The post-college path for young innovator Ashlyn Sanders is like the nonlinear algebraic graphs she studied as a UNC Chapel Hill mathematics major.
It’s an erratic waveform only fully understood when zoomed out to see how each plot point holds enough weight to cumulatively influence an outcome.
Everything about Sanders’ startup story breaks from the “graduate-to-founder” narrative. It’s riddled with multiple pit stops and diversions; unfortunate medical circumstances, altered career plans and unexpected time off from school. But all of it came together when Sanders decided to solve a routine frustration she faced after being diagnosed with a seizure disorder.
She needed a way to control her tongue and jaw during an episode so she could avoid biting her tongue and suffering from intense oral pain days and weeks after. And she thought others would appreciate a solution to this common problem too.
The advanced problem-solving skills she learned in school, coupled with a passion for public health policy, provided the motivation and basis for her venture called NeuroVice.
It’s bringing to market a guard-like device called PATI (short for Protector Against Tongue Injury), which fits over the tongue as a barrier from harm.
Sanders’ mission is well-captured in the company mantra: “to make having a seizure a little bit easier,” a phrase only people who’ve dealt with seizure-related conditions can fully understand.
The device impressed grant application reviewers in the U.S. Federal Drug Administration-funded New England Pediatric Device Consortium, which advanced NeuroVice to a finalist round where it will compete with other medtech startups for a cash prize.
The funds and accompanying access to FDA regulation resources could propel PATI from prototype to manufacturing, commercialization and eventually to patients.
So far, the time spent refining her idea, building a team of advisors, researching tongue anatomy and designing a solution adds up to a little over a year. With the financial support of family, Sanders has also secured a patent for her device.
But the next steps will perhaps be the most difficult: finding funds to take on the FDA approval process, nailing down a manufacturer and launching a pilot trial where doctors prescribe PATI to patients. This is all meant to prove the concept’s ability to drive revenue and retain patients as customers, leading to what Sanders hopes to be an exit.
She isn’t daunted by the challenge though, and a three-year history of coping with unexpected setbacks is precisely what compels her to press on.
Enduring adversity, embracing flexibility
As a UNC undergrad, Sanders decided to apply her knack for problem-solving and joy of unlocking logical puzzles in earlier STEM classes. She chose a major in mathematics and developed and refined skills in getting from point A to point B using formulas and proofs.
By by the time she graduated in 2013, she’d decided to hold off on an entry-level mathematics career to explore the public policy field, influenced by her mother who is secretary of the North Carolina Department of Administration. Sanders pursued and landed a prestigious White House internship.
This recourse was inspired by her mom, who is secretary of the North Carolina Department of Administration.
The internship placed Sanders in the Obama administration right when the Affordable Care Act was rolling out.
She worked with the Office of Public Engagement healthcare team on data projects like analyzing who was registering for the ACA, thinking up ways to target young people and helping vet White House visitors. She was also involved with some policy-making projects in the Office of Science and Technology.
Sanders left the semester-long internship fulfilled and ready to apply her math and logic skills to the healthcare policy conversation in the U.S.
She found an outlet for that energy in a new master’s degree program at Duke University, and was accepted into the inaugural Bioethics and Science Policy cohort in fall 2014. There, she dug into all the different ways to direct policy decisions toward public impact and engagement, especially from a clinical evidence standpoint.
Focuses of study included the legal defense and ethical challenges for the medical field, covering topics from physician-assisted suicide to patient advocacy and activism.
One night just five weeks into the program, Sanders was struck with a sudden seizure, the first she’d ever experienced. She was taken to the emergency room, where her CT scan and lab results read normal and doctors said she suffered a panic attack.
But the seizures kept coming after that night, and doctors kept referring Sanders to mental health counseling until a particularly serious episode happened at a primary care doctor appointment.
Later in the ER, doctors diagnosed Sanders with Chiari Malformation, a rare and complex brain abnormality that causes seizures. Research indicates the condition is present at birth, but some patients don’t discover it until adulthood when symptoms are prominent.
In Sanders’ case, the initial misdiagnosis of panic attacks left the disorder untreated, which caused a life-threatening condition that required immediate brain surgery to relieve pressure. After the surgery, she spent weeks recovering in the ICU.
When she finally returned home, she spent the remainder of the year using a walker to regain her strength.
She returned to grad school in January 2015 only to find seizure symptoms resurfacing.
Sanders’ second diagnosis was conversion disorder, a condition in which the body converts psychological stress into physical symptoms. Doctors reasoned the seizures were a manifestation of post traumatic stress disorder after undergoing brain trauma, plus a quick surgery that she may not have had time to process.
In spite of the diagnosis, Sanders continued through the program while juggling doctors appointments and managing symptoms.
And while writing and completing her thesis, Sanders came up with an idea to combat the tongue biting that she’d struggled with during seizure episodes.
Sanders immediately dove into the project upon graduation, rigorously researching the anatomy of the tongue and how seizures implicate oral health, while also sifting through online community forums where patients discuss tongue biting.
An unlikely business model out of seizure control management
Doctors and resource sites advise anyone who happens to observe a seizure not to place items in a patient’s mouth to prevent tongue biting. Items can become dislodged and block open airway and respiration, sometimes causing choking.
As such, there’s no available solution to the problem.
To design a solution, Sanders started with a team of advisors including four clinical professionals in neurology, pediatrics and emergency medicine, and a business advisor who was a colleague of Sanders’ mom at her former job as a Biogen executive.
Based on their feedback and online research, Sanders created a rough design for a disposable guard that would serve as a shield to oral trauma. The material is sturdy enough to withstand biting, and it’s made up of an absorbent component to help manage saliva production during an episode.
A doctor would prescribe PATI to these patients in a kit they can take with them on the go and refill as they run out.
They can retrieve the kit whenever they feel early seizure symptoms (this varies by the patient, but can last anytime from seconds to minutes before an episode).
They then place the guard along the back molars of the teeth, where it sits right above tongue as a barrier to biting. After an episode, patients dispose of the protector, storing refills inside the kit for a time when they need it again.
The majority of people with uncontrolled seizure disorders respond to medication and can manage daily symptoms.
But Sanders’ target customers are the 30-45 percent of patients unable to respond to medication.
Sanders says the ideal outcome for NeuroVice is acquisition by an existing wearable medtech company, particularly one that has products to warn patients of physiological changes they may not immediately recognize prior to having a seizure.
She believes PATI gives patients a mode of comfort in an otherwise uncomfortable situation, and compliments other medical treatment technologies.
Sanders’ parents funded NeuroVice to patent approval, but more funds will be needed to get it to sale or market.
Sanders hopes she’ll win a $10,000 pre-seed award from the New England Pediatric Device Consortium (and eligibility to receive another $50,000 later), in addition to guidance as she seeks approval from the FDA.
Regardless, winning a spot as a grant finalist from a pediatric foundation gives NeuroVice an edge and expands the target reach for PATI, Sanders says.
Kids who suffer seizures are almost always accompanied by their parents or teachers, who can help them administer medications or treatments like PATI.
Sanders is applying for other grants and meeting with venture capital firms too. This weekend, she’ll travel to Charlotte to pitch at an open call for Shark Tank auditions.
Sanders hopes investors and potential acquirers will take interest in her business model. Since PATI is disposable, there’s a near-constant revenue stream from prescription refills.
An acquisition could help free her to pursue long-term career aspirations outside of entrepreneurship. She’s currently taking medical school prerequisites at UNC, preparing to eventually enter a clinical profession.
A consistent part of Sanders’ story is an ability to defeat odds and overcome obstacles, personally, academically and now entrepreneurially. She considers this an advantage as she brings her venture to life.
“I think patients have what it takes to be the best entrepreneurs,” Sanders says. “They’re people who’ve been through health situations and understand what it takes to keep going and get through their experience. That’s what entrepreneurship is all about: hard work, perseverance and taking advantage of opportunity.”
Though Sanders doesn’t intend to be a startup CEO long-term, she plans to use her unlikely entrepreneurial story to encourage others who’ve been in chronic health situations to help solve the problems healthy people might not ever notice.
This goal is designed to outlive whatever happens with NeuroVice, and will still stand as Sanders prepares to face the unknown.