New generation of female entrepreneurs tackles women’s heart health

“We cannot let women continue to die avoidable deaths,” said Maayan Cohen, co-founder and CEO of Hello Heart, a Menlo Park, Calif.-based company founded in 2013 that offers Bluetooth-enabled blood pressure monitors and sex-specific digital coaching to help both women and men reduce their risks for heart attacks and strokes.

Many of these firms are dubbed FemTech because they employ technology to address health issues that affect women in unique ways, from life cycle changes such as menstruation and menopause to chronic illnesses such as heart disease. In the case of the heart-health-focused companies, some of their founders are also scientists and clinicians who seek to close historical gender research gaps that they say have made the male body the default standard — with the result that women with heart disease are not just understudied, but also often underdiagnosed and undertreated.

Heart disease is still the No. 1 killer of women

“This presumption that women are somehow lower risk because they’re a woman, or that heart disease doesn’t affect women before menopause is simply not true,” said Erin Michos, director of women’s cardiovascular health research at Johns Hopkins Medicine. “I just published a paper … showing a certain type of heart attack is on the rise in women under the age of 45. … This is why we all need to start thinking about prevention really early.”

Federal data show that over 60 million women in the United States, or 44 percent, have some form of heart disease, which can affect them at any age — not just after menopause, as is commonly believed.

Women share risk factors with men, such as high blood pressure, elevated levels of LDL cholesterol, diabetes, obesity, smoking, depression and a sedentary lifestyle. But they also have distinct risks related to early menstruation or menopause, inflammatory conditions such as lupus and rheumatoid arthritis, and polycystic ovary syndrome. Pregnancy complications such as gestational diabetes, giving birth prematurely and preeclampsia can also pose long-term cardiac risks. “Even 50 years after a pregnancy with preeclampsia, a woman has greater cardiovascular risk and earlier mortality compared to women who didn’t have preeclampsia,” Michos said.

The good news is that most coronary artery disease can be prevented or managed through lifestyle changes and treatment, if caught early. But the health-care system has done a poor job at identifying those at risk — especially women and people of color. In 2021, the latest year for which data is available, heart disease was responsible for the deaths of 310,661 women, or about 1 in 5 female deaths. Yet more than half of women cannot identify heart disease risks and are unaware of their own susceptibility. Worse, diagnostic tests and treatment guidelines are still largely based on the disease’s progression in men — a factor that sometimes leads to subpar treatment in women.

Michos noted that women have been shown to benefit as much as men from lipid-lowering drugs, for instance, “but across the board, they’re under-prescribed these therapies.” Even those who have had heart attacks or strokes are less likely to get lifesaving medications and other interventions.

Solutions by women for women

Enter the FemTech companies — over 60 percent of which have been founded in the last five years, and over 85 percent of which are led by women, said Brittany Barreto, founder of FemHealth Insights and host of the FemTech Focus podcast, who tracks the sector.

“Women in STEM science are disproportionately working on women’s health solutions, and they are also funding those solutions,” Barreto said.

Cohen of Hello Heart compares investors’ newfound interest in women-focused health-tech companies to advertisers’ realization in the 1950s that female consumers constituted an enormous untapped market. “‘Mad Men’ portrays how they had this revelation that women buy things, and they should be a major advertising target. We’re seeing some of the same thing now in digital health — [a realization by venture capitalists] that there is a huge, potentially lucrative market that they haven’t been serving.”

While many of the companies are fledgling — in some cases, still awaiting regulatory sign-offs for new devices — investors and analysts are bullish about the sector’s potential. “While it’s still early days, our research indicates that the dynamics underlying FemTech are accelerating: Public awareness, company formation, and funding are surging,” said a 2022 McKinsey report entitled “The Dawn of the FemTech Revolution.”

Alicia Chong Rodríguez’s start-up, Bloomer Tech, named for the 19th-century suffragist, for instance, has developed the Bloomer Bra — an everyday piece of underwear redesigned to track data about the wearer’s heart, lungs, hormones and metabolism. Chong Rodríguez’s goal is not just to enable better diagnostics and monitoring, but to accelerate collection of medical-grade data to drive development of new therapies and care models for women with heart disease.

She and her colleagues have developed, patented and tested flexible, washable circuits to turn articles of clothing into devices that can relay reams of information to the wearer’s smartphone through a Bluetooth-enabled app: data that the wearer can also choose to share with her doctors.

Chong Rodríguez said she was spurred to this work by the fatal heart attack of her grandmother for whom she was named. Later, as a grad student working in MIT’s computational cardiovascular research group, she was struck by how much of the data used for medical decision-making is “basically missing women.” That’s because premenopausal women were excluded from clinical trials until 1993 — a policy born out of the desire to protect women and their children from potential adverse effects after the thalidomide scandal, and reinforced by researchers who regarded menstruation and pregnancy as complicating variables. Despite calls and even mandates for their inclusion in trials today, women — especially those of color — are still underrepresented.

Heart health, women and the limits of exercise

“For a long time, there was this mistaken idea that women are basically small men, except of course for reproduction,” Chong Rodríguez said. “This oversimplification can lead to harm. It is already harder to recognize, diagnose and treat women with heart disease because there are a lot of things about the physiology of women we don’t know or fully understand. And training AI with limited data and variables could actually perpetuate this problem.”

Bloomer Health recently received $1.9 million from the National Institutes of Health for a clinical study, which Chong Rodríguez believes will accelerate the device’s adoption. “The more women who wear this medical device, the more we will understand female physiology, and be able to develop female-specific digital biomarkers that give us better ways to diagnose and treat all the conditions in the heart that are unique, disproportionate or different in women.”

Kathy E. Magliato, a cardiothoracic surgeon whose 2010 memoir, “Heart Matters,” inspired a TV series about a female heart surgeon, also became an entrepreneur out of frustration with the status quo. She said she founded Cordex Systems, a health tech start-up, because she was discouraged to be operating on increasing numbers of young women. “We can prevent 80 percent of heart disease,” she recalled thinking. “So why is it still the No. 1 killer of men and women? And the answer goes back to how we’re really missing the boat on early diagnosis.”

She and her business partner, bioengineer Michael Whitt, sought to change that by designing, patenting and testing a “smart” blood pressure cuff that can detect the earliest signs of stiffening of the arteries through subtle changes in vessel linings — a process that makes women more prone to heart disease. The SmartCuff has been tested in over 700 patients at Johns Hopkins Medicine. Magliato said she is raising money to expand the number of testing sites and to seek regulatory clearance.

After that, the company plans to market the tool to track the effectiveness of lifestyle changes and medications in individuals with coronary artery disease. “I can only operate on one or two patients a day, right?” she said. “But imagine if I build a technology that can serve thousands of patients every day. That’s what keeps me going.”

Cohen, of Hello Heart, is attempting to change women’s health outcomes by educating them. The company launched a public campaign in 2023 with the slogan, “If you feel something, say something,” to raise awareness about how heart attacks in women may look different than they do in men, or from what’s portrayed in the movies. Women’s symptoms may include nausea and stomach upset; and fatigue and soreness in the jaw, arm, shoulder, upper back and neck, in addition to pain or pressure in the chest area.

The challenge of caring for women’s hearts

Meanwhile, the 2 million members (about equal numbers of women and men) in Hello Heart’s digital coaching program — largely through their employers or health plans — get real-time, sex-specific feedback. The app informs them not just about their blood pressure, but about potentially irregular heartbeats, lab results and the impact of medications, weight and physical activity. They might see a chart pop up on their cellphone after taking a walk, for instance, showing how it lowered their blood pressure. A peer-reviewed 2021 study validated its approach, finding that 84 percent of those with high blood pressure not only reduced it but kept it down for up to three years.

Cohen said she’s just getting started. “We’ve waited long enough,” she wrote in a letter published in the New York Times Magazine, announcing a campaign to seek more funding for women’s heart research and better clinician training around their symptoms. Among the several hundred signatories were Thrive Global CEO Arianna Huffington, NCAA volleyball star and heart health advocate Asjia O’Neal and former Food and Drug Administration commissioner Peggy Hamburg.