CARY – NeuroVice, a medical technology start-up based in Cary, has received FDA clearance for its first-to-market seizure disorder device, the Protector Against Tongue Injury (PATI) device.
Inspired by her own experience of living with seizures, NeuroVice founder Ashlyn Sanders created this device, raising over $2M to date from angel investors, grant funding, and family-and-friends rounds—and even receiving support from NBA star Charles Barkley.
In an exclusive interview with WRAL TechWire, Sanders shared that NeuroVice has been in communication with the FDA for over a year. They took advantage of the FDA’s pre-submission process twice, submitting documentation to the FDA that outlined the device and its indications in order to get feedback.
Sanders shared that, although there was a long 60-90 day turnaround for each round, the feedback was worth the wait because it gave her direction on how to proceed and what she needed to fundraise for.
“I found it to be more beneficial than not, in the overall process,” said Sanders. “And it just feels great to be done because we’re on the other side of it.”
PATI provides first-of-its-kind support for seizure sufferers
Sanders, who’s a third-year medical student at Wake Forest University, shared that current seizure safety guidelines instruct caregivers not to put anything in the mouth of a person who is having a seizure.
Many patients and caregivers ignore those guidelines, Sanders told me. She said that some patients will put spoons, towels, or even pencils in their mouths to try and prevent oral injuries.
“You will hear caregivers say, ‘When it comes to my child, I can’t stop the seizure, but the least I can do is grab something nearby and try to prevent this horrible oral injury that can happen, and I don’t care what the guidelines say, because it’s my child and they’re going to be hurt,’” said Sanders.
Now that the PATI has FDA clearance, these guidelines can change.
“Since the FDA has cleared this product and as the market adopts the product, that guideline can’t be there anymore,” said Sanders. “They won’t be able to say ‘Don’t put anything in the mouth’ because now, there is something that can be placed safely and do its job.”
Sanders also shared what it means to her as a patient to see her product receive FDA clearance.
“What’s really great about this entire story and process is that it took a patient to develop a solution,” said Sanders. “It wasn’t a medical professional, someone who’s on the other side of the treatment aspect of it, but it really took someone who has lived this day to day.”
Support for seizure safety emergency situations
The PATI was designed to prevent oral injuries, but according to Sanders, the device can also support “a seizure safety emergency situation.”
“There’s already a problem with maintaining the airway during a seizure, which is why you probably have seen another guidance that says, ‘Place the patient on their side,’” said Sanders. “That’s really for maintaining an open airway as best as possible, recognizing that if a patient does have an oral injury, the blood can fill up the oral cavity very quickly. That can create a choking hazard.”
The PATI device, Sanders said, can help support a patient’s open airway during a seizure, even a severe one.
“So we’re really are introducing a product that addresses quality of life but also can enable more efficient care as it relates to managing the airway or administering a rescue medication,” said Sanders.
NeuroVice grows Advisory Board, adds former BCBS CEO
Sanders is the daughter of NC Commerce Secretary Machelle Baker Sanders. She holds a BA in Mathematics from UNC Chapel Hill and a Master of Arts in Bioethics and Science Policy from Duke University.
As a full-time medical school student at Wake Forest, her goal is to exit NeuroVice.
To that end, she recently onboarded Sam Searcy, Chief Commerical Officer at Elixia Health, and Brad Wilson, former CEO of BCBS NC to the NeuroVice Advisory Board.
“They’ve come on to assist with that endeavor of selling the company to either a medical device company or pharmaceutical company that is in a seizure or epilepsy world that can understand this product, add it to their pipeline, and leverage their infrastructure to really accelerate commercialization,” said Sanders.
Current NeuroVice Advisory Board members include Dr. Kimberly Garko, Senior VP of Quality at Akebia Therapeutics, and Kathy Meserve, Senior Director of Investments & Emerging Company Development at NC Biotech Center.
“My goal has always been to de-risk the business through regulatory clearance and then find a commercial partner who can take it and go to market to commercialize it,” said Sanders.
Learn more about NeuroVice at neurovicellc.com.