Episode 8: Startup Biotech Spotlight - BioAesthetics with Key Opinion Leader Nick Pashos

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Welcome to Bio from the Bayou, and I'm James Zanewicz, one of your hosts. Today is our first Startup Science Spotlight on the company BioAesthetics. Our guest is Dr. Nick Pachos, founder and CEO of BioAesthetics. Nick, welcome to the podcast.

Thanks, James, for having me today. I appreciate it.

Well, Nick, we go back a long, long way when this was just some lab research and you were a grad student. So, can you tell us a little bit about the science behind BioAesthetics?

Yeah. So, I guess BioAesthetics as a whole is focused on transforming lives through the advancements in biomaterials. So, at BioAesthetics, we're really focusing on cell-free graft applications for reconstructive surgeries, things that have huge quality-of-life impacts on patients, but not necessarily or doesn't have to be life-saving. So, we're not focused on regrowing hearts or lungs, we're focused on regrowing As in our inaugural product, a nipple and areola complex for women who've had mastectomies due to breast cancer. We're focused on regrowing skin in third-degree burns and pressure ulcers. And so the science behind all of our grafts is really making use of donated human tissues or animal tissues and the regenerative medicine properties within those. So we utilize something that's very much like a personalized transplant. That can be transplanted on any person without immunosuppressants and without rejection. And it allows for the patient's own body to grow into it and reestablish full-thickness skin.

Oh, that's fascinating, especially the lack of rejection possibility. So how did you get a scientific idea to come up with this?

Yeah, so I guess that kind of goes back a little ways. When I was applying to graduate school, I was originally working at the Massachusetts General Hospital up in Boston working on Huntington's disease research. And when I was applying to graduate schools, I just was reading a bunch of tissue engineering papers that were interesting, and I came across this one paper that was about regrowing lungs outside the human body as an alternative to transplants. It just so happened to be in Dr. Bruce Pannell's lab at Tulane University. He's now at UNT in Texas, but before he was at Tulane. And so I read this paper and it was all about taking transplanted or transplantable lungs, removing all the cells and DNA in the process known as decellularization. So, it gives basically just an empty lung scaffold in the exact same shape and size as that lung, but has no cells, no DNA, isn't living. And the idea was to take a patient's or recipient's cells and to regrow it inside of this empty lung scaffold and to regrow it outside the human body to give them a brand-new lung, essentially, and to be able to transplant it in. And I was just kind of really blown away by that paper. And so when I applied to schools, I specifically applied to Dr. Brunell's lab, and I ended up getting in. And about a year into that research working on regrown lungs, I came across a documentary at nighttime at like 2 o'clock in the morning called Becoming Chaz. And Becoming Chaz is about the transition from Chassidy to Chaz Bono, Cher's son. And they go see a top surgeon during this transition period and to have the breasts removed. And the breast surgeon or the top surgeon explains about the potential of not having nipples anymore, about the blood supply being too weak and stuff like this. And it just kind of really stuck with me. I thought about that all night. Like I said, I would watch that documentary maybe like 2 or 3 o'clock in the morning and I stayed up until 8 or 9 in the morning reading about all types of breast surgery. And I became aware that breast cancer patients, for example, about 70% of them undergo a mastectomy during the recovery period of breast cancer, and most of them do not have nipples anymore. A mastectomy includes removing the breast tissue and most generally also removing the nipple and areola complex. And I just I guess I just never realized that. I never knew breast cancer survivor. I never knew what a mastectomy was. And I just figured we could transfer what we were doing with the lungs over to nipple and areolas and to give these patients back a new outcome of their breast reconstruction.

Oh, wow. This is just so, so impressive to learn even more about right now. And so I guess we've talked about the nipple and areola complex. Are you doing studies on any of the other projects outside of that that you mentioned? I know the nipple areola is your first kind of product line. But some of the other applications you mentioned, what is going on with those?

Yeah. So right now, the nipple and areola complex, we are in a clinical study. The other lines is a platform technology line used to regrow full-thickness skin or other soft tissue reconstructions. And we are currently in preclinical models for those. We actually partner with several labs at Tulane University, as well as University of Miami, for these projects. They include A graft for pelvic organ prolapse reconstruction. They include grafts for third-degree burn to— third-degree burns to regrow full-thickness skin, as well as pressure ulcers to regrow full-thickness skin for pressure ulcers and decrease the bioburden within pressure ulcers, as well as abdominal wall reconstruction too.

And so with these product lines, are you in clinical trials? Where are you as far as getting them into patients?

Sure.

Yeah. So the nipple and areola complex, or the NACraft is what we call it, that is currently in 2 different clinical studies. One is actually located in New Orleans. And then the other product line for the pressure ulcers and burns, those are all in preclinical models. Those will have to go through a little bit more intensive testing. So that's probably, you know, a good 5 years away from clinic.

And so for your nipple areola complex, since you're in clinical trials now, when do you see the product potentially being available to the public?

So right now we're actually FDA registered, so we're already through the FDA for the nipple graft product, the NAC graft. We are doing clinical studies to formally collect data for our own reimbursement codes, and that's important from a payer perspective so that everything is reimbursed properly. Other than that, we are currently in our early adopters. We expect some time in 2023 to start selling it.

And are the trials that are currently active still open and enrolling, or are they kind of closed right now and you're collecting the data to move towards full product?

We are currently enrolling with them. Some of the sites have, you know, are at their full capacity, but within that, there are other sites that are still enrolling.

Great. We'll put some information about that in the show notes for folks as well. Is there anything that I haven't asked you about the science today that you feel like you'd like to share with folks?

No, I think that's it.

And the one question we always ask of our startup guests, are you in any sort of fundraising round right now that people can get in on if they're interested?

I think every startup is always in fundraising mode, but yes, we currently are. We currently have a round open and, you know, we've had wonderful investors, VC and angels alike. So, you know, we continue to get support from those and, you know, we're excited to continue to grow.

Fantastic. And I think that's a wrap for this episode of Bio from the Bayou. I want to thank everyone for tuning in. And if you want to learn more about Nick, BioAesthetics, or how you can get in on this funding round with Nick, we'll have his contact info and relevant links in the show notes. And if you go to those show notes, you can always stay up to date on our activities with Tulane, LSU Health, or any of our Bio from the Bayou guests. And you can visit biofromthebayou.com for more information as well.

Thanks, James.

Nick, thanks so much for joining us today.

Thank you very much for having me.

Thanks for joining us for Bio from the Bayou, and we hope you'll join us again.

If you'd like to learn more about the emerging biotech scene in New Orleans and the Gulf Coast region, visit us at biofromthebayou.com, where we have more info on who we are, how to get involved and connected in biotech in New Orleans, and the industry events we'll be hosting where you can meet with us in person.

And we'd be remiss if we didn't give a special thanks to the Accelerator Network for providing funding for this podcast. Learn more about them in our show notes.

We'll catch you on our next episode of Bio from the Bayou.