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Biotech may help mastectomy survivors
October 14, 2017

Bianca Cerqueira (left) and Lauren Cornell are the founders of NovoThelium, a biotech startup company working on nipple regeneration. William Luther / San Antonio Express-News

By Silvia Foster-Frau STAFF WRITER, San Antonio Express-News

Imagine staring at your body in the mirror every morning and feeling like something was missing. Or that it was abnormal - deformed, even.

Two women who co-founded an award-winning company called NovoThelium, which would provide nipple regeneration technology for women who have had mastectomies, have heard about that reaction.

"What we hear most often from these women is they want to feel complete. That word is universally used," said Lauren Cornell, 30, a doctoral student in a translational science joint program at UT Health San Antonio, the University of Texas at San Antonio and other institutions.

"The women that decide to go through it have almost unanimously told us, when they looked in the mirror, it reminded them of what they'd been through. But they wanted to move on with their life," said Bianca Cerqueira, 31, who recently received her Ph.D. in biomedical engineering.

For years, doctors have used a "decellularization" process to replace defective heart valves with functional ones and regenerate skin for burn victims. The process has not been used to regenerate nipples - and this startup is hoping to change that.

NovoThelium proposes to take donor nipples and dunk them in a serum that strips them of their DNA and other cells, leaving intact a cellular scaffolding - called the extracellular matrix - and growth cells that allow for regeneration. When the nipple is attached to a reconstructed breast, the patient's own cells are expected to repopulate the cellular gaps in it, returning some sensation and possibly some color.

The nipple, in essence, will become the patient's own. NovoThelium plans to begin animal testing on pigs this fall, with clinical trials on humans next summer.

Since last year, NovoThelium, which means "new nipple" in Latin, has placed in all 11 competitions it's entered, and won first place in nine.

The national InnovateHER: Innovating for Women Business Challenge put it in the top 10 out of 150 first-place winners in cities across the United States. On Oct. 26, Cerqueira and Cornell will fly to Washington, D.C., to give a two-minute presentation and try to win the $40,000 first-place prize.

So far, the two women said, they're $15,000 deep into their international patent application and expect to wind up paying at least $30,000 for it by the time it's approved.

"We think about nipples all day, every day, all the time," Cerqueira said.

Breast reconstruction often follows mastectomies but the two found many drawbacks to nipple and aureola reconstruction. They're hoping their process will ensure a permanent, minimally invasive solution.

"There's a lot of research showing that nipple reconstruction significantly improves the woman's sense of self, being able to liberate herself, and her overall sense of well-being - things that are a little more difficult to quantify," Cornell said.

She said her grandmother got breast cancer and didn't want a mastectomy because she didn't want to appear deformed. When she eventually had the procedure it was too late, Cornell said. She died when Cornell was 11 years old.

Some women get tattoos to fill in the blank stretch of skin, adding three-dimensional shading to give the nipple a more realistic look. Others opt for a silicone prosthesis, which can be costly and must be applied to the breast daily, like a sticker.

A third option is a surgical skin flap, in which skin on a reconstructed breast is cut and folded like origami to create a scar mound in the shape of a nipple. Some women then choose to get a tattoo over the mound to add color.

"All of these just recreate the look of a nipple," Cerqueira said. "And there's not really a very good permanent solution for them. It's very temporary."

The tattoos lack the dimensionality of a nipple. The prosthesis must be applied daily. As for the surgical skin flap, the body works to heal the scar over time, flattening and spreading the pseudo-nipple, and the multiple surgeries it requires is often the last thing women want if they've already been through radiation treatment, a mastectomy and breast reconstruction.

Cerqueira and Cornell met while working on their master's degrees in biomedical engineering at UTSA, calling it "love at first sight." It was 2011 and the scientists would meet outside of class and brainstorm future inventions.

"We'd come together and have tea at my house. I have a fancy little tea set," Cerqueira said.

"We started off with silly things like banana bread or quilts - we were very entrepreneurial - and then kind of worked our way up to biotechnology," Cornell said with a smile.

Two years ago, they took their nipple regeneration idea to UTSA's Center for Innovation, Technology and Entrepreneurship, which kicked their business into gear. That summer, they attended the seven-week MD Anderson I-Corps Regional Program and by October, the company was founded.

Their first competition was one year later, where they won first place in the Women's Start Up Pitch Competition at the Governor's Business Forum for Women. A photo of them holding their $5,000 check hangs in their office at the San Antonio Technology Center.

They haven't stopped placing in local and regional competitions since. It's not without challenges. They acknowledge that being young women talking about nipples in the STEM field has brought its share of gender-based criticism.

Some people are less likely to take them seriously, and one time a male scientist recommended they restructure their business model in case of "life changes."

"We keep showing up," Cornell said. "And people are like, 'They're not going away.' And we're not."

The two have met with 80 to 90 women with breast cancer for their research. It's knowing those women, they said, that pushes them every day.

"This project has given me purpose, enthusiasm and drive that I lost along the way," Cerqueira said. "I'm grateful that we have this. And that I get to do it with my best friend. I mean, how lucky are we?"

sfosterfrau@express-news.net

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