KNoW Biological, an Atlanta-based firm, has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its innovative seizure prediction wearable, the VoLI. This designation expedites the review process for devices addressing serious or life-threatening conditions where preliminary evidence suggests substantial improvement over existing therapies.
The VoLI monitor can alert people with epilepsy to impending seizures up to 40 minutes before they occur, providing crucial time for patients to reach safety and communicate with caregivers or healthcare providers. This advance represents a potential paradigm shift in epilepsy management, particularly for the 35% of epilepsy patients whose seizures remain uncontrolled by current treatments.
"We are incredibly thankful to our early investors for believing in us," said KNoW founder Gary Arnold. "This device will be life-changing for so many, and we're eager to move forward with the next steps."
Addressing a Significant Unmet Need
Epilepsy affects approximately 65 million people worldwide, including nearly 4 million in the United States alone. For patients with uncontrolled seizures, the unpredictability of episodes creates constant anxiety and significantly impacts quality of life. Current seizure detection devices typically alert only after a seizure has begun, limiting their preventative value.
The FDA's Breakthrough Device designation acknowledges both the significant unmet need and the promising preliminary data behind the VoLI technology. Since the program's inception, only a select number of neurological devices have achieved this status.
Biomimetic Technology Inspired by Seizure-Alert Dogs
The development of the VoLI monitor stems from decades of research with seizure-alert dogs. KNoW Biological's research team identified specific volatile organic compounds (VOCs) unique to seizures that begin accumulating prior to seizure onset—the same compounds that trained dogs detect when alerting patients to impending seizures.
In collaboration with Sandia National Laboratories in Albuquerque, KNoW developed a miniaturized detection system capable of identifying minute concentrations of these target VOCs. The technology employs a three-stage detection process:
- A patch approximately the size of a large bandage captures VOCs from the user's skin
- Gas chromatography separates the collected chemicals
- Miniaturized ion mobility spectrometer technology identifies the specific compounds
This innovation represents a significant technological advancement, as previous monitoring systems with similar capabilities required equipment the size of a copy machine. The VoLI's wearable format allows for continuous sample collection and analysis throughout the day.
Award-Winning Innovation
The technology's significance has already received recognition beyond the FDA designation. R&D World magazine selected the VoLI as one of the top 100 global innovations of 2023, an honor known as the "Oscar of Innovation." The R&D 100 Awards have recognized groundbreaking innovations for 60 years.
Clinical Development Timeline
With the Breakthrough Device designation secured, KNoW Biological will commence full-scale clinical trials in the third quarter of 2025. These trials will generate the comprehensive data necessary for FDA submission, review, and potential approval.
Simultaneously, the company is pursuing a second round of investor funding to support the ongoing development of the multi-patented device. The Breakthrough designation is expected to facilitate both the regulatory pathway and investment opportunities.
Technological Specifications
The VoLI represents a significant miniaturization of complex analytical chemistry techniques. By combining gas chromatography with ion mobility spectrometry in a wearable format, KNoW has overcome substantial engineering challenges. The device continuously monitors for the specific VOC biomarkers that precede seizure activity.
This approach differs fundamentally from existing seizure detection systems that rely primarily on motion sensors or EEG monitoring. By detecting the biochemical precursors to seizures, the VoLI aims to provide a substantially longer warning period than current technologies.
Potential Clinical Impact
For epilepsy patients, particularly those with uncontrolled seizures, the potential benefits of advanced warning are substantial. A 40-minute warning window could allow patients to:
- Cease dangerous activities such as driving or swimming
- Take rescue medications that might prevent or reduce seizure severity
- Notify caregivers or medical professionals
- Position themselves in a safe environment to prevent injury
The psychological impact of reduced uncertainty could also significantly improve quality of life for patients who currently live with constant anxiety about unexpected seizures.
