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Oby: From the campus of Harvard Medical School, this is ThinkResearch, a podcast devoted to the stories behind clinical research. I'm Oby, your host. ThinkResearch is brought to you by Harvard Catalyst, Harvard University's Clinical and Translational Science Center, and by NCATS, the National Center for Advancing Translational Sciences.

Foot ulcers are a common complication for diabetics, leading to chronic wounds, amputation, and in some cases death. Today we are joined by Dr. Wendy Slone, CEO and Founder of bTECH, and a recent course participant of the 2022 Harvard Catalyst course Transforming Care with Emerging Novel Devices. Dr. Slone talks with us about her novel wound care technology, the Halcyon SMART Patch, and provides valuable insight into building a medtech business.

Hi, Dr. Sloan. Welcome to the show.

Wendy Slone: Thank you.

Oby: So you are currently the founder and CEO of bTECH, but you have a very diverse and winding career path. Can you walk us through how you found your way to bTECH?

Wendy Slone: Yeah, sure. So my mom was a diabetic, and I saw her develop a diabetic foot ulcer because she unfortunately broke her ankle. You know how when you run water in your backyard when you're doing your grass and things like that? We have a little tiny hill on the back of our back door to come in, and the water was draining off from that and it made it slick. And so she fell and broke her leg.

And so we was like, OK. OK. And they put a little pin in in order to stabilize where the break was and they told her to wear this boot. And so she did all of that, and they told her to keep the boot on. That boot being on and the pressure of it caused her to get a pressure ulcer.

And that pressure ulcer, what people don't realize is that they go deep. So by the time they're on the surface, they're really deep, deep beneath the surface of the skin. And that's what happened to my mom.

And she ended up having an ulcer, that first one, that took us about two years to close. And when it closed, it still was always unstable in my mind because you could touch it and you could feel like, ooh. Something-- ooh, ooh-- it's going down underneath it. Eventually it closed again because it opened up again, and she had the unfortunate incident of breaking the other leg.

Oby: Oh, goodness.

Wendy Slone: And so it was the same kind of break, the same kind of scenario. And she ended up going into a nursing home to have them deal with it. Long story short, between those two wounds she had lost the first leg. And then within a year and a half, she lost the other leg. So within a span of three years, she lost both of her legs.

I really saw in that journey how we haven't changed how we treat chronic wounds. We haven't changed how we manage wounds. And we're still using the same thing. You know, gauze, something wet on it, some kind of gel, but it's still the same process. And I said, oh my gosh. There's got to be something else out here.

So I started looking around at light therapies. That's just the geek in me. I've always liked research. I said, let me get out here and look and see what's out here.

I was fascinated. And I said, oh, I could do something with that. But I don't want to build another laser. There's many lasers out here. People are all building them. What can I do to unplug, take the battery out, give people back their freedom of mobility?

A patch. I was like, that's brilliant, Wendy! A patch. And I think it's brilliant because I saw my mother when she had to go through negative pressure and she had to go through all of these other things, it really impacted her ability to go places, do things. So my mom became homebound. It really changed the quality of her life and her social ability to connect with other people. And I'm like, it's got to be something there.

So really in developing the Halcyon SMART Patch, my thought was, we need a device that is user-friendly because again, with diabetes a lot of times the comorbidity is people being overweight. And some people unfortunately don't have human capital, so they don't have somebody that can come in and wrap and re-wrap and gel and whatever these wounds. They need something that they can just slap on anywhere and work for them.

And that was the birth of the Halcyon SMART Patch, something that was using light therapies embedded onto a patch that works and functions similar to how you use an Icy Hot patch, how you embed that lidocaine onto that patch. And then you can slap it on to wherever you've got this pain at. It's a similar process.

Oby: Thank you for walking us through that and being willing to share what the beginning of this story was and a little bit about your company and the Halcyon SMART Patch. Can you give us a little bit more information about how the patch works?

Wendy Slone: Yeah. So you know, diabetics in particular suffer with poor circulation. And poor circulation totally impacts the supply of oxygen and ultimately the nutrients that go to the tissue. And that's the bedrock of a wound closing is that oxygen, which allows the skin to say, you know what? Don't die, don't go into apoptosis, but instead let's go into a growth cycle. Let's repair ourselves. And it needs those nutrients in order to do that.

If you don't have that, you've got poor circulation, you're increasing the risk of that wound becoming chronic. And so the availability of that oxygen to the cells and the wound area and the presence of that adequate blood flow are so important to the healing process because that's what tells the body to lay down extracellular matrix.

And so the oxygen plays a critical role in helping to reduce the inflammation so that you get a good inflammation response and not the bad inflammation response. And when I mean bad, meaning just taking it to the place where I'm just angry in the wound and I just need to continue to die, die, die.

But there is a good happy medium place of inflammation that a wound needs. And so that comes with good proper oxygen and nutrient supply. And that's what forms that collagen and helps with the growth of new capillaries.

Now with our product, what we focus on is doing all of that, increasing that oxygen, which is a big term of microcirculation. And so microcirculation has its root in the dermis of the skin because that's where all of the blood vessels and capillaries are. But when you've got poor circulation, that microcirculation also becomes impaired and you get a deficiency of nitric oxide.

So what our device does is it helps to increase and enhance that microcirculation. And by doing that, it helps to increase the production and flow of that nitric oxide.

So let me just park here and say this. Nitric oxide is just a strong vasodilator, so it helps to open up those capillaries, those blood vessels that are found in the dermis layer, which actually sit about 1.5 inches beneath the surface of the skin.

So we use far infrared wavelengths because far infrared wavelengths have the ability to penetrate deeper into the tissue of the skin. And it gets down to that level of where your microcirculation system resides.

And so this energy of this far infrared is ultimately transformed into a gentle, radiant heat. Well, why is that important? Because your body needs a small heat stressor in order to kickstart that mitotic function, saying, don't go into apoptosis meaning cell death, but instead go into cell repair.

And so with this little energy jolt, it helps the body say, oh, I've got something that I need, this little stressor, and now I can kick over into mitosis. And we're all familiar with mitosis from sixth grade biology and on, right?

Oby: [laughs]

Wendy Slone: And so if you just dig back a little bit-- I had to dig back too. I'm like, oh, yeah, this is the mitotic cycle. That's all we're doing. So when I say that this product works at the cellular level, I literally mean that because it actually kicks that ATP up out of the mitochondria, kicks it into a cycle which says, oh, let's produce some nitric oxide, and then we're off and running with the increased microcirculation.

Because microcirculation is a function of the cardiovascular system, by increasing that microcirculation in the body you get a full systemic effect. So it doesn't really have to have the device, our patch, right on the bed of the wound because of that. And so it's going to help increase that circulation throughout the entire body.

But more importantly, because we use this biopolymer nano matrix proprietary product that's our patch itself, it helps to direct that healing process, that natural healing process that we help kickstart down to that wound bed, giving you this effect of healing that wound from the inside out. And so this is why our product can be placed anywhere on the body to promote healing because of that low-level amount of far infrared wavelengths.

Now let me just say this because people often ask me this. Well, is the patch itself-- does it heat up? Does it heat the body up? No, because low radiant heat-- it's like if you go from an ice, from a solid to a liquid to a gas. It's the same principle with energy. It goes from one form to another.

And so our patch, once you apply it to the skin, it helps the body to transform that far infrared wavelength-- let me say this-- which is like sunlight, right? That's what happens with sunlight. It helps to transform it into the radiant heat, which is what the body understands and acknowledges and is able to process and work with.

Oby: Perfect. Thank you so much. That is very helpful that you stepped us back into middle school and gave some of those roots to cling to to be able to better understand.

So I'm going to step us back for a second before we go forward. You talked about your winding career path, but I'm actually curious to step a little further back and talk about your education path.

Wendy Slone: Yeah. So I started out life when I'm feeling like five years old thinking I wanted to be a medical doctor, right? But then I began to realize when I got to college, I really didn't want to see patients so much, and so I was very interested in the research aspect of it. And then with the Halcyon SMART Patch, I got interested in the patient experience. So it began to all congeal together.

But academically wise when I started out college and undergraduate school, I was a biology major/religious studies. So I've always had these two brains. Right, left, it worked together. We all do, right? But some of ours really work together, and mine really gelled and work together.

And I was on a path to try to go to medical school and decided I was going to pursue a degree in biology because I got very interested in tissue culture when it was very early before it really took off to where it is now. And there's always been there, but it really grew exponentially. And I was interested in regenerative medicine.

I was working on that in graduate school, and then I landed a job at the VA hospital as a research assistant looking at cancer cells and nerve cell regeneration. And so some of the modalities in the mechanism of action, what we were studying were very similar.

And so I was able to employ the use of my knowledge and skills of tissue culture in both of those areas. And so it was a win-win for me.

But I ended up getting hurt on my job at the VA. And one of my friends worked as the ombudsman at the school I was going to. And she said, hey. Hey, hey, I've got something for you. Why don't you go over here and look at public administration? I was like, no way! No way. No way. That is a soft science. We don't really know how to think over there. It's not structured. She said, no, go take a class.

And I went and I took a class, and I fell in love and I stayed. And so I ended up getting a master's degree in public administration and thought, well, you know, I'll just make a full pivot and I'll go off and be a city manager.

And then one of my friends who had a great love of candy like myself-- we would study together and she had a drawer of candy. We would go to her house and pull this candy drawer out. She said, I need you to stay in this program and go and get a PhD with me, because she had already started the PhD program. And I was like, OK, I can see that.

And so [laughs] I ended up staying and ended up getting a PhD in public policy. But that right side brain and mind, that science brain of mind flowered and grew because of statistics. And so I understood numbers. I understood data. That's that biology side of me that was coming together, that science side of me.

And so I grew greatly in that. And some of my friends decided in my cohort, we can do a business. And so my area of my business expertise was always statistics, data analytics, and writing these reports and managing people's budgets.

And so we all worked together as a cohort. So that's how I learned the business of how to have a business because I kind of fell into it with my cohorts of PhD students and was very prolific at it. Had a lot of business from it.

That's how I ended up having worked with a company here locally that had all of NASA as one of their clients. And I would do what I did best, numbers. Just run the numbers.

So I had another business before this and then I realized, oh my god. You're a serial entrepreneur. I didn't even realize that, right? [laughs] And so people kept saying, you've had another business.

But in the process of that, I had finished my PhD, finished my master's, and then the bug of medical school hit again. So I decided, I'm going to go and try it one more time, and got in and was taking some courses like a preliminary, and ended up with another degree in health sciences. So all of these degrees started racking up too, you know? I wasn't looking for them. They just happened along the path.

Then one of my brothers had a stroke, so I had to back out and back away to help him. During that time, that's when the idea of the Halcyon SMART Patch started being birthed. In the process of the Halcyon SMART Patch being birthed, people would always ask me, well, how do you have knowledge of this? How do you have science knowledge? How do you this, that, or another?

And the response of, well, I read [laughs] and I'm kind of like a geek, and I don't have another life besides reading wasn't flying. So I was always good at chemistry. Organic chemistry and anything above that always came really just-- I didn't even have to think about it.

So when I was in this other program, students would come and they would want to study with me. I'm like, no way. Why are you trying to study with me? Don't you see I'm over here struggling? But they were like, but you're the one who's always getting an A. And I was like, well, you've kind of got a point there.

And so I went and I applied and got into a chemistry program for a PhD program because people were always asking me, how do you have this technology? I said, well, let me just go over here and study a little bit, you know, officially.

Oby: [laughs]

Wendy Slone: And [laughs] so I have two undergraduate degrees, a master's degree, a PhD, and somewhat loosely I can say I'm in another PhD program. And so that's my academic journey.

Oby: Thank you so much. That is incredible. I also love that you started a PhD because a friend asked you to stay with them.

Wendy Slone: Yeah. [laughs]

Oby: What can we expect to see from bTECH in the future?

Wendy Slone: Oh my god, I think you're going to see great things, amazing things from bTECH. And I'm not just saying that because it's my company. I think that the market is so right for biopolymer-based technologies. It's not just the market. It's the patients and the end users, the actual end users that are crying out for something different, for something that's going to be life changing for them.

And I think that biopolymer-based businesses, this is our time. Not just nanotechnology, but anything that is using different materials in order to bring about change and enhancement is the way to go. I think in the States we might be a smidge behind because we can be elitist sometimes [laughs] in our processes of adopting new technologies. But nevertheless, I think it's the wave of the future. And the marketplace is ripe for it in many ways.

I liken our technology with the Halcyon SMART Patch to Coca-Cola in that Coca-Cola started out with one formula. And then when the Coke wars happened they said quickly, we need to be able to adapt and shift and pivot within the market space in order to grow and stay alive and stay viable. And I think they did a great job of that, and that's why we've got all of these Coke products now.

And so I look at our product as that as well. So we're starting in a place which is diabetic foot ulcers, but I see us branching off into burns and surgical wounds and veterinarian medicine to help animals with wounds, field medicine for our military personnel. There's applications that I'm also interested in for personal radiation protection. So there's many ways that we have identified and that we're interested in, but we're starting in my place of love with the wounds.

Oby: Hmm. Sounds incredible. I can't wait to see how it all unfolds and evolves.

Wendy Slone: Me too.

Oby: You too. [laughs] Yeah, exactly. As a CEO, you need skills that might not come naturally to someone in a different background, in the sciences, liberal arts, whatever the case may be. What skills have helped you in your business success?

Wendy Slone: I think the greatest skill is being able to embrace having a Barney Rubble moment and saying, I don't know.

Oby: [laughs]

Wendy Slone: People don't understand Barney Rubble. Like, Fred was the brain between him and Barney, right? They shared Fred's brain. But Barney every now and then, he would have lucid moments. And in those lucid moments he would come up with something great.

And I feel that that's the same way with this. You've got to be willing to say even though you might be an expert at something, have a great body of knowledge, be willing to say, I don't know, and I'm willing to go out here and learn it, and I'm willing to go out here and figure it out.

But I've taught myself how to make websites. I've taught myself how to make my digital background. I've taught myself how to do documents that I'm not familiar with that vendors would ask for. And I'm like-- they were like, oh, do you have such and such? And I was like, nope, but I'll send it to you.

Oby: Yeah.

Wendy Slone: And I get out there and I either ask through my connections, how do you do this, or I research it and I'm able to develop it. And so it helped keep my learning curve fresh, and it helps to keep me on my toes, and it helps to keep me business-entrenched and really moving my business further along the pathway.

I think sometimes with entrepreneurs we get so caught up in our technology that we forget that we also need to have a viable business. And that business needs to be viable around the technology and not just what you have. Your product is your product, but the business is what people are investing in.

You don't want to be a one-hit wonder. So you'll hear people say, whatever happened to so-and-so and so-and-so? That's why we have shows like Unsung. And so you don't want to become an unsung in the life sciences. You want to continue to be able to grow. And the way you grow is by really knowing all aspects of your business.

You don't have to be an expert in everything. You hire people to do that. But you've got to understand where you need to hire someone and you've got to understand what you also need to have some understanding for yourself so as you're hiring someone, you're hiring the right talent in order to help bring the business to where it needs to be at.

Oby: That is excellent. Thank you so much. So you attended one of our courses that specializes in medical device development, TRANSforming Care with Emerging Novel Devices, or TRANSCEND. Could you talk a little bit about your experience and some of your takeaways?

Wendy Slone: When I first got the email from Anna, I was like, I don't want to do this. This is just another product valuation, the same old hash, old hash. I'm going somewhere good with this, people. And I'm not-- I'm going somewhere good, I promise.

And then I started asking around in the ecosystem and I was like, do you know anything about the program? And nobody could really answer me until I talked to someone whose voice I respect a lot, Nancy Briefs I just have to say it because I just adore her. Nancy said, whatever you do, you need to do that program. That was it. All I needed to do is hear Nancy say that.

And so I did the program, and I tell you, I was not only pleasantly pleased and pleasantly surprised, but absolutely glad that I did it because it was from a different breadth and perspective. So for me, you can get inundated with the business model canvas, but I always felt that nobody ever really explained it correctly or to a place where I could apply it and understand it. And this is even after I look it up myself. It just didn't click for me.

But when I did the TRANSCEND program, it was focused solely on life sciences. It was in a cohort with other people who are in a real life science space with me. And I was able to glean from that.

And then the people that you had on the virtual part of the program, their level of expertise in the field was just amazing. And being able to have touchpoints with them and being able to connect with them when otherwise you wouldn't have that ability unless you knew somebody that knew somebody that knew them, right?

And so it was such a phenomenal experience for me that when I came away, one of my greatest takeaways that I tell everybody from business colleagues to family is that I finally understand the business model canvas and how it actually fits and how mind works in that process. And I had not, and I've been exposed to it for more than four years now and had not had that understanding, that level of it all this time. And so for me it was a great, impactful exposure to something that is everyday common that everybody talks about, but really doesn't do a good job of explaining.

Oby: Thank you so much. It has been such a pleasure to have this conversation with you. Thank you for being here.

Wendy Slone: Thank you for having me.

Oby: We look forward to seeing more about your company.

Wendy Slone: I hope so too in the near future. [laughs]

Oby: Thank you for listening. If you enjoyed this episode, please rate us on iTunes and help us spread the word about the amazing research taking place across the Harvard community and beyond. We are always looking to connect and collaborate with the research community and would like to hear from you. Please feel free to email us at onlineeducation.catalyst.harvard.edu to inquire about being a guest on the podcast.

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