KNoW Biological Gains Prestigious FDA Designation
KNoW Biological has proudly announced that it has achieved Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This noteworthy status is part of an FDA initiative that is aimed at accelerating the evaluation of devices that can drastically aid in serious or potentially life-threatening health conditions. What’s especially exciting is that this designation is granted when there is substantial preliminary evidence showcasing that a device may significantly outperform current available therapies.
The Revolutionary Seizure Monitor: VoLI
At the forefront of this exciting news is the VoLI device—a cutting-edge wearable monitoring system developed by KNoW Biological. This innovative device has a remarkable ability to alert individuals suffering from epilepsy to impending seizures, potentially providing warnings of up to 40 minutes prior to the occurrence. With epilepsy affecting over 65 million individuals globally, including nearly 4 million in the United States alone, KNoW Biological is on a mission to alleviate the unending anxiety faced by many who live with this condition.
A Lifeline for Epileptic Patients
Statistically, a significant 35% of individuals with epilepsy endure uncontrollable seizures, causing them to live in constant uncertainty about when the next seizure may strike. The introduction of the VoLI device stands to offer crucial early warnings, enabling users to find safety and alert loved ones or healthcare professionals ahead of time, significantly enhancing their quality of life.
FDA's In-Depth Review Process
To achieve the Breakthrough Device designation, the FDA undertook a thorough evaluation of initial clinical trials, investigative data, and early-stage research conducted on the VoLI. It’s important to note that only a select number of neurological devices have received this highly sought-after designation since the program's inception. Following this, KNoW Biological is set to embark on full-scale clinical trials for the VoLI and is also looking to secure additional funding to support continued development of this innovative, multi-patented device.
Innovative Science Behind VoLI
The inception of the VoLI device stemmed from KNoW’s extensive experience collaborating with seizure-alert dogs over several decades. This partnership with a dedicated team of research scientists led to the discovery of specific volatile organic compounds (VOCs) that are produced right before a seizure occurs. These VOCs begin to accumulate in the body, prompting the alert from seizure-alert dogs. The dogs are adept at detecting minute changes in the body’s chemical makeup.
Collaboration for Technological Advancements
Taking this innovative science to the next level, KNoW Biological partnered with Sandia National Laboratories, where they worked on the development of a compact detection system that could identify even the slightest presence of these VOC gases. Their three-phase detection system begins with a skin patch, which captures VOCs. These are then analyzed using state-of-the-art gas chromatography paired with advanced miniaturized ion mobility spectrometry technology. Unlike previous monitoring systems that were bulky and cumbersome, the VoLI comfortably fits into a user-friendly wearable format.
A Recognition of Innovation
This groundbreaking technology has received accolades, including being named one of the top 100 innovations globally by R&D World magazine in 2023. This recognition is a testament to the VoLI’s potential impact, with the R&D 100 Awards being revered in the industry as the "Oscars of Innovation" for over six decades.
Looking Ahead: Next Steps for KNoW Biological
With the FDA’s guidance, KNoW Biological anticipates launching full-scale clinical trials for the VoLI in the near future, poised to gather essential data required for FDA submission and approval. The founder, Gary Arnold, expressed gratitude towards early investors for fostering belief in this transformative technology, emphasizing its potential to positively impact lives. KNoW Biological is eagerly moving forward to bring the VoLI to market and change the lives of many.
Frequently Asked Questions
What is the VoLI device?
The VoLI is a wearable monitor designed to alert individuals with epilepsy of impending seizures, providing critical warnings up to 40 minutes prior.
What does Breakthrough Device designation mean?
Breakthrough Device designation is an FDA status that expedites the review process for devices that show potential for significant improvement in treating serious health conditions.
How does the VoLI function?
VoLI detects specific volatile organic compounds emitted by the body before a seizure happens, allowing users to take precautionary measures.
When will clinical trials for VoLI begin?
Full-scale clinical trials for the VoLI are scheduled to begin in the third quarter of 2025.
Who is behind KNoW Biological?
KNoW Biological is led by founder Gary Arnold, who has a long-standing expertise in developing seizure-alert systems.
