Sleep Solutions, Inc. (SSI) is a privately held diagnostic service provider for home testing and evaluation of sleep-disordered breathing, which includes the diagnosis of Obstructive Sleep Apnea (OSA). Sleep Solutions® offers physicians and their patients a fast, cost-effective, accurate and comfortable alternative to in-laboratory sleep studies. Utilizing proprietary sound analysis technology, our NovaSom® QSG® home-diagnostic system is delivered directly to the patient.

The Market — OSA is a serious and potentially life-threatening sleep disorder that afflicts as many as 18 million Americans of which only 5% have been diagnosed. The U.S. represents approximately half of the worldwide market opportunity for OSA testing. Once properly diagnosed, highly effectively treatments are available.

The Problem — The standard method for diagnosing OSA requires placing the patient in a sleep laboratory overnight and performing polysomnography (PSG). This process is expensive, ranging from $1,000 to over $2,500 per night. The estimated 2,200 sleep laboratories in the U.S. can only accommodate a fraction of the patients that require diagnosis. Patients often resist submitting to this uncomfortable and expensive procedure.

Sleep Solutions’ NovaSom® QSG® Diagnostic Service offers sleep medicine professionals an immediate, cost-efficient approach to quickly and accurately identify patients suffering from sleep-disordered breathing, especially OSA, without additional staff or equipment. The comprehensive service combines sophisticated, clinically validated diagnostic technology with an innovative program for direct-to-patient delivery of prescription sleep-testing services and medical products.

NovaSom® QSG® is the first physician-prescribed at-home diagnostic device for OSA that has undergone rigorous clinical validation. Delivered directly to the patient through Sleep Solutions’ diagnostic service, the system is the only one cleared by the U.S. Food & Drug Administration specifically designed for unattended and unassisted use in the patient’s home and clinically proven to be equivalent to in-laboratory PSG. NovaSom® QSG® utilizes patented audio digital-signal processing (DSP) technology to sense, analyze, and process the patient’s respiratory sounds and convert these sounds to airflow volume. The device collects up to three nights of sleep data using three small sensors easily applied by the patient, and is then returned to Sleep Solutions for analysis.

Sleep Solutions’ MediTrack® System is a comprehensive program for cost-efficient, direct-to-patient delivery of testing services and medical products. With MediTrack, Sleep Solutions’ service can be provided to any patient, anytime, anywhere – virtually eliminating geographic and socioeconomic factors that often reduce access to leading-edge technology.

Sleep Solutions’ Study Viewer® electronic data analysis system utilizes proprietary algorithms for automated scoring of apneas and hypopneas. A technician is not required to manually score each event. Detailed data on each event is available to the interpreting physician online, as well as raw data in a graphic format. Data from the multi-night study are interpreted by a physician from a panel of sleep medicine specialists and qualified staff of our Joint Commission accredited IDTF. The completed and interpreted study is delivered within 48 hours to the referring physician, allowing for accurate, rapid diagnosis of obstructive sleep apnea and appropriate treatment recommendations.

The NovaSom® QSG® System has been clinically tested at the University of California, San Francisco. Clinical data comparing results from the device to simultaneous polysomnography (PSG) was presented in October 2000 at the American College of Chest Physicians annual meeting.