tag:blogger.com,1999:blog-53643407154041125012024-03-13T16:45:40.919-07:00Sleep Disordersblog and news, companies about African sleeping sickness, insomnia,OSA, obstructive sleep apnea, RLS, Restless Legs Syndrome, sleep maintenance, sleep architecture and sleep quality,Obstructive, Central or Complex Sleep Apnea, daytime fatigue, reduced alertness, sleep scoring, Trypanosomiasis, hypopnea syndrome, OSAHS, narcolepsy, wakefulness, sleepiness, continuous positive airway pressure (CPAP), sleep diagnostic device, Wake (time) After Sleep Onset (WASO), nasal resistance...Unknownnoreply@blogger.comBlogger167125tag:blogger.com,1999:blog-5364340715404112501.post-90073528983204907912024-02-13T09:21:00.000-08:002024-02-13T09:21:43.310-08:00RemSleep Holdings Inc.'s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)<p><i>TAMPA, Fla., Jan. 22, 2024</i> -- <a href="https://remsleep.com/" rel="nofollow" target="_blank">RemSleep Holdings Inc. (OTCQB: RMSL)</a>, 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.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhYJVxV_hjxgm7S28uu0V31Uf8Nlxzel6MaSqOvdzPDEZhyVpdXtqGYgiioV59mDyg50R5iL3FvBZTF0gXNJHKLosLV1yKNrwgxRvlYGjCJdRoL0kJ2PYSyf4h5XBbP450U1TdTru8tOJ9Y_C1X4D6aaJBZIvdN6G5g5hEx4uTdt56sgoPdUyyusYqdIkc/s241/RemSleep%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="RemSleep" border="0" data-original-height="117" data-original-width="241" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhYJVxV_hjxgm7S28uu0V31Uf8Nlxzel6MaSqOvdzPDEZhyVpdXtqGYgiioV59mDyg50R5iL3FvBZTF0gXNJHKLosLV1yKNrwgxRvlYGjCJdRoL0kJ2PYSyf4h5XBbP450U1TdTru8tOJ9Y_C1X4D6aaJBZIvdN6G5g5hEx4uTdt56sgoPdUyyusYqdIkc/s16000/RemSleep%202024.PNG" /></a></div><br /><p style="text-align: left;">The agency has also requested additional Shelf-Life testing for <a href="https://remsleep.com/deltawave-desc/" rel="nofollow" target="_blank">DeltaWave</a> 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.</p><p><br /></p><p>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”.</p><p><br /></p><p>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.”... <i><span style="font-size: x-small;"><a href="https://www.globenewswire.com/news-release/2024/01/22/2813247/0/en/Remsleep-Holdings-Inc-s-DeltaWave-Mask-has-received-questions-from-FDA-regarding-510k-submission-K233415.html" rel="nofollow" target="_blank">RemSleep's Press Release</a></span></i> - </p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-75398117785017317502024-02-07T03:06:00.000-08:002024-02-07T03:06:19.045-08:00Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia<p><i>WASHINGTON, Feb. 5, 2024 -</i>- <a href="https://www.vandapharma.com/" rel="nofollow" target="_blank">Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)</a> announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review. In a letter to Vanda dated July 17, 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiWKhI6sqGnv68fjr3BKRY8YGug9DCpG2H3mPG8LOLAo3U0nhoBgp5N9nbHbB_ysldwPkHz0UDLae-2wvFq-2r6Y2DmwrKxCKJ_K6uDdGGnclWdmg17sIe0P5XmDlLVoalgmdK3hBKZgG3bcERVUGSlUmBXBTARphts_78RexyHVVZ99jVHRyEl6ntwztc/s194/vanda%20pharmaceuticals%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Vanda Pharmaceuticals" border="0" data-original-height="61" data-original-width="194" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiWKhI6sqGnv68fjr3BKRY8YGug9DCpG2H3mPG8LOLAo3U0nhoBgp5N9nbHbB_ysldwPkHz0UDLae-2wvFq-2r6Y2DmwrKxCKJ_K6uDdGGnclWdmg17sIe0P5XmDlLVoalgmdK3hBKZgG3bcERVUGSlUmBXBTARphts_78RexyHVVZ99jVHRyEl6ntwztc/s16000/vanda%20pharmaceuticals%202024.PNG" /></a></div><br /><p style="text-align: center;"><br /></p><p>Vanda has extensively studied the efficacy of HETLIOZ® in the treatment of insomnia characterized by difficulties with sleep initiation. A Phase III, multi-center, placebo-controlled, 4-week trial evaluated patients with chronic primary insomnia. Two transient insomnia studies induced by phase advance of the sleep-wake cycle were also conducted with five-hour and eight-hour phase advance, which showed a significant effect the first night in improving sleep parameters... <i><span style="font-size: x-small;"><a href="https://vandapharmaceuticalsinc.gcs-web.com/node/15716/pdf" rel="nofollow" target="_blank">Vanda Pharmaceuticals' Press Release [PDF]</a></span></i> - </p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-87458673806478340122024-01-25T05:53:00.000-08:002024-01-25T05:53:39.433-08:00Apnimed Announces First Patient Dosed in SynAIRgy, the Second Phase 3 Clinical Study of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea<p><i>– 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</i></p><p><i><br /></i></p><p><i>– Part of a two-study registrational Phase 3 program that also includes LunAIRo which began enrollment in September 2023</i></p><p><br /></p><p><i>CAMBRIDGE, Mass., December 21, 2023 </i>– <a href="https://apnimed.com/" rel="nofollow" target="_blank">Apnimed, Inc.</a>, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of <a href="https://apnimed.com/obstructive-sleep-apnea/" rel="nofollow" target="_blank">obstructive sleep apnea (OSA)</a> and related disorders, announced the first patient dosed in its SynAIRgy Phase 3 study designed to examine the efficacy and safety of <a href="https://apnimed.com/pipeline/" rel="nofollow" target="_blank">AD109 (aroxybutynin/atomoxetine)</a> 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.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgE54x5rrleIDWqw6dJRmA_n1R7N_KEh7gRCniCcMpzK4g9b_edw96nRD9SaiDRfbCbW5Io74wHVk3nI3uPaygHQVhrNw5QXpy98r_yA-qI99Ki5eR_Xnr0EWlTV8WlRQMTnvJAiPpzDTt4mOfUez3qgPBlWvktXZLjzsqrAr1qkO1dLzwzbsF3mJjfZNk/s239/apnimed%202024.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="Apnimed" border="0" data-original-height="68" data-original-width="239" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgE54x5rrleIDWqw6dJRmA_n1R7N_KEh7gRCniCcMpzK4g9b_edw96nRD9SaiDRfbCbW5Io74wHVk3nI3uPaygHQVhrNw5QXpy98r_yA-qI99Ki5eR_Xnr0EWlTV8WlRQMTnvJAiPpzDTt4mOfUez3qgPBlWvktXZLjzsqrAr1qkO1dLzwzbsF3mJjfZNk/s16000/apnimed%202024.PNG" /></a></div><br /><p style="text-align: left;">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.</p><p><br /></p><p>“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.”... <a href="https://apnimed.com/apnimed-announces-first-patient-dosed-in-synairgy/" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">Apnimed's Press Release</span></i></a> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-70067777849625511522024-01-16T07:43:00.000-08:002024-01-16T07:44:02.783-08:00Vivos Therapeutics Receives First Ever FDA 510(k) Clearance for Oral Device Treatment of Severe Obstructive Sleep Apnea<p><b>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</b></p><p><br /></p><p> <i>LITTLETON, Colo., Nov. 29, 2023</i> — <a href="https://vivos.com/" rel="nofollow" target="_blank">Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS)</a>, 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.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhVoDt9ETf45d2TYz0aR11hA6sTqnQL4e-uX2-c6aNoMDQxBLFuGhmWjAurk4lUaNub7bC-P3BQuq1kgchQKoqShKb1wGA67B6jCUmIjtm3rDdXFN7FS2-oDN8Qm5dhqK48IZM5EqKpFioo4hd98K_y6yqmHSp6gU_W79-4r2jM71bEAVrIA1Ui0j1t6k8/s144/vivos%20therapeutics%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Vivos Therapeutics" border="0" data-original-height="62" data-original-width="144" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhVoDt9ETf45d2TYz0aR11hA6sTqnQL4e-uX2-c6aNoMDQxBLFuGhmWjAurk4lUaNub7bC-P3BQuq1kgchQKoqShKb1wGA67B6jCUmIjtm3rDdXFN7FS2-oDN8Qm5dhqK48IZM5EqKpFioo4hd98K_y6yqmHSp6gU_W79-4r2jM71bEAVrIA1Ui0j1t6k8/s16000/vivos%20therapeutics%202024.PNG" /></a></div><br /><p style="text-align: left;">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.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj5JLmksqHnsiQxvdpeR_BHj6hVABmJWM1EEAstY9q2B10H0KzhsXPXI7eKEtWBExzYnwMuS8xRZBTv9zvuca8xmEiKTjHeJdjhiivZhk-84DiwOJGq3WlldECIYN_ccZ7hyphenhyphenKd5pa8dwP8ch4clsHkXSIqdeLRjbk-5kd6XqLEV8ZCvCLotC9UBipaH18o/s620/vivos%20therapeutics%20oral%20device%20osa%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="vivos therapeutics oral device osa" border="0" data-original-height="620" data-original-width="256" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj5JLmksqHnsiQxvdpeR_BHj6hVABmJWM1EEAstY9q2B10H0KzhsXPXI7eKEtWBExzYnwMuS8xRZBTv9zvuca8xmEiKTjHeJdjhiivZhk-84DiwOJGq3WlldECIYN_ccZ7hyphenhyphenKd5pa8dwP8ch4clsHkXSIqdeLRjbk-5kd6XqLEV8ZCvCLotC9UBipaH18o/w132-h320/vivos%20therapeutics%20oral%20device%20osa%202024.PNG" width="132" /></a></div><br /><p style="text-align: center;"><br /></p><p>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.”</p><p><br /></p><p>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.”... <a href="https://vivos.com/vivos-therapeutics-receives-first-ever-fda-510k-clearance-for-oral-device-treatment-of-severe-obstructive-sleep-apnea/" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">Vivos Therapeutics' Press Release</span></i></a> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-9447772971598635232024-01-10T03:23:00.000-08:002024-01-10T03:23:25.028-08:00Data Published by Cureus Journal of Medical Science Shows Successful Treatment of Obstructive Sleep Apnea with ProSomnus Precision Oral Appliance Devices<p style="text-align: center;"><b>Additional clinical research indicates patients using ProSomnus devices have decreased apnea-hypopnea index events per hour, with strong treatment adherence</b></p><p><i>PLEASANTON, Calif., Dec. 19, 2023 -</i>- <a href="https://prosomnus.com/" rel="nofollow" target="_blank">ProSomnus, Inc. (NASDAQ: OSA)</a> (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced the <a href="https://www.cureus.com/articles/171406-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#!/" rel="nofollow" target="_blank">publication of a study by the Cureus Journal of Medical Science</a>, in which the Company’s precision oral appliance therapy (OAT) devices successfully treated patients’ OSA.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEih6dFaTqqFAi_b1Q8JZ6zv3KJcq0tRtKzZ_xnfYleU5hf6WEbyLL-Ppm52myIDHXA5qt4ow7NG1XZPXrXNZGtoXmUBBJVFExpOgpZyX5AjfGq_G9dgfdkYHs_qORlbo_sD60hKO0516P1WHAwTr2syACzIknpgaR586pluBcMIiku2InCftrB4YcBxlmk/s239/prosomnus%20sleep%20technologies%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="ProSomnus" border="0" data-original-height="74" data-original-width="239" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEih6dFaTqqFAi_b1Q8JZ6zv3KJcq0tRtKzZ_xnfYleU5hf6WEbyLL-Ppm52myIDHXA5qt4ow7NG1XZPXrXNZGtoXmUBBJVFExpOgpZyX5AjfGq_G9dgfdkYHs_qORlbo_sD60hKO0516P1WHAwTr2syACzIknpgaR586pluBcMIiku2InCftrB4YcBxlmk/s16000/prosomnus%20sleep%20technologies%202024.PNG" /></a></div><p style="text-align: left;"><br /></p><p style="text-align: left;">“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.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgjN2A4V1o-CpBVC1n6Aquf6geeLZNXdiEhC58_-kOrHAaWor9TPMHWA78S7GprsjFfv72ezlFpq7XOF_7V5r_D9zP8T-P5byOGLiK-5Jd_Ep5uzEI5rImP-iN4bNubJXytNvgmauCPMdiKDrPOWhwkT9_LSUiutudczqrM0bQdYRK5JD2XEv__mCuwc7g/s679/prosomnus%20sleep%20technologies%20device%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="ProSomnus Device" border="0" data-original-height="653" data-original-width="679" height="308" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgjN2A4V1o-CpBVC1n6Aquf6geeLZNXdiEhC58_-kOrHAaWor9TPMHWA78S7GprsjFfv72ezlFpq7XOF_7V5r_D9zP8T-P5byOGLiK-5Jd_Ep5uzEI5rImP-iN4bNubJXytNvgmauCPMdiKDrPOWhwkT9_LSUiutudczqrM0bQdYRK5JD2XEv__mCuwc7g/w320-h308/prosomnus%20sleep%20technologies%20device%202024.PNG" width="320" /></a></div><br /><p style="text-align: center;"><br /></p><p><br /></p><p>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:</p><p><br /></p><p>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.</p><p><br /></p><p>80% of severe OSA patients were treated to an AHI of fewer than 20 events per hour with a 50% improvement.</p><p><br /></p><p>After a minimum one-year follow-up period, 96% of patients continued using their precision OAT devices.</p><p><br /></p><p>“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.</p><p><br /></p><p>“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.”... <i><span style="font-size: x-small;">ProSomnus' Press Release</span></i> - </p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-70100076375421229222023-12-27T07:19:00.000-08:002023-12-27T07:21:32.877-08:00StimAire Completes First-In-Human Study of Injectable Stimulator for Obstructive Sleep Apnea (OSA)<p><b><a href="https://www.uaventurecap.com/" rel="nofollow" target="_blank">UAVenture Capital</a> Portfolio Company StimAire Completes First-In-Human Study of Injectable Stimulator for Obstructive Sleep Apnea (OSA)</b></p><p><i>TUCSON, Ariz., Oct. 11, 2023 </i>-- <a href="https://stimaire.com/" rel="nofollow" target="_blank">Paradigm-shifting neuromodulation company, StimAire</a>, 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.</p><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3grkjJpQ9BMB5jIHEY3CSzMsXiUftxcAmlsVoRwqsg6kQikPVO5jGw2QdVeo1ZzkC2ydhomBpLfdCdgFjFqtSU0FKlW6Vol5WYKXSE30GWlmPWNgJiMUgS3NyWKyXcUkUwP24fatQF5FYRtKqXegZh6jPbAQRfuuXsRtAXZ_hKhoi9yg4hLtP6NAQNTQ/s573/StimAire%202023.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="StimAire" border="0" data-original-height="168" data-original-width="573" height="94" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3grkjJpQ9BMB5jIHEY3CSzMsXiUftxcAmlsVoRwqsg6kQikPVO5jGw2QdVeo1ZzkC2ydhomBpLfdCdgFjFqtSU0FKlW6Vol5WYKXSE30GWlmPWNgJiMUgS3NyWKyXcUkUwP24fatQF5FYRtKqXegZh6jPbAQRfuuXsRtAXZ_hKhoi9yg4hLtP6NAQNTQ/w320-h94/StimAire%202023.PNG" width="320" /></a></div><br /><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: left;">There were no adverse events during the study. Furthermore, no significant pain or discomfort was experienced from the injection procedures.</div><p>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.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhZNIoqOuu-9IS7JjZqbHNgpGbtEitpDCnNI7cfJzcPWyAP7pb82f37j3uz0nXPMzUjlb_tAI33s350m4iV4FLfvRHyPUfFaNxZHWHqkB3g5ctpv_CNgqD_Iwq1R3QLHc2OqZpNi8IAowxXXn6ZaKYQZZ3UYdjcrFYVcVFNLzP_TymEV8cAtnaw6b85gq4/s1269/stimaire%20product.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="StimAire neuromodulation platform obstructive sleep apnea" border="0" data-original-height="305" data-original-width="1269" height="77" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhZNIoqOuu-9IS7JjZqbHNgpGbtEitpDCnNI7cfJzcPWyAP7pb82f37j3uz0nXPMzUjlb_tAI33s350m4iV4FLfvRHyPUfFaNxZHWHqkB3g5ctpv_CNgqD_Iwq1R3QLHc2OqZpNi8IAowxXXn6ZaKYQZZ3UYdjcrFYVcVFNLzP_TymEV8cAtnaw6b85gq4/w320-h77/stimaire%20product.PNG" width="320" /></a></div><br /><p style="text-align: center;"><br /></p><p>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." </p><p>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... <span style="font-size: x-small;"><i><a href="https://www.prnewswire.com/news-releases/uaventure-capital-portfolio-company-stimaire-completes-first-in-human-study-of-injectable-stimulator-for-obstructive-sleep-apnea-osa-301954189.html" rel="nofollow" target="_blank">UAVenture Capital's Press Release</a></i></span> -</p><div><br /></div>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-41603871123678688892023-11-13T03:41:00.000-08:002023-11-13T03:41:51.821-08:00Signifier 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<p><b><a href="https://signifiermedical.com/" rel="nofollow" target="_blank">Signifier Medical Technologies LLC</a></b>, a Boston-based medical technology company, is pleased to announce that the <a href="https://openres.ersjournals.com/content/early/2023/10/12/23120541.00474-2023" rel="nofollow" target="_blank">publication of AEGIS clinical trial results is in press at the ERJ Open Research</a>. The objective of the trial was to determine whether patients with mild obstructive sleep apnea (OSA) would adhere to <a href="https://exciteosa.com/" rel="nofollow" target="_blank">eXciteOSA</a>, 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).</p><p>“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.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjuWgkdTHJaoXB7I028L8D7HpoOoFDJVh42XBl9umvcfF6zndExKwWAKeg8h9uQADFZbk7LCJmdgmxnvwG92M_yhCIGgAmoeZzm-jaHKf4-IzKS0fMAZcAR6aadWq_-QgTeYv2BL2j-C4EQhJtH5RNMoLbhyphenhyphenldgLqWNweg0F8C_vrqaq2WIavMTDcs6OI4/s177/signifier%20medical%20technologies%20logo%2013%2011%202023.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Signifier Medical Technologies" border="0" data-original-height="66" data-original-width="177" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjuWgkdTHJaoXB7I028L8D7HpoOoFDJVh42XBl9umvcfF6zndExKwWAKeg8h9uQADFZbk7LCJmdgmxnvwG92M_yhCIGgAmoeZzm-jaHKf4-IzKS0fMAZcAR6aadWq_-QgTeYv2BL2j-C4EQhJtH5RNMoLbhyphenhyphenldgLqWNweg0F8C_vrqaq2WIavMTDcs6OI4/s16000/signifier%20medical%20technologies%20logo%2013%2011%202023.PNG" /></a></div><br /><p><br /></p><p>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.</p><p>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....<a href="https://signifiermedical.com/2023/11/01/signifier-medical-technologies-announces-upcoming-publication-of-randomized-controlled-trial-results-examining-high-intensity-active-vs-low-intensity-sham-neuromuscular-electrical-stimulation-in/" rel="nofollow" target="_blank">Signifier Medical Technologies' Press Release</a> - </p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-36347155920579478562012-07-04T13:34:00.000-07:002012-07-04T13:35:25.464-07:00Omron Launches Sleep Monitor With ResMed Technology<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Omron" border="0" height="38" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj48lMRvUFnyLuwlF8f9Z6jz2HH_VFEX2BSPA8QRVJfCxtotDLfY3QXODQiFf9Jr-PmzdvYQdfROMXyfVwDuvjMFmRmvKm2Syd5Sr9zMhNBK6fgjGmCObVwH4bWnnSMok6fXmqVOxZymwg/s200/omron.jpg" width="120" /></a></div>
SAN DIEGO, May 23, 2012 - <i>The Omron Sleep Design HSL-101 offers wireless sleep monitoring and connection to Wellness Link</i> - <a href="http://www.resmed.com/">ResMed Inc. (NYSE:RMD)</a> announced the launch of the first product in Japan using technology from its recently acquired company, <a href="http://biancamed.com/">BiancaMed</a>. The product, launched by BiancaMed partner <a href="http://www.omronhealthcare.com/">Omron Healthcare</a>, is a new wireless sleep monitoring device. The Omron Sleep Design HSL-101 is part of a new strategy by Omron, named "All for Healthcare."<br />
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<a imageanchor="1" style="margin-left:1em; margin-right:1em"><img border="0" alt="ResMed" height="62" width="104" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhu4Wk_R5UZnxwvgmenNDtsHdLdmy7UExHCz2UUzaqhr9qydCA8YmBB_B-vqj46huZ9-21KwqmCxx6iPKsfyfwjuNvkryBWRnVtO3E5fKEFzeAcf8wHkaP0nI4gsTZfs7C0679xtvQpzKQ/s200/resmed.jpg" /></a></div>
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<i><b>How Omron Sleep Design Works</b></i><br />
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The device uses ResMed technology to offer wireless, non-contact sleep monitoring which in turn connects to health care support services in Japan. To use the Omron Sleep Design HSL-101, a patient places the device beside the bed. With ResMed's non-contact sensing technology, the device measures sleep throughout the night and can report key sleep quality metrics, such as sleep onset time and total sleep time. In the morning, users can generate a full report on the night's sleep with the push of a button. When the data is connected to the cloud as part of Omron's Wellness Link service, a full picture of sleep health is provided, alongside a customized summary of health tips and advice... <span style="background-color: white;"><a href="http://investor.resmed.com/phoenix.zhtml?c=70291&p=irol-newsArticle&ID=1699240&highlight=">ResMed's Press Release</a> -</span>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-5854197380213602852012-05-17T15:00:00.000-07:002012-05-17T15:00:37.909-07:00Somaxon and CJ CheilJedang : Silenor® Collaboration in South Korea<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Somaxon Pharmaceuticals" border="0" height="61" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiJ578HK_hXswNdxUHAjqjhBWTcfCehID7vwVmc5uogX3uylNuIGkXZ0Mig3AE_woelLQDYnfETBhbkHL3OjeEoVkcDmFJ9QkjY0td3tbpr-AHBVsHROtKa0FbR81y0NyAuM9Vf-IhKPhY/s200/Somaxon+Pharmaceuticals+2011.gif" width="161" /></a></div>
April 27, 2012 - <a href="http://www.somaxon.com/">Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX)</a> and <a href="http://eng.cjcheiljedang.com/">CJ CheilJedang Corporation</a> announced that they have entered into an exclusive collaboration under which CJ CheilJedang will commercialize Silenor® (doxepin) for the treatment of insomnia in South Korea.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="CJ CheilJedang" border="0" height="75" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgqdpjvW0Ov4EPZFYr8NXAsho1WhQrLjQnxnP7Isz2BR8dVTZ_qp6KxtrM_Sj3PQtjoMODsvzjkDlAJ4tn_8CCDtACDGWT0jAs19_pXBdf3OtPXy4_6vOhN2qPP845aXgUMQ8LWrmj5xKI/s200/CJ+CheilJedang.gif" width="150" /></a></div>
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Under the terms of the agreements, Somaxon will receive an up-front payment of US$600,000. CJ CheilJedang will be responsible for regulatory submissions for Silenor and will have the exclusive right to commercialize Silenor in South Korea. Once Silenor is approved in South Korea, Somaxon will also be eligible to receive sales-based milestone payments as well as a royalty based on net sales of Silenor in South Korea. Somaxon will also supply CJ CheilJedang's requirements for commercial quantities of Silenor in South Korea at a separate transfer price... <a href="http://investors.somaxon.com/releasedetail.cfm?ReleaseID=668032">Somaxon Pharmaceuticals' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-75727754664902305542012-04-19T15:22:00.001-07:002012-04-19T15:23:31.407-07:00Zephyr Sleep Technologies : FDA 510 (k) Clearance for MATRx™<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Zephyr Sleep Technologies" border="0" height="50" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh5vJ3FLyTwlNCjujRWAnwUVy-Qb3PIOxHAabJXjRmtnFGx-JNyiNil-elBEHifSUwCXmW1imTBmo7tEBsHhwyBTNqK2nsRrPjbbia3d-ZS335U77vWG9IOHvHnOjY87qrXmtLt3P07Y0A/s200/Zephyr+Sleep+Technologies.jpg" width="145" /></a></div>
March 28, 2012 - <a href="http://www.zephyrsleep.com/">Zephyr Sleep Technologies Inc. (Zephyr)</a> is pleased to announce that they have been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin selling the MATRx medical device system.<br />
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The MATRx system will be used in sleep laboratories to identify patients that will be successful with oral appliance therapy while establishing the protrusive position of the lower mandible for effective therapy. “The MATRx system changes the way oral appliance therapy is prescribed, bringing the knowledge and expertise of both Sleep Physicians and Dentists into the therapy decision much earlier. This new technology will certainly change how things are done” says Paul Cataford, Zephyr’s President & CEO.<br />
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A MATRx study is performed in a sleep laboratory by a sleep technician in conjunction with a polysomnographic study (“PSG test”). Using this new technology Sleep Physicians will, for the first time, be able to reliably predict the effectiveness of oral appliance therapy as a treatment for obstructive sleep apnea patients. This clears the way for Sleep Physicians to confidently prescribe oral appliance therapy in advance of patients being fitted with an oral appliance. MATRx also provides Sleep Dentists with an effective target protrusive position for the lower mandible. This enables dentists to fit oral appliances with confidence in therapeutic outcome while eliminating the need for an iterative titration process that previously could take weeks.<br />
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“Understanding a patient’s airway response to mandibular protrusion is a critical component of confidently prescribing and administering oral appliance therapy. The MATRx study offers many features that are comparable to and commensurate with the traditional continuous positive airway pressure study (“CPAP study”). In fact, the two studies can now work hand-in-hand to optimize sleep apnea management.” says Zephyr’s Chief Medical Officer, Dr. John Remmers.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="SomnoMed" border="0" height="94" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjY1BOEIh6oTbpbD51Q8qStYeVh383NcD4b_gTz73egg3FpeissH4jpUTBLx08ZLGZHMe4SI-uxXF15FkL_sphh5UfxSwFH3yIJb0me8P8k4syyQa2rX_ETOuYzqKpTH3JRKMAgPYM2XE8/s200/somnomed.jpg" width="200" /></a></div>
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In Dec 2010, Zephyr signed an exclusive worldwide distribution agreement with <a href="http://www.somnomed.com.au/">SomnoMed Limited</a> to market and sell this device under the name SomnoMed MATRx... <a href="http://www.zephyrsleep.com/pdf/MATRx%20FDA%20510%20(k)%20FINAL%20Release.pdf">[PDF] Zephyr Sleep Technologies' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-43965771715081217462012-04-02T10:22:00.005-07:002012-04-02T10:23:11.235-07:00Teva : Launch of Authorized Generic of Provigil<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear:left; float:left;margin-right:1em; margin-bottom:1em"><img border="0" alt="Teva Pharmaceutical" height="57" width="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjoCoaLpPpluJ1dibqZ4-z9oeQbni7gn1aTZC_4O1Kp4pSMCSPwrwUY4sRsOMYQHF9z_349sO1XJEIfD1Gks7PAohBJE8HiBFf6aN0Pym0TWgB7xKK4_1IpI67H2DWhCdhi8G7xLTNP-No/s200/Teva+Pharmaceutical+Industries+Ltd..jpg" /></a></div>
Mar. 30, 2012-- <a href="http://www.tevapharm.com/">Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA)</a> announces the launch of the authorized generic of <a href="http://www.provigil.com/">Provigil® (modafinil)</a>. Provigil® is marketed by <a href="http://www.cephalon.com/">Cephalon, Inc.</a>, a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.<br />
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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... <a href="http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=RssLanding&cat=news&id=1678505">Teva Pharmaceutical's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-15290933630159665332012-03-19T11:43:00.001-07:002012-03-19T11:44:06.965-07:00CareFusion and Fisher & Paykel Healthcare Renew Exclusive Distribution Agreement for U.S. Hospital Market<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="0" border="CareFusion" height="58" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjfHmxBc0aZQegXFlq4_XsJTPi5pQzTIv4H30enZm-gBsO3yzOXM6TDjwM4phhgQhcZo3r28UKyVJr3LZCF62tsfdoyM3OVnnDaN7qNgAdLxymEm85alrPa3y04sl-d6dSpGXbxpYXAhvg/s200/CareFusion.jpg" width="200" /></a></div>
Feb. 8, 2012 - <a href="http://www.carefusion.com/">CareFusion</a>, a leading, global medical technology company, and <a href="http://www.fphcare.com/">Fisher & Paykel Healthcare</a>, a leading designer, manufacturer and marketer of products and systems for use in respiratory care, acute care and the treatment of <a href="http://sleeposition.blogspot.com/search/label/obstructive%20sleep%20apnea">obstructive sleep apnea</a>, 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.<br />
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"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."<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Fisher and Paykel Healthcare" border="0" height="68" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgPlfQT9UaEU6fp352Ugcx1Qfo873oyHRpbBVYpLOw7BVZPG1-tfggO_VyENA5Y1631LSpR2pex06lVEsWox24aI5oWb50_Rr1QRINCIKbRGDsWGWUkfxy2wQI6XBu2uR78PLAiw_OT1wc/s200/Fisher+%2526+Paykel+Healthcare+fphcare.png" width="199" /></a></div>
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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... <a href="http://media.carefusion.com/index.php?s=43&item=137">CareFusion's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-62548542463902082042012-03-08T09:45:00.000-08:002012-03-08T09:48:30.022-08:00HypnoCore : SleepRate - Sleep Monitoring Solution<iframe allowfullscreen="" frameborder="0" height="344" src="http://www.youtube.com/embed/jzjEORoeGbM?fs=1" width="459"></iframe><br />
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February 5, 2012 - <a href="http://www.sleeprate.com/">SleepRate</a> aims to revolutionize the field of sleep, utilizing web, mobile, and consumer devices, to allow accurate and affordable access to sleep diagnostics solutions for the consumer market.<br />
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<a href="http://www.youtube.com/user/MySleepRate">SleepRate on YouTube</a>- <a href="http://www.hypnocore.com/">HypnoCore's website</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-41058190520764032292012-02-06T14:54:00.000-08:002012-02-06T14:55:43.450-08:00Merck : Update on Development Program for Suvorexant, an Investigational Orexin Receptor Antagonist for the Treatment of Insomnia<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Merck" border="0" height="38" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhgfH8-pzkKotJbCvuZiAeW_-612vdR36ApzuhgLO1ptzrS5eQrawdrUbCllbytRvpaM2FsJWvTUmD9cK9Pj51gaK7Ydwnz912uH6TX1OVF7QkkAX69ZIoX7dwIh92I8EN8nKeqb5fFbVs/s200/Merck+2010.jpg" width="123" /></a></div>
Feb. 6, 2012 - <i>Company Confirms Plans to File NDA for Suvorexant in 2012</i> -<br />
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<a href="http://www.merck.com/">Merck (NYSE:MRK)</a>, known as MSD outside the United States and Canada, provided an update on the development program for suvorexant, the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of <a href="http://sleeposition.blogspot.com/search/label/insomnia">insomnia</a>. The two pivotal Phase III efficacy trials for suvorexant have been completed and, based on the positive results of these studies, Merck plans to file a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug Administration (FDA) in 2012.<br />
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Both Phase III studies were multicenter, randomized, double-blind, placebo-controlled clinical trials that evaluated suvorexant compared to placebo in adult patients ages 18 years and older. The primary endpoint was change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months. Merck plans to submit these data for presentation at major medical meetings later this year... <a href="http://www.merck.com/newsroom/news-release-archive/research-and-development/2012_0206.html">Merck's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-67223420983042893112012-01-25T14:39:00.000-08:002012-01-25T14:41:14.555-08:00Alfresa Pharma and Mitsubishi Tanabe Pharma : Approval of Additional Indication for MODIODAL® Tablets 100 mg a Sleep Disorder Treatment<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Alfresa Pharma" border="0" height="24" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiVBtn_ts-vokLO7f3uXsWmtA7WxKaD_VEk2dMDvFNn3e8Z7aX_RPi01i5p0scy-RvXIjQXkGp_6cgmcsN9JR49-Jin5tztXe5epA67aBqmg9Nz9LjQ-rC80RlH-FT_0jWVg0NAh747ei0/s200/Alfresa+Pharma.jpg" width="200" /></a></div>
November 25, 2011 - <a href="http://www.alfresa.com/">Alfresa Holdings Corporation (head office: Tokyo, Representative Director & President: Denroku Ishiguro)</a> and <a href="http://www.mt-pharma.co.jp/">Mitsubishi Tanabe Pharma Corporation (head office: Osaka, President & CEO: Michihiro Tsuchiya)</a> announced that <a href="http://www.alfresa-pharma.co.jp/">Alfresa Pharma Corporation (head office: Osaka, President & CEO: Kenichiro Iwaya)</a>, 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.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Mitsubishi Tanabe Pharma" border="0" height="28" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgrrRshsUOqclT5Oyu6OMYXlBWKlinN6H5cz2oHJ_VfetyL3j3cE8FHABTme4dDfFMVBxUx-C8hMgUktsqeKlvVE8PbaVT2iOrml7uggoMHFyKJhzkRP-Wo3THjt0uCWe1F0gk6MtlCIo0/s200/Mitsubishi+Tanabe+Pharma.jpg" width="200" /></a></div>
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Since March 2007, MODIODAL® has been jointly marketed by the two companies as a treatment for excessive daytime sleepiness associated with <a href="http://sleeposition.blogspot.com/search/label/narcolepsy">narcolepsy</a>, a sleep disorder characterized by intolerable daytime sleepiness. The new indication, approved for the first time in Japan, is “excessive diurnal sleepiness accompanied with <a href="http://sleeposition.blogspot.com/search/label/obstructive%20sleep%20apnea">obstructive sleep apnea syndrome (OSAS)</a> 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.<br />
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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... <a href="http://v4.eir-parts.net/v4Contents/View.aspx?template=announcement&sid=8280&code=2784">[PDF] Alfresa's Press Release</a> - <a href="http://www.mt-pharma.co.jp/e/release/nr/2011/pdf/eMTPC111125_3.pdf">[PDF] Mitsubishi Tanabe Pharma's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-59543133157484026082012-01-18T09:08:00.000-08:002012-01-18T09:09:37.780-08:00EISAI RECEIVES APPROVAL TO MARKET INSOMNIA TREATMENT LUNESTA® IN JAPAN<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Eisai" border="0" height="96" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiSx-FWVv013EiUcXSJg9z1e5cT_GcjtuoD8JI1e9jcceR3CoSI1LDmaOuHSrsaP7QZkWHIKWo-cQmhbnWFMV3V1Erpz1BhvvibjWzSYUuwA9v5g9o1nA-l0of0iUZZEMiNswdF3cGJuLw/s200/eisai.jpg" width="160" /></a></div>
January 18, 2012 - <a href="http://www.eisai.com/">Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”)</a> announced that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta® (eszopiclone), a product the company has been developing in Japan, as a treatment for <a href="http://sleeposition.blogspot.com/search/label/insomnia">insomnia</a>.<br />
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Lunesta, originally discovered and developed by <a href="http://www.sunovion.com/">Sunovion Pharmaceuticals Inc.</a> (“Sunovion”; formerly Sepracor Inc., “Sepracor”; a U.S. subsidiary of <a href="http://www.ds-pharma.com/">Dainippon Sumitomo Pharma Co., Ltd.</a>), has been marketed in the United States since April 2005. The agent was approved as the first insomnia treatment not to have restrictions on its length of use, and is widely used by individuals suffering from insomnia. Eisai has been pursuing the development of Lunesta since acquiring the exclusive rights to develop and market it in Japan from Sunovion (at the time known as Sepracor) in July 2007. The company submitted a marketing authorization application to the MHLW in November 2010.<br />
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Lunesta is a non-benzodiazepine type GABAA agonist that is believed to enhance GABA activity while exerting hypnotic and sedative effects. Results from clinical studies conducted in Japan and overseas demonstrated that the agent is effective in those patients who have trouble falling asleep or wake up often during the night, two major symptoms of insomnia. A distinctive feature of Lunesta is that patients do not experience clinically problematic issues such as dependency or carry-over effects or develop a tolerance (experience diminished efficacy) with long-term use... <a href="http://www.eisai.com/news/news201203.html">Eisai's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-68662874601824379772012-01-09T15:14:00.000-08:002012-01-09T15:14:49.399-08:00Pfizer : Positive Results From Phase 3 Trial Of Lyrica (pregabaline) Capsules CV In Restless Legs Syndrome<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Pfizer" border="0" height="52" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgxzLycGycFkfNAqvpxrt_jo7Xx-uCqLpuVTeoJJKbtpoUtY_0crj-S9E3aVhCXjM2Ei57og7jLb49BOaPAc8sb6Xb6g0P1Vvp1WeVvgB3tG_k0JVgRkfRj-AF2XNOgieEtLWpNsasXF4c/s200/pfizer+2010.jpg" width="107" /></a></div>
December 16, 2011 - <i>Top-Line Results Show Lyrica Met All Co-Primary Endpoints</i> -<br />
<a href="http://www.pfizer.com/">Pfizer Inc. (NYSE: PFE)</a> announced that a Phase 3 study for Lyrica (pregabalin) in patients with <a href="http://sleeposition.blogspot.com/search/label/RLS">Restless Legs Syndrome (RLS)</a> met each of its three co-primary endpoints, showing significant benefit as compared with placebo and pramipexole. Pfizer will continue to further analyze these top-line results.<br />
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The study, A0081186, was a randomized, double-blind, 12-month trial. It enrolled more than 700 patients, who received either a placebo, Lyrica at 300 mg/day, pramipexole at 0.25 mg/day or pramipexole at 0.5 mg/day.<br />
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Patients treated with Lyrica experienced a statistically significant improvement compared with placebo in RLS symptom severity as measured by the International Restless Leg Group Rating Scale following 12 weeks of treatment. The Lyrica group also demonstrated a statistically significant improvement following 12 weeks of treatment in the proportion of patients responding to treatment compared with those on placebo as measured by the Clinical Global Impression Improvement scale. In addition, Lyrica treatment resulted in a statistically significant reduction in the rate of augmentation (worsening of RLS symptoms that occur after starting a medication to treat RLS) compared with pramipexole 0.5 mg/day over 12 months.<br />
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The results for this study indicate that the most common adverse events in Lyrica-treated patients were dizziness, somnolence, fatigue, headache and nasopharyngitis (inflammation of the nasal cavity and throat). The adverse event profile is consistent with that known for pregabalin.<br />
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Restless Legs Syndrome is a neurological condition that is characterized by an unpleasant irresistible urge to move the legs and, in severe cases, other parts of the body. The symptoms have a circadian pattern and occur mostly in the evening and bedtime. It often results in difficulty falling or staying asleep and can result in periodic limb movements while sleeping, causing partial awakenings that disrupt sleep. RLS has profound negative impact on patients’ quality of life... <a href="http://www.pfizer.com/news/press_releases/pfizer_press_release_archive.jsp#guid=20111216005892en&source=RSS_2011&page=1">Pfizer's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-12941390232176955522011-12-20T06:59:00.000-08:002011-12-20T07:01:40.015-08:00Impax Pharmaceuticals : Phase IIb Trial of IPX159 in Restless Legs Syndrome<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Impax Pharmaceuticals" border="0" height="49" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi3dwaf5VP1Vzt-mewr6DLnKLaZS62a3k4uRN9ehyphenhyphenFQGOjWIl08w2zqq-G1a_2xu6xMc2BzuYuPG4iBedRNd0m1CuSWRCO5X4gY5j8yNWiukV3J0ZK43CvOuq8_QqZllZgXmfzwQp1z56M/s200/Impax+Pharmaceuticals.png" width="200" /></a></div>
Dec. 19, 2011-- <a href="http://www.impaxpharma.com/">Impax Pharmaceuticals</a>, the branded products division of <a href="http://www.impaxlabs.com/">Impax Laboratories, Inc.</a> (NASDAQ: IPXL), announced that it has initiated a Phase IIb trial of its drug candidate IPX159 in patients with moderate to severe <a href="http://sleeposition.blogspot.com/search/label/RLS">Restless Legs Syndrome (RLS)</a>.<br />
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“We are pleased to advance IPX159 to this Phase IIb study, which will help establish its clinical profile in moderate to severe RLS patients. We look forward to reporting the results from this study and providing an update on the program in mid-2013,” said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.
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The Phase IIb study is a multicenter, randomized, double-blind, placebo-controlled, safety and efficacy study to evaluate IPX159 in the treatment of moderate to severe RLS. The trial is expected to randomize approximately 120 adult subjects who will receive either IPX159 or placebo and will be treated for up to 11 weeks. The trial will be conducted at multiple sites in North America. The primary endpoint is the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale... <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=67240&p=irol-newsArticle&ID=1641008&highlight=">Impax Pharmaceuticals' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-30265418439222694922011-12-01T07:58:00.001-08:002011-12-01T08:06:03.969-08:00Pierre Fabre Médicament : JONCIA® milnacipran treating fibromyalgia in Australia<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear:right; float:right; margin-left:1em; margin-bottom:1em"><img border="0" alt="Pierre Fabre Médicament" height="78" width="111" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjPeU3hN4poNHYgKFqxkZHVjSQyk7GDcrSvMjwW2EwVpT6XC4oqnmRQZ_cp_fXUcBdwBybJR-WOW9fTCfXchpzwcoIK3NTLFXQZ2WdZhRbs3kqdlO6eH2w3bDOb94rE5q21WiQC6_I8ocM/s200/Pierre+Fabre.jpg" /></a></div>
<i>On November 17 in Australia, <a href="http://www.pierre-fabre.com/">Pierre Fabre Médicament</a> obtained marketing authorization for Joncia® milnacipran in the treatment of fibromyalgia.</i><br />
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Australian drug regulation agency the Therapeutic Goods Administration (TGA) has granted Pierre Fabre Médicament marketing authorization for Joncia® milnacipran, a molecule used in the treatment of fibromyalgia. First discovered by Pierre Fabre's research teams, milnacipran has since been developed for this indication in collaboration with <a href="http://www.cypressbio.com/">Cypress Bioscience</a> (acquired by <a href="http://www.royaltypharma.com/">Royalty Pharma</a>) and <a href="http://www.frx.com/">Forest Laboratories</a>.<br />
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Approval was granted on the basis of three 3-month Phase III clinical trials conducted in the United States and Europe. These studies, involving over 3,000 patients evaluated using a self-assessment questionnaire, revealed that 100 mg and 200 mg doses of milnacipran resulted in a clinically significant reduction in pain, an overall improvement in symptoms, and a significant improvement in fatigue and sleep. In addition Milnacipran was generally well tolerated with most adverse events being recorded as mild to moderate, and the TGA has announced a positive Joncia® milnacipran benefit/risk ratio... <a href="http://www.pierre-fabre.com/common/0,4157,2072_1956987_0_en_US_0,00.html?vid=11976642"><i>Pierre Fabre Médicament's Press Release</i></a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-7112603172150910322011-11-14T15:12:00.001-08:002011-11-14T15:21:27.526-08:00Circadiance : Revolutionary New CPAP Tube<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Circadiance" border="0" height="45" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgqXZPZZbeHlJFB9fHJqBmOWaNw33CMuy_5h-vv3VcxsdDzEJCuX-Ak6DI2jvzKuzB2c7uBsMM5wSj-NzIcQdH6y5SoxZk0060f5fbg3l_AnZDx5SYe0ySQakBfj6ZZtbdLBz3nHNDV0QI/s200/circadiance.jpg" width="130" /></a></div>
November 7, 2011 - <i>Lightweight and flexible design provides better overall user experience</i> -<br />
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Building on the success of their revolutionary soft cloth nasal SleepWeaver CPAP (Continuous Positive Airway Pressure) mask, <a href="http://www.circadiance.com/">Circadiance</a> is proud to introduce a mask tube so lightweight and flexible, that CPAP users will hardly know it’s there.<br />
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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.<br />
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“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.”<br />
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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.<br />
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“These features give users the full benefit of CPAP therapy so they can enjoy a deep, restorative sleep,” says Mahofski.<br />
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Launching in November 2011, the new tube is designed to fit any CPAP mask with a 22-millimeter connection... <a href="http://www.circadiance.com/news.php#tube">Circadiance's News</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-68086770188350641912011-10-25T14:30:00.000-07:002011-10-25T14:33:50.590-07:00Midmark Corporation partners with Cleveland Medical Devices Inc., introducing Portable Home Sleep Testing Monitor...<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Midmark" border="0" height="67" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhIpF0sor8_qhkoSjBpB1LQvHrCegn4ihdZfbufYhYht5TKWejO4v4A17AXL4IbPuKCHAO66KzWIK9c5KJeMMbGwnW_5xU_N6oUCnQfP7DlAc9wOJ3N7tjUCwk2R7TLi70Ayt9nx3xwDn4/s200/midmark.gif" width="123" /></a></div>
October 17, 2011 - <b>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</b><br />
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- <i>The FDA-cleared, physician-prescribed SleepView® provides a convenient and cost-effective alternative for diagnosing the most common type of breathing-related sleep disorder</i> -<br />
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<a href="http://www.midmark.com/">Midmark Corporation</a>, a trusted leader in digital diagnostic devices for ambulatory care, announced a partnership with <a href="http://www.clevemed.com/">Cleveland Medical Devices</a>, a leader in sleep diagnostics technology, launching the Midmark SleepView® Monitor and SleepViewSM Portal.<br />
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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.<br />
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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.
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Cleveland Medical Devices clevemed" border="0" height="55" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgoP-SMqvUDGpGaQTlqlr9axB3oKjtbigGoScJAKuZZ4fOmaWVXLtSvG-szCAKnf8G-625c3tBz-vWB2l3VH0bg78fOIFrupFYc42tBgDWMH6E-nrS315r4VPnArjtjEwfVyYWsKPnisVQ/s200/clevemed.gif" width="200" /></a></div>
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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."<br />
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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... <a href="http://www.clevemed.com/clevemed_newsreleases/2011_pr_Midmark_partners_with_CleveMed_introducing_Portable_Home_Sleep_Testing_Monitor_for_OSA_testing_in_Comfort_of_Home.shtml"><i>Cleveland Medical Devices' press Release</i></a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-54392767603845029562011-10-14T02:39:00.000-07:002011-10-14T02:41:18.422-07:00Philips : Home oxygen measurement solution for sleep and ventilation launched at ERS 2011<div class="separator" style="clear: both; text-align: center;">
<a href="" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Philips" border="0" height="43" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipSykyywG3nrzV0uUykKcEY4Ix3EiXz8yXbq-xogAsBuypZHbwiw7NB5jQo487LvnScx3NIMpH3z53lN_d5IDPDUK-4_DveW6zTlbkF9UGKE0i6nNYFaTd7qK9qn_VihWF4yXr3bBd8wo/s200/philips.gif" width="162" /></a></div>
September 29, 2011 - <b>Philips’ latest launch reinforces its commitment to providing monitoring solutions that support patient care at home</b> - <i>Home oxygen measurement solution for sleep and ventilation launched at ERS 2011</i> - <a href="http://www.philips.com/">Royal Philips Electronics (NYSE: PHG, AEX: PHI)</a> 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.<br />
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The Oximetry Module, which was launched during the <a href="http://www.erscongress2011.org/">2011 Congress of the European Respiratory Society (ERS) in Amsterdam</a>, is designed to help physicians to better determine whether complex respiratory events are present during a person’s period of sleep at home.<br />
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“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... <a href="http://www.newscenter.philips.com/main/healthcare/news/press/2011/20110929_oximetry.wpd">Philips' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-67799787510160032182011-10-03T14:09:00.000-07:002011-10-03T14:11:31.675-07:00Siesta Medical : 510(k) Clearance for Encore™ System<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Siesta Medical" border="0" height="64" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgXoYsnWRJ1LZW-sTOUxvtY1_ZSKCNUpdf2HgqMmNFJK1NHggs6_wAIX5RzOfk-jCBJCDwP8TfEMo_zhL7yGM2TRXf4v55tfXbpTYlgtiAMQCtpIhHpGf-gyC3D2gAP2r_Il1gl76ofC7A/s200/Siesta+Medical.gif" width="200" /></a></div>
September 12, 2011 - <a href="http://www.siestamedical.com/">Siesta Medical, Inc. (Private)</a>, 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.<br />
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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.<br />
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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.<br />
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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.<br />
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The Encore™ Tongue Suspension System<br />
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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.<br />
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Siesta Medical is currently planning a multi-center U.S. post-marketing study... <a href="http://www.siestamedical.com/press/siesta_medical_inc_510k_clearance_20110912%20.pdf">[PDF] Siesta Medical's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-73577382194912161442011-09-26T13:59:00.000-07:002011-09-26T14:34:22.260-07:00Eiken : First Field-based Molecular Diagnostic Test for African Sleeping Sickness in Sight<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Eiken" border="0" height="30" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhzcDHtrJ9ignKdMlSqVrkWp0EMXKCGb5fFSjVSUhNuXlsQvGf-NnMBWNgebpjBkShbVhgBclVaI75lw2PlzAk0x_EDPcVg5eu8SRjpVTZW10-fi45d2xWQeN66WjCneAYLKUys448jWtY/s200/EIKEN+CHEMICAL.gif" width="200" /></a></div>
15 September 2011 – <a href="http://www.finddiagnostics.org/">The Geneva-based not-for-profit foundation FIND</a> and <a href="http://www.eiken.co.jp/en/index.html">Japanese diagnostics company Eiken</a> announced that a next-generation molecular test designed specifically for sleeping sickness – a deadly parasitic disease also known as human African trypanosomiasis (HAT) - is ready to enter accelerated field trials in sites across the Democratic Republic of Congo and Uganda. If all goes well, the LAMP (Loop-mediated Isothermal Amplification) test - which has completed design and development phases - will be available for clinical use in 2012.<br />
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The announcement was made at the 31st biennial of the International Scientific Council for Trypanosomiasis Research and Control (ISCTRC), in Bamako, Mali.<br />
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Designed to be suitable for use in rural African settings where the disease is most common, the LAMP test promises to dramatically improve the ability to confirm a diagnosis of sleeping sickness - even when parasites are present in low numbers - through detection of the parasite's DNA in patient samples. FIND is also exploring LAMP's utility as a tool to confirm cure after treatment of HAT, which would significantly reduce the follow-up period, and could eliminate the need for repeated lumbar punctures.<br />
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If not diagnosed and treated early, sleeping sickness inexorably progresses to a stage where the parasites enter the brain, making treatment more difficult and the likelihood of irreversible neurological damage more likely... <a href="http://www.eiken.co.jp/en/news/pdf/20110916-1.pdf">[PDF] Eiken's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-5364340715404112501.post-14815067113386238082011-09-19T14:15:00.000-07:002011-09-19T14:16:33.697-07:00Natus Acquires Embla, Leading Sleep Diagnostic CompanySep 16, 2011 - <i>Acquisition expected to add $0.08 to 2012 non-GAAP Earnings Per Share</i> -- <a href="http://www.natus.com/">Natus Medical Incorporated (Nasdaq:BABY)</a> announced that it has acquired <a href="http://www.embla.com/">Embla Systems LLC</a>, 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.
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Natus Medical" border="0" height="59" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhPeIo81tH-7JfN1p_QR9V4HOlvmeC0qAnfh0KdDAyOYleXJygsS5lM7jM4rSV-cuZfKdEhO-E1OfAQQs8r-oBgFizuyOa4DmnJqXBxOg4Cr73e81wN3fMWnTicV9PAnE-v5IxMyN-FdUY/s200/natus.jpg" width="183" /></a></div>
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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.
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Embla Systems" border="0" height="113" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg6uBW7R-i15iFuvGzmqTW8FWdMHV22CrsPVRpPt5Bt8QRYfTouDj2FQthRBzJQsq_PV75dQn76BX2L2rcjZaLRByXfliAwG9Z6Uwz2C4blKGsihWy8KMZSGX_kHhbkNxRC7ujMwkm9jsk/s200/embla.gif" width="200" /></a></div>
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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... <a href="http://investor.natus.com/phoenix.zhtml?c=129675&p=irol-newsArticle&ID=1607535&highlight=">Natus Medical's Press Release</a> -Unknownnoreply@blogger.com