Innovating Preterm Birth Prevention with the Hannah Cervical Cup

Can a simple shift in how we approach preterm birth prevention save millions of lives? Discover Galena Innovations, which is developing the Hannah Cervical Cup, the solution to spontaneous preterm birth. Their mission is to change the trajectory of obstetrics from stagnation to innovation by creating solutions that meet the needs of mothers everywhere, from Mississippi to Malawi, ending the health and social inequities that are pervasive in our world, beginning with birth.

The women and the story behind Galena Innovation

Founder Ashley Crafton is a dedicated obstetric nurse with a distinguished 22-year career, demonstrating a profound passion for family, exceptional medical expertise, and unwavering empathy for women and children. Her impactful service to thousands of families includes perinatal bereavement support and vital contributions to humanitarian efforts like Operation Allied Refuge (2021 Afghanistan evacuation) and the 2022 Ukraine evacuation.

In 2019, Ashley founded Galena Innovations, aiming to enhance family wellbeing. Renowned for her knowledge in preterm birth, early start-up execution, and preclinical research, she is listed as the inventor on a number of patents, including the Hannah Cervical Cup. She earned her BSN from Northwest Nazarene University and is currently pursuing a master’s at Johns Hopkins University in Biotechnology Enterprise and Entrepreneurship. In 2022, she won the Boise Entrepreneur Week Pitch Competition, further solidifying her status as an accomplished entrepreneur. She has been happily married for 19 years and is the mother of five accomplished children.

Her journey in women’s health began at 17 as a nurse’s aide in an OBGYN office, which sparked her passion for obstetrics. She went on to study nursing, working nights in the NICU while in college, and later spent eight years in labor and delivery at IU Health Bloomington Hospital. Her experience continued with travel nursing and as a civilian nurse for the U.S. Army, where she served during the evacuations of Afghanistan and Ukraine, marking some of the most significant moments of her career.

In 2018, her focus shifted after years of working on a perinatal bereavement team, caring for families who lost their babies. Frustrated by the system's inability to prevent preterm births, she began researching the issue. She realized that existing treatments focused on compressing the cervix, which weakened it. Instead, she found that stretching the cervix strengthened it by encouraging collagen regrowth.

A tragic incident where a woman lost her baby after a cerclage procedure tore through further fueled her resolve. Recognizing that she could no longer ignore the problem, she took action, creating the Hannah Cervical Cup and founded Galena Innovations to address preterm birth prevention.

Preventing preterm birth with the Hannah Cervical Cup

Every year, 15 million babies are born preterm, the leading cause of death among children under five. Those who survive often face lifelong health complications, long hospital stays, and costly medical bills. The common factor in all preterm births is early cervical change. During pregnancy, the cervix keeps the baby inside the womb; when delivery nears, the cervix softens and opens. Without cervical change, labor cannot happen.

Traditional approaches to preventing preterm birth focus on compressing the cervix, which only worsens the problem by further breaking down collagen. The Hannah Cervical Cup works differently, applying gentle tension to strengthen the cervix, encouraging collagen regeneration. It is easy to use, it can be placed in a few minutes, and is non-invasive, making it ideal for patients and providers alike. This approach has demonstrated significant success in trials, with long-term results showing a 38% increase in cervical stiffness. The cup can also treat conditions like early rupture of membranes, which currently have no treatment options, allowing babies to develop in the womb and be born healthy.

Solving Key Issues in Pregnancy and Birth and Achievements

The biggest challenge she faced in her journey was overcoming the hesitancy to adopt novel approaches in preventing spontaneous preterm births. Despite the limitations of existing methods, there was resistance in the clinical and research communities to explore alternatives. Her persistence in pushing for a different approach was key to the development of the Hannah Cervical Cup.

Galena Innovations has made considerable progress, refining five iterations of the Hannah Cervical Cup prototype. Notable achievements include winning the Grand Prize at the 2022 Boise Entrepreneur Week Pitch Competition, securing NIH SBIR’s Application Assistance Program, and completing various research studies such as the Cervical Model study, In Vitro study, and a Cadaver study. Galena also reached a milestone by initiating the First in Human Study and securing its first patent in 2022. Participation in accelerators like MassChallenge and Tech4Eva has further boosted the company's growth.

Looking Ahead

In the next five years, the health tech industry will see a growing focus on digital health and AI. However, there remains a need for concrete diagnostic tools and preventive interventions in pregnancy and birth. Addressing the four major areas of maternal and infant health—mental health disorders, gestational hypertensive disorders, postpartum hemorrhage, and spontaneous preterm birth—will be critical for improving birth outcomes. Solving these issues will lead to significant improvements in human health overall.

In conversation with the Founder Ashley Crafton

Advice for aspiring innovators

One of the things that I hear a lot of founders say is that they have a “chicken or the egg problem” meaning that they need money to create something of value but that to raise money, they need to have created something of value already. I think one of the biggest realizations for me, was that my job as a founder is to create something of value with little resources. Anyone who goes on to become a successful founder is someone who has been able to create a chicken with no egg. Also, those that built something without resources oftentimes create something of greater value and more focused than those with resources—at least in my personal observations. So, I think the best advice I could give other founders is to find the way to build what you are building without the resources you “need.”

The role of Tech4Eva

The program of Tech4Eva is invaluable to me because it provides access to mentorship from industry experts and a community of like-minded innovators. This support is crucial for accelerating the development and success of Galena Innovations.

More info: www.galenainnovations.com

Follow: www.linkedin.com/company/galena-innovations and https://www.facebook.com/GalenaInnovations