SOURCE: Apnicure

ApniCure

June 05, 2013 08:00 ET

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

Long-Term Compliance and Therapy Naive Data Presented at 2013 SLEEP Conference

REDWOOD CITY, CA--(Marketwired - Jun 5, 2013) - ApniCure, Inc., a medical device company focused on developing and commercializing novel home-use devices for the treatment of obstructive sleep apnea (OSA), presented positive results from three studies of its Winx® Sleep Therapy System, a first-of-its kind, lifestyle-friendly treatment for OSA. Results demonstrated high patient compliance over a three month period, which is important for predicting long term usage of sleep apnea treatments. Additionally, upper airway MRI imaging showed substantial increases in airway opening with Winx, and therapy naïve patients treated with Winx achieved significant reductions in their apnea-hyponea index (AHI), a common measurement of sleep apnea severity. The data were presented at the 27th Annual Meeting of the Associated Professional Sleep Societies (SLEEP) in Baltimore, MD.

The Winx system, ApniCure's first product for the treatment of mild, moderate and severe OSA, has an innovative design to increase treatment adherence and overall efficacy without the inconvenience of a 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 studies provide further evidence that Winx is a viable long-term treatment option for sleep apnea, including patients without prior OSA treatment," said Steve Carlson, president and CEO of ApniCure. "Many sleep apnea treatment options are uncomfortable and difficult to tolerate as long term solutions. For this reason, we developed Winx as a lifestyle-friendly treatment option to fit into the user's life with minimal disruption."

Oral Pressure Therapy for Obstructive Sleep Apnea in Subjects without Prior Treatment Experience (Abstract #0504): In a study of therapy naïve patients with mild, moderate, and severe sleep apnea, treatment with Winx was shown to be safe and effective, with significant improvements in AHI and symptoms. Winx was used on 93% of nights for an average of 5.9 hours during the study, showing high compliance.

Examining the Mechanism of Action of a new Device Using Oral Pressure Therapy (OPT) for the Treatment of Patients with OSA (Abstract #0354): In this study, treatment with Winx was shown to increase the size of the airway in both the anterior-posterior and lateral dimensions in 14 patients with mild, moderate and severe sleep apnea. Winx opens the airway by drawing the soft palate and anterior segment of the tongue forward.

Compliance with Oral Pressure Therapy for Treatment of Obstructive Sleep Apnea (Abstract #0391): In a study of 32 patients, treatment with Winx had high patient compliance, averaging 5.2 - 5.6 hours of usage per night for each month of the three-month testing period and this resulted in improved sleep apnea symptoms. Patient compliance was objectively measured using Winx's proprietary data management software and built-in SD card.

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 patient 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.

Contact Information