Contact:
Sleep Solutions, Inc.
410.590.0443
info@sleepsolutions.com

SLEEP SOLUTIONS, INC.
Real Answers. At Home. At Last.

Sleep Solutions Inc., of Pasadena, MD., provides technology and services for at-home testing and evaluation of sleep-disordered breathing, including Obstructive Sleep Apnea (OSA). The most common form of sleep-disordered breathing, OSA is a serious and potentially life-threatening disorder characterized by repeated narrowing or collapse of the upper airway during sleep that restricts or prevents breathing. OSA afflicts an estimated 2% of women and 4% of men in the United States - roughly 18 million Americans of which only 5% have been diagnosed.

Combining proprietary sound analysis technology and an innovative direct-to-patient delivery system, Sleep Solutions' service facilitates a multi-night sleep study with equivalent accuracy, greater convenience and lower cost than standard sleep laboratory tests used to diagnose OSA. Cleared for marketing by the U.S. Food and Drug Administration (FDA), the company's NovaSom® QSG® is the only device specifically designed for unattended, unassisted use in the patient's home to have achieved rigorous clinical validation with a demonstrated 96% correlation to conventional in-laboratory sleep testing.

Introduced in 2001, Sleep Solutions' physician-prescribed service is designed to help healthcare providers manage the growing demand for sleep studies by leveraging the cost-efficiencies of ambulatory testing - without compromising the quality of test results.

The Sleeping Giant - Obstructive Sleep Apnea

The morbidity and mortality rates associated with sleep apnea are significant. New research shows that OSA is a potentially life-threatening disorder that correlates to high blood pressure and is strongly associated with congestive heart failure, irregular heartbeat, and greater risk of heart attack or stroke. Sleep-disordered breathing in patients with coronary artery disease is associated with a 60%-70% increase in the risk of death and cardiovascular morbidity in long-term follow-up . A study reported in the New England Journal of Medicine found that people who experience apneic events during sleep are up to three times more likely to develop high blood pressure, with increased rates of systemic hypertension, stroke, angina, myocardial infarction, pulmonary hypertension and ventricular failure.

OSA also has been linked to diabetes, depression, epilepsy, headaches, daytime sleepiness and an overall decreased quality of life . Sleep apnea, and subsequent disrupted sleep patterns, has been identified as a major cause of vehicular and industrial accidents, and impaired cognitive performance. Individuals with sleep apnea are six times more likely to be involved in a traffic accident than individuals without sleep apnea.

Diagnosing OSA

Undetected and untreated OSA is a major cost to the healthcare system. Prior to treatment, people that suffer from OSA consume twice as many healthcare resources as those who do not have OSA , and have nearly three times as many hospitalizations and physician office visits.

The standard method for diagnosing OSA is polysomnography (PSG), an overnight sleep study performed in a hospital or laboratory with an attending technician. PSG is costly, ranging from $1,000 to more than $2,500 per night. The estimated 2,200 U.S. sleep laboratories can accommodate only a fraction of the patients requiring diagnosis. Patients often resist submitting to this uncomfortable and expensive procedure. Moreover, referring physicians are often reluctant to refer their patients for a sleep study due to the high cost, scheduling delays, and patient resistance to in-lab overnight tests.

Recent research suggests that multi-night studies, though too costly to be practical in a laboratory setting, may be preferable for diagnosing disorders such as OSA. Single-night studies may not be adequate to safely reject a diagnosis of sleep apnea since the testing conditions and environment often result in a "first night effect" that disrupts the patient's normal sleep pattern . Additionally, the possibility of false negative outcomes due to intra-scorer variability is increased when the diagnosis is based on data from a single night.

Once detected, OSA can be effectively treated a number of ways. The most widely used therapy is continuous positive airway pressure (CPAP), which uses carefully controlled air pressure delivered through a mask to prevent airway collapse. Other options include behavioral modification, surgical resection or radio-frequency ablation. Acceptance and utilization of therapy is growing. The market for CPAP products is growing at an annual rate of approximately 20%, and is a strong indicator of the need to expand diagnostic capabilities.

Sleep Solutions' Diagnostic Service & NovaSom® QSG®

Sleep Solutions' diagnostic service utilizes the first FDA-cleared, at-home testing device with clinically validated equivalence to PSG for diagnosing OSA. Prescribed by a physician, NovaSom® QSG® is delivered directly to the patient for self-administered use at home. Consisting of three small, comfortable sensors and a bedside console, the device collects up to three nights of sleep data, including respiratory events, snoring intensity, blood oxygen saturation, pulse rate and respiratory effort. Patented audio digital-signal processing (DSP) technology is used to sense, analyze, and process the patient's respiratory sounds and convert these sounds to airflow volume. After three nights of use, the patient returns the system to Sleep Solutions where the data is extracted and analyzed. Sleep Solutions generates a comprehensive diagnostic report using its Study Viewer™ electronic analysis system with proprietary algorithms for automated data scoring. The physician or technician is no longer required to perform manual analysis of the test data or waveforms. The Sleep Study report provides concise, conclusive data that enables the physician to make an accurate and rapid diagnosis.

NovaSom® QSG® is designed to be very user-friendly. Instructional materials and automatic voice prompts guide patients through the setup process. A patient satisfaction survey showed 93% of patients had no difficulty connecting the three NovaSom® QSG® sensors.

MediTrack™ - Any patient. Any time. Anywhere.

Delivery of Sleep Solutions' service is facilitated by its proprietary MediTrack System, a comprehensive healthcare management program for the direct-to-patient delivery of testing services and medical products. MediTrack allows the diagnostic service to be provided to any patient, any time, anywhere - virtually eliminating geographic and socioeconomic factors that often reduce access to leading-edge technology. MediTrack permits immediate physician verification, online or phone ordering submission, compliance with state and federal patient privacy regulations, and secure data viewing so physicians have access to test files and medical records. It also provides a cost-effective and scalable operational infrastructure to support increased patient volume and international expansion.

SENIOR MANAGEMENT

Jan Barker, Chairman of the Board
Jan Barker brings wide-ranging experience to Sleep Solutions. She is a Principal with MedVenture Associates, one of the country's leading venture capital firms specializing in medical technology and a primary investor in Sleep Solutions.

Ms. Barker has a broad combination of complementary skills in the healthcare entrepreneurial environment. Her diverse experience has included management, research and development, sales and marketing, human resources, information technology, development of e-healthcare technology and systems, devices and manufacturing.

As a founding and managing member in The Crucible Group, L.L.C., a venture development organization, she participated in focusing on privately negotiated equity and equity related investments in the systems and information technology segments of the healthcare industry. Along with the team of professionals, she provided seasoned capability to assist entrepreneurial ventures in obtaining seed capital, business plan development, strategic planning insight, operations assistance, and recruitment of key personnel and/or Board of Director participation.

Ms. Barker has worked/invested with private and public corporations in the healthcare systems, technology and medical device industries, including IPCM, The Hospitalist Company, PointShare, Networks for Healthcare, Alere Medical, Incorporated. With experience in venture development, strategic and analytical planning; the design and implementation of management systems for running complex, high growth, healthcare systems; fiscal analysis; understanding of information system technologies, and Internet business modeling, Ms. Barker brings strong expertise to the MedVenture team. Previously Ms. Barker has worked with Alere Medical, Inc., MedPartners, Inc., Lucile Salter Packard Children's Hospital at Stanford and CDP Primary Care.

Michael Thomas, President and CEO
Thomas has over 14 years of experience in the healthcare industry in various sales, marketing, and business development positions. Most recently, he was Executive Vice President of Sales and Marketing for National Sleep Technologies Inc. (NST). As an executive and board member, he identified and closed acquisitions that led to NST becoming the largest U.S. sleep-testing company at that time. He helped create the first national brand in the highly fragmented sleep-testing services market.

Previously, Thomas was instrumental as Vice President of Sales in building sales and marketing for Patient Infosystems, a healthcare start-up specializing in the development of disease management programs for the healthcare industry. During his tenure, he hired, trained and managed a national sales force and was instrumental in taking the company public within two years of its formation. Having held various sales and marketing positions, including seven years with Merck and Glaxo Wellcome, he has earned numerous awards for sales and management achievements. Thomas graduated from Cornell University with a bachelor's degree in microbiology.

Gary Corbett, CIO and VP Operations
Joining Sleep Solutions in 2000, Gary Corbett is responsible for the company’s information product development and communications infrastructure by developing systems, networks, processes and procedures for cost-efficient operations and client/partner system integration. With a career involving positions in the military, government and large corporations, he brings broad experience developing successful programs employing communications media and information systems across multiple industries.

In 1986, Mr. Corbett was recruited by Northrop Corporation to work on strategic planning and communications programs to the White House, Congress, and the Pentagon for the company’s multi-billion dollar defense programs. While there, he helped develop an Executive Information System and the first national secure Intranet connecting Northrop, Boeing, Grumman, Lockheed, TRW and the Pentagon. Mr. Corbett was issued an engineering certification and still holds a Top-Secret clearance.

Later, at the Los Angeles Times, he developed campaigns for national advertisers and helped establish the corporation's initial Internet strategy. Mr. Corbett joined a large publisher of trade journals, where he worked with executives across 50 industry segments on the integration of the Internet into corporate operations. After working with a leading management consulting company in Silicon Valley, Corbett joined Sleep Solutions. He majored in Communications at the University of California and served in the U.S. Air Force working with communications media for military intelligence.