SOURCE: ApniCure, Inc.

ApniCure, Inc.

May 20, 2013 14:01 ET

ApniCure Presents Positive Results From Two Clinical Studies of the Winx® Sleep Therapy System for the Treatment of Obstructive Sleep Apnea

Long-Term Efficacy and Safety and Response Prediction Data Presented at 2013 American Thoracic Society Conference

REDWOOD CITY, CA--(Marketwired - May 20, 2013) - 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 two studies of its Winx® Sleep Therapy System, a first-of-its kind, lifestyle-friendly treatment for OSA. Results demonstrated that treatment with Winx is safe and produces durable results over a three-month period. Additionally, treatment success with Winx was not dependent on such variables as sleep apnea severity and body mass index (BMI), unlike other OSA treatments. The data were presented in a poster session at the American Thoracic Society Conference in Philadelphia.

The Winx system, ApniCure's first product for the treatment of mild, moderate and severe OSA, is designed to increase treatment adherence and overall efficacy without the inconvenience of the mask. The Winx system is designed with a soft, flexible mouthpiece and slim tubing to offer a comfortable sleeping experience, allowing users to breathe normally. Winx uses a proprietary platform technology called oral pressure therapy (OPT) to gently draw the soft palate forward and stabilize the tongue to actively open the airway for uninterrupted breathing during sleep.

"These data provide further evidence that Winx is a safe and effective treatment for sleep apnea and are especially encouraging because patients were very compliant with treatment for a three month period, which is considered significant for predicting long term usage in sleep medicine," said Steve Carlson, president and CEO of ApniCure. "Sleep apnea is vastly undertreated in the United States, and we have developed Winx as a lifestyle-friendly treatment option to increase treatment adherence for people suffering from this serious condition."

Safety and Effectiveness of Oral Pressure Therapy: 3-Month Treatment Evaluation (Abstract A2119): In 32 patients with sleep apnea, treatment with Winx for three months was shown to be safe and to produce clinically significant improvements in apnea-hyponea index (AHI) compared to baseline without treatment. Measures of sleep architecture were also improved with Winx. There were no serious or severe adverse events.

Predicting Response to Oral Pressure Therapy for Obstructive Sleep Apnea (Abstract A3752): In an analysis of ATLAST study data from 63 patients treated at six centers, treatment success with Winx, unlike with other OSA therapies, was shown to be independent of age, gender, sleep apnea severity, body mass index (BMI), or positional or REM dependence. Anatomical abnormality in the oral cavity was associated with a reduced likelihood of treatment success and represents an opportunity to better select patients who will respond to Winx treatment.

About the Winx Sleep Therapy System
Continuous positive airway pressure (CPAP), the current standard treatment for OSA, is difficult to tolerate for many people with OSA due to the bulky mask, forced air and inconvenience of the device. Winx liberates users from the traditional burdens of a CPAP mask by using a soft, flexible mouthpiece and slim tubing that allow for sleeping in any position. The quiet, discrete console and travel-friendly design allow Winx to fit into the user's life with minimal disruption to the user or their bed partner. Winx uses a proprietary platform technology called oral pressure therapy (OPT) to gently draw the soft palate forward and stabilize the tongue to actively open the airway for uninterrupted breathing during sleep.

ApniCure received clearance from the U.S. Food and Drug Administration in March 2012 to market the Winx system and subsequently launched the product in select U.S. markets. ApniCure plans broader distribution this year.

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) 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.

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