Sleep Profiler PSG2™ Cleared by FDA to Diagnose Sleep Apnea

CARLSBAD, Calif.–(BUSINESS WIRE)–#homesleeptestAdvanced
Brain Monitoring, Inc.
announces the U.S. Food and Drug
Administration (FDA) has granted 510(k) clearance for Sleep Profiler™,
the most widely used, self-applied system for the assessment of overnight
in patients with insomnia or mood disorders, to be used in the
diagnosis of sleep apnea.

“Sleep Profiler PSG2 meets the requirements for unattended
polysomnography, the most accurate method for in-home assessment of
sleep-disordered breathing,” stated Dr.
Philip R. Westbrook
, Chief Medical Officer, Advanced Brain
Monitoring, and Past‐President, American Academy of Sleep Medicine.
“Clinical study results, required for FDA clearance, showed the Sleep
Profiler PSG2 delivers unparalleled accuracy in the automated detection
of sleep stage-dependent mild and moderate sleep apnea.”

The Sleep Profiler provides clinicians a powerful new tool to
objectively evaluate sleep patterns which are proven contributors to
disability, morbidity and mortality. Clinicians can now obtain a home
sleep test that assesses rapid eye movement (REM) related obstructive
sleep apnea, a condition associated with hypertension and depressive
symptoms. A Sleep Profiler PSG2 study result can identify patients with
abnormal sleep duration and efficiency, decreased slow wave sleep, and
increased cortical arousals, factors which have been associated with
increased hypertension, obesity, diabetes, and memory impairment. An
overnight EEG assessment with Sleep Profiler allows clinicians to
differentiate sleep state misperception from insomnia and circadian
rhythm sleep disorders.

“Sleep Profiler includes automated sleep staging,” stated Daniel
J. Levendowski
, President and principal investigator of the study.
“Results showed the Sleep Profiler accuracy in detection of REM sleep
and slow wave sleep was equivalent to manual scorers from different
sleep laboratories.”

About Sleep Disorders

According to the American Academy of Sleep Medicine, 23.5 million adults
in the United States have undiagnosed obstructive sleep apnea, which has
an estimated annual cost of $199 billion, based on increased healthcare
costs, lost productivity, motor vehicle and workplace accidents. An
additional 25-30% of the adult population suffers from insomnia and mood
disorders resulting from poor sleep quality. Insomnia has been estimated
to contribute to 24% of all workplace accident costs, resulting in a $31
billion per year loss to employers.

About Advanced Brain Monitoring

Advanced Brain Monitoring, headquartered in Carlsbad, CA, is a privately
held industry leader focused on developing innovative solutions for the
diagnosis and treatment of sleep, neurological, and psychiatric
disorders. The Company has been issued 20 patents for its diagnostic and
therapy products, which have been used on over 350,000 patients


Advanced Brain Monitoring, Inc.
Daniel J. Levendowski,