GE’s Virtual Sleep Lab Enables Sleep Apnea Testing in Hospitalized Cardiac Patients

March 16, 2010--GE Healthcare introduced MARS® Virtual Sleep Lab (VSL), the first device to provide a streamlined view of quantitative cardiac and sleep apnea analysis from any GE-monitored inpatient bed, helping enhance speed of diagnosis. MARS VSL is being featured at the American College of Cardiology (ACC) 59th Annual Scientific Session, held March 14 to 16 in Atlanta.

Integrating a sleep disorder diagnostic tool into hospital cardiac care represents an important advance, as obstructive sleep apnea (OSA) impacts up to 50 percent of all heart disease patients.1 When sleep disorders are diagnosed and treated early, it has been shown to improve cardiac conditions. Left undiagnosed, sleep apnea can increase heart disease risks... GE Healthcare's Press Release -

ImThera Medical Successfully Implants First Patients with Neurostimulation Device to Treat OSA

December 1, 2009 – ImThera Medical, Inc. announced that two patients have been surgically implanted with ImThera’s aura6000™ neurostimulation device for treating tongue‐based Obstructive Sleep Apnea (OSA).
Patients are being enrolled in ImThera’s pilot clinical investigation in Belgium with the first results expected to be published in the first half of 2010. The patients were implanted with the aura6000, during which the hypoglossal nerve was briefly stimulated to verify system and nerve integrity. One week postsurgery, the patients underwent an in‐laboratory Polysomnography (PSG) titration process during which stimulation parameters were determined in order to maintain proper tongue position and to provide an open airway during sleep.
“The surgical procedures went smoothly, taking approximately 90 minutes to complete. There were no surgical complications; minor surgical issues were quickly resolved. At one week, patients were not disturbed by the implanted stimulator, lead or electrode,”...[PDF] ImThera Medical's Press Release -

Lupin : FDA tentative approval for Eszopiclone tablets

March 20, 2010 - Pharma Major, Lupin Limited announced that its U.S subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration (USFDA).

Lupin’s Eszopiclone tablets are the AB-rated generic equivalent of Sepracor’s LUNESTA® tablets, indicated for the treatment of insomnia. The brand product had annual sales of approximately $761 million for the twelve months ended December 2009, based on IMS Health sales data... Lupin Pharmaceuticals' Press Release -

Vantia Therapeutics' lead candidate VA106483 enters Phase IIb trial for nocturia.

2nd February 2010 – Vantia Therapeutics, an emerging pharmaceutical company developing novel, small molecule drugs targeting large, underserved medical markets, today announces it has begun its planned Phase IIb trial of its lead development compound VA106483 for nocturia. The study is a randomised, double‐blind, placebo‐controlled study and is expected to recruit approximately 120 male patients at 20 centres in the US. The study will primarily assess number of nocturnal voids per night. Secondary endpoints include quality of life and sleep duration measures.
Nocturia (defined as waking to urinate at night thereby significantly disturbing sleep) is a common condition, with prevalence increasing markedly with age. It is often the presenting symptom in men with benign prostatic hypertrophy (BPH) and affects at least 70% of BPH patients. There are currently significant limitations in the treatment for nocturia and it represents a potential market estimated at more than US$1 billion... [PDF] Vantia Therapeutics' Press Release -

ResMed : Next-Generation CPAP Series in Europe

Feb 22, 2010- The S9 Series Offers More Comfort & Sleek Design; New CPAP Expected to Increase Patient Compliance - ResMed (NYSE:RMD), a leading developer, manufacturer, and distributor of sleep and respiratory medical equipment, introduced its new cutting-edge sleep apnoea therapy platform called the S9 Series in Europe. The S9 Series combines a sleek design with superior functionality and more comfort. Combined climate control and humidification delivers unsurpassed comfort to the patient by controlling both the temperature and humidity that the patient breathes. The S9 Series is expected to help more sleep apnoea patients adhere to the treatment, but also help sleep professionals make more informed decisions.

The most effective treatment for sleep apnoea is Continuous Positive Airway Pressure (CPAP) therapy. In this non-invasive treatment, air is pressurised by a small device and delivered to the airway of the patient through a mask that fits on/over the nose, or nose and mouth. The pressurised air keeps the upper airway open and helps the person to get a restful night without interruptions caused by apnoeas.

"With patients across the world in mind, we are thrilled to introduce a true revolution in positive airway pressure therapy," ... ResMed's Press Release -

Apnex Medical : Additional $14 Million

December 2, 2009 - Apnex Medical, Inc., a private medical device company, announced that it has completed a second round of private equity financing totaling $14 million. The funds will be used to complete a clinical study and develop a second generation of its proprietary implantable technology designed to treat obstructive sleep apnea (OSA).
Participants in the financing include Domain Associates, New Enterprise Associates (NEA), Polaris Venture Partners and Michael Berman. The current board includes Robert Atkinson, CEO, and Michael Berman, Chairman, together with Brian Chee, John Nehra and Nimesh Shah representing Polaris, NEA and Domain, respectively. This financing brings the total investment in Apnex Medical to $30 million.
“We are very excited about the early results with the Apnex Hypoglossal Nerve Stimulation (HGNS™) System in our clinical study. Our technology really has the potential to change the lives of people suffering from OSA. This round of financing will allow us to finish our initial clinical study and get us that much closer to market,”... [PDF] Apnex Medical's Press Release -

VIVUS : Positive Results From Phase 2 Study of Qnexa in Obstructive Sleep Apnea

Jan 07, 2010 - Qnexa Treatment Results in 69% Reduction in Sleep Apnea Events - VIVUS, Inc. (Nasdaq: VVUS) announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa(R), an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication. The study announced today demonstrated statistically significant improvement in the apnea/hypopnea index ("AHI" - a measure of the severity of sleep apnea) in patients with OSA treated with Qnexa for 28 weeks. Qnexa-treated patients also experienced significant weight loss, improvements in blood pressure, and overnight blood oxygen levels. OSA is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. OSA is associated with an increased risk of hypertension, diabetes, stroke, sudden cardiac death and all-cause mortality. Approximately 18 million Americans have sleep apnea... VIVUS' Press Release -