San Antonio-based HERA Biotech holds the keys to a technology that could improve the lives of millions of women worldwide.
HERA is developing an innovative nonsurgical diagnostic test for endometriosis, a chronic disease that causes tissue growth outside the uterus, according to the World Health Organization.
Endometriosis affects approximately 190 million women globally. The condition has no known cause and no known cure, and it has long required invasive surgery for diagnosis, though ultrasound imaging has recently been used. That ultrasound imaging is not always accurate though, so HERA is developing a new, nonsurgical diagnostic test meant to more accurately diagnose endometriosis and reveal the stage of the disease.
"The only way, according to the FDA, to definitively diagnose endometriosis is to conduct a surgical procedure (that) goes into the women's abdomen and tries to find the lesions growing," said Somer Baburek, co-founder and CEO of HERA Biotech. "The problem with that is about half the time, what they biopsy from the abdomen is not endometrial tissue."
HERA's patented method, MetriDX, utilizes single cell micro-fluidic analysis of endometrial cells obtained through a uterine brush biopsy to diagnose and stage endometriosis. Not only does MetriDX eliminate unnecessary surgery, it also delivers results much more quickly, according to Baburek.
"Right now in the U.S., it takes eight years to get a diagnosis, mostly because of that surgical procedure," Baburek said. "We're talking about something that could be as simple and routine as a Pap smear."
HERA is targeting multiple markets with its solution, including OB/GYNs and fertility clinics, and even drug manufacturers.
"If a drug manufacturer wants to develop a drug that can claim that it treats endometriosis, they have to be able to prove to the FDA that their drug is having efficacy on the disease state itself," Baburek said. "The only way to prove that today would be to cut the woman open multiple times over a clinical trial to show somebody or visualize that the lesions were getting smaller or that there weren't as many of them. Our tests can do that without cutting anybody open, and nobody's going to let you cut women open multiple times."
With a second clinical trial underway, HERA is already attracting attention from investors and prospective buyers. In August, HERA raised approximately $2 million in seed funding led by Althea Ventures and three other investors. HERA also recently signed a Letter of Intent with Oklahoma-based Mate Fertility, Baburek told the San Antonio Business Journal.
HERA is a rare woman-led startup that has succeeded in securing venture capital funding. Women-led startups receive less than 3% of all venture capital investments, according to the Harvard Business Review.
What has helped, according to Baburek, is using her background in venture capital to "relate to the investor as opposed to trying to make them understand the problem."
"A lot of female founders, especially in women's health, start behind the eight ball because they spend a huge portion of the time that they have with an investor convincing them of the problem," Baburek explained. "It leaves little time for them to really dig into the business case and why the investor should care. So, I really try to equate it to something relatable to men, and from there, simply focus on the business case."
HERA will launch a $15 million Series A funding round to fund its third trial, launch its lab-developed test, and complete FDA and IP filings of new indications.
