LivaNova Announces a Positive Predictive Outcome of Trial Success in its OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea

 LONDON--Mar. 20, 2024-- LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, announced its OSPREY clinical study, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation, has achieved a positive predictive outcome and will conclude enrollment earlier than anticipated. This means there is a greater than 97.5% probability that the OSPREY trial will successfully meet its primary endpoint. OSPREY is a prospective, multi-center, randomized controlled open-label trial demonstrating the safety and effectiveness of the aura6000(™) Hypoglossal Nerve Stimulator System versus a no stimulation control in subjects with moderate to severe obstructive sleep apnea (OSA) who have failed or are unwilling to use positive airway pressure treatment. LivaNova notified the U.S. Food and Drug Administration (FDA) and its partner trial sites of this significant milestone for the OSPREY study.

“A planned interim analysis, per the approved protocol, was conducted for the first 90 patients enrolled in OSPREY. We are now able to estimate a high chance of success for achieving the primary endpoint in this unique randomized controlled trial without further patient enrollment,” said Dr. Atul Malhotra, Professor of Medicine at University of California, San Diego and Principal Investigator for OSPREY. “While this milestone shows we are on a positive trajectory, long-term follow-up visits will continue for each patient through the primary endpoint and beyond.”

The OSPREY study’s primary efficacy endpoint is the demonstration that the apnea-hypopnea index (AHI) responder rate of subjects with device stimulation activated is statistically significantly higher than the rate of subjects without stimulation after seven months of follow-up. For OSPREY, response is defined as at least a 50% improvement from the baseline AHI, leading to an AHI value below 20. After the full cohort completes the seven-month follow-up visit and the results are compiled, LivaNova will submit OSPREY’s final clinical module to the FDA... LivaNova's Press Release -

RemSleep Holdings Inc.'s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

TAMPA, Fla., Jan. 22, 2024 -- RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) has received a response to the company’s 510(K) submission K233415. The agency has determined that additional information is required. The agency has asked for additional information regarding Administrative Information, Device Description, Substantial Equivalence (SE), Labeling, Biocompatibility, and Performance testing. All these questions can be answered, and we are in the process of responding with the answers.

The agency has also requested additional Shelf-Life testing for DeltaWave packaging. We are in the process of initiating accelerated Shelf-Life testing for the DeltaWave packaging. This request was a surprise to us, but we will promptly comply.

Remsleep CEO, Tom Wood, commented: “Investors want a 510(K) almost as much as Remsleep. We understand the frustration. Investors can be assured we will answer the questions from the agency, perform the additional tests required, and we will make every effort to gain approval for 510(K) submission (K233415) as soon as possible”.

Judy Strzepek comments: “Remsleep submitted our 510(K) on 10/10/2023. Remsleep received feedback from FDA with a request for additional information. This is not unusual. The type of information requested varies based on the type of product. CPAP device and the mask with accessories needed for sleep apnea therapy is a class II device that requires extensive data and information. So, the agency’s request for clarification of any part of the submission is not unexpected. We are working diligently to address any of FDA’s questions. We will do this as quickly as possible, while ensuring our response is thorough and complete.”... RemSleep's Press Release - 

Apnimed Announces First Patient Dosed in SynAIRgy, the Second Phase 3 Clinical Study of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea

– SynAIRgy Compares AD109 to Placebo Over 6 Months in People with OSA who Are Intolerant of or Refuse Positive Airway Pressure (PAP) Therapy, the Current Standard of Care

– Part of a two-study registrational Phase 3 program that also includes LunAIRo which began enrollment in September 2023

CAMBRIDGE, Mass., December 21, 2023 – Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced the first patient dosed in its SynAIRgy Phase 3 study designed to examine the efficacy and safety of AD109 (aroxybutynin/atomoxetine) compared to placebo at six-months. AD109 has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.

Currently, fewer than half of the people using PAP therapy are compliant long-term, leaving many people at risk from the consequences of untreated OSA, including a higher risk for stroke and heart attack.

“Together, LunAIRo and SynAIRgy represent the largest ever prospective evaluations of a novel pharmacologic for OSA,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “These trials are a major step in developing a potential treatment that meets the needs of patients who have limited or no other options. It’s vital to discover and test alternative treatments for people with OSA to potentially help improve their quality of life both at night and during the day. Based on the results, AD109 has the potential to be a major advance in how we treat OSA. Topline results from the Phase 3 program of AD109 are expected in the first half of 2025.”... Apnimed's Press Release -

Vivos Therapeutics Receives First Ever FDA 510(k) Clearance for Oral Device Treatment of Severe Obstructive Sleep Apnea

With this unprecedented FDA clearance, Vivos redefines what it means to have a truly non-invasive treatment for all levels of OSA severity, opening new revenue opportunities for Vivos

 LITTLETON, Colo., Nov. 29, 2023 — Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance.

As a result of this FDA clearance, Vivos becomes the first company ever to have approved and bring to market a clear alternative treatment to CPAP or surgical neurostimulation implants for patients with severe OSA. This latest clearance comes just eleven months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA, and represents the first time the FDA has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

Nationally renowned medical sleep specialist, author and lecturer, Dr. David McCarty, MD, elaborated on the impact of this landmark decision, stating “Make no mistake: this is a huge development on the landscape of treatments for OSA. As the medical profession has gained a better understanding of the complex factors contributing to OSA, we now recognize that a critical component to this condition is the form and functionality of the oral vault. This is where medical collaboration with an airway-centered dentistry approach like Vivos offers is a game-changer. This decision by the FDA could be life changing for patients who suffer from severe OSA and for whom other treatments have failed.”

Kirk Huntsman, Chairman and CEO of Vivos, stated, “This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine. It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention.”... Vivos Therapeutics' Press Release -

Data Published by Cureus Journal of Medical Science Shows Successful Treatment of Obstructive Sleep Apnea with ProSomnus Precision Oral Appliance Devices

Additional clinical research indicates patients using ProSomnus devices have decreased apnea-hypopnea index events per hour, with strong treatment adherence

PLEASANTON, Calif., Dec. 19, 2023 -- ProSomnus, Inc. (NASDAQ: OSA) (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced the publication of a study by the Cureus Journal of Medical Science, in which the Company’s precision oral appliance therapy (OAT) devices successfully treated patients’ OSA.

“The study underscored what we see daily in our practice at Star Sleep & Wellness. Our team continues to favor the ProSomnus® EVO® Sleep and Snore Device, as it not only garners the fewest number of patient complaints regarding fit and comfort, but also shows to be superior in resolving chief complaints such as partner discontent, fatigue and daytime sleepiness,” said Dr. Kent Smith, D-ABDSM, ASBA, a co-author of the study.

Key findings from the study, titled “Evaluating the Clinical Performance of a Novel, Precision Oral Appliance Therapy Medical Device Made Wholly from a Medical Grade Class VI Material for the Treatment of Obstructive Sleep Apnea,” include:

89% of all patients and 98.5% of mild to moderate OSA patients were treated to an apnea-hypopnea index (AHI) of fewer than 10 events per hour.

80% of severe OSA patients were treated to an AHI of fewer than 20 events per hour with a 50% improvement.

After a minimum one-year follow-up period, 96% of patients continued using their precision OAT devices.

“Oral appliance success is traditionally evaluated with the AHI metrics. My experience with the ProSomnus® EVO® precision oral appliance is that it exceeds the American Academy of Sleep Medicine (AASM) and the American Academy of Dental Sleep Medicine (AADSM) standards for efficacy. This study shows that residual AHI using an EVO device is superior to other oral appliances, and superior to hypoglossal nerve stimulation in reducing the AHI. Clinically speaking, I have delivered over 300 EVO devices. I find EVO to have great patient compliance, minimal delivery adjustments, and overall better patient comfort than other traditional oral appliances for sleep apnea,” said John A. Carollo, DMD, D-ABDSM, D-ASBA, a co-author of the study.

“My experience with ProSomnus began in 2019 and since that time, I have come to appreciate the benefit to my patients in delivering precision oral appliances such as these. The study irrefutably demonstrates this,” said Dr. Aditi Desai, BDS, MSc, FCGDent, a co-author of the study. “The ethos of the company has certainly helped drive the field of oral appliance therapy as a most credible alternative to CPAP.”... ProSomnus' Press Release - 

StimAire Completes First-In-Human Study of Injectable Stimulator for Obstructive Sleep Apnea (OSA)

UAVenture Capital Portfolio Company StimAire Completes First-In-Human Study of Injectable Stimulator for Obstructive Sleep Apnea (OSA)

TUCSON, Ariz., Oct. 11, 2023 -- Paradigm-shifting neuromodulation company, StimAire, has completed its first clinical trial in Australia. The first-in-human study tested a tiny injectable stimulator to treat obstructive sleep apnea (OSA). This study assessed the safety of the injection procedure, the operation of the patented device, and the feasibility of the approach. In addition, the first overnight sleep studies were conducted of an OSA patient with and without the StimAire device modulating the hypoglossal nerve throughout the night.

There were no adverse events during the study. Furthermore, no significant pain or discomfort was experienced from the injection procedures.

Efficacy results from the sleep studies of the OSA patient, as measured by obstructive events, were as expected. Furthermore, this patient slept 2.5 times longer with our device than without it and enjoyed 30 minutes of REM sleep vs. none without it.

Robert Dean PhD MD/ENT, StimAire Chief Clinical Officer, said, "After developing this injection procedure for StimAire at the University of Arizona College of Medicine, I was delighted to see these results. This technology has the potential to move treatments like this from the operating room to the doctor's office, lowering the cost of care and enabling immediate recovery." 

StimAire's device modulates peripheral nerves, like the hypoglossal, using a tiny, battery-free, injectable receiver/stimulator activated by a small wearable. StimAire's system can be built with readily available components, expediting the path to production. The tiny injectable is placed in close proximity to the nerve through a 17-gauge needle under ultrasound guidance... UAVenture Capital's Press Release -

Signifier Medical Technologies Announces Upcoming Publication of Randomized Controlled Trial Results Examining High-Intensity (Active) Vs. Low-Intensity (Sham) Neuromuscular Electrical Stimulation in Patients for 6 Weeks

Signifier Medical Technologies LLC, a Boston-based medical technology company, is pleased to announce that the publication of AEGIS clinical trial results is in press at the ERJ Open Research. The objective of the trial was to determine whether patients with mild obstructive sleep apnea (OSA) would adhere to eXciteOSA, a daytime neuromuscular electrical stimulation (NMES) therapy. Results showed high adherence, with approximately 90% of participants in each arm adherent to NMES. This trial demonstrates the potential of Signifier Medical’s innovative medical technology to significantly improve the lives of individuals suffering from obstructive sleep apnea (OSA).

“The encouraging results from our first randomized controlled trial further validate the data from our previous studies, and we’re thrilled to see how well patients accept the therapy,” says Co-founder and Director, Akhil Tripathi.

The current standard of care for treating mild OSA, positive airway pressure (PAP), has long been plagued with low adherence and low patient satisfaction. Clinical trials and observational studies indicate 25-46% of patients are not adherent to PAP.1-3 There is also evidence that those with mild OSA are 34% less likely to adhere to PAP than those with moderate/severe OSA.4 Given that adherence to positive airway pressure (PAP) therapy in OSA is suboptimal, alternative strategies are needed, particularly for patients with mild OSA.

The AEGIS clinical trial was a randomized, double-masked, sham-controlled study to assess the adherence and overall impact of Signifier Medical’s innovative medical device, eXciteOSA, in managing and treating obstructive sleep apnea. Using NMES to “exercise” the upper airway muscles, eXciteOSA improves tongue muscle endurance and reduces the occurrence of airway collapse during sleep. The trial involved 40 patients and was conducted in collaboration with a network of renowned medical institutions and healthcare professionals....Signifier Medical Technologies' Press Release - 

Teva : Launch of Authorized Generic of Provigil

Mar. 30, 2012-- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announces the launch of the authorized generic of Provigil® (modafinil). Provigil® is marketed by Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.

This product will continue to be manufactured under the brand product's new drug application at the same facility where it is currently produced. Shipping of the product has commenced... Teva Pharmaceutical's Press Release -

CareFusion and Fisher & Paykel Healthcare Renew Exclusive Distribution Agreement for U.S. Hospital Market

Feb. 8, 2012 - CareFusion, a leading, global medical technology company, and Fisher & Paykel Healthcare, a leading designer, manufacturer and marketer of products and systems for use in respiratory care, acute care and the treatment of obstructive sleep apnea, announced a three-year renewal of their longstanding agreement providing CareFusion the exclusive right to distribute Fisher & Paykel Healthcare products into the U.S. hospital market.

"For more than 25 years, we have partnered with Fisher & Paykel Healthcare to bring its portfolio of clinically differentiated respiratory solutions to U.S. hospitals," said Vivek Jain, president of the Procedural Solutions segment for CareFusion. "As we extend and strengthen our strategic relationships with proven partners like Fisher & Paykel Healthcare, our customers benefit from continued access to market-leading technologies that help improve the cost, quality and safety of patient care."

Under the agreement, CareFusion, through its AirLife™ Respiratory Consumables business, will continue to serve as the exclusive U.S. distributor of Fisher & Paykel Healthcare's extensive portfolio of respiratory consumable products, including the MR850 Heated Humidification System with Evaqua™ circuit technology, AIRVO™ high flow device, Optiflow™ nasal cannula, and FlexiFit™ non-invasive interfaces... CareFusion's Press Release -

Alfresa Pharma and Mitsubishi Tanabe Pharma : Approval of Additional Indication for MODIODAL® Tablets 100 mg a Sleep Disorder Treatment

November 25, 2011 - Alfresa Holdings Corporation (head office: Tokyo, Representative Director & President: Denroku Ishiguro) and Mitsubishi Tanabe Pharma Corporation (head office: Osaka, President & CEO: Michihiro Tsuchiya) announced that Alfresa Pharma Corporation (head office: Osaka, President & CEO: Kenichiro Iwaya), a subsidiary of Alfresa Holdings engaged in manufacture of pharmaceuticals etc., received approval of a partial change in the indications of MODIODAL® Tablets 100 mg (generic name: modafinil), a sleep disorder treatment, that has been jointly developed in Japan by Alfresa Pharma and Mitsubishi Tanabe Pharma.

Since March 2007, MODIODAL® has been jointly marketed by the two companies as a treatment for excessive daytime sleepiness associated with narcolepsy, a sleep disorder characterized by intolerable daytime sleepiness. The new indication, approved for the first time in Japan, is “excessive diurnal sleepiness accompanied with obstructive sleep apnea syndrome (OSAS) under treatment for airway obstruction by continuous positive airway pressure (CPAP) therapy and the like”. The two companies expect MODIODAL® will contribute to improve quality of life of patients whose daily lives would otherwise be disrupted by excessive diurnal sleepiness in OSAS as well as narcolepsy.

MODIODAL® is currently approved in more than 30 countries in the world, and in seven countries, including the US, it is marketed with approval for the new indication... [PDF] Alfresa's Press Release - [PDF] Mitsubishi Tanabe Pharma's Press Release -

Circadiance : Revolutionary New CPAP Tube

November 7, 2011 - Lightweight and flexible design provides better overall user experience -

Building on the success of their revolutionary soft cloth nasal SleepWeaver CPAP (Continuous Positive Airway Pressure) mask, Circadiance is proud to introduce a mask tube so lightweight and flexible, that CPAP users will hardly know it’s there.

Used in the treatment of sleep apnea, the new SleepWeaver Feather Weight Tube from Circadiance complements the CPAP mask with a 15-millimeter hose composed of revolutionary, lightweight material that reduces the weight at the mask connection point, making the hose less likely to pull and disrupt the seal. The new tube also extends the hose length by 1.5 feet.

“Our new hose is lighter and more flexible than standard CPAP hoses,” says Circadiance Director of Engineering, Ron Mahofski. “It also includes smaller lightweight connectors, which reduce the pull between the hose and the mask.”

Also, unlike the majority of hoses, the SleepWeaver Feather Weight Tube offers the unique ability to stretch, providing a more forgiving connection to CPAP devices. It can also be used as a quick release.

“These features give users the full benefit of CPAP therapy so they can enjoy a deep, restorative sleep,” says Mahofski.

Launching in November 2011, the new tube is designed to fit any CPAP mask with a 22-millimeter connection... Circadiance's News -

Midmark Corporation partners with Cleveland Medical Devices Inc., introducing Portable Home Sleep Testing Monitor...

October 17, 2011 - Midmark Corporation partners with Cleveland Medical Devices Inc., introducing Portable Home Sleep Testing Monitor that enables patients to be tested for Obstructive Sleep Apnea in comfort of their own homes

- The FDA-cleared, physician-prescribed SleepView® provides a convenient and cost-effective alternative for diagnosing the most common type of breathing-related sleep disorder -

Midmark Corporation, a trusted leader in digital diagnostic devices for ambulatory care, announced a partnership with Cleveland Medical Devices, a leader in sleep diagnostics technology, launching the Midmark SleepView® Monitor and SleepViewSM Portal.

The Midmark SleepView Monitor developed by Cleveland Medical Devices is the market’s smallest and lightest portable home sleep monitor that meets the American Academy of Sleep Medicine’s recommended channel set for Type III monitors.

The Midmark SleepView Portal offers prescribing physicians secure, HIPAA compliant online access to registered polysomnographic technologists and board-certified sleep physicians who provide scoring, professional interpretation and treatment recommendations.

Obstructive sleep apnea (OSA) is a repeated interruption of normal breathing during sleep due to a collapse of the upper airway. It is estimated to impact as many people as asthma and diabetes; yet, 85 percent of the population with the disease is undiagnosed and untreated. "There is a real need in the healthcare industry to address this large and growing clinical concern," said Tom Treon, senior product manager for Midmark. "We want to improve the effectiveness and efficiency of care for patients with OSA by providing another diagnostic option, which enables patients to be tested in the comfort of their own bed and convenience of their own home for a more natural night of sleep."

OSA does in fact hold serious health and economic consequences. Numerous studies link OSA to major chronic diseases such as stroke, heart failure, diabetes, obesity, hypertension and increased odds of serious car crash injuries. Economic studies have also shown that people with untreated OSA have 200 percent higher healthcare costs than similar people without OSA. Midmark has entered into a strategic partnership with Cleveland Medical Devices Inc. (CleveMed) for licensing of the SleepView technology. Established in 1990, CleveMed is a leader in sleep diagnostics technology with products serving sleep labs, institutional and home settings... Cleveland Medical Devices' press Release -

Philips : Home oxygen measurement solution for sleep and ventilation launched at ERS 2011

September 29, 2011 - Philips’ latest launch reinforces its commitment to providing monitoring solutions that support patient care at home - Home oxygen measurement solution for sleep and ventilation launched at ERS 2011 - Royal Philips Electronics (NYSE: PHG, AEX: PHI) has launched the new Oximetry Module, a home oxygen measurement device designed to monitor people diagnosed with respiratory disorders such as sleep apnea and chronic obstructive pulmonary disease (COPD) and to record their blood oxygen level by means of a single finger probe.

The Oximetry Module, which was launched during the 2011 Congress of the European Respiratory Society (ERS) in Amsterdam, is designed to help physicians to better determine whether complex respiratory events are present during a person’s period of sleep at home.

“Non-invasive ventilation (NIV) (or home ventilation) has been demonstrated to be effective treatment in some forms of respiratory failure. When starting NIV, it seems desirable to verify whether this particular form of treatment is effective and has no untoward effects. Greater insight, provided by simple cost effective monitoring tools like oximetry and other signals obtained from non-invasive positive pressure ventilation (NPPV) devices; help identify issues early in the patient’s therapy. This subsequently improves their long term outcomes and quality of life... Philips' Press Release -

Siesta Medical : 510(k) Clearance for Encore™ System

September 12, 2011 - Siesta Medical, Inc. (Private), a developer of minimally invasive surgical solutions for obstructive sleep apnea (OSA), announced today that it has received FDA 510(k) clearance for its Encore™ Tongue Suspension System for the treatment of obstructive sleep apnea.

Obstructive sleep apnea (OSA) is a major heath problem in the United States. As many as 17 million people in the United States have moderate to severe OSA, which is characterized by frequent awakening during sleep, heavy snoring and daytime sleepiness. If left untreated, OSA has been implicated in the increased risk for cardiovascular disease, including hypertension and heart failure. Despite its prevalence and role as a cardiovascular risk factor, OSA remains largely under diagnosed.

The first line and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated three million Americans. While effective, CPAP is difficult for patients to use.

Surgical therapy for OSA is less common than CPAP therapy. Although there are approximately one million new diagnoses of OSA in the U.S. each year, there are only approximately 100,000 surgical treatments for OSA performed annually. Surgery is less prevalent as most current procedures are not highly effective, are painful to the patient and do not address tongue based obstructions. The tongue is implicated in approximately 80 percent of OSA.

The Encore™ Tongue Suspension System

The EncoreTM System is used in a minimally invasive surgical procedure where the tongue is suspended forward with the intent of preventing collapse of the airway during sleep. The procedure is performed under local or general anesthesia by Ear, Nose and Throat Specialists, also known as Otolaryngologists. During the procedure, an intra-tissue suture passer is used to place a suspension loop in the tongue which is then attached to the base of the chin with a knotless bone anchor. The EncoreTM System greatly simplifies tongue suspension and provides the surgeon excellent control of positioning and tensioning of the suspension loop.

Siesta Medical is currently planning a multi-center U.S. post-marketing study... [PDF] Siesta Medical's Press Release -

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 -

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 -

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 -

SeptRx begins CE Mark trial of the SeptRx® Intrapocket PFO Occluder (IPO)

June 16, 2011—SeptRx, an emerging medical device company that is developing the SeptRx® Intrapocket PFO Occluder (IPO)—a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO)—announced that the first implants have been completed in the InterSEPT™ clinical trial at the CardioVascular Center at Sankt Katharinen Hospital, Frankfurt, under principal investigator Horst E. Sievert, M.D.
InterSEPT™ (In-tunnel SeptRx European PFO Trial) is a prospective, multi-center, single-arm safety and efficacy trial of the SeptRx® IPO. Data from InterSEPT™ will be used to apply for CE marking. The SeptRx® Intrapocket PFO Occluder has already completed a successful 11-patient first-in-human (FIH) clinical trial. SeptRx’s FIH trial was the first and only PFO device trial to demonstrate 100% closure and 100% safety (out to 3 years)...

[...]

...PFO is a tunnel-like defect connecting the right atrium with the left atrium. A remnant of fetal circulation, it usually seals itself within a few months after birth. Unfortunately, in about 25% of the population the PFO does not fully close and may allow blood (and emboli) to pass directly between the right and left atria. The presence of a PFO has been identified as a contributing factor in cryptogenic stroke, chronic migraine, decompression sickness, and obstructive sleep apnea. A PFO contributes to these conditions by providing a pathway for emboli (blood clots, air bubbles) in the venous system to reach the arterial system by passing directly from the right atrium to the left... [PDF] SeptRx' s Press Release -

DynaFlex : FDA Clearance for Sleep Aid Devices

MARCH 9, 2011 - DynaFlex, a manufacturer specializing in orthodontic appliances, has obtained FDA 510(k) clearance (K103076) from the US Food and Drug Administration for its DynaFlex® Anti-Snoring & Sleep Apnea Devices line of sleep aid products. Designed to treat snoring and sleep apnea, the DynaFlex products function by repositioning patients’ lower jaws to improve breathing ability during sleep. The devices are available in four model types, and are custom-fitted for each patient based on jaw measurements taken by prescribing health care providers.

The company undertook its FDA 510(k) clearance process in early 2010 with the assistance of Emergo Group, a medical device regulatory and quality assurance consultancy. Emergo Group provided an initial analysis of DynaFlex® Anti-Snoring & Sleep Apnea Devices to determine the most cost-effective and accurate method for submitting DynaFlex’s 510(k) documents, followed by preparation and submission of the 510(k) application to the FDA for review and clearance. Emergo Group also assisted DynaFlex in assuring compliance with the FDA Quality System Regulation, 21 CFR Part 820... DynaFlex's Press Release -