Ventus Medical Receives CE Mark for Provent® Sleep Apnea Therapy
BELMONT, Calif., March 3, 2011 /PRNewswire/ -- Ventus Medical, Inc. a privately-held medical device company dedicated to providing novel products to treat sleep-disordered breathing, today announced that it has received CE Mark for its Provent® Sleep Apnea Therapy.
"We are pleased to accomplish this important regulatory milestone. Receiving CE Mark for Provent Therapy will facilitate our international commercialization strategy and allow us to launch this product in selected countries over the next several months," said Peter Wyles, president and chief executive officer of Ventus Medical. "We intend to introduce Provent Therapy internationally in a systematic way through established distributors, focusing on countries with a high prevalence of obstructive sleep apnea. There is a clear need for therapeutic options other than CPAP and Provent Therapy represents an attractive new alternative."
About Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is the most common type of sleep-disordered breathing. It is estimated that one in 20 adults worldwide suffer from sleep apnea, with population-based studies suggesting that certain countries have a higher prevalence of OSA. In those with OSA, the airway collapses during sleep when the muscles, that hold the airway open, relax. People with this disorder can stop breathing while sleeping---in some cases hundreds of times each night---usually for periods of ten seconds or longer. Importantly, many recent studies have shown that people with OSA experience higher rates of car accidents as well as serious health problems including high blood pressure, heart attack, stroke and diabetes.
Unfortunately, OSA often goes undiagnosed and therefore untreated. Of the patients that do receive treatment, most are prescribed a CPAP machine. CPAP is extremely effective at treating OSA if worn as directed. However, more than half of all patients stop treatment with CPAP due to its cumbersome nature. Provent Therapy was developed to help patients who do not use CPAP regularly and who can benefit from a non-invasive and clinically effective treatment alternative.
About Provent Sleep Apnea Therapy
Provent Therapy is a prescription device indicated for the treatment of obstructive sleep apnea. It is an easy-to-use, disposable treatment that works across mild, moderate and severe OSA. Provent Therapy is cleared by the U.S. Food and Drug Administration (FDA) and numerous peer-reviewed published studies have demonstrated that Provent Therapy improves sleep apnea and oxygenation. The device works through Ventus Medical's proprietary MicroValve technology that uses the patient's own breathing to create expiratory positive airway pressure (EPAP) to keep the airway open during sleep. For more information, please visit www.proventtherapy.com.
About Ventus Medical
Ventus Medical is a privately-held medical device company dedicated to providing non-invasive medical solutions for people with sleep-disordered breathing. Based on its innovative MicroValve technology and patented designs, Ventus Medical has developed a unique line of clinically-proven medical devices to address the continuum of sleep disorders from severe obstructive sleep apnea to snoring. Ventus Medical devices work by creating expiratory positive airway pressure (EPAP). The company markets FDA-cleared, prescription-only Provent Therapy, a discreet, easy-to-use nasal device, for the treatment of obstructive sleep apnea and is developing an over-the-counter device for snoring.
SOURCE Ventus Medical, Inc.