Boise Entrepreneur Week Main Pitch Competition winner fights against preterm births 

Ashley Crafton, winner of the $50,000 Main Pitch Competition during Boise Entrepreneur Week 2022, is in a fight for life.

That fight is guided by her desire to prevent preterm births and miscarriages using a cup she developed to reinforce a woman’s cervical tissue. 

“The impetus for each early birth is unique, but has one commonality: early cervical change,” said Crafton, founder of Galena Innovations. Preterm births occur when supportive collagen tissues break down too early in the pregnancy. 

To prevent those changes from causing the loss or injury to a preterm baby, Crafton developed the Hannah Cervical Cup. The device, she said, is applied with a small amount of suction, causing collagen realignment and stiffness. 

“Over time, tissue becomes more supportive with an increase in collagen synthesis, among other things — a known phenomenon with collagen,” she said. “Stiff cervices don’t change, and these babies don’t deliver early.” 

Crafton said Galena Innovations performed in vitro studies that showed these changes, and the intent is to place the cup on cervical specimens this fall. 

“It can be used to treat early rupture of membranes — for which there’s no treatment — by allowing fluid to re-accumulate. This solves a huge problem because amniotic fluid is crucial to lung and limb development,” Crafton explained further. “These babies can then be born healthy. The goal is that we improve birth outcomes and decrease hospital stays, money lost in Medicaid reimbursement, and prematurity associated costs.” 

After delving deeply into research covering preterm birth, Crafton said she knew she had to be the impetus for changing interventions that largely hadn’t changed since 1960. 

“As I was reading, I had an idea of what I thought it would take to prevent a (preterm) birth from happening,” she said. “This spurred me to talk to a patent attorney and file a provisional patent, talk to some medical device companies, and eventually get the courage to reach out to a group of cervical physiology researchers studying preterm birth. To my surprise, they wanted to talk to me and verified the concept. I also reached out to some medical device entrepreneurs at Stanford, and they told me I was on to something.” 

“Since that time, we’ve grown a lot,” she continued. “We have a working prototype, have completed our first round of research, have our first patent issued, have a very supportive business and scientific advisory board, and are raising a seed investment round.” 

There is still plenty of work to do before the device becomes widely available; the device needs to go through a series of clinical trials and gain FDA approval.  

“We are working on that process now,” Crafton said. “We had our first patent issue in April, we have another pending in Europe, and more provisionals filed.” 

The plan is for the device to be placed on human women for the first time in 2023. 

“The money from Boise Entrepreneur Week is going toward the creation of our prototype that is ready for human use for this study,” Crafton also said. “We are a few years from market, as medical devices take time to develop, so things like manufacturing, distribution and scaling will come with time.” 

The goal at Galena Innovations, she said, is to ensure the Hannah Cervical Cup is a solution for everyone, including those on Medicaid and those in low-income, low-resource countries.  

“We plan on ensuring that the Hannah is available for families on Medicaid — over half of mothers receiving maternity care,” she said. “We also plan to lend our IP to our own nonprofit that will make the device available to (millions of) women in the developing world. Because of the simplicity of the Hannah, it is perfectly suited to be used in this setting. Any solution that cannot do both of these things only contributes to health and social inequities.” 

“The health of a woman and her child are inseparably connected — the improvement of one always improves the other,” Crafton said. “When you improve the life of a woman or her baby, you improve a family, a community, a generation, and a society. I want to be that change.”