U.S. Food and Drug Administration Gives Huxley Medical 510(k) Clearance for SANSA Home Sleep Apnea Test

ATLANTA, Aug. 7, 2024 / -- Huxley Medical, a developer of technologies that streamline cardiopulmonary care, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking, chest-worn, sleep apnea diagnostic patch, SANSA.

With this clearance, Huxley Medical can move forward to market its device.

The patch is a first-of-its-kind, at-home, single-point-of-skin-contact diagnostic device and represents a breakthrough in medical innovation. Unlike current patches, rings, watches, or finger probes, SANSA does not require additional attachments, wires, belts, or hoses.

Its patented combination of sensors and materials precisely measures eight physiological channels including blood oxygen saturation, EKG-derived heart rate, respiratory effort, chest movement, sleep staging, snoring, body position, and actigraphy.

This clearance is a significant milestone for Huxley and positions its 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.

"Our SANSA technology offers healthcare providers a cutting-edge tool to enhance diagnostic accuracy and patient outcomes," said Chris Hallett, Huxley Medical's co-founder and chief commercial officer with more than 25 years of experience in the field. The announcement is the latest milestone for the company, which has raised more than $20 million in investment capital and grant funding since its founding in 2019.

Sleep apnea is a serious disorder characterized by repeated interruptions in breathing during sleep, leaving patients tired and irritable, even after a full night's sleep. It can lead to more serious health issues, including heart and metabolic diseases, and strokes. The disorder 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, according to the American Academy of Sleep Medicine.

"From my prior experience developing programs to engage sleep physicians and cardiologists, I know first-hand the difficulties in getting patients with sleep apnea and comorbid arrhythmias diagnosed and managed," Hallett said. "SANSA will begin to eliminate these barriers for physicians and patients."

The SANSA platform has already undergone a comprehensive clinical trial involving 533 patients across seven U.S. sites, including at the University of Pennsylvania, the University of Michigan, Emory University, and Atrium Health Wake Forest Baptist. SANSA has demonstrated its efficacy in measurement reliability and performance for use in diagnosing mild, moderate, and severe sleep apnea.

The clinical trial provided robust data supporting SANSA's safety and effectiveness, including:

• high accuracy, sensitivity, and specificity in sleep apnea detection compared to in-lab sleep tests;
• improved patient compliance and comfort due to its non-invasive nature;
• excellent performance on all skin tones for diverse patient management, which had been a challenge in the past.

Clinicians who have utilized the SANSA device say it's a milestone in innovation.

"As electrophysiologists, we are already quite comfortable in using patch-based EKG monitors for arrhythmia monitoring," said Dr. Suneet Mittal, Chair of Valley Health System's Cardiovascular Service Line as well as director of electrophysiology. "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, namely atrial fibrillation and sleep apnea."

Dr. Douglas Kirsch, past president of the American Academy of Sleep Medicine and medical director of Atrium Health Sleep Medicine in Charlotte, N.C., agreed.

"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," Kirsch 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."

About Huxley Medical
Huxley Medical, Inc. is a privately held medical technology company that develops products and services to streamline care for any patient anywhere. The company has received funding from the National Science Foundation, National Institutes of Health, the Georgia Research Alliance Venture Fund, Invest Georgia, the Georgia Tech Foundation Research Impact Fund, and Duke Capital Partners to translate its growing technology portfolio. To learn more, email info@huxleymed.com.