U.S. Food and Drug Administration Gives Huxley Medical 510(k) Clearance for SANSA Home Sleep Apnea Test
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ATLANTA, Aug. 7, 2024 ~ Huxley Medical, a leading developer of technologies that streamline cardiopulmonary care, has recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their revolutionary sleep apnea diagnostic patch, SANSA. This groundbreaking device is worn on the chest and represents a significant breakthrough in medical innovation.

Unlike current sleep apnea diagnostic tools such as patches, rings, watches, or finger probes, SANSA does not require any additional attachments or wires. Its patented combination of sensors and materials allows for precise measurement of eight physiological channels including blood oxygen saturation, EKG-derived heart rate, respiratory effort, chest movement, sleep staging, snoring, body position, and actigraphy.

This FDA clearance is a major milestone for Huxley Medical and positions their SANSA device as the first and only FDA-cleared chest-worn patch that utilizes advanced signal processing and artificial intelligence to detect sleep disordered breathing while simultaneously providing an electrocardiogram (EKG) reference channel to record electrical signals from the heart.

Chris Hallett, co-founder and chief commercial officer of Huxley Medical with over 25 years of experience in the field, expressed excitement about this achievement. "Our SANSA technology offers healthcare providers a cutting-edge tool to enhance diagnostic accuracy and patient outcomes," he said. This announcement is just the latest in a series of milestones for Huxley Medical since its founding in 2019. The company has raised over $20 million in investment capital and grant funding.

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Sleep apnea is a serious disorder that affects millions of people worldwide. It is characterized by repeated interruptions in breathing during sleep which can leave patients feeling tired and irritable even after a full night's rest. If left untreated, it can lead to more serious health issues such as heart disease and strokes. According to the American Academy of Sleep Medicine, sleep apnea costs $86.9 billion in lost productivity, $26.2 billion in motor vehicle accidents, and $6.5 billion in workplace hazards in the U.S. each year.

Hallett, drawing from his prior experience developing programs to engage sleep physicians and cardiologists, understands the difficulties in getting patients with sleep apnea and comorbid arrhythmias diagnosed and managed. "SANSA will begin to eliminate these barriers for physicians and patients," he said.

The SANSA platform has already undergone a comprehensive clinical trial involving 533 patients across seven U.S. sites, including prestigious institutions such as the University of Pennsylvania, the University of Michigan, Emory University, and Atrium Health Wake Forest Baptist. The results of this trial have demonstrated SANSA's efficacy in measurement reliability and performance for diagnosing mild, moderate, and severe sleep apnea.

The clinical trial also provided robust data supporting SANSA's safety and effectiveness, including its high accuracy, sensitivity, and specificity in detecting sleep apnea compared to traditional in-lab sleep tests. Additionally, patients reported improved compliance and comfort due to its non-invasive nature. One of the most significant achievements of SANSA is its ability to perform well on all skin tones for diverse patient management – a challenge that has been faced by previous diagnostic tools.

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Clinicians who have utilized the SANSA device have praised it as a milestone in innovation. Dr. Suneet Mittal, Chair of Valley Health System's Cardiovascular Service Line as well as director of electrophysiology said, "As electrophysiologists, we are already quite comfortable using patch-based EKG monitors for arrhythmia monitoring." He added that "the ability to diagnose sleep apnea using the same platform using the SANSA device represents an exciting opportunity to manage two diseases that often co-exist."

Dr. Douglas Kirsch, past president of the American Academy of Sleep Medicine and medical director of Atrium Health Sleep Medicine in Charlotte, N.C., also shared his enthusiasm for SANSA. "It's excellent news for the sleep community that Huxley's SANSA device has been cleared by the FDA to evaluate obstructive sleep apnea at all severity levels with reliable performance across all skin tones," he said. "This 8-channel wearable patch, including an EKG sensor, should be easy for patient self-application and improve the experience for diagnosis of obstructive sleep apnea."

With this FDA clearance, Huxley Medical can now move forward to market their SANSA device and provide healthcare providers with a cutting-edge tool to enhance diagnostic accuracy and improve patient outcomes. This groundbreaking technology has the potential to revolutionize the way sleep apnea is diagnosed and managed, providing a more comfortable and accurate experience for patients.
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