One of the biggest traumas in a person’s life is the loss of a wanted pregnancy. Ashley Crafton is working on a way to prevent that.

The device she’s developing, the Hannah cervical cup, is similar to a menstrual cup, but instead of catching something that’s coming out, it’s strengthening the cervical opening by stimulating it.

“Obstetrics has been a stagnant field as far as innovation since 1960s,” Crafton said. “The innovators and entrepreneurs focused elsewhere. You can 3d-print an exact replica of a 65-year-old man’s heart to build a valve just for him. It’s time for things to change.”

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Crafton’s background

Crafton started working for a Nampa obstetrician when she was 17 and has largely worked in women’s and children’s health since then, including a stint at the newborn intensive care unit at St. Luke’s Health System through college. 

Crafton and her husband both graduated from college in Idaho, went to Indiana for his master’s and doctorate degree, came back to Idaho for a brief period, and then went to Germany on a civilian assignment for the military for six years.

“I’m a nurse by trade,” Crafton explained. She worked at an army hospital, helping evacuate soldiers who were injured in the Middle East and in Africa. 

When Crafton’s position with the military ended, her husband got a job in Idaho, and she decided it was time to grow her business, Galena Innovations, which she had started in October 2019. 

How the Hannah cervical cup works

The cervix is made up of large amounts of collagen, which is the protein in our bodies that creates structures such as bone, the nose, and tendons, Crafton explained. During pregnancy, the cervix typically stays stiff due to the collagen, and the cervix is a ring of muscle tat stays tightly closed. 

However, compression breaks down collagen, and as the pregnancy progresses, the weight of the fetal head and the tension from the amniotic sac puts pressure on the cervix, which makes it soft and brings on dilation and effacement, which is what allows the baby to come out, Crafton said.

But if this happens too soon, the baby can be born too early. There are many potential causes of this, including genetics, infection, and issues with the placenta, Crafton said. And while there were caps, known as pessaries, that some people used to try to prevent this, the rates of preterm labor didn’t improve much.

“I had a patient come in, she was 20 weeks pregnant, with preterm labor symptoms,” Crafton recalled. Despite having cerclage – sewing the cervix shut with what she described as “basically a shoestring and a large needle,” the woman delivered a baby too young to survive. “It’s not the first time this had happened to me, but it really bothered me. I walked away from that knowing that if change was going to happen, it was going to start with me.”

One of the interesting things about collagen is, if you pull on it, it gets stiffer, Crafton said. “The body builds more collagen, increases collagen cross-links, and changes the biochemistry to better sustain the collagen,” she said, noting that stress on bones also makes them stronger. 

Crafton recalled that one technique for inducing labor is to compress the cervix with a balloon, so she thought of how to do something similar, more active than a pessary that just covered the cervix, that would instead use negative pressure, or suction, to strengthen the collagen over time.

The next step was to talk to researchers. “There’s only a handful of people who study pre-term birth,” Crafton said. “I wasn’t expecting to hear back. But they did.”

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What’s the status of the product now?

Based on information from the researchers, Crafton sketched out the first version of the device, had it patented, and started developing prototypes. It can be placed as early as 13 weeks, and can remain in place for the entire pregnancy, until 37 weeks, which is considered full-term, she said. 

Currently, the Hannah is in two trials. The first is basically in a petri dish, which the second one is considered ex vivo, where the device is placed on cervical specimens from uteri that were removed during a hysterectomy, Crafton explained.

Galena was awarded a grant from the National Institute of Health (NIH) to help her write an Small Business Innovation Research (SBIR) grant. The NIH awards such grants to just one person per field, and Grafton was chosen as the representative for women’s and children’s health. “They will fund our feasibility study, which will begin in January, assuming we get the grant,” she said – and the vast majority of those accepted by the program succeed in receiving their grants, she said. 

The first phase awards Galena $380,000, and as long as companies meet their deliverables, they typically move on to the next phases, which in her case will be $2 million and approximately $4 million, respectively.

Assuming the first two trials go well, the next step is to place the device on non-pregnant women and see if it creates the expected stiffness change. If it does, the next step would be to try it on a small cohort of pregnant women with short or soft cervixes, and then a larger trial after that, she said. 

Funding and exit strategy

Thus far, Galena is self-funded, and Crafton is looking to raise $2 million, probably from medical technology venture capital firms. “That’s a lot of money for an angel in Idaho,” she said. She’s also acquired a new partner, experienced in medical technology, who’s been doing startups for the past 20 years focused on women’s health, she said. 

Crafton’s goal, assuming the Hannah passes all its trials, is to sell the device when it’s ready to come to market, in about four or five years. “We will get through the regulatory and reimbursement part, do clinical research, then sell to a larger medical device company,” she said. “I want everyone to have the opportunity to have the best outcomes for their children.”

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Sharon Fisher is a digital nomad who writes about entrepreneurship.

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