Starting with any relevant education, walk me through the twists and turns of your career to date? How did one opportunity lead to the next + what was the key takeaway/ experience in each role + how did this lead you to where you are now?
I began working in women’s health when I was 17 as a nurse’s aide in an OBGYN’s office, ironically enough on September 11, 2001. I fell in love with all things obstetrics and decide to study nursing in college, knowing that women and children would be my life’s work. I also knew that I had to be ready to help in a time of crisis—I was never one to sit on the sidelines. I worked nights in the NICU while attending college and got a job at IU Health Bloomington Hospital labor and delivery in Indiana as soon as I graduated. I worked there for 8 years. This is where I was taught by a great group of nurse-moms what it means to be a nurse, advocate for moms & babies, and problem solve. I worked some travel jobs for a few years after that and then was blessed with the opportunity to work for the U.S. Army at Landstuhl Regional Medical Center in Germany as a civilian nurse alongside my military teammates. While there, I had the opportunity to be on the medical team that evacuated Afghanistan during Operation Allied Refuge in 2021. 20 years to the day of my first experience serving mom’s and babies, I was serving my country by caring for mom’s and babies. This was followed with volunteering to evacuate Ukraine as well. Both were some of the biggest privileges of my life.
The trajectory of my career, though, really changed in 2018. For the entirety of my career, I’ve been a part of the perinatal bereavement team, taking care of families that lose their babies. Whenever a family loses a baby, the same question always comes up: “Why can’t we do anything about this?” And hearing this question and not having a good way to answer it was disheartening, to say the least. I was frustrated by a system that was failing families, so I decided to just read about preterm birth. This is the biggest contributor to bereaved families and seemed like a good place to start.
As I read through the research it seemed pretty clear—the job of the cervix is to keep a baby inside until its time for delivery and then its job is to open up and allow a human to exit someone else’s body. There’s a lot of things that contribute to preterm birth, and birth in general, but regardless of any factors, 1 truth remains: without cervical change birth can’t result. Not that it won’t—it can’t (unless you exit through the sunroof). Any time you compress the cervix (like with a contraction, or pressure from two babies, or even with some labor induction methods) it breaks down the tissue and it becomes soft, shortens, and dilates. Interestingly, almost all techniques that have been tried to stop or reverse cervical change focus on compressing the cervix closed, which only further breaks down tissue. But, stretching or pulling on the cervix stiffens the cervix and then stimulates the collagen to rebuild itself, causing the tissue to become stronger. So it seemed pretty simple: stretch the cervix.
The night I came to this conclusion, a woman came into the hospital where I worked complaining of labor symptoms. I had assisted in tying her cervix closed with a surgical technique called cerclage. This tore through, and she delivered a baby that was too young to survive.
This wasn’t by any means, a new scenario for me. I have no idea how many times over my career that I’ve seen this happen. I realized something: I was part of the problem. If I sat here and did nothing about this, I was just like “them”—the people in the system that were ignoring problems, not trying anything new. There was no way I could go, sit at this woman’s bedside & cry with her unless I was willing to do something about it.
This spurred me into a whole new direction, including creating the Hannah Cervical Cup and founding Galena Innovations.
Can you provide a summary of the technology/ area of innovation and its potential application? Have there been any pivot points in the company’s lifetime and what triggered these?
The impetus for each early birth is unique but has one commonality: early cervical change. In pregnancy, the cervix keeps the fetus inside the womb. At delivery, the role reverses and it then facilitates birth by softening, shortening and dilating. Sometimes contractions happen or water breaks, but without cervical change, birth can’t result. The cervix is made up of collagen, the scaffolding for the body. Positive pressure throughout pregnancy breaks down collagen. When this happens, it leads to cervical change and then birth. To prevent delivery, collagen breakdown must be stopped.
Aside from medications that don’t work and cause harm, all other preterm birth prevention techniques focus on compressing the cervix closed. This only further weakens the cervical tissue and can lead to birth. In fact, compressing the cervix is a technique used in labor inductions to create cervical change.
Our technology strengthens the cervix rather than adding to collagen breakdown. The patented Hannah Cervical Cup applies tension, causing collagen regrowth and stiffness. Stiff cervices don’t change and these babies don’t deliver early.
Collagen exposed to tension over time becomes more supportive with an increase in collagen synthesis among other things. This means the cervix can withstand the load of pregnancy.
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. These babies can then be born healthy.
It is easy to use, can be placed in a few minutes’ time, and is noninvasive making it ideal for patients and providers alike.
We recently concluded our first in human study which increased cervical stiffness by 38% long term, while demonstrating safety.
What stage are you at?
We have just completed our First-in-Human clinical trial and are now prepping for our safety study.
Discuss the biggest challenges of getting to this point? With the benefit of hindsight, what would you have done differently if anything?
There have been some big challenges to get to this point and I would say that my biggest challenge has been an attitude of hesitancy surrounding trying something different to prevent spontaneous preterm birth from people in the clinical setting, research, innovation, and medical device. None of the things we’ve tried to date have been very successful and if we keep trying the same things, we will get the same result. We have to do things differently if we want improvements.
I wish that it had taken me less time to find my clinical path forward. Being new in medical device development made my progress slower than others. Next time I will know better!
How have you approached funding?
We’ve gotten to this point with bootstrapping and non dilutive funding and are now raising a seed round.
What has been the greatest source of help/ guidance along the way?
I don’t know if I can pinpoint one person. I feel like I’ve been able to find a person to help me with almost every aspect of growing Galena. Jennifer West has been a tremendous help with our clinical path and commercialization plan. Tiam Rastergar and Ron Rudnick taught me how to pitch. Cathy Skinner taught me how to raise money. My husband and family have been my biggest cheerleaders.
One of the things my husband said to me early on was: “You don’t need anyone’s permission to learn anything.” I think that thought gave me the courage to dig in to all aspects of the medical device development process (prototyping, clinical trial design and management, regulatory & reimbursement, commercialization, fundraising, etc.). It also helped me recognize that if I don’t have a particular skill set or knowledge base, I can go find someone who does. Being able to do those two things has been the foundation of our growth.
Best advice you’d pass on to other founders?
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 in order 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 very 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 focus than those that 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”.
What do you think are broadly the biggest needs and opportunities in the Women’s Health Market?
I’d like to address Maternal & Fetal Health in particular. Right now, there’s a big push in society to improve birth outcomes and there are arguably many people focused on this, but until we have concrete diagnostic tools and preventive interventions—actual interventions—in the four most prevalent and damaging (highest rates of maternal and infant mortality and morbidity) pregnancy, birth, and postpartum disorders, we will not substantially move the needle in birth outcomes. These are:
- Pregnancy related mental health disorders
- Gestational hypertensive disorders
- Postpartum hemorrhage
- Spontaneous preterm birth
When—not if—these problems are solved, it will radically improve birth outcomes and since pregnancy and birth are the foundation of a healthy life for every human being, it will radically improve human health and society as a whole.
What’s going to have the single biggest impact on change in your area of the market?
I think the thing that will have the single biggest impact on change in my area of the market will be when clinicians realize that the time for innovation in obstetrics is now. This will create a flood of the changes that are so desperately needed.
What do the next two years have in store for you?
We will be completing 2 more clinical trials, reaching regulatory and reimbursement milestones, building our IP fence, and getting to the place where we are changing birth outcomes for the better!
