At a nondescript office nestled on Edison Way in North Fair Oaks, a small company is hard at work developing a medical device that could transform the way physicians treat postpartum hemorrhage, the world's leading cause of maternal death.
Alydia Health, led by CEO and longtime Menlo Park resident Anne Morrissey, is working with the Food and Drug Administration to complete a clinical trial to evaluate whether the device the company has developed effectively stops bleeding after a woman gives birth in instances of postpartum hemorrhage.
The condition causes about 35 percent of all maternal deaths, according to the World Health Organization. According to the Centers for Disease Control and Prevention (CDC), severe maternal morbidity – defined as when a labor or delivery has unexpected, significant short- or long-term consequences on a woman's health – has been steadily increasing in the U.S. in recent years, nearly tripling between 1993 and 2014.
Generally, in the U.S. and developed countries, drugs are the first line of defense against bleeding after a baby is born and the placenta comes out. Specifically, mothers are typically given a drug called pitocin, which induces the uterus to contract to close off the arteries that had been used to nourish the fetus. If that doesn't work, then often what's called a "balloon tamponade" is used to apply pressure to the bleeding parts. In mild cases, the woman may be sent home anemic or may need to receive a blood transfusion, and in more serious cases, a woman may be required to undergo a hysterectomy or may even die if the bleeding can't be stopped.
The device Alydia is developing is a simple one, built on an idea developed, in large part, by Jessie Becker, a young biomedical engineer. In 2010, as a student at California Polytechnic State University, Becker was on a team of two doctors and two engineers in a competition put together by PATH, a Seattle-based international global health nonprofit, to develop a better balloon tamponade – a medical device that essentially operates like a balloon, inflating inside the uterus and applying pressure to the source of the bleeding.
Morrissey said the idea for Alydia's device came about when the two doctors and engineers were gathered together one weekend to brainstorm about their project for the competition.
"These engineers, like good engineers, and not knowing anything (about the physiology of childbirth) or having preconceived notions, asked the basic question, which is, 'When a woman has a postpartum hemorrhage, physiologically, what's happening?'" Morrissey said.
The doctors, she explained, said something to the effect of, "Well, the majority of the time it's because the uterus can't contract."
What can happen after childbirth, she said, is that in some cases, the uterus is too exhausted to contract anymore.
"It's like if you go run a marathon and you have nothing left to run another 500 feet. That's basically this: The uterus is all out of gas," she said.
If the uterus is unable to close itself off, then the big blood vessels that the mother has developed to feed the fetus through the placenta can keep bleeding, up to 800 milliliters a minute, one Alydia Health employee said.
Then, Morrissey added, the engineers asked, "'Then why would you put something in there (the uterus) and blow it up? That doesn't make any sense.'"
Becker and her colleagues concluded that the balloon method does the opposite of what the woman's uterus naturally does to stop the bleeding, which is to collapse inward. She and her colleagues completed the competition, but held onto the idea that perhaps working along with the body's natural programming might be more effective, Morrissey explained.
Becker further developed the concept at The Fogarty Institute for Innovation, a Mountain View-based center that promotes medical innovation, Morrissey said.
The device that was developed is a simple lasso-shaped silicone loop soft, like a pacifier, Morrissey said attached to a low-pressure vacuum that helps compress a woman's uterus when she is bleeding after childbirth by sucking out the blood and helping the uterus contract naturally.
Becker was 21 years old when she co-founded Alydia, then called InPress Technologies, with Nathan Bair in 2011. After graduating from Cal Poly, she worked at the university's Center for Innovation and Entrepreneurship while she developed the device until the summer of 2013.
"What drew me to InPress was the clear need for the technology, my vision that it could make a clear difference in improving maternal health globally, and the fact that I was well-suited to bring the company forward from its early days," she said in an email.
Testing its impact
A pilot study of the device, published in "Obstetrics & Gynecology" or the "Green Journal," found that in 10 out of 10 cases, the woman's bleeding stopped within two minutes after it was determined that drugs weren't stopping excessive bleeding.
Currently, Alydia Health is conducting a clinical trial of 107 patients to evaluate the device's effectiveness. The trial is in its early stages: The company has so far tested the device on only five patients at six centers across the U.S., but plans are in the works to have the device ready for use at 12 centers by the end of the first quarter of 2019, Morrissey said.
The trial is expected to run for 12 to 18 months, and the device may reach the market as soon as the end of 2020, she said.
The business' strategy has changed since Morrissey began leading the company, according to a recent article about the business in Forbes. While Becker's focus had been on bringing the product to the developing world, Morrissey has shifted the focus to include distribution on domestic soil too, with the first goal of attaining product approval from the FDA.
But the goal of helping mothers safely deliver babies in the developing world "is an essential part of our strategy," she said. The product aimed at the developing world will likely have to be differentiated so it can work in places where medical providers can't rely on a stable source of electricity, she noted. "I think it's the right thing to do as a human, but I think it makes good business sense to have a longer view of the product trajectory and making it as easy as possible to use."
The company now has about nine full-time employees, plus consultants, and on Sept. 20 it closed an initial $10 million in Series B fundraising, led by Global Health Investment Fund.
People who work on medical devices generally like developing products that impact lives, Morrissey said, but this specific device is unusual in the industry.
"Not very often do you get to work on one that so clearly saves lives," she said.