Biotech Startup Takes On the Challenge Of Nipple Reconstruction
Surgeons have several options when it comes to rebuilding breasts after surgery related to breast cancer. But for replacing nipples, women have fewer choices.
A startup biotechnology company in San Antonio is working to develop a better way to rebuild nipples after cancer surgery. Two young scientists saw a niche and decided to try and fill it.
Melissa Ramirez, 40, of San Antonio had breast reconstruction with implants after a double mastectomy four years ago. But no nipples.
"You feel like you’re a little bit incomplete," Ramirez explained, "like something is missing."
She decided not to have tattoos or a plastic-surgeon created piece of scar tissue to replace that lost part of her anatomy.
"It’s not that it’s bad. It’s not that it’s highly important. But to you it’s very personal," she said.
Ramirez chose to have her breasts removed when she found out she carries the gene that women of seven generations before her had…one that puts her at high risk for early, aggressive breast cancer. But the current options for a new nipple weren’t for her.
"It’s like slapping a coat of paint on something," she commented. "It just covers up but doesn’t really serve a purpose. It’s just aesthetics."
Enter Bianca Cerqueira, a newly-minted biomedical engineering Ph.D. She just earned her doctorate at the University of Texas at San Antonio.
"The paradigm of a nipple reconstruction hasn’t changed in over forty years," Cerqueira said. "We decided, okay, you know what. Let’s do it. Let’s go forth and try to make this a reality."
Cerqueira and her partner, Ph.D. student Lauren Cornell, are developing a new way to replace nipples after breast surgery. Their company is NovoThelium. In Latin, that means new nipples.
Cerquiera and Cornell are perfecting their technique in lab space at the San Antonio Technology Center. It was donated to them after they won a business model competition at UTSA.
Using nipple and areola tissue from cadavers, the lab team starts by decellularizing the skin.
"So basically, you take the piece of tissue and you remove the DNA and cellular components, and that leaves behind a collagen scaffold that can be implanted into the patient," Cornell said.
Cornell says that scaffolding would provide the environment for the patient’s cells to grow into.
The pair has applied for a patent on the technique. Testing on pigs could start later this year.
According to Cerqueira, the fledgling company has relied on contest winnings and grants to move forward. "We are scientists trained as engineers," she stressed. "We didn’t have a lot of business background."
She says a grant from the National Science Foundation funded a trip to Houston’s renowned MD Anderson Cancer Center. There they interviewed breast cancer patients and plastic surgeons about their needs.
"You have to interview people who would be potential end users for your product to see if the product that you have addresses a need that they have," Cerqueira said.
In just two years, these young entrepreneurs won 13 science business model and innovation competitions. That’s added up to free office space and more than $132,000.
If their idea is successful in human trials, they stand to make back that investment plus much more. With more than a hundred thousand breast reconstruction surgeries in the U-S each year, the potential market for their product is huge.
Cerqueira says the business side is complicated, but their ultimate goal is simple. "Instead of just recreating the appearance of a nipple, we want to give women an actual nipple made from their own cells after mastectomy."
The scientists acknowledge not every woman would opt for their product.
"There are going to be some women who say ‘I don’t need a nipple’ and some women who are writing us now and saying “please tell me when this is available. I need this, like I want this for my emotional well being and my sense of self.’ We’re in the age of tissue engineering," Cornell added. "We should probably apply some of this to women’s reconstruction."
Women like Ramirez say the idea is appealing. "Having a complete reconstruction with the possibility of a natural nipple that’s grafted into us is very thrilling and exciting at this point in time…just the possibilities," she said.
So far, business and bioengineering experts have supported the commercialization of that possibility with dollars.