SOURCE: Apnicure

Apnicure

May 18, 2012 08:00 ET

ApniCure Receives FDA 510(k) Clearance to Market Winx™ Sleep Therapy System for Treatment of Obstructive Sleep Apnea

Winx System Allows Users to Breathe Naturally Without a Mask

Clinical Data From ATLAST Study to Be Presented at 2012 American Thoracic Society Conference

REDWOOD CITY, CA--(Marketwire - May 18, 2012) - ApniCure, a medical device company focused on developing and commercializing novel home-use devices for the treatment of obstructive sleep apnea (OSA), today announced that 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. The Winx system is an innovative device designed to be comfortable and easy to use while allowing users to breathe naturally without a mask.

"The Winx system is a first-of-its kind, patient-friendly treatment option for OSA patients," said Steve Carlson, president and CEO of ApniCure. "We anticipate a commercial launch of the Winx system in select U.S. markets this year, with broader distribution in 2013."

OSA is a serious disease that is associated with long-term medical and social consequences. A common sleep-related breathing disorder, OSA is characterized by collapse of the upper airway during sleep. Continuous positive airway pressure (CPAP) therapy, the standard of care for treating moderate and severe OSA,1 is consistently associated with physical and lifestyle challenges related to its forced air delivery through a mask. These may include skin irritation, nose stuffiness, air leaks around the mask, claustrophobic reactions to the mask, problems with spontaneous intimacy with a bed partner and the noise of the machine.2,3

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, flexible 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.

The FDA clearance of Winx was based in part on clinical data from the ATLAST study, a multi-center, prospective clinical trial of patients with mild, moderate or severe OSA. Study results will be presented as a late-breaking abstract at the upcoming 2012 American Thoracic Society (ATS) Conference in San Francisco on May 21.

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.4 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 can be highly symptomatic and is associated with significant long-term negative health issues, including heart disease, diabetes, stroke and obesity. 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.

About ApniCure
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.
3 Health belief model predicts adherence to CPAP before experience with CPAP. European Respiratory Journal, 2008.
4 Harvard Medical School. The Price of Fatigue. December 2010.

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