Over the course of her career, Bobbi Chapman has developed a keen understanding of how women struggle with heart issues that arise, or worsen, during pregnancies.
What's frustrating to Chapman, a cardiologist and medical director for heart failure at Massachusetts-based med-tech company Abiomed, is the lack of technology to help medical professionals intervene before such conditions turn fatal.
"I can tell you, as a physician, there's nothing more devastating than having a young mother come in with a disease that is fatal, and you — if you had seen her even days or weeks or months earlier — you could have prevented an untimely death and prevented leaving a newborn without a mother," Chapman said.
Inside a small suite at the 4Front Technology campus in Oakdale, a group of healthcare professionals are developing a system designed to curb a discouraging trend in heart failures among pregnant women.
Spun out of Mayo Clinic in 2018, Marani Health, previously called Odonata Health Inc., is piloting an in-home prenatal and postpartum care system that uses an artificial intelligence application for measuring the heart rates of pregnant women and their unborn fetus. The device also monitors contractions.
A limited supply of in-home telehealth systems for pregnant women — coupled with little to no input from women in clinical trials, which are predominantly tested on white men— has led to a lack of clinical research and innovation around maternal health, said Chapman, who also leads the company's Women's Heart Initiative.
Marani's ability to send physicians real-time data about how patients are doing in their homes helps close the gap in maternal care, especially with high-risk patients, Chapman said.
U.S. maternal mortality is on the rise. In 2021, 1,205 women in the U.S. died of maternal causes, which the National Center for Health Statistics determines are deaths of women while pregnant or within 42 days of termination of a pregnancy. That's up from 861 maternal deaths in 2020, and 754 in 2019.
"For us to be a developed country and despite those medial and device innovations that we're having, an increase in our maternal mortality across all races is really alarming," Chapman said.
Ann Holder, Marani Health's chief executive, joined Mayo in 2017 as entrepreneur-in-residence, following a stint with Medtronic. She worked alongside engineers and medical officials at the world-renowned health system to create the technology.
"When Mayo first asked me if I would be interested in working on this project, that's when I started doing market research to really understand what the need was," Holder said. "And that's when I was really taken aback by how poor the technology was and the lack of investment in this area and the horrible outcomes that we have in the U.S."
Standard pregnancy monitoring systems haven't changed much in the past 30 years and can be bulky and limiting. Heart valve problems can go undetected or undiagnosed, Chapman said.
Marani's M-care system includes a wearable band filled with sensors, called the M-Wrap, that encircle a woman's stomach to measure heart beats. It also includes a smartphone app, a weight scale, a glucometer for measuring glucose levels and a blood pressure cuff.
The data and assessments are uploaded to a dashboard that doctors and clinicians can view remotely. This can help the care team prioritize patients based on data they receive.
Marani Health is piloting the system in Cody, Wyo., with Andrea Chisholm, an obstetrician and gynecologist at Cody Regional Health. When Marani asked her to participate in the pilot, Chisholm jumped at the chance.
"As a rural obstetrician, I have pregnant patients that may travel up to two hours for prenatal care. That is time consuming and can get very expensive. Sometimes this leads patients to skip visits, which compromises their care," Chisholm said.
Using Marani increased appointment attendance by her patients and reduced stress on several of them, she said. "My patients have been very happy and grateful for this technology," she said,
According to March of Dimes, in 2020, 36% of all U.S. counties were designated as maternity care deserts — a term for areas where hospitals don't offer obstetric care. Meanwhile, the number of women who experience pregnancy-related complications, or severe maternal morbidity, is steadily rising, affecting at least 50,000 women each year, the nonprofit reported.
"The benefits of the Marani platform make quality obstetrical care much more achievable," Chisholm said.
While available for home use, the M-care system can also be used in clinics during pregnancy appointments, or in the hospital during labor and delivery. It aims to give providers sharable, real-time data on patients before needing an ultrasound machine to confirm a diagnosis.
The app has resources for expectant moms, including digitized sections of Mayo Clinic's pregnancy guidelines, assigns times for moms to use the devices to check their health and can act as a communication platform for chatting with clinicians. Women can take mental health and social determinants assessments to monitor non-medical factors.
The company recently completed clinical trials for the wrap and are preparing to submit paperwork for U.S. Food and Drug Administration clearance.
Holder and fellow co-founder Kathy Tune have raised $16 million in seed funding from investors to grow the business, and have received roughly $550,000 in grants from the National Science Foundation, Duke Foundation and Launch Minnesota, an initiative of the state's economic development department that supports startups.
The cost of the M-care system for the duration of the pregnancy, and at a minimum two months after delivery, is between $1,000 to $1,500, Holder said, depending on the devices the woman needs for her particular pregnancy.
The cost of the system would usually be covered under value-based contracting with health providers, but also insurance companies, self-insured employers and possibly Medicaid, Holder said.
"There's a huge interest by the organizations that carry the financial risk for pregnancy to cover the cost of this," she said.