Hello, and welcome to the Gifted Life podcast, where we have conversations about organ tissue and eye donation. I'm Roy Steele. I'm Joey Woodrow. I'm Sally Gentry.
And we want to know, do you know of someone impacted by breast cancer because this episode is free? Yeah, we're going to talk about advancements in breast reconstruction, post mastectomy, and how tissue donation really plays a big role. Some neat things come out. And we're also going to have a group discussion about why people take their names off the donor registry.
Oh, group discussion. Yes. Okay, I like that. That's interesting because we've been having lots of talks about that in the community.
So, good topic. Hopefully, you will join us in that. We certainly appreciate you listening to the Gifted Life. Our goal is to make life happen.
You're part of our team, but we need people learning this information and spreading the word. You can find us on Apple Podcast, Google Play, or whatever your favorite podcast that might be. And now on Spotify. You were excited Sally about that.
I like it. And as always, you can find us also on our website, thegiftedlife.org. And social media, it's a big thing. And a lot of our lives on Facebook, the Gifted Life podcast, or you can follow us on Twitter and Instagram at Gifted Life Pod.
I'm has some special guests coming up to talk about latest and advancements in reconstruction for breast cancer. You guys ready to get to that? Any questions? All right, let's do it.
Here on the Gifted Life, we are excited about this segment coming up because there's new information that's coming out. We always talk about people making a difference. And you never know what's going to happen tomorrow. We talk about that in a lot of our presentations across the state.
Well, these two guys are helping to really make a difference when it comes to breast cancer recovery. So, Joe, we want to introduce? Yeah. So, of course, we talk about a lot of guys that we talk to with big brains.
And these are certainly two of the big brains that we will be talking to today. We've got Nick Pashos. Anybody saying that right, Nick? Yes, sir.
And he heard you. But people don't understand me often. So, he's a founder and CEO and the inventor of Bioesthetics. And along with Nick, we've got Billy Heim, who's a chief operating officer.
And so, Nick, can you tell us a little bit about Bioesthetics and how you guys got started? Yeah, definitely. So, Bioesthetics is focusing on transforming the lives of breast cancer patients through regenerative medicine. And our first product is a nipple graft.
And we provide a cellular nipple and aerial look raft from affecting patients to be sutured onto their chest and allow their cells to grow into it and to essentially regrow a new nipple and aerial look complex after a mastectomy. And then, goodness, you have the knowledge to be able to even think about that. But tell us how this got started. Like, why would you go into this field and this path?
Yeah. So, both Billy and my background in the bottom of the medical engineering. And previously, I was working on spinal cord injury repair and then I worked on Huntington's disease for a little while. And then I went on to do my PhD at Thule University in Zilow, Louisiana, at Baltimore Medical School and at the primary center to regrow lungs outside of the human body outside of the trans plants.
And what we were doing was we were taking organs that couldn't be transplanted, taking them in and removing all this cells in DNA. And what we were left with was this protein scaffold and the same shape and size as the donor lung. And the idea was to then take patient cells, combine it with that lung scaffolding that we just derived and grow it inside of the bioreactor outside of the human body and use it as an alternative trans plant. So, I was working on that for a year and a half, trying to regrow the blood vessels inside those lungs.
And then when I was watching a network documentary on one of those things, this might be what we all have. And in it, they were talking about the second reason not having nipple and aerialers after breast reconstruction. And I just couldn't believe it. And so, I stayed up all night reading about reconstruction options for breast cancer.
And I even had to start to what was an effect. I didn't know anyone that had breast cancer at the time. Thankfully, nobody in my family had breast cancer. So, my second need to me was just removal of cancer from breast tissue.
But it's actually much more than that. It's removing sometimes partial or all of the breast, including the nipple and aerial. And it's an extremely extensive surgery. And the recovery period is very long and very intense for these breast cancer survivors.
Reading about it and watching the documentary, I realized there was a need to regrow the nipple and aerial it. So, I thought we could take the same method that we were using with the lung. You can transfer it over to nipple and aerialers. So, I switched my PhD project a year and a half into it.
And then spent the next three and a half years working on this product and spent on another company. And then Billy and I got hooked up together as business partners. And we've just taken off from there. So, from there, of course, you guys have to have partners in the donation field.
And I first found out about you guys in sometime around the summer of 2017 when Tina Madair, who is our research manager, came to our team and said, look, you know, this is what these guys are doing. You know, basically taking nipple aerial, the complex and desalurizing them, turning them into scaffolding for patients who have had mastectomy so that they can then have their own tissue kind of grow in between and above and around so that they can have that kind of sense of pride back when they, you know, instead of having to tattoo and things. And for us, almost everyone in the room has had someone that they've contacted or been into contact with some, you know, with cancer. And many of them have had, you know, people with breast cancer.
So, it was an obvious, you know, yeah, of course, we're going to partner up with you guys. And that's been a great partnership since then. So, can you tell us a little bit more first about the desalurization process and how you really don't need any rejection medicines and things? Yeah, so the desalurization process, what we do is, you know, we work with organizations like you guys and thankfully for donor families as well to supply the raw materials of a donor nipple and aerial complex.
So, that encompasses the nipple and the surrounding tissue of the aerial or the round portion. We take it in-house and we wash it over the course of several days with different salts and detergents, much like a washing machine. And through that process, we can remove all the cells and the cellular contents in a DNA. And what's left over is a nipple and aerial with scaffolds in the exact same shape and size of that donor nipple without any DNA in any cell.
So, it's not moving anymore, but it has human-derived proteins inside of it. And it's these human-derived proteins that would allow us to then draft it onto a person and their own cells take it over and use it as a building block to regrow and unipalnaryllas and incorporate that scaffold into their body without a listening and immune response, allowing us to be a safe graph. So, this is a safe graph for a lifetime as opposed to someone who's gotten an organ transplant that's cellularized that, you know, you need to be on immunosuppressants and things like that, right? Exactly.
So, no immunosuppressants and it integrates into the person's body. They're going to have their own cell to grow into it and it becomes part of their body. So, it's their blood vessels that grow into it, it's their skin that grows into it, and it's a permanent living structure. How do you get a little color on the cause of rejection?
Oh, yeah. Oh, yeah. So, one of the major causes of rejection is actually the protein outside of the cells themselves. So, you know, when you put an organ into somebody else's body and organ, you don't have to recipient, you know, those cells on that organ are not native to the recipient at all.
And so, they have distinct proteins on the outside that the body sees the recipient body sees as a foreign body. And that's why you have to take immunosuppressants. And so, I have desorization of removing the cells. We remove those cells.
We remove the proteins. And we also remove the DNA. And free-floating DNA around can also elicit immune response as well. So, removing this component at least for a very nice and safe bio compatibility to allow this part to go on to it without having any stress.
And there's published, I guess, literature related to desolurization and, you know, kind of the values of, you know, DNA quantity as well as size that elicits the immune response in the body. All the studies we performed show that were about tenfold below what the current commercially available desalurized skin products are. So, we're, you know, extremely confident that we, you know, there will be no rejection issues and no, you know, antidepressants and very safe products for patients. And building up what Billy said as well.
And products like these have been used on the market for, you know, probably over 30 years and it's actually fifty-six percent of all breast reconstructions right now utilize human derived desalurized skin as extra support underneath the recipient skin to hold up the implant. So, plastic surgeons are very familiar with it, most women who have undergone reconstructions with implants or utilize materials like these that have been processed very similarly without having immunosuppressants or immunorejection problems. As you just mentioned, women are usually who we think of when this sort of surgery takes place. Does this also apply to men who have breast cancer?
Absolutely. There are much smaller populations of men who actually have breast cancer in the mastectomy, but almost all men who have breast cancer and have a mastectomy actually have their niponereal that we move as well. So the major population of people that this product will be able to help are female, the mastectomy to breast cancer, then it's actually male breast cancer survivors. And then it would be people who have to have a mastectomy for other reasons, either a transition or accidents or something, and then also pediatric usage that we've also liked to help out as well.
There's a syndrome called Polin syndrome where babies are born with underdeveloped chest muscles and a lot of times also missing the nipple and garyola. And they reconstruct their nipples just like they would mastectomy patients and breast cancer survivors. And so that's what the most important part can also be used for them as well. So it looks like you've done your research, you've been in the lab and you've been doing the research portion.
What's next? So through next PhD, we went through in vitro studies and then he also went into an in vivo mouse model where we saw a very nice biocompatibility. Then we've gone into a large animal, a non-human primate model and we've completed our fourth animal back in December. And all the data looks very nice from all of that.
We see we're looking at the blood work to make sure that our immune response is good. All the animals are healthy. The reduction issues, all their blood values are within their baseline range. And then we're also seeing the majority of the grafts surviving the animal.
It is an animal model so there's some limitations in terms of being able to control the clinical care. But overall, all the data is very positive. So therefore, next steps are really directed straight towards the clinic. So right now we have to meet general FDA requirements as a tissue processor through the HCTP regulations.
So right now our goal is we're building out a processing room where we can actually process the tissues, make the product packages and then implement our quality system to make sure we're tracking all the products from donor to recipients and through the processing to ensure we have a quality product. And then next would be we register with the FDA and then begin to market the product. And we are planning to conduct a small 15 patient clinical study. It will be a post-marketing study to gather data for broader adoption so that we can publish in journals with some of our early adopted doctors.
And then also begin collecting data to apply for a reimbursement code specifically for this product. And then we have to ask what type of psychological benefits do you anticipate finding from? And that might not be maybe I'm underestimating what's going to happen here. But I would think it would be a very, very beneficial.
Yeah. So there are actually a lot of studies on that. And you know, being really not being too men who do not have breast cancer, I haven't had a reconstruction yet. We rely on those studies and rely on patient feedback as well.
You know, one of the biggest things that we did when we started this company was go out and talk to patients and listen to what they wanted, right? And to listen to the impact that it may have. We talked to you, you know, healthcare professionals, psychological, health professionals, psychiatrists and psychologists, we deal with breast cancer survivors and also plastic reconstruction surgeons. And studies have shown that women is actually more likely to undergo a life saving mastectomy if you can have a nipple reconstruction than the other after.
And that a nipple reconstruction actually can increase on the steam body image and decrease the treatment distress they want to have during her recovery period of the mastectomy. So billion I think on it is, you know, if somebody wants to be reconstructed and they want to have a, you know, biocidic graft, fantastic, we're there to help them. And if a reconstruction, if that be a tattoo or surgical reconstruction right now, a woman is more likely to undergo a life saving mastectomy if they can have that afterwards, you know, how much more likely are they to have a, a second if they can have completely regrown in a scenario or complex. And to us that's the most important part, right?
We want to help people out, our company to name this biostatic study is actually very much deep to that on the individual level. And that's where our company is focused, not the life saving solutions, but the life enhancing solutions. That's right. Now you all have a mutual friend whose mom was recently diagnosed, had to have chemo surgery, expanders put in, had some trouble with that.
There's an infection. So do you think what you guys are developing would change the way that that kind of rolls out the pike when it comes to a diagnosis and recovery? Yeah, so that's one thing that, you know, we, I'm a PhD, Billy's biomedical engineer, and we are not going to be the ones and grafting it. We are working with doctors, the medical professionals on the reconstruction side of it.
So we won't be changing the prognosis or how they deal with, you know, breast cancer in general. What we will be working with is the processing and reconstruction for specifically breast reconstruction at the later stage of it. So after they undergo the tissue expanders, and some patients have more trouble with it than others, sometimes reconstruction is one surgery and sometimes it's seven to ten surgeries. The nipple area is always the last piece of that reconstruction process.
So that's always in the correct place. You never want to put the nipple on first because if you have to have any modifications, you know, it could change the position. And that's where we're focusing on it. And we will be able to change the standard of care for nipple reconstruction so that everyone can have a fully regrown nipple area complex and, you know, not go to the alternatives of a tattoo which can fade over time or prosthetic or rub a nipple and arrow complex that somebody takes on an off at night time with adhesive.
And then you can also have currently a surgically reconstructed nipple, pre-existing skin, femuridoty or the arms part of breast tissue. From what we hear from patients and in literature and from doctors as well, those actually fail over time. They tend to lose shape inside about 96% of it within about two years. So we're really focusing on that last stage in transforming that to have biosexity, you know, the standard of care for nipple reconstruction specifically.
Did that answer your question? Yes. So any timeline I know you said this is what's coming up? This is what's coming up.
Do you have like a, you know, spring of 2020? I mean, our goal that we're moving pushing forward towards right now and, you know, this is all contingent upon. We're also, you know, raising money right now to continue funding and development of our work. But, you know, getting that money in, you know, our goal is to be on our first patient by the end of this year.
And that would likely be in the form of a clinical study that we are intending right now to, you know, conducting potentially two lane, but, you know, then we could also potentially be marketing the products as well to other surgeons as well as conducting that clinical study. Wow. Changing the future. I like it.
And then there are lots of questions on just because it is a topic that's close to our heart. So we appreciate you guys letting us pick your brains there, Nick and Billy. So if people want more information, I know that's what kind of we do. We turn to social media.
So if folks want more information, they want to learn more from you guys. Where can you do that? Yep, so they can go for, you know, for website www.bioch aesthetics.com. We also have a Facebook page linked in and Twitter, Twitter is bio underscore aesthetics.
In addition, you know, they can reach out via email to info, on F O, at bio, bi-o-est aesthetics, S T H E T I C S dot com if they have further questions. Yeah, I think a lot of people are going to be interested in watching what you guys have to offer. So we appreciate you taking the time. Thanks for what you do.
And thanks for kind of pushing that glass ceiling. We like that. Thanks guys. Thank you.
Thank you for what you're doing as well. And thanks for what we do for being such a great partner and helping us work on this product and eventually get it to the patients. So thank you for that. All right, making a difference team effort.
You're on the gift of life. It's group discussion time. We're excited to show everybody. Please talk if you want to hear from you too, if you're listening, have something to the time and please do.
But Sally, you're kind of leading the way. What's on your mind? You know, recently we've been talking about the number of people who are taking their names off the donor registry or removing a heart from the driver's license. And I thought maybe we could just talk about, you know, maybe some of the rationale that people give for doing so that maybe it's not real accurate or factual information.
So you're here in the south in the community, Laurie. What's what's the reasons that people are given that you hear? Well, just in the studio on one of the last podcast that we did, recipient mom, Brittany Ellis, her was in here and she said, I'm so embarrassed to admit that I had the heart of my license. And then I took it off because I was pregnant and believe the myths and thought, I need to be here for my children.
And then when she was in that world and they were telling her my son needs a transplant, she ran back to put that heart on there. So I think some people are scared to talk about death. I think maybe a lot of people are scared to talk about death. Yeah.
And, and, you know, there's just a lot of violence in the headlines. So some folks are just worried, not a lot of trust in the medical field. Some of them when they come to the table and tell us that just a lot of different reasoning. But I think when we sit down and we talk facts or they talk to someone who's been impacted, that seems to make a difference.
We just had to reach those people. You know, I've heard several of our family advocates say that people have told them, well, my religion doesn't believe this. But, you know, we know that there's only one and that's the gypsies that do not believe in organ donation. All the rest are pro giving life when, you know, your loved one cannot.
Yeah, but listen, I was in a classroom setting and so gypsies and shin to indians are the two groups that, you know, we know that don't support donation. But there was this child beautiful and she said, I'm a gypsy, which intrigued me because I had never met. I just saw on TV. They had a show not too long ago about gypsy life.
And I said, what do you guys think about donation? This is interesting. Like teach me. And she said, Oh, she goes, my pup on the kidney.
And I said, okay, so how do we deal with that? And she goes, well, we wanted to save his life. And she said, so we did what, you know, we had to do and through all the steps. And she goes, we are pro donations.
I think it depends on your seat at the table. If you've been impacted, I mean, it's just interesting to hear, you know, different people's walks of life, I guess. So maybe it boils down to people really just being afraid and they don't have good information or they listen to someone down the line. So you're not going to believe what they did to my loved one.
And whether that's true or not, because you know, in the midst of all the grief and trauma and everything that happens, many times what you thought you had heard is not what you heard at all. It was all because of you were so confused. Right. So often what we hear from families and you know, you know, is that they can hear and understand maybe 20, 30, 40% of all the information that they're given.
You know, so when you just able to comprehend, especially in that acute stage of grief, that severe stage of grief that you're in, you know, it's difficult to understand everything that's been thrown at you, especially when it comes to donation. And what about my loved one? How's that impact us? And so that is one of the challenges is being able to understand everything.
And you touched on a little bit earlier with the family advocates, you know, we have a lot of conversations about, you know, how we can support families better. And it is quite often the myth about lack of fairness or not sure maybe if you're rich, you get a lot more access and, you know, people hear about certain, yeah, certain certain, you know, CEOs and things we've gotten, you know, transplants and of course that resonates more, you know, and we make sure that they understand, you know, the truth, you know, which is that that this is just because you're rich or famous, you don't automatically get bumped up, you know, it's a very anonymous list. And that's why I love our volunteers, real life testimonies, their walk of life. I'm also one of our biggest myths that we battle each and every day is that I have that heart of my license, they won't work as hard to try to save me, right?
And so we work with college students in the state, and so they hear that myth too. So on our staff at Lopa, we have some paramedics, and we have folks who have that type of background, and so they are starting to utilize them in some of their outreach, like talk to them and say, Hey, what step one step to, you know, we don't go and look for your license, like we're trying to save your life. And so that seems to be working. So spreading the facts, and we hope that you use this podcast to do, you know, just that.
Yeah, and you know what I'm hoping to is that I'm sure that most of the people who listen to us are pro donation, they may not be I don't know that for sure. But what I would suggest is if any of you who are listening that you're hearing people say, Oh, just what we've discussed here, check out, you know, our website or have them give us a call or talk with someone that's received a transplant to know how beneficial and helpful, you know, just saying yes, when you're just not able to be helped, can help save someone else's life. Yeah, we love when people call and say, Hey, we're out of school, we heard this, we'd like you to come in and do some education, we love that so reach out to the OPO organ procurement organization on where you are, or maybe have a specific topic that you want us to discuss here info at the gift life.org we'd love to hear from you. On every episode of the gift life, we honor a hero today's hero, Matthew Edward Hull.
And we're here for Matthew's mother. Nothing hurts the heart of a mother more than when her children lose their brother. Nothing heals the heart of a mother more than her son giving life to another. Matthew was hard working, caring, fun loving and one of the smartest people I've ever known.
He was the most caring son a mother could hope for with a bright smile and a tight hug that warms your heart. He has loved and will always be greatly missed by his mother, brothers, sisters, sons, cousins and countless friends. At this time we pause and say thank you to Matthew for the gift of life. And today's question and answer segment.
My doctor told me I was going to have to have an aligraph as part of my reconstruction. Is that donor tissue? Yeah. Well, the quick answer is yes, Laura.
Yes, oftentimes, especially during orthopedic procedures, the surgeon might mention something like aligraph or might mention donor tissue. And oftentimes won't really go any further in that discussion because there's a lot of things that they're trying to capture about the surgery that are, you know, of course, you've got to talk about all the potential pitfalls that are there. So, so that kind of gets lost over sometimes, but it is important in my opinion to recognize it that that is, you know, a donor hero, a tissue donor who because they said yes or their family said yes, you now have that second chance at performing whatever task that the surgery is going to enable you to perform to go ahead and perform it. It's only with that yes, that that's taking place.
Simply amazing. So we'd like to hear from you. If you should have a question about this or anything we've discussed here on the podcast, reach out to us. Your story can inspire others to give the gift of life and you can find us on social media, email or you know what you can give us a call.
And that number is 5046483477. We look forward to hearing from you. And that'll do it for episode 104 of the gifted life power pact. Yes, it was special things go out to Nick and Billy for all the work that they're doing at Bioesthetics and the advancements in reconstruction for those who are post mastectomy and while first patient later on this year, who's going to be involved in clinical trials.
That's amazing. We hope this has inspired you to say yes to donation. Put that heart on your driver's license or go to register me dot org. We appreciate you listening, everyone out there and we hope that you go out and do something that you would normally do to help us make life happen.
We're a team and we'll talk to you next time. This is a production of the Louisiana Organ Procurement Agency, our Loca, the gifted life is hosted by Lori Steele, Joey Boudreau and Sally Gentry. Our executive producer is Kirsten Heinz. Producer is Shalom Caraway.
Intern is Rebecca Rannamem and we are recorded, engineered and mixed in our Covington, Louisiana studio by Troy Perez.