SOURCE: Apnicure

Apnicure

September 06, 2012 06:30 ET

ApniCure Presents Additional Positive Data From ATLAST Clinical Trial of Winx™ Sleep Therapy System for Treatment of Obstructive Sleep Apnea

Findings Provide Further Support for Safety and Efficacy of New, Non-Invasive Oral Pressure Therapy Device

Data Presented at 2012 European Sleep Research Society Conference

REDWOOD CITY, CA--(Marketwire - Sep 6, 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 additional positive results from the ATLAST trial of its Winx™ Sleep Therapy System in patients with obstructive sleep apnea (OSA). Study results demonstrated that Winx significantly improved the severity and symptoms of OSA, was safe and well tolerated, and was associated with high nightly usage and patient satisfaction. These clinical data, along with results from another analysis of the ATLAST study demonstrating improvements in sleep architecture and sleep stability with Winx therapy, were presented today at the 21st Congress of the European Sleep Research Society (ESRS) in Paris.

The Winx system is 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.

"With so many undertreated patients, Winx is a new and encouraging step forward for patients suffering from OSA," commented Philip M. Becker, M.D., president of Sleep Medicine Associates of Texas and clinical professor of Psychiatry at the University of Texas Southwestern Medical Center at Dallas. "The positive clinical results indicate that Winx offers a new and well accepted treatment option for my sleep apnea patients."

"These new results provide additional evidence of the safety, tolerability and efficacy of Winx, a first-of-its kind, patient-friendly treatment for OSA," said Matt Vaska, chairman of the board, chief technology officer and founder of ApniCure. "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. In contrast, Winx allows users to breathe naturally without a mask, representing a new alternative for the treatment of OSA."

"We recently received clearance from the U.S. Food and Drug Administration to market the Winx system and are excited to be commercially launching in select U.S. markets this year with broader distribution in 2013," said Steve Carlson, president and CEO of ApniCure.

ATLAST Trial Design and Results
The multi-center, prospective ATLAST study examined the safety, effectiveness and tolerability of the Winx system in 63 patients (44 men and 19 women) 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 apnea-hypopnea index (AHI), a common measurement of sleep apnea severity; and oxygen desaturation index (ODI). ODI and AHI were 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 Winx system console, which collected data on a standard data card.

Earlier findings from the ATLAST study were presented at the 2012 American Thoracic Society (ATS) Conference in May. The new and updated findings, based on data from 63 patients, show that Winx significantly reduced AHI, ODI and symptoms of OSA after 28 days. Median ESS scores were unchanged in patients who switched directly from CPAP therapy to Winx therapy and were significantly reduced in those untreated for two or more weeks prior to Winx study participation. A substantial proportion of patients (41.3 percent) met the prospectively defined clinical success criteria (AHI reduction >50 percent and treatment AHI <20). These patients were easy to identify and included those with mild, moderate and severe OSA.

Compliance with the Winx system was high, with nightly usage high in both frequency and duration. Study participants used the system 6 hours each night (median), and the median percentage of nights with more than 4 hours of use was 88.9 percent. Study participants had a high opinion of Winx, with 76 percent indicating that they would use the system to treat their OSA. In the study, Winx was safe and well tolerated, with no severe or serious device-related adverse events.

Winx treatment also was 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.

Improvements in Sleep Architecture and Sleep Stability with Winx
Additional analysis of data from the ATLAST study evaluated the effect of Winx therapy compared with non-treatment on the sleep architecture and sleep stability of study participants. Polysomnographic sleep measures, including arousal index, sleep-stage shifts, and duration of sleep stages were evaluated in 63 patients.

Results showed that the significant improvements in AHI produced by Winx were associated with increased sleep stability, significantly decreased time in non rapid eye movement (NREM) stage 1 sleep and increased time in rapid eye movement (REM) sleep on both the first night of treatment and again after 28 days of treatment. Shifts to stage 1 sleep, overall stage shifts, total awakenings and arousals per hour were all significantly decreased with Winx.

Benefits of 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 is a serious disease that is associated with long-term medical and social consequences. It 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.

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 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.

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