REDWOOD CITY, CA--(Marketwire - May 21, 2012) -
ApniCure, Inc. a medical device company focused on developing and commercializing novel home-use devices for the treatment of obstructive sleep apnea (OSA), today presented positive results from the ATLAST trial of the Winx™ Sleep Therapy System in patients with obstructive sleep apnea (OSA). Study results demonstrated significant improvements in apnea-hypopnea index (AHI), a common measurement of sleep apnea severity; oxygen desaturation index (ODI); sleep architecture and symptomatic measures of OSA, as well as high patient satisfaction with Winx. These clinical data as well as mechanism of action data were presented today as late-breaking abstracts during the "Diagnostic and Therapeutic Approaches in Sleep Apnea" session at the 2012 American Thoracic Society (ATS) Conference in San Francisco.
The Winx system is ApniCure's first product designed to offer a comfortable sleeping experience, allowing users to breathe naturally without a mask. Winx uses a proprietary platform technology called oral pressure therapy (OPT) to treat OSA. OPT is a light, oral vacuum delivered by a quiet console through a slim tube connected to a soft mouthpiece. The mouthpiece and vacuum work together to gently pull the soft palate forward and stabilize the tongue, increasing the size of the airway and allowing for natural breathing to occur during sleep.
"In the ATLAST trial, Winx significantly improved the severity and symptoms of OSA, was shown to be safe and was associated with high nightly usage and patient satisfaction," said Richard K. Bogan, M.D., chairman and chief medical officer of SleepMed Inc. and associate clinical professor of the University of South Carolina School of Medicine. "These are important findings because continuous positive airway pressure (CPAP), the standard treatment for OSA, can be associated with physical and lifestyle challenges related to its forced air delivery through a mask. Winx, which allows users to breathe naturally without a mask, represents a new, non-invasive alternative for some patients with OSA, a serious disease that is associated with long-term medical and social consequences."
ATLAST Trial Design and Results
The multi-center, prospective ATLAST study examined the safety, effectiveness and tolerability of the Winx system in 60 patients ages 32 to 80 with mild, moderate or severe OSA, with or without prior CPAP use.
Study participants underwent laboratory polysomnography at baseline with and without Winx treatment and again following 28 nights of treatment with Winx to determine ODI and AHI, which was calculated using American Academy of Sleep Medicine criteria by a blinded scorer. OSA symptoms were assessed with the Epworth Sleepiness Scale (ESS) and a modified Functional Outcomes of Sleep Questionnaire (mFOSQ). Nightly usage of Winx was assessed objectively by the system console which collected data on a standard data card.
The ATLAST study showed a significant reduction in AHI and ODI and was safe and durable. A substantial proportion of patients met the prospectively defined clinical success criteria, and these patients were easy to identify and included mild, moderate and severe OSA. Patients had significant improvement in sleep architecture and quality of life measures.
Patients showed high nightly compliance and preference over alternative therapies. Winx treatment was also shown to be compatible with current clinical practice due to features such as in-lab mouthpiece fitting, objective compliance monitoring, and compatibility with polysomnography systems.
"Based in part on these exciting data, we recently received clearance from the U.S. Food and Drug Administration to market the Winx system," said Steve Carlson, president and CEO of ApniCure. "We expect to commercially launch this first-of-its kind, patient-friendly treatment in select U.S. markets this year, with broader distribution next year."
Data from a study evaluating the mechanism of action of Winx also was presented at the ATS Conference. This study evaluated airway changes in five adults with OSA who were identified as responders to Winx. The study found that Winx significantly increased the size of the airway by pulling the soft palate forward and the anterior segment of the tongue forward toward the teeth.
"These data help identify ideal candidates for the Winx system," said Richard J. Schwab, M.D., professor of medicine and co-director of the Penn Sleep Center at the University of Pennsylvania Medical Center. "With so many untreated and undertreated patients suffering from OSA, there is a clear need for new treatment options such as Winx."
Benefits of the Winx System
Winx is designed to offer several benefits to OSA patients, including:
- Soft, flexible mouthpiece allows breathing naturally through the nose without a mask or forced air
- Slim tubing that allows sleeping in any position
- Quiet console creates a peaceful sleeping environment for users and bed partners
- Discreet design allows users to appear and feel natural while they sleep
- Small, portable and travel friendly
- Simple to use, clean and maintain
- Easy for patients to trial
About Sleep Apnea
OSA occurs when the muscles relax during sleep, causing soft tissue in the back of the throat to collapse and block the upper airway. This leads to pauses in breathing that can reduce blood oxygen saturation. The brain responds by rousing the body from sleep to restore normal breathing. The result is fragmented sleep that is often characterized by excessive daytime sleepiness.(1)
OSA is estimated to occur in more than 6.5 percent of the adult population, or more than 20 million Americans.(1) It can occur in any age group, but the prevalence is higher among those of middle and older age.(1) It is more common in men than in women.(1) OSA is a significant yet under-diagnosed and under-treated chronic disease in the United States. About 80 to 90 percent of adults with OSA remain undiagnosed.(1) Untreated OSA is highly symptomatic and is associated with significant long-term negative health issues, including heart disease, diabetes, and stroke. Studies have shown that healthcare utilization is 1.7-fold higher in patients with OSA than in those without the disease due to more hospitalization days, consultations and drug costs, particularly for cardiovascular drugs. The annual economic cost of moderate to severe OSA in the United States is estimated to be $65 to $165 billion, which is greater than asthma, heart failure, stroke and hypertensive disease ($20 to $80 billion).(2)
Important Safety Information
The Winx Sleep Therapy System is intended for use only by order of a physician. It should not be used to treat central sleep apnea or by anyone who has a severe respiratory disorder, such as severe lung disease, pneumothorax, etc.; has loose teeth or advanced periodontal disease; or is under the age of 18. Assessment of effectiveness should be conducted by a physician to ensure adequate treatment effect.
ApniCure is a private Redwood City, Calif.-based medical device company focused on developing and commercializing novel home-use devices incorporating a proprietary platform technology called Oral Pressure Therapy (OPT) for the treatment of obstructive sleep apnea (OSA) and other sleep related disorders. The U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its Winx™ Sleep Therapy System in the United States for home-use treatment of OSA. The Winx system is the first in a series of products that ApniCure plans to introduce. For more information, please visit www.apnicure.com.
(1) American Academy of Sleep Medicine Fact Sheet. www.Aasmnet.org/resources/factsheets/sleepapnea.pdf.
(2) Practice parameters for the use of continuous and bi-level positive airway pressure devices to treat adult patients with sleep related breathing disorders. SLEEP, 2006.