Embedded Connected Wound Care Technology

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Pretika MedTech delivers Connected Wound Care technology - a non-invasive, imaging device embedded within wound dressings with wireless enabled connectivity directly into the EHR patient record system for clinicians to monitor the healing process of acute and chronic wounds remotely without having to remove the surgical dressings, bandages, wraps or casts. If wound healing complications go undetected, they can lead to serious infections, delayed healing, amputations and even death in severe cases. This technology allows clinicians to capture complications before they become serious.

Transcript:

Paul Kim, DPM, MS, FACFAS:
Welcome everyone to SAWC Tech Spotlight. I'm really delighted to be here with Thomas Nichols from Pretika MedTech. They have a very novel and interesting technology I think everybody will be interested in. So, Thomas, tell us a little bit about your company before we get into showing everybody this really cool thing. Tell us about how your company evolved and where you are right now.

Thomas Nichols:
It evolved from October of 2019 receiving patent allowances from the USPTO with connected technologies. And in mid-2020, we looked at how can we take this patented technology and reposition it into the medical category. And what stood out was the area of wound care. And the ability to bring not just gauze and adhesives and dressings and cast material, it's to bring the technology to allow clinicians to monitor within that, a device that's embedded to provide clinicians with the healing process of the wound.

Dr. Kim:
So, Thomas, you've been kind of teasing us. Let's see it. Let's see what you guys got. 

Nichols:
So, it's connected wound care technology. It comprises a full spectrum of LED lights,
a B plus polarization, anti-glare film, plus the camera technology and the lens technology to capture images up to 8 cm with a single lens, and adding an array of lenses we can go much wider in terms of the field of view for clinicians to monitor much larger wounds.

Dr. Kim:
Well, let's talk about that monitoring. What is it actually monitoring? It's not just taking photos, is it? 

Nichols:
The first phase 1 version is focused on just the images. And so it's allowing clinicians to see what's underneath the dressings without having to see the patient or send out outpatient nursing teams to where the patient is. And hidden within those dressings are some very serious issues. And if complications go undetected, there can be some serious complications. 

Dr. Kim:
So, I want to just unravel that a little bit, because you just talked about a lot of really interesting things that I want to discuss and address. One of the things is this idea of remote monitoring, and that's what this really is catered towards, which we have now begun to understand is really the future. I mean, it is the future, not only the wound care space and many other disciplines as well. And we learned our lesson during COVID as well. That's one of the examples where patients just couldn't come in and they weren't allowed to come in. But there was no real way to monitor them in real time. And we had some disasters come back, you know, when our doors opened again and we learned a valuable lesson. 

The wound photography piece that you talked about. That gives you 1 piece of information. You say that right now that's where your company is kind of focused on. What other things are you going to embed into a device like this so we can better closely monitor our patients? 

Nichols:
So, with that question, I'd like to just point out where we are from a sustainable and scalable patent standpoint, because we are scalable not only where we are with our first phase, but it's the additional phase 2 that will provide curative properties. For example, placing UVC illumination lights within the device technology. So, as the clinicians are monitoring it, if they're seeing infections, they can turn that on remotely. That's amazing. We also have therapeutic and diagnostic technologies that are going to follow. 

Dr. Kim:
It seems to me that with all of the, I mean, that's incredible what you just said. I think it has far-reaching implications. But right now we see a device that's relatively small. When you start integrating all that technology into a single platform, doesn't it make it kind of bulky?

Nichols:
Well, we're finding with the technologies in cameras, within Wi-Fi antennas and the Bluetooth technology needed, the size of batteries and the PCB required for programming,
for example, the frequency of how often clinicians want to see images, and also the ability to go in in real time and wake up the system and look, it is getting much smaller. So, what we'll be launching in phase 1, by phase 2, it'll be even much smaller even with the addition of these new technologies. 

Dr. Kim:
So, I guess we should have talked about this a little bit earlier, but is this currently available to be placed on patients now? 

Nichols:
We are currently in the adoption phase. Where we've de-risked in terms of IP, we have completed 2 track ones and have successfully received 17 allowances from the USPTO with the device side and the computer-related side, which deals with the cloud, the technology in the software and the cloud, and our ability to get right into the EHR patient record. Each device is synced to that patient's MRN number. And from there, we can send the images right into, through the Epic and Cerners of the world, into that specific patient's record in the EHR, so clinicians can monitor it.

Dr. Kim:
Okay, so just to be clear, it is available. It is being used. 

Nichols:
We're doing adoption studies in hospitals, and leading clinicians, because from the FDA, they've put us in a class 2 product code under LLZ, which is radiology. So, we're in the same class as MRI and CAT scans, and yet we're a noninvasive device that's placed above the wound, and it's embedded within the wound care dressings.

Dr. Kim:
So, let's talk about that, and you've mentioned that a couple of times as well. So, just talk me through this. So, you see a wound, and do you apply this first and then the dressings? How does that work?

Nichols:
That's really the chronology. The wound is, surgery's completed, so it can be placed on right after post-op. And then from there, it's raised above this wound area utilizing medical grade foam. 

Dr. Kim:
So, there's a platform, and then you apply the device over the top. 

Nichols:
And the platform has the ability to be contouring to the area from neuro to orthopedic.
Really covers a broad range. 

Dr. Kim:
And this looks like a little bit like a Tegaderm kind of dressing, is that right? And you mentioned after the surgery, and so it's only available for post-surgical patients?

Nichols:
No, because when you're getting the patient ready to go home, the nursing teams can program it, embed it within the overall dressings, and release the patient. And one of the assets of this particular technology is it allows clinicians and nursing teams to release the patient earlier, because they can begin the monitoring process right away.

Dr. Kim:
So, this is after a patient's been admitted to the hospital, had surgery. What about in the outpatient clinic space? I can't see why this can't be used for just monitoring of chronic wounds.

Nichols:
It absolutely can be. When you look at the technology, you have a built-in Wi-Fi antenna. So, with an inpatient in the hospital setting, we utilize Wi-Fi technology to communicate through that hospital's IT to get that information right into that patient's MRN, their record. But when the patient is released, we utilize a Bluetooth technology that is called mHealth, or mobile health, which is an FDA-cleared wireless platform that the major wireless carriers have all been approved so that we can embed a SIM card within that patient's smartphone, and it will send the information from the device right into their smartphone and right into the wireless network that's private and cleared by the FDA for privacy and cyber security. 

Dr. Kim:
So, it goes into cyberspace, then goes back to your local EMR program, is that right? 

Nichols:
It's the cloud. So everything takes place in the cloud.

Dr. Kim:
Right, but does it go back into the local servers of the facility, hospital, private practice?  Like for example, if I were to integrate this into my practice we use Epic EMR. So, it somehow talks to my EMR and lets me know, it gives an alert or so there's some change that has happened, and then I can then react to that. Is that right? 

Nichols:
That is correct, and the device can be programmed to send a frequency of the images based upon the type of wound or surgery. It sends it right into the cloud where the cloud platform is so important, because here we're utilizing machine learning, because clinicians and their schedules, very busy, and so even though they program the device to send the images up or they go in in real time to look, what is there available time to do that in the course of monitoring? So, we've developed an alert system that's included in our patent that allows us to incorporate an API database of software of anomalies.

Dr. Kim:
I see. So, if something changes, then it can automatically detect an alert. 

Nichols:
And send that alert to the clinician. So, now they have an additional failsafe mechanism.

Dr. Kim:
Do you think that the future then is that alert's not necessary, it will self-adjust? It'll say, "Something wrong, I'm to fix it.” Do you think that's where you're going with your technology?

Nichols:
That's the diagnostic and therapeutic side. So, that's the incredible asset to digital health, how it's changing and evolving. It's all about the hospital at home. And it's allowing clinicians and hospitals to treat more patients on a remote basis. And when we look at the use inpatient in hospital, we see about 20%. So, the bulk of this technology and how it's going to benefit the digital health and digital care space is on the outpatient monitoring side. 

Dr. Kim:
Absolutely. And that's so critical because I want to say just in my experience, the disasters happen when patients are at home. They don't happen while the patient's in the hospital. This isn't happening. It happens when they're home. And then they come into the clinic, for example, outpatient clinic or through the ED and you uncover the disaster. And I think that this would be a nice fit to ensure that the patients getting assessed in real time and being monitored, although not overly monitored, because as you know, physicians and nurses are very busy and we don't have, to getting hundreds of alerts doesn't make sense to us, because then we just, we will just block it out and won't respond.

I think it fits a really nice area of virtual remote monitoring medicine that is the future. There's just not enough space in the hospitals and clinics. Patients are too old and they're too sick. So, keep them at home, closely monitor, adjust treatment plans remotely, makes total sense. And I think that is the future. 

In your mind, as your company continues to evolve, and I know you're at multiple stages and you're early on right now, where do you see ultimately, what is the goal for your company? I mean, what is your target? 

Nichols:
So, it's an expansive category, digital health, and so how we implement it and use it to benefit the patients, to provide more information to the clinicians, lowering the negative outcomes, and more importantly, really making an incredible savings to the healthcare system is where our focus is on. And so this technology, we've really found a white space within remote patient monitoring. And when we approach the FDA, they said to us, we have not seen a device of this nature. We approach them from a de novo standpoint. And yet here they place this into a class 2, into radiology, and one of the benefits to this is that within radiology, there are multiple codes, not just the device and its usability, but the time used to read the film or the images, the time to, as you spoke, to have the telecommunication with that patient. And then there's also new streams of revenue for hospitals and clinicians in this technology. So, it's a great fit, and it's just the start of an incredible pathway for digital health and remote patient monitoring. 

Dr. Kim:
Well, I'm very excited for you and your company, Thomas, and I appreciate you being on today. If you want more information, please go to their website, pretikamedtech.com. Is that right? 

Nichols:
Correct. 

Dr. Kim:
All right. Thank you very much.