Q&A: BioAesthetics co-founder and CEO, Nick Pashos, on Transforming Nipple Reconstruction
“When we met Hemi, it was abundantly clear that their mission was to support the entrepreneur in their endeavor. Hemi has been supporting us to get to market as fast and as effectively as possible.”
BioAesthetics is transforming plastic and reconstructive surgeries through regenerative medicine. Their initial product is a tissue-engineered nipple-areolar complex (NAC). This product will be provided to plastic and reconstructive surgeons as an off-the-shelf ready, acellular, NAC graft. During the breast reconstruction phase, after a mastectomy, the surgeon would engraft the regenerated nipple and areola onto the patient’s reconstructed breast.
Hemi led the seed round funding for BioAesthetics in 2018 together with San Francisco’s IndieBio, the New Orleans BioFund, and the New Orleans Startup Fund. BioAesthetics founder and CEO, Nick Pashos, PhD, spoke with Hemi about his experiences as a tech rebel in the field of biomedical engineering.
What is your personal mission that led you to found BioAesthetics and become a tech rebel?
I founded BioAesthetics as part of my Ph.D. work because I wanted to bring the nipple/areola graft to market and see it through to completion. It’s a personal challenge of mine to see something move from the idea phase to clinic. Even more than that, from a patient standpoint, my personal mission is to help people. If what we’re doing can help just one person, then the work I’ve been doing all these years has been 100% worth it.
The NAC graft BioAesthetics offers will be a game-changer in nipple reconstruction. Why is this important and how did you achieve this?
Women are more likely to have a lifesaving mastectomy if they can have nipple reconstruction afterward. We know that nipples play a significant psychological role in the mental health of an individual recovering from a mastectomy. This is why we are pushing forward for FDA registration. We don’t need to do preclinical or human clinical trials in order to get an approval through the FDA, but we do have to show that no communicable diseases are transferred from donor to recipient when we create the grafts.
How do you see the industry as being ripe for disruption today?
What we’ve been hearing from patients, as well as plastic and reconstructive surgeons, is that there is a need to standardize the procedure and give breast cancer survivors a new option for replacing the nipple and areola after a mastectomy.
Currently, there are three options available to women after a mastectomy. They can use a removable, prosthetic rubber nipple and areola that are non-living and non-permanent. They can get a tattoo of an image of a nipple that is also non-living and non-permanent. While this can look realistic, it has no depth to it and tattoos tend to fade, especially when there is scar tissue in the area. The other option is a nipple reconstruction where the surgeon uses skin grafts from the patient to create a nipple-like structure. These tend to fail and lose volume after a few years.
BioAesthetics offers a complete regeneration of a nipple and areola. We give breast cancer survivors a permanent solution with a fourth option at a similar cost. Ours is a permanent structure that is a living feature. The industry is ready and excited for it; now we just need to get it to market.
Your previous experience was in research. How was your experience transitioning from research to application, from academia to startup?
I’ve found my passion, and I love the field of reconstruction. Transitioning from the lab to being an entrepreneur is about going to the experts, telling them exactly what we’re trying to do, and getting their honest feedback. That feedback can be difficult to take sometimes, but it’s important to hear it no matter what. Generally, if an expert in the field can see that what you are trying to do can have a positive impact, they are willing to give helpful feedback. You have to be ready to hear some no’s and be confident to move forward.
What has been your biggest success and your greatest learning as an academic turned entrepreneur?
Building this company has taken some trial and error. I’ve learned that for things I cannot do very well, I need to find someone else to work with who has that skill set. My biggest success has been putting together a team that makes up for the areas where I lack experience and knowledge. My business partner, Billy Heim, has a skill set that compliments mine. He has an MBA and has had experience with startup companies. Our board, in particular, has helped and guided the company in the right direction.
I think the biggest challenge I faced, was self-doubt. There’s always a bit of self-doubt when you start out doing something new. Even now, several years after founding BioAesthetics, I still experience it, but I get past it by preparing myself as best as I can. You have to remind yourself that you are an expert in certain areas and then rely on the team for help with what you don’t know.
What makes you excited to go to work every day?
I love the people who I work with and that makes going to work fun. From a scientific perspective, I love the challenge of tissue engineering and regenerative medicine. Every time we overcome a challenge, there’s the excitement of moving forward and finding the next challenge. Also, from a personal standpoint, I think it’ll be really incredible to be able to help out even just one breast cancer survivor.
What would people be surprised to learn about you?
I think people would be surprised that I originally wanted to grow lungs outside the human body as an alternative to transplants. That was my project when I began my Ph.D. I had part of my lung removed when I was younger, so it was very personal for me. Then one night I was watching a documentary called Becoming Chaz where Chaz’s surgeon discussed the possibility
of not having nipples after the mastectomy. This struck me, and I stayed up all night researching reconstruction methods for nipples and areolas. I soon realized that there was a missed opportunity in the plastic and reconstructive space. I knew that I could take what I was doing with the lungs and transfer it over to the nipple and areola so I switched my entire Ph.D. project and started over from scratch.
What are some important milestones for the company ahead?
Our clinical study will be a critical milestone. Even though we can begin selling after we register with the FDA, which we have planned for the end of 2019, as part of our roll-out strategy, we want to do a clinical study first. The study will be following 15 patients over the course of one year to collect data for safety and efficacy of wound healing. We’ll also be looking at patient satisfaction and nipple projection.
Looking forward, what upcoming products, plans or geographic expansions are in the pipeline?
BioAesthetics is focused on transforming lives through advancements in biomaterials. Our first product is a nipple/aerola graft for mastectomy patients to give them a living nipple and areola. Our goal is to eventually expand this to other plastic and reconstructive needs using biomaterials, biomaterials, such as pelvic organ prolapse reconstruction.
What’s your favorite memory working with Hemi?
My favorite memory of working with Hemi is when I met Justin and Amy for the first time. When we were looking for our seed round of funding and needed an investor that would be a true partner. When we met Hemi, it was abundantly clear that their mission was to support the entrepreneur in their endeavor. Hemi has been supporting us to get to market as fast and as effectively as possible.