumped at the chance. They have this kind of tremendous history. Kaiser, for example, worked at the Jet Propulsion Laboratory and for the Ford Motor Company. Automotive, aeronautics, and space exploration experience that he could apply to the world of medicine. He took some of the thinking from the Mars Rover, which is the one that’s still running around on Mars at the moment; functioning wonderfully. He applied it to medicine. So, what you are finding is that here on this device, its capacity sensor has at least a portion of its origin from that work. Another BBI device, the OrthoSonos, has some of its origin from the aeronautics industries. The sensors on this listen to the sound of, in our case, knees and hip joints. In the aeronautics industry, anybody flying a Boeing 787 at the moment, those sensors are sitting on the 787 listening to the sound of the fuselage to determine whether the airplane is properly structural intact.
Very cool, that’s very cool. Okay. Before I forget, what does SEM stand for?
Burns: Yes, SEM, is Sub Epidermal Moisture. Sub-epidermal meaning being underneath the skin, and moisture that comes with the inflammatory response. A bedsore, otherwise, known as a pressure ulcer brings injuries to the skin and the tissue. At the earliest stages, it just presents as redness on the skin surface. I don’t want to trivialize that because the reality is that underneath the skin surface, it’s damaged and deteriorating. From there, they get worse. I’m sure you have heard about Christopher Reeves. The actor that played Superman died from complications from the stage four-pressure ulcer. Within the US, there are four main categories of ulcers and then two others. The four main categories go from stage one which is intact with red skin, to stage four, which without being gruesome, I’ve seen these on patients and it’s the type of injury that you can actually see all the way down through the skin, the tissue, the fat, the muscle, all the way to the bone and they are gruesome. Only about half the patients with them recover. The typical treatment is skin grafting, which is both painful, expensive and often times doesn’t work and it’s quite temporary. The worst part about it is it’s a major source of local infections and then systemic infections, a form of sepsis.
All right, all right.
END OF INTERVIEW
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