KNoW Biological Receives FDA Breakthrough Device Designation

Atlanta-based firm to begin clinical trial on advanced warning seizure monitor

ATLANTA, May 13, 2025 /PRNewswire/ — KNoW Biological has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This designation is an FDA program designed to expedite the review of devices and medications for serious or life-threatening conditions where there’s preliminary evidence suggesting substantial improvement over existing therapies on the market.

KNoW Biological makes a wearable monitor, the VoLI, that can alert people who have epilepsy to seizures as much as 40 minutes before they happen. More than 65 million people in the world have epilepsy; nearly 4 million in the United States. Thirty-five percent of people who have epilepsy have seizures that cannot be controlled. These people live in constant fear, never knowing when their next seizure will occur. VoLI provides critical early warning, allowing users time to get somewhere safe and communicate with family, friends, or healthcare providers.

As part of the Breakthrough Device evaluation process, the FDA reviewed initial limited clinical trials, investigative science, and preliminary research. Since the inception of the program, only a small number of neurological devices have been granted this status. With Breakthrough Device designation, full-scale clinical trials for the VoLI can begin along with seeking a second round of investor funding to facilitate ongoing development of the multi-patented device.

The Nose Knows
KNoW began developing the VoLI after spending decades working with seizure-alert dogs. KNoW and a team of research scientists were able to identify the presence of several key volatile organic compounds (VOCs) unique to seizures. The target VOCs start building in concentration just prior to seizure onset. These VOCs are what seizure dogs alert to when telling a patient that a seizure is oncoming. The dogs smell the change in the body’s chemistry. 

Partnering with Sandia National Laboratories in Albuquerque, the team began to develop a miniaturized detection system, sensitive enough to detect even minute amounts of VOC gases. The three-stage detection process starts with a patch about the size of a large bandage that captures VOCs from the user’s skin. The collected chemicals are separated using gas chromatography and then identified using miniaturized ion mobility spectrometer technology. The wearable VoLI can collect and analyze samples throughout the day. Previous monitoring of this kind was only possible using copy machine-size devices.

The technology was selected by R&D World magazine as one of the top 100 innovations globally in 2023. Known as the “Oscar of Innovation,” the R&D 100 Awards have served as a prestigious innovation awards program for the past 60 years.

Next Steps
With FDA guidance, full-scale clinical trials of VoLI will begin in Q3 2025, providing the data needed for FDA submission, review, and approval. “We are incredibly thankful to our early investors for believing in us,” KNoW founder Gary Arnold said. “This device will be life-changing for so many, and we’re eager to move forward with the next steps.”

www.knowmonitors.com
Media: spolk@redfolderconsulting.com
Investors: gee@knowbiological.com. 

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SOURCE KNoW Biological