Apnea-risk evaluation system for home use receives clearance for sale
14 February 2005
Carlsbad, California, USA. Advanced Brain Monitoring, Inc. today
announced that it received the CE Mark in the European Union for its Apnea
Risk Evaluation System (ARES). With this CE Mark, Advanced Brain Monitoring
can now market the ARES in the European Union. The ARES was cleared by the
FDA in October 2004.
The patented ARES is an easy-to-apply, in-home system for diagnosing
obstructive sleep apnea (OSA). The ARES combines a miniaturized,
battery-powered device to measure blood oxygen levels, pulse rate, snoring
sounds, nasal pressure and head position/movement with a questionnaire to
assess known risk factors. A multi-site clinical trial, including direct
comparisons with laboratory testing and in-home studies on 280 participants,
proved ARES was as accurate as the gold standard laboratory sleep study.
"We believe the ARES will be well received in Europe where the prevalence of
OSA is high, but the availability of sleep labs is severely limited", Dr.
Philip Westbrook, Medical Director of Advanced Brain Monitoring commented.
"Untreated sleep apnea can result in daytime drowsiness and memory
impairment as well as increased risk of hypertension, diabetes
cardiovascular disease and stroke. We also know from studies conducted
worldwide that untreated OSA patients are 3-5 times more likely to be
involved in industrial and motor vehicle accidents".
The National Sleep Foundation estimates that over 18 million Americans have
OSA and 90% have not yet been diagnosed. In the United Kingdom, there are 84
sleep laboratories to serve a population of nearly 59 million, resulting in
waiting times for a laboratory sleep study of 7 months to five years.
According to Frost and Sullivan, the international market for OSA-related
products is growing at an annual rate of 25% and the US market growth is
Chris Berka, Chief Executive Officer of Advanced Brain Monitoring, said,
"This CE Mark is another step in our broad-based strategy of commercializing
products that are accurate, affordable and easy to use. This approval will
help physicians in Europe adequately address the demand for diagnosis and
treatment of patients with suspected sleep apnea, offering an alternative to
the expensive and often unavailable laboratory sleep studies."
About Advanced Brain Monitoring, Inc. is addressing OSA, memory dysfunction,
and alertness monitoring with patented instrument systems that combine
laboratory-level accuracy with the portability, ease-of-use and low cost of
consumer electronics. The Company's second product launch, of the AMP
(Alertness and Memory Profiler), features wireless EEG monitoring to enable
portable, user-friendly brain assessment. The AMP simultaneously measures
brain function and cognitive performance during vigilance, attention and
memory tests. Alternatively, the EEG systems provide real-time monitoring of
alertness and workload to ensure safety and effectiveness in military
operations or other high-risk occupations. Advanced Brain Monitoring systems
enable widespread use by physicians, dentists, industrial/transportation
companies and consumers.
Source: Advanced Brain Monitoring, Inc.