Home care, sleep disorders  

Apnea-risk evaluation system for home use receives clearance for sale in EU

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 20%.

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.
Website: www.b-alert.com



To top