ATLANTA, Aug. 7, 2024
/PRNewswire/ -- 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.
Media Contact:
Chris F.
Hallett
Chief Commercial Officer
Huxley Medical
chris.hallett@huxleymed.com
321.439.8577
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SOURCE Huxley Medical, Inc.