Sinead Miller was an Olympic-bound competitive road cyclist and member of the national USA Women’s Road Cycling team for a decade. But in 2010, during a race in the Netherlands, Miller crashed. The accident resulted in multiple injuries, including broken bones and a traumatic brain injury at just 20 years old.
That life-changing moment led her to the medtech industry.
“I decided to go into the engineering side of healthcare because I wanted to be at the forefront of developing these new technologies in the space,” says Miller.
While earning her Ph.D. in Biomedical Engineering at Vanderbilt, her research focused on sepsis — a condition when bacteria infect the bloodstream, typically through a wound infection — and how to use magnetic nanoparticles to pull toxins out of the blood. More than 1.5 million people get sepsis each year in the U.S, according to the Centers for Disease Control and Prevention, with about 250,000 Americans dying each year from it.
Miller saw significant potential in the technology and decided to take the entrepreneurial route to commercialize it. She founded PATH EX, a blood cleansing device similar to a dialysis machine, designed to selectively remove multi-drug resistant bacteria and other toxins circulating in the blood to prevent sepsis.
Alongside co-founder Alex Wieseler, Miller has raised $425,000 in grants for the Charleston-based PATH EX, including some from the National Science Foundation, as well as $50,000 in venture capital to gather more data and apply for patents. Miller shares more about their groundbreaking technology and how the current dialysis device informed their design.
Once you realized the potential of this technology, how did you validate your idea?
That was a big learning process for me because I’ve been in academia forever; I never even took a business class, but that’s where my co-founder Alex comes in with his finance background. I got involved with the National Science Foundation, and I can’t even describe how great that program is — because it supports high-risk, early-stage ideas that have huge potential in healthcare. Their support has validated our research and development.
On the business side, we went through medical device accelerator program Zeroto510, which helps entrepreneurs with ideas for medical devices to help be cleared for commercial deployment through the 510(k) process. During that program we did over 100 customer discovery interviews trying to figure out exactly what the user is looking for, what they need, and form our business model.
How does the PATH EX technology help remove the pathogens in the blood?
The technology itself is very similar to a hemodialysis filter with about the same dimensions. You can hook it up to a patient using a central line, like you would in hemodialysis, and use a blood pump or a hemodialysis machine, and continually filter the patient’s blood through our device. Many of these pathogens now are multi-drug resistant which can’t be treated by antibiotics, so our device can provide a solution.
How did you put together a team to help you commercialize this product idea?
We’ve slowly put together a team of advisors as we build our relationships. Our advisors have expertise in certain areas, such as nephrologists that work in hospitals. They have insights into the issues hospitals face on a day-to-day basis and give us an idea of what our product needs to look like so that it can fit into their workflow in the hospital.
We also have an engineer who’s an advisor for us and has been helpful in terms of us trying to develop and refine our product, figure out what testing we need to do, and ensure that all goes according to plan. We’ve had conversations with the FDA regarding our device just to make sure that we’re on the right path and we know what we need to do to get this device approved on the road. That part is difficult because I don’t think anyone really knows much about that until they experience it firsthand.
Why did you decide to go with a device that was similar to a hemodialysis machine — how did it help you penetrate the market?
We learned along the way that it’s really hard to incorporate something that’s totally new and outside their normal day-to-day operation. We realized that if we made our device compatible with a hemodialysis machine, that would mean that the hospital would never need to buy a new blood pump and just use existing hemodialysis machines that are in every hospital ICU worldwide.
That was one of the driving things behind our thinking. We have this disposable cartridge that is relatively inexpensive and we thought, why not just hook it up to a hemodialysis machine that does everything we need plus more. In addition, we’ve learned that the second leading cause of death in hemodialysis patients is bloodstream infections. That’s because these chronic dialysis patients have lines in them for days and eventually they get bacteria in them leading to an infection.
What are some lessons you’ve learned so far as a founder?
One of the earliest things that I learned — maybe most people know this — but it’s so important to rely on trusted advisors. That’s been one of the most important things for us is to find a handful of advisors that you can trust and rely on to help you make decisions or work through things, because as a founder you’re not going to know everything.