Ashley Crafton, a former nurse and CEO of Galena Innovations, is building an AI system to prevent preterm birth, which kills 13 million babies yearly and costs the U.S. $25 billion. Her approach: an ultrasound to detect cervical softening, plus a daily treatment that stretches the cervix to rebuild collagen. A prototype stiffened a cadaver cervix in three minutes.
Chapters
After witnessing preterm birth for years as a nurse, my patient began to show signs of birth. We sewed her cervix closed, but this tore through and she delivered a baby that was too young to survive, and I had to solve this. 13 million babies are born preterm yearly, and it's the leading cause of death for young children.
My name is Ashley Crafton, and I'm the CEO of Galena Innovations. We are developing the solution to preterm birth. I'm actually a nurse by trade. I started working in women's health when I was 17. There's a lot of A lot of things that are similar about nursing and what I do now— nurses are problem solvers at the very core. Most nurses have been taught that they have a sandbox that's this big and they better be problem solving in this, and I'm not willing to accept the sandbox. I worked a lot in 2 main arenas: perinatal bereavement, which is when people lose their babies, and the other was I worked in refugee work. I evacuated Afghanistan in 2021 and Ukraine shortly thereafter. When I was evacuating all of that, I was running my startup, but then I went full-time in 2022 with my startup. Whenever anything goes wrong in pregnancy, the same question always comes up. Why can't we do anything about whatever just happened to me? Regardless of what it is, people don't understand, like, the emotional and familiar burden that it is to have these babies early. It's monumental. I realized one day I was part of the problem, that if I didn't do anything about it, nothing was going to change.
We've tried.
for the last 60 years, medications that cause harm and don't work, and we've tried them over and over and over again with the same outcomes. And we've tried to compress the cervix closed in order to stop early cervical change, which was very backwards to me because it's actually a technique that we use to induce labor. So thinking it would ever prevent a baby from coming out was bananas. I built something on my kitchen table and used those prototypes that I built to go do a cadaver study, and we stiffened this within 3 minutes, and it was just kind of miraculous, and we just kept moving forward. I have 5 kids, and my husband's an opera singer, so we already live, like, a pretty crazy life. One of my kids still lives in Germany and plays soccer for a club there, so, like, we are just ultra crazy, I guess. My parents were super supportive, actually, and so was my husband, and I honestly think there's been times, I think, for every entrepreneur out there where you're like, yeah, this is not gonna work. I don't know why we did this. My husband being like, no, this is a really important thing. I will continue to be able to have doors slammed in my face, and I will continue to have failures, and I will continue to have all of those things and push forward and cross these boundaries because it's that important. I realized one day I was part of the problem, that if I didn't do anything about it, nothing was going to change. We've tried for the last 60 years medications that cause harm and don't work, and we've tried them over and over and over again with the same outcomes. And we've tried to compress the cervix closed in order to stop early cervical cancer, change, which was very backwards to me because it's actually a technique that we use to induce labor. So thinking it would ever prevent a baby from coming out was bananas. I built something on my kitchen table and used those prototypes that I built to go do a cadaver study, and we stiffened this woman's cervix within 3 minutes, and it was just kind of miraculous, and we just kept moving forward. I have 5 kids, and my husband's an opera singer, so we already live like a pretty crazy life. One of my kids still lives in Germany and plays soccer for a club there. So like, we are just ultra crazy, I guess. My parents were super supportive actually, and so was my husband. And I honestly think there's been times, I think for every entrepreneur out there where you're like, yeah, this is not gonna work. I don't know why we did this. My husband being like, no, this is a really important thing that needs to happen. I will continue to be able to have doors slammed in my face and I will continue to have failures and I will continue to have all of those things and push forward and cross these boundaries because It's that important. Where I'm from in Idaho, there are a lot of mountains and a lot of really beautiful scenery, and so that's something that's really nice to be able to connect with the outdoors always, and something that I appreciate about this area as well. I think that is one thing that is unique about the Bay Area in general is that it's a very diverse place, and I think diversity breeds good ideas, innovation. It's embraced when people think about things differently, which isn't the case in a lot of other areas. And that's something that is really refreshing as an entrepreneur to see good ideas spur on and grow other good ideas. I've been in other pitch scenarios where their whole intent is to tear down Everything you're trying to build. Tim's not like that at all.
After witnessing preterm birth for years as a nurse, my patient began to show signs of birth. We sewed her cervix closed, but this tore through and she delivered a baby that was too young to survive. And I had to solve this. 13 million babies are born preterm yearly, and it's the leading cause of death for young children. Survivors face complications and hospital stays costing the U.S. $25 billion yearly, with racial inequities and a 60-year tech gap. Causes are varied but have one commonality: cervical change. In pregnancy, the collagen-rich cervix keeps the fetus inside the womb. At delivery, the role reverses, and it then facilitates birth by changing. Positive pressure through pregnancy breaks down collagen, leading to cervical change and then birth.
A baby!
Aside from medications that cause harm and don't work, prevention tools aim to compress the cervix closed. This weakens the cervix and can lead to birth. Our unprecedented tools work completely opposite. The ultrasound diagnostic detects a soft cervix, and our daily treatment used in early pregnancy stretches the cervix, causing collagen regrowth and stiffness. Stiff cervices don't change, and babies don't deliver early. We'll be to market in 3 years, Selling to developed world health systems, and we will be bringing access to the developing world. And when you improve the life of a mother or her child, you improve a family, a community, a generation, and a society. Let's be that change together. What percentage of preterm births come preterm because of the cervix problem? It's interesting, 100%. In order for a baby to come out, regardless of what the cause is, the cervix has to—
So sometimes they die in there? Yep.
That's not preterm birth. But anytime the cervix changes and a baby comes out of the body, that is a preterm birth.
