PolarityTE’s Denver Lough, MD, PhD, discusses the company’s new approach to treating burns with SkinTE  (“autologous” tissue – meaning it comes from the patient being treated, significantly decreasing the chance for rejection by the immune system), the need for additional treatments in this area and case studies to highlight the efficacy of SkinTE.

Dr. Denver Lough, Founder, Chairman & Chief Executive O­fficer of PolarityTE, Inc has always sought to investigate reality, pursue complex simplicity and develop a new paradigm in translational science. He left his original career plan behind at the Johns Hopkins Hospital Department of Plastic and Reconstructive Surgery to provide tangible and pragmatic therapies for patients who were trapped in the trenches of medicine and to improve health outcomes and health economics for patients, providers and payors. He recognizes that the health care system is broken and that industry has a responsibility to humanity to continue to develop not only consistently better therapies, but also to deliver them at lower costs and assure access for patients. Dr. Lough has significant experience with bench-to-bedside translational research applications which include tissue regeneration; intestinal transplantation; hand, face, and penile transplantation and life science product development. He holds a medical degree (MD) as well as a doctorate (PhD) in Biochemistry, Molecular and Cell Biology from Georgetown University. In 2015, following the largest civilian mass casualty fire in the world at the Formosa Water Park in Taiwan, President Ma Ying-Jeou selected a Johns Hopkins emergency response team, including Dr. Lough, to assist the Taiwanese government and health care system in the evaluation and treatment of over 500 adolescent youth tragically burned in the event (PTE.Cool/JH-ERT). This event spurred the acceleration of the founding of PolarityTE.

Transcript

Neal Howard: Hello and welcome to the program. I’m your host Neal Howard here on Health Professional Radio for this Health Supplier Segment, thanks for joining us today. Our guest is joining us as chairman of the board, CEO and chief R&D officer for PolarityTE. He’s an MD and a PhD and he’s joining us here to talk about some breakthroughs in the treatment of burns. Thank you for joining us today Dr. Denver Lough.

Dr. Denver Lough: Thank you so much for having me, I’m really excited to be on the show.

Neal: Now you’re an MD and PhD. A bit of background about yourself and how did you end up at PolarityTE.

Dr Lough: Yeah, absolutely. I have a medical degree and a PhD, my PhD is in biochem cell molecular biology, I earned it at Georgetown University. I focused primarily on intestinal transplantation and research that had to do with sort of the way that the intestine underwent rejection process, is when transplants would occur with parts of the intestine. Ultimately, it came down to, I was really excited about the way that cell biology worked. I ended up completing my MD, PhD and going on to Johns Hopkins for plastic and reconstructive surgery. And it was at that time that I began to recognize that there were a lot of patients that were unfortunately suffering and some dying simply because they needed something they couldn’t have and that was their own skin. Burn patients, wound patients and those who have suffered from trauma simply need their skin back in order to have a barrier and have appropriate function. So it was a group of myself included but Johns Hopkins physician scientists and mid-level providers that left our careers behind to take on a real change and make a real difference. We were tired of seeing all these patients suffering and some even dying because they simply needed skin and we found a technology called an MPFU (minimally polarized functional unit) that would allow us to regenerate full thickness hair bearing skin and in 2016 we took the leap and started a public company called PolarityTE.

Neal: Okay. Now you’re talking about patients suffering and perhaps dying because of something that they can’t get, you say their own skin. I’ve never experienced a skin transplant or anything like that but what about the skin from other people like your normal transplants? Why is it important to a patient to have their own skin?

Dr Lough: That is an absolutely great question. Your skin itself is highly antigenic, meaning that it actually is some type of tissue that will actually cause your immune system to respond very quickly. So just like if you transplanted say your skin on to mine, we would even suffer rejection just like if you gave me your liver and transplanted it into me. You have to be on immune- suppressive drugs. So when large burn patients are wound patients that need skin receive what they call allograft donor skin, it’s only temporary. It only stays on for a few days and then your own body, your own immune system rejects that. So the ideal situation is to be able to take some of your own skin and let it grow and regenerate back on you, the patient yourself, so that you don’t reject that tissue and you don’t reject your own skin. And so we found a technology where you can take essentially a dime sized piece of skin, about the size of a square centimeter, you can take that piece of skin from somewhere on your body. You’re growing your axilla, an area you can hide it relatively well. We create that SkinTE™ product and we can return it back to that patient as early as same day and they could basically cover the patient just like you would ice a cake and smear it onto the wound and over the course of essentially one, two and then three weeks, you begin to regenerate hair follicles, sebaceous glands, sweat glands as well as all of the layers of your skin.

Neal: So let’s talk about this technology because it is fascinating to me. How does taking a piece of skin from a person’s own body and then you expand it, regrow it? Talk about how this actually works because it sounds fascinating.

Dr Lough: Yeah, absolutely. If you take a look at just your hand or your arm and you look closely, you can see small little hair shafts are coming out next to those hair shafts exist a certain cellular population called the follicular bulge. Inside of that population of cells, there is a stem cell in the center of that which has something that we call potency – a capability of that cell to regenerate other types of cells as well as other types of structures. So if you take that small piece of skin, a dime-sized piece of skin from your own body, PolarityTE manufactures the product by fractioning essentially that follicular bulge into thousands of pieces and when you have multiple follicular bulge units, you can get millions upon millions of these fractions. Those fractions contain elements of those certain cells and those transit amplifying cells that allow you to actually regenerate the hair follicle, sebaceous gland and sweat gland. Those are called appendages, those are regenerating those appendages is actually what generates your own skin on your body just like it’s happening to you, myself and all of the listeners right now. That’s how your skin normally turns over, so our technology essentially  regenerates appendages, hair follicles, sebaceous glands and sweat glands and by allowing those to expand and grow on the patient themselves. You can simply regenerate their full thickness hair bearing skin. We basically utilized science, we utilize biology and evolution to work for us in this particular setting and that’s why we’re able to return the product around back to the patient and the provider essentially immediately. That’s why we’re able to keep our cost so significantly lower than any other type of product that’s out there and why we’re able to regenerate full thickness, hair bearing skin.

Neal: How deeply involved is PolarityTE in the education of physicians and practitioners, plastic surgeons, folks such as yourself in dealing with this breakthrough? They’re used to one thing,  they’re used to other types of products but this sounds like something that none of them have seen before.

Dr Lough: Yeah, you’re absolutely correct and that’s why we knew that when we started this company that it needed to be by physicians and for physicians and the patients that we collectively treat. By simply turning this technology over to something like the pharmaceutical industry, other medical device companies where you have very comprehensive corporate structures. They would begin to feed it into an algorithm that I do not think we would develop a successful sort of outcome for this type of technology. I think what it really required was a group of physicians to leave their careers behind and to take this technology in a complete state and educate and teach other providers, other clinicians, other nursing staff how to use this type of product because you’re absolutely right, It is entirely different than anything that has ever been seen before. This isn’t an off-the-shelf product, this isn’t just another widget that we’re trying to iterate and create a new type of product for. It is an entirely different type of technology and it has led to an entirely different type of paradigm shift not just for the field of regenerative medicine but for medicine in general and we believe that as a group of physicians and scientists, that we were really the ones that could try to carry that torch and really begin to educate our peers on how to utilize the technology like this. Not just for our skin but also for other types of tissue substrates including bone cartilage, muscle as well as Hull and solid organ systems like hepatic liver parenchymal, pulmonary tissue and even your intestine.

Neal: Well where can our listeners go online and get some more information about PolarityTE?

Dr Lough: We have an amazing website that is developed specifically for listeners like that are listening into your show as well as patients and even providers at polarityte.com. At the very top, you’ll see ‘learn more about SkinTE™’ and it can take you through illustrations’ videos as well as even patients that have undergone the procedure and the outcomes that they have been able to experience and really getting their skin and their life back.

Neal: Well I thank you for talking with us today Doctor. It’s been fascinating and very eye-opening and I’m hoping that we’ll get some updates in the future.

Dr Lough: Thank you so much Neal, I really appreciated it.

Neal: You’ve been listening to Health Professional Radio on this Health Supplier Segment. I’m your host Neal Howard in conversation with Dr. Denver Lough, chairman of the board CEO and chief R&D officer for PolarityTE and we’ve been talking about PolarityTE’s brand new approach to treating burns with SkinTE™. transcripts and audio of this program are available at hpr.fm and healthprofessionalradio.com.au. You can also subscribe to this podcast on iTunes, listen in and download at SoundCloud and visit our Affiliate Page at hpr.fm and healthprofessionalradio.com.au

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