/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..

/PRNewswire/ -- KNoW Biological 已获得美国食品药品监督管理局 (FDA) 的突破性设备认定。该认定是 FDA 的一项计划，旨在加速针对严重或危及生命的疾病且有初步证据表明其相比现有市场疗法具有显著改进的设备和药物的审查。

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

KNoW Biological公司制造了一款名为VoLI的可穿戴监测器，可以在癫痫患者发作前40分钟提醒他们。全世界有超过6500万人患有癫痫；将近400万人在。

. 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..

百分之三十五的癫痫患者有无法控制的癫痫发作。这些人生活在持续的恐惧中，永远不知道下一次发作何时会发生。VoLI 提供了关键的早期预警，让用户有时间到达安全的地方，并与家人、朋友或医疗保健提供者进行沟通。

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..

作为突破性设备评估过程的一部分，FDA 审查了初步的有限临床试验、调查科学和初步研究。自该计划启动以来，只有少数神经设备被授予此地位。通过突破性设备认定，VoLI 的大规模临床试验可以开始，并且可以寻求第二轮投资者融资，以促进这款拥有多项专利的设备的持续开发。

The Nose Knows

Nose

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.

KNoW在花费数十年时间与癫痫预警犬合作后，开始开发VoLI。KNoW和一组研究科学家能够识别出几种癫痫特有的关键挥发性有机化合物（VOC）。目标VOC会在癫痫发作前开始增加浓度。

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. .

这些挥发性有机化合物是癫痫警犬在告知患者癫痫即将发作时所警示的物质。这些狗能闻到身体化学成分的变化。

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.

与阿尔伯克基的桑迪亚国家实验室合作，该团队开始开发一种微型检测系统，该系统足够灵敏，可以检测到即使是非常微量的挥发性有机化合物气体。三阶段检测过程始于一个大约大创可贴大小的贴片，该贴片从用户的皮肤上捕获挥发性有机化合物。

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..

收集到的化学物质通过气相色谱分离，然后使用微型离子迁移谱仪技术进行识别。可穿戴的VoLI可以全天收集和分析样本。以往这种监测只能通过复印机大小的设备来实现。

The technology was selected by

该技术被选中

R&D World

研发世界

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.

杂志评为2023年全球100项最佳创新之一。被誉为“创新界的奥斯卡”的R&D 100奖项在过去60年中一直是一个享有盛誉的创新奖项计划。

Next Steps

下一步

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

在FDA的指导下，VoLI的全面临床试验将于2025年第三季度开始，为FDA提交、审查和批准提供所需的数据。KNoW创始人表示：“我们非常感谢早期投资者对我们的信任。”

Gary Arnold

加里·阿诺德

said. 'This device will be life-changing for so many, and we're eager to move forward with the next steps.'

说：“这个装置将改变很多人的生活，我们渴望继续推进下一步。”