Ventus Medical : Publication in Sleep Journal Demonstrates Positive Results of Large Multi-Center Clinical Trial for Provent® Sleep Apnea Therapy

April 4, 2011 - 19 Center, 250 Patient Study Shows Non-Invasive Provent Therapy Significantly Improves Sleep Apnea with High Patient Compliance – Ventus Medical, Inc. reported positive results from a 19 center clinical trial using its FDA-cleared Provent® Sleep Apnea Therapy device to treat obstructive sleep apnea. Provent Therapy uses the patient’s own breathing to create expiratory positive airway pressure (EPAP) to keep the airway open during sleep. The full results of this three month study were published in the April 2011 issue of the peer-reviewed medical journal SLEEP, an official publication of the American Academy of Sleep Medicine.
“This randomized, sham-controlled study demonstrates that Provent Therapy significantly improves the apnea hypopnea index (AHI), a scale to measure the number of breathing interruptions or stoppages per hour of sleep, as well as subjective sleepiness, as measured by the Epworth Sleepiness Scale (ESS) in patients with obstructive sleep apnea,” said study author Richard B. Berry, M.D., professor of medicine at the University of Florida College of Medicine, medical director of the University of Florida and Shands Sleep Disorders Center, and former president of the American Sleep Medicine Foundation. “Importantly, self-reported patient adherence on Provent Therapy was almost 90 percent.” ... [PDF] Ventus Medical's Press Release -

IntelGenx : Positive Bioequivalence Study with Insomnia Thin Film

April 6, 2011 - IntelGenx Corp. (TSX VENTURE:IGX) (OTCBB:IGXT) ("IntelGenx") announced the completion of a pilot biostudy indicating that IntelGenx has developed a novel oral film, INT0020, that suggests bioequivalency to a leading branded product for the treatment of insomnia. INT0020 has been developed using IntelGenx' proprietary immediate release "VersaFilm" drug delivery technology.

IntelGenx' President and CEO Dr. Horst Zerbe commented, "We are very pleased to have successfully completed another human study with our thin films. Insomnia is a largely untapped, multi-billion dollar market and our insomnia product is based on one of the leading medications within its class and could represent a very large opportunity for us."

Dr. Zerbe added. "Insomnia is a great example of an indication where convenience and quick onset of action are important for the patient making this an ideal application for our VersaFilm delivery system. We have previously completed successful studies in the areas of migraine, erectile dysfunction, and bipolar disorder. We are extremely pleased to have added a fourth product to our already strong pipeline of pharmaceutical films with positive human pharmacokinetic data."... IntelGenx's Press Release -

Inspire Medical Systems : FDA approval for Pivotal Clinical Trial

November 30, 2010 - Inspire Device for Obstructive Sleep Apnea will be tested at sites in US and Europe – Inspire Medical Systems, a leading developer of neuro stimulation therapies for the treatment of obstructive sleep apnea (OSA), announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial. The STAR trial (Stimulation Therapy for Apnea Reduction), is a multi‐center study that will evaluate both the safety and effectiveness of Inspire™ Upper Airway Stimulation (UAS) therapy in patients with moderate to severe obstructive sleep apnea (OSA). The STAR trial will be conducted at leading medical centers across the United States and Europe. The results of this study will be the basis for a Pre‐market approval (PMA) application to the FDA.
“OSA is a prevalent disorder affecting over 15 million adults in the U.S. alone. Current front line therapies for OSA, including CPAP, can have a significant impact on the lifestyle and comfort for both the OSA patient and their bed partner. As a result, patient compliance for these front line therapies is sub‐ optimal. A substantial number of patients suffering from OSA are looking for a new approach to treat this challenging condition,” commented Tim Herbert, President and CEO of Inspire Medical Systems. “Our goal with Inspire therapy is to significantly reduce the burden of sleep apnea and restore restful sleep without the lifestyle tradeoffs that some other therapies require.”... [PDF] Inspire Medical Systems' Press Release -