Natus Acquires Embla, Leading Sleep Diagnostic Company

Sep 16, 2011 - Acquisition expected to add $0.08 to 2012 non-GAAP Earnings Per Share -- Natus Medical Incorporated (Nasdaq:BABY) announced that it has acquired Embla Systems LLC, a leader in the development, manufacturing, and sales of devices used in the diagnosis of sleep apnea. Embla is the largest company in the world focused solely on sleep diagnostics (Polysomnography or PSG and Home Sleep Testing). The company offers a wide spectrum of innovative sleep diagnostic solutions including Embletta home sleep testing devices and three leading PSG platforms: Sandman, REMbrandt, and RemLogic, and Enterprise Sleep Business Management Systems. This breadth of product offerings provides a unique set of tools to help optimize the efficiency of sleep labs.

Natus acquired all outstanding shares of Embla capital stock for $16.1 million in cash, exclusive of direct costs of the acquisition. Embla reported revenue of approximately $30 million for its fiscal year ended December 31, 2010.

Natus expects the acquisition will be accretive to earnings in 2012, adding $0.08 to non-GAAP earnings per share for the year. The non-GAAP results will exclude amortization of acquired intangible assets and potential restructuring and other one-time charges related to the acquisition... Natus Medical's Press Release -

Chelsea Therapeutics : New Patent for Use of Droxidopa in Fibromyalgia

Sept. 6, 2011 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,008,285 entitled "Droxidopa and pharmaceutical composition thereof for the treatment of fibromyalgia." The claims of the patent are related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications, to patients diagnosed with fibromyalgia. Chelsea recently completed enrollment of 120 patients in its Phase II trial of droxidopa for the treatment of fibromyalgia. Top-line results of the trial are expected by the end of the year.

Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and, as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels... Chelsea Therapeutics' Press Release -

Apnex Medical : FDA Approval for Pivotal Clinical Study for Obstructive Sleep Apnea

Aug. 2, 2011 - Apnex Medical, Inc., received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a clinical study to evaluate the safety and effectiveness of its Hypoglossal Nerve Stimulation (HGNS®) System to treat obstructive sleep apnea (OSA). Data from this clinical study are intended to support the Pre-Market Approval (PMA) application for the HGNS System to the FDA.
"Many patients who suffer from OSA are unable to tolerate existing therapies such as continuous positive airway pressure (CPAP). The HGNS System provides a fundamentally new approach to the treatment of OSA. This study will help us further understand the potential role this device will have in treating the millions of people who suffer from OSA," said the study's co-principal investigator, Dr. Atul Malhotra, Clinical Chief, Division of Sleep Medicine, Brigham and Women's Hospital.
Sponsored by Apnex Medical, the Apnex Clinical Study is a prospective, randomized, multi-center clinical trial. It is being conducted in leading medical centers in the United States, Europe and Australia. The trial is designed to demonstrate the safety and effectiveness of the HGNS therapy in treating patients with moderate to severe OSA. To be enrolled in the study patients must not have received lasting benefit from CPAP or other OSA treatments... [PDF] Apnex Medical's Press Release -

Meda and Valeant Pharmaceuticals : Sublinox approved in Canada

July 25 2011 – The insomnia drug Sublinox (Edluar) has been approved in Canada. Meda and its partner Valeant expect to begin the launch in the fourth quarter 2011.


Sublinox will be marketed by the joint venture between Meda and Valeant, Meda Valeant Pharma Canada Inc. Meda has global rights to the drug and markets it in the USA since 2009 under the name Edluar. Orexo, who has developed the drug, is entitled to royalties on sales.


The approval is for short-term treatment of insomnia. Sublinox is based on Orexo's sublingual tablet technology. The drug is placed under the tongue where it rapidly disintegrates and the active substance zolpidem is absorbed through the oral mucosa... Orexo's Press Release - Meda's Press Release - Valeant's Press Release -

ResMed : Acquisition of BiancaMed

July 6, 2011 - ResMed Inc. (NYSE: RMD and ASX: RMD), a leading developer, manufacturer and distributor of medical equipment for treating, diagnosing and managing sleep-disordered breathing and other respiratory disorders, announced that it has acquired BiancaMed Ltd., a leading Irish medical technology company. ResMed purchased all of BiancaMed's outstanding shares with cash.

BiancaMed has developed and is marketing an innovative, convenient, non-contact device to monitor sleep and breathing in the home and hospital. BiancaMed's SleepMinder(TM) is an accurate, touch-free device that measures sleep and breathing with sophisticated biometric software. The core of BiancaMed's proprietary technology is a motion sensor that can detect respiration and movement without physical contact with the human body. The company is developing a number of other applications for the technology, across a range of medical and consumer settings.

BiancaMed will become a part of ResMed's newly-created Ventures and Initiatives unit. ResMed estimates the acquisition will dilute ResMed's earnings per share by approximately $0.04 in fiscal year 2012, excluding amortization of intangibles and one-time acquisition related costs... ResMed's Press Release - [PDF] BiancaMed's Press Release -

DeVilbiss Healthcare : Clinical Trial Confirming the Effectiveness of SmartFlex™ Technology

July 5, 2011 – DeVilbiss Healthcare recently sponsored a randomized, double-blind, crossover clinical study which confirmed the effectiveness of DeVilbiss SmartFlex Technology, a new exhalation pressure relief solution to enhance patient comfort.

Positive Airway Pressure (PAP) represents the gold standard in the treatment of Obstructive Sleep Apnea (OSA). In recent years, pressure modification has become accepted as an important feature improving patients’ comfort and compliance. However, there has been some speculation that excessive pressure relief may compromise the effectiveness of therapy.

The study confirmed SmartFlex Technology to be equally effective to standard Auto-PAP therapy in that respiratory events and oxygen saturation during sleep were normalized among the participants. In addition, treatment with SmartFlex showed a lower leak rate, which likely contributes to the greater subject acceptance rates. As expected, both modalities resulted in improved daytime alertness, but improved daytime energy levels, ability to relax and nocturnal sleep were also demonstrated with SmartFlex Technology... DeVilbiss Healthcare's Press Release -

Acurest : Custom CPAP Mask Now Available for Sleep Apnea Sufferers in the U.S.

May 31, 2011 - Acurest, the world's only provider of custom-made Continuous Positive Airway Pressure (CPAP) nasal masks for the treatment of sleep apnea disorder, announced that the solution is now available to sleep apnea sufferers in the U.S. Made specifically for each individual from the mold of the patient's face, Acurest's TrueFIT™ Custom Mask features hypo-allergenic materials which will not produce skin reactions, is leak free and fits comfortably, allowing for ease of movement during sleep. The new mask lasts three times longer than off-the-shelf masks.
For Robert Couch, a sleep apnea sufferer who resides in Irving, Texas, purchasing the TrueFIT™ Custom Mask from Acurest proved life-altering.
"I was deep into my stages of sleep apnea and was resigned that I would have to undergo multiple intrusive surgeries that were not guaranteed to work," said Couch. "I continued to purchase uncomfortable, leaking masks which forced my wife to sleep in another room so she could get rest at night. The first morning after using the mask, I woke up refreshed and for the first time in years, felt like I finally knew what a good night's sleep was."... Acurest's Press Release -