Multiple Presentations Confirm Clinical Efficacy and High Rate of Patient Compliance Using Provent® Sleep Apnea Therapy to Treat Obstructive Sleep Apnea
BELMONT, Calif., June 14, 2011 -- Ventus Medical, Inc. today announced that several independent board-certified sleep specialists presented positive clinical data supporting use of Provent® Sleep Apnea Therapy in their obstructive sleep apnea patients. These presentations, at SLEEP 2011, the 25th Annual Meeting of the Associated Professional Sleep Societies in Minneapolis, Minnesota, highlight the clinical efficacy and high compliance rate for patients with obstructive sleep apnea (OSA) using Provent Therapy.
"Together, these presentations provide conclusive evidence from clinical practices throughout the United States that Provent Therapy offers an effective treatment option for patients with obstructive sleep apnea who are not compliant on CPAP therapy," said Philip Westbrook, M.D., Chief Medical Officer of Ventus Medical and Emeritus Clinical Professor of Medicine at the University of California, Los Angeles. "In addition to the consistent evidence of reduced apnea hypopnea index (AHI) and Epworth sleepiness scale (ESS), the presentations today include positive long-term (12-month) Provent Therapy results. We are excited to see how Provent Therapy is being used by sleep specialists across the country and incorporated into their therapeutic protocols for untreated patients suffering from obstructive sleep apnea."
Oral Presentation Highlights Use of Provent Therapy over 12-Month Duration
Meir Kryger, M.D., of Gaylord Sleep Medicine in Wallingford, CT presented data from a 13-center, 12-month prospective study. Results showed that patients treated with Provent Therapy over a period of 12-months reduced their AHI by 70 percent. AHI is a measure of how many times a person stops breathing per hour of sleep. In addition, the study confirmed a very high nightly compliance rate of nearly 90 percent. Average ESS reduction was five points in addition to a 74 percent reduction in snoring for treated patients.
"With this extension trial, we were pleased to see that the dramatic AHI reduction for patients was maintained for 12 months," said Dr. Kryger. "Long term nightly compliance remained close to 90 percent in this longer term study."
Multiple Presentations Highlight Use of Provent Therapy in Clinical Practice
A poster presentation by Glenn Adams, M.D., Medical Director for the Sleep Disorders Center at Sarasota Memorial Hospital in Sarasota, FL featured data using Provent Therapy in clinical practice. Dr. Adams showed that Provent Therapy when used alone or in combination with positional therapy (side sleeping) and/or chin straps was very effective in the treatment of OSA. AHI was reduced to less than 10 in more than 80 percent of patients (mild, moderate and severe) using Provent Therapy, and over 90 percent of patients with mild to moderate OSA. Approximately 75 percent of patients acclimated to Provent Therapy within 10 days.
Additional poster presentations from Dennis Hwang, M.D., of the Sleep Medicine Clinic at Kaiser Permanente in Fontana, CA, and Clifford Massie, Ph.D., Clinical Director of the Chicago Sleep Group and Suburban Lung Associates in Elk Grove Village, IL confirmed that in clinical practice, Provent Therapy is a viable alternative for patients with mild to moderate OSA who cannot tolerate CPAP therapy.
Finally, a poster presentation by Paula Schweitzer, Ph.D., Director of Research for the Sleep Medicine and Research Center in Chesterfield, MO, analyzed pooled data from past clinical trials to conclude that Provent Therapy demonstrated a meaningful response in patients with OSA.
About Obstructive Sleep Apnea
Obstructive sleep apnea is the most common type of sleep disordered breathing. It is estimated that 40 million people in the United States suffer from sleep apnea. In people 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 regular 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. 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.