A pair of earrings could provide much more than a fashion statement with the help of two Greenville entrepreneurs.
Dr. Lindsey Calcutt and Theresa Gevaert plan to soon begin clinical studies in Greenville for an earring that could help women track their fertility, sleep, energy, thyroid function, heart rate, breathing, stress, and more. They co-founded Incora Health to study and market the earrings.
“It’s similar to an Apple Watch or a Fitbit, but we’re focused on fertility and overall holistic health,” Calcutt says.
The data collected by the earrings – and the app and software that go with them – is beyond the capacity of a smartwatch, she says.
“The Incora smart earrings are made for women, by women, to empower women with personalized and reliable insights. Each wearer can get a full picture of her health,” says Gevaert, who moved to Greenville in 2005 and spent five years as Executive Producer at WYFF television news station.
“The meeting place of human need and new technical capabilities is where great products are born,” she says. “That’s exactly why our smart earrings are poised to become an incredible advancement in women’s health.”
Gevaert says she was taking her temperature and recording the results each day as a method of natural family planning when she realized that the earlobe could be a more convenient and accurate place to collect biodata.
“The earlobe has a consistent blood flow, which means that temperature readings are steady and less affected by external factors,” she says. “The earlobe doesn’t have bones and muscles to interfere with readings.”
Gevaert created a prototype of a temperature-sensitive earring for pierced ears with the help of her husband, Matt.
To obtain a patent, she sought help from Calcutt – who has a doctorate in bioengineering from Clemson University and was consulting with startup companies to help market their medical devices.
The women began exploring other data that the earrings could collect and formed Incora Health two years ago.
So far, 1,000 women have asked for information about the earrings through the company’s website, incorahealth.com. The earring resembles a pearl stud, though other designs are in the works.
The earrings have been studied in-house, but the company has applied to the Institutional Review Board at Prisma Health for approval to recruit patients for clinical studies.
Calcutt says the initiative is championed by Marjorie Jenkins, M.D., Dean of UofSC School of Medicine Greenville and Chief Academic Officer for Prisma Health-Upstate.
The School of Medicine and Incora working together is a “great example of innovation and academic medicine collaborating to improve the health of women,” Jennings says.
FDA approval is not required to market the earrings as a wearable health device, Calcutt says. “To market the earrings as birth control, we do have to get FDA approval for that,” she says.
A woman’s body temperature increases slightly when she is most likely to become pregnant. But the burden of taking a temperature reading every day and faithfully charting results – plus variables such as time of day and hydration – can interfere with what has been known as natural family planning.
“You need to capture your body temperature, ideally, when you’re in your deepest sleep. It’s not convenient. That’s why it’s not been widely adopted,” Calcutt says.
“We’re collecting that temperature automatically through the earring. We anticipate the probability that it will be more accurate.”
Regardless of their goals, women need more information about their health, says Calcutt, who moved to Greenville six years ago.
Even with her education and experience, Calcutt says she had many questions and no answers when she experienced complications during and after her pregnancy.
“I was back in the ER on Christmas Eve, four days after having my daughter,” she says.
Her blood pressure was high, she was fainting.
“I thought, ‘This is completely unacceptable. If I can’t figure out what’s going on with my body, what are other women doing?’” Calcutt explains.
“Everybody was in the dark hole of not understanding. There were no baby blues conversations. No focus on the mom. The U.S. is No. 1 in maternal death rates among all developed countries in the world. It is unacceptable. Unacceptable. Things need to change.”
Until 1993, pharmaceutical companies and medical companies were not required to include women in their clinical studies, Calcutt says. “That is mind-blowing. Think about the conditions that women experience, whether it’s a heart attack, thyroid, gastrointestinal, autoimmune. We don’t know what’s going on with women, specifically because their health has never been researched properly.”
Dr. Jennings says that gender bias is woven into the fabric of scientific data and health care. “This first-of-its-kind wearable will both inform and empower women to own their health narrative. Through precision technology, such as Incora, women can move past one-size-fits-all health care delivery.”
Gevaert concurs. “As women, we face unique health challenges. Our bodies experience changes, not only on a daily cycle, but also on a monthly cycle.”
Traditional medicine is based on a 24-hour cycle, which is a man’s cycle of physical and hormonal changes, Calcutt says.
If a woman understands her unique cycle of hormones, energy, mental acuity, and physical and emotional health, she can more easily fulfill her priorities for life, work, family and sleep, Calcutt says.
A woman will also be aware when something seems amiss.
“The purpose and mission of Incora is to empower women to understand and be more educated about their bodies and to have more informed conversations with their doctors, seek better care, and to do the things they want to do in life,” Calcutt says.
“Understanding your overall health can benefit your overall life. Understanding is powerful.”
Incora Health is continuing to collect the names of women who are interested in the earrings or want to participate in future clinical studies. For information, go to incorahealth.com or find Incora Health on Facebook or Instagram.
The company also plans to host educational sessions in Greenville to introduce the product. Plans are for the earrings to be on sale in the next several months, after the clinical studies.