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 -

ECR Pharmaceuticals : Zolpimist Oral Spray

February 2011 - ECR Pharmaceuticals Co., Inc., a subsidiary of Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced the immediate availability of Zolpimist Oral Spray, a novel delivery system of the most widely prescribed sleep aid in the US, zolpidem tartrate. The Zolpimist Oral Spray unit contains 60 metered sprays and provides the flexibility of administering either a 5 or 10 mg dose of the zolpidem active ingredient. As with most prescription hypnotic agents, Zolpimist Oral Spray is federally classified as a CIV controlled substance. Zolpimist is only available by prescription.

Hi-Tech President and CEO David Seltzer indicated that "Zolpimist is a significant addition to ECR, our branded products subsidiary, and reflects our continuing commitment to build this segment of our business through the marketing of widely used, innovative products."

Steven Ratoff, the CEO of Novadel Pharma Inc., the developer of Zolpimist Oral Spray, said "we are pleased to have Zolpimist available in the U. S. marketplace." Over 79 million prescriptions are written annually in the US for sleep aid products... ECR Pharmaceuticals' Press Release - Novadel Pharma's Press Release -

Somnetics : New Transcend Sleep Apnea Therapy System Offers First Radical Advancement Since CPAPs Were Invented

January 10, 2011 - Wearable Therapy System Offers Hassle-Free Convenience, Unlimited Mobility and Freedom to Sleep Anywhere; Surpasses Any Conventional CPAP in Size, Design, and Technology – Designed to fit today’s active lifestyle, Transcend—which will be available for sale on January 21, 2011—is the first practical, wearable sleep apnea therapy system on the market that offers patients an innovative replacement to their old-fashion, cumbersome CPAP (continuous positive airway pressure) machines.

According to Ralph Germscheid, President of Somnetics, LLC, the maker of Transcend, “We’ve developed a completely new kind of therapy system. Transcend is FDA-approved and weighs approximately one pound. Its compact design, unique patent-pending heat moisture exchange technology, and portable power options make it ideal for travel and provide users with convenience and mobility not available from existing CPAP machines.”... Somnetics' Press Release -

Pico-Tesla : pilot study of Magneceutical® Therapy for fibromyalgia

Dec. 15, 2010 — Pico-Tesla, The Magneceutical® Company, announced that it has commenced a randomized, double-blind, placebo-controlled pilot study of 30 patients who have fibromyalgia. The pilot study seeks to determine whether the application of magnetic fields generated by Pico-Tesla’s patented Resonator™ system can be effective as an adjunctive therapy to oral medications in ameliorating the symptoms of fibromyalgia.

The study will be coordinated by Miguel Trevino, M.D., Medical Director, Innovative Research of West Florida, Clearwater, Fla. Dr. Trevino is certified to practice medicine by the American Board of Internal Medicine. Innovative Research of West Florida is a leading Clinical Research Site... Pico-Tesla's Press Release -

Nonin Medical : Next-generation wrist-worn pulse oximeter provides SpO2 monitoring flexibility and accuracy in ambulatory, sleep-study settings

Jan. 19, 2011 – Nonin Medical, Inc., the inventor of fingertip pulse oximetry and an innovator of noninvasive physiological monitoring solutions, announced the United States and Canadian launches of its WristOx2™, Model 3150 wrist-worn pulse oximeter.

The WristOx2, Model 3150 is a compact, wireless wrist-worn monitoring device that accurately monitors blood-oxygen saturation (SpO2) levels and pulse rate in patients undergoing ambulatory monitoring to screen for breathing disorders such as chronic obstructive pulmonary disease or sleep disorders such as obstructive sleep apnea. Engineered with Nonin’s PureSAT® SpO2 technology, the WristOx2, Model 3150 is proven clinically accurate in the widest range of clinical settings and challenging patient conditions such as motion and low perfusion. Featuring Bluetooth® wireless technology, a new ergonomic design and larger screen size, the WristOx2, Model 3150 is designed to increase patient comfort and ease of use... Nonin Medical's Press Release -

Philips strengthens home healthcare portfolio with acquisition of main business of medSage Technologies

January 6, 2011 - Royal Philips Electronics (AEX: PHI, NYSE: PHG) announced that it has acquired substantially all of the assets of medSage Technologies LLC, a leading provider of patient interaction and management applications (“medSage Technologies”). The acquisition will allow Philips to offer a web-based solution that enables home care providers to manage ongoing compliance and replenishment services for individuals under treatment for obstructive sleep apnea (OSA), diabetes, respiratory and other conditions. The acquired business will become part of the Sleep business within Philips Home Healthcare Solutions.

“We believe the need to manage chronic diseases by an aging population, coupled with health economics, will continue to drive a greater need for healthcare delivery at home,” said Steve Rusckowski, CEO of Philips Healthcare. “This acquisition is fully aligned to our strategy of providing home care providers with new opportunities to enhance their service offerings with an effective and cost-efficient application.” Philips' Press Release -