Continuous positive airway pressure

Study Published in "Military Medicine" Reports 88% Success Treating Obstructive Sleep Apnea Patients with Precision Oral Appliance Therapy

Retrieved on: 
Thursday, December 8, 2022
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SAN FRANCISCO, Dec. 08, 2022 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (“the Company”) (NASDAQ: OSA), a pioneer in precision medical devices for the treatment of Obstructive Sleep Apnea (OSA), today announced the publication of a peer-reviewed, independent, study in Military Medicine, in which 88% of patients with Obstructive Sleep Apnea (“OSA”) were successfully treated using the Company’s novel precision intraoral medical devices. Following approval from the Carl R. Darnall Army Medical Center Institutional Review Board and the Defense Health Agency, the investigators analyzed the records of active-duty military patients treated for OSA to determine the success of precision oral appliance therapy (“OAT”) based on a symptom-driven titration.

Key Points: 
  • “Sleep is an incredibly important factor in one’s overall health and daily performance, so we are especially interested in ways to improve soldiers’ rest.
  • Our primary goal was to evaluate if OSA can be effectively managed with Precision OAT.
  • The study also reported statistically significant improvements in respiratory disturbances (“RDI”), oxygen saturation, REM sleep, sleep efficiency and daytime sleepiness, with a 79.6% mean reduction in sleep apnea events.
  • With more than 150,000 patients treated, ProSomnus’ devices are the most prescribed Precision Oral Appliance Therapy in the U.S. To learn more, visit www.ProSomnus.com .

Incannex Expands Intellectual Property Position over IHL-42X

Retrieved on: 
Tuesday, December 6, 2022
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Dronabinol is believed to activate muscles in the upper airway during sleep, thereby reducing incidence of airway collapse.

Key Points: 
  • Dronabinol is believed to activate muscles in the upper airway during sleep, thereby reducing incidence of airway collapse.
  • Incannex previously discovered that the two drugs act synergistically to reduce the Apnea Hypopnea Index (AHI) in patients with OSA.
  • CEO and Managing Director of Incannex Healthcare, Mr Joel Latham said; “Incannex works closely with its patent attorneys to build upon its competitive position through the ongoing development of intellectual property assets.
  • Results from a Phase 2 proof of concept clinical trial undertaken by Incannex were published in 2022.

Incannex Development Update for IHL-42X for Obstructive Sleep Apnoea (‘OSA’)

Retrieved on: 
Thursday, November 17, 2022
Hypertension, THC, Dronabinol, Pharmacokinetics, Food, Blood, IND, Risk, Safety, ASX, API, Patient, Cardiovascular disease, Sleep, Fatigue, AHI, OSA, Anxiety, Accident, US, Patent, Depression, Continuous positive airway pressure, Research, Sleep-related breathing disorder, Clinical trial, Irritability, Government budget balance, Acetazolamide, FDA, BA, CPAP, Pharmaceutical industry, Medical device

MELBOURNE, Australia, Nov. 17, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that Incannex has initiated a BA/BE study and is targeting submission of an IND application with the FDA in Q1 2023.

Key Points: 
  • The design of the BA/BE study is consistent with FDA recommendations for BA/BE and specific advice received by Incannex in the pre-IND meeting.
  • In parallel with the BA/BE study, Incannex is preparing an IND application for submission to the FDA.
  • Once the IND is opened, it is continuously updated with research and development results for the purpose of ongoing assessment by the FDA.
  • It is estimated that the annual economic burden of undiagnosed sleep apnoea among U.S. adults is approximately US$149.6 billion per annum.

ProSomnus® Announces FDA 510(k) Clearance for ProSomnus EVO™ [PH] Sleep and Snore Device

Retrieved on: 
Wednesday, November 2, 2022
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SAN FRANCISCO, Nov. 02, 2022 (GLOBE NEWSWIRE) -- ProSomnus (“the Company”), a pioneer in precision medical devices for the treatment of Obstructive Sleep Apnea (OSA), today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the ProSomnus EVO™ [PH] Sleep and Snore Device. The device joins the Company’s flagship product, the ProSomnus EVO™, in its line of FDA-cleared, patient-preferred, less invasive Precision Oral Appliance Therapy (OAT) devices for the treatment of OSA.

Key Points: 
  • The ProSomnus EVO [PH] Sleep and Snore Device is specifically engineered to meet Centers for Medicare Services coding guidelines, offering Medicare beneficiaries a non-invasive, comfortable, easy-to-use, and effective alternative to CPAP machines, surgical procedures, and legacy oral devices.
  • Every ProSomnus EVO [PH] device is personalized and digitally manufactured based upon the patients unique anatomy and healthcare providers treatment plan for each patient.
  • The ProSomnus EVO [PH] is the only Herbst-style device made from engineered, Medical Grade Class VI-rated material, the highest material quality grade offered by US Pharmacopeia.
  • Receiving FDA clearance for the ProSomnus EVO [PH] is a significant milestone for the Company and for patients suffering from OSA, said Len Liptak, Co-Founder and Chief Executive Officer of ProSomnus.

Inspire Medical Systems, Inc. Expands Therapy Access to Thousands of Federal Medical Facilities Through SDVOSB Partner, Lovell Government Services, Inc.

Retrieved on: 
Thursday, October 20, 2022
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PENSACOLA, Fla., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (Inspire) and Lovell Government Services, Inc. (Lovell) announced today that they have partnered to provide the Inspire therapy system to Federal Healthcare Systems.

Key Points: 
  • PENSACOLA, Fla., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (Inspire) and Lovell Government Services, Inc. (Lovell) announced today that they have partnered to provide the Inspire therapy system to Federal Healthcare Systems.
  • Inspire is a medical innovation company based in Minneapolis, MN, dedicated to elevating and redefining the standard of care for obstructive sleep apnea.
  • As Inspire's SDVOSB Vendor, Lovell is excited to help bring this product portfolio to federal healthcare providers.
  • Lovell partners with Medical and Pharmaceutical Suppliers to fast-track and distribute the latest in life-saving and essential technologies to the Federal Government.

Global Sleep Apnea Devices Market Report (2022 to 2027) - Industry Trends, Share, Size, Growth, Opportunity and Forecasts - ResearchAndMarkets.com

Retrieved on: 
Thursday, October 13, 2022
Health, General Health, Non-invasive ventilation, Hypertension, Sleep apnea, Prevalence, Central sleep apnea, Growth, CVD, Mandible, Diagnosis, MAD, VPAP, CPAP, Sleep, OSA, Miniaturization, Awareness, Diabetes, SDB, Continuous positive airway pressure, Brain, Pulse oximetry, Degenerative disease, COVID-19, OOC, Pharmaceutical industry, Medical device

Sleep apnea, or sleep-disordered breathing (SDB), is an acute medical condition in which oxygen supply to the brain is obstructed during sleep.

Key Points: 
  • Sleep apnea, or sleep-disordered breathing (SDB), is an acute medical condition in which oxygen supply to the brain is obstructed during sleep.
  • Apart from this, numerous oral devices, including the Mandibular Advancement Device (MAD) and tongue retaining device, are also utilized to treat mild to moderate cases of sleep apnea.
  • The increasing prevalence of obstructive sleep apnea disorder (OSA), central sleep apnea and complex sleep apnea syndrome, are among the key factors driving the growth of the market.
  • The publisher provides an analysis of the key trends in each sub-segment of the global sleep apnea devices market report, along with forecasts at the global, regional and country level from 2022-2027.

ProSomnus® Sleep Technologies to Participate at the Oppenheimer Private Company Showcase

Retrieved on: 
Wednesday, October 5, 2022
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SAN FRANCISCO, Oct. 05, 2022 (GLOBE NEWSWIRE) -- ProSomnus Holdings Inc. (ProSomnus), the leader in patient preferred medical devices for the treatment of obstructive sleep apnea (OSA), today announced that Laing Rikkers, Executive Chairwoman and Co-Founder, is scheduled to participate at the Oppenheimer Private Company Showcase on October 17-18, 2022 at the Four Seasons in Palo Alto, California.

Key Points: 
  • SAN FRANCISCO, Oct. 05, 2022 (GLOBE NEWSWIRE) -- ProSomnus Holdings Inc. (ProSomnus), the leader in patient preferred medical devices for the treatment of obstructive sleep apnea (OSA), today announced that Laing Rikkers, Executive Chairwoman and Co-Founder, is scheduled to participate at the Oppenheimer Private Company Showcase on October 17-18, 2022 at the Four Seasons in Palo Alto, California.
  • Laing Rikkers will present at 10:25 am Pacific Time, and will be available for investor meetings throughout both days.
  • In May 2022, ProSomnus entered a definitive merger agreement with Lakeshore Acquisition I Corp. (Nasdaq: LAAA), a special purpose acquisition company.
  • Upon closing, the combined company is expected to change its name to ProSomnus, Inc. and its Class A common stock is expected to be traded on the Nasdaq Capital Market under the symbol OSA.

Signifier Medical Technologies’ eXciteOSA®, the Only FDA-Authorized Daytime Therapy for Primary Snoring and Mild Obstructive Sleep Apnea, Demonstrates Real-World Adherence to Treatment of Over 80%

Retrieved on: 
Wednesday, September 21, 2022
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The results demonstrate that patients have used eXciteOSA therapy on over 80% of days during the first six weeks of treatment.

Key Points: 
  • The results demonstrate that patients have used eXciteOSA therapy on over 80% of days during the first six weeks of treatment.
  • Sleep apnea is a serious condition, and adherence to treatment is both a challenge and a requirement.
  • We understand patients desire for effective treatments that fit their lifestyle, said Dr. Jessie Bakker, Executive Vice President of Medical Affairs at Signifier.
  • Signifier is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials.

ProSomnus® Announces Availability of Insurance Reimbursement for Oral Appliance Therapy Devices in Germany

Retrieved on: 
Thursday, September 15, 2022
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ProSomnus is the first manufacturer of precision, mass-customized oral appliance therapy devices to treat OSA, which affects over 74 million Americans and is associated with serious comorbidities, including heart failure, stroke, hypertension, morbid obesity and type 2 diabetes.

Key Points: 
  • ProSomnus is the first manufacturer of precision, mass-customized oral appliance therapy devices to treat OSA, which affects over 74 million Americans and is associated with serious comorbidities, including heart failure, stroke, hypertension, morbid obesity and type 2 diabetes.
  • ProSomnuss patented devices are a more comfortable and less invasive alternative to Continuous Positive Airway Pressure (CPAP) therapy, and lead to more effective and patient-preferred outcomes.
  • With more than 150,000 patients treated, ProSomnuss devices are the most prescribed oral appliance therapy in the U.S. To learn more, visit www.ProSomnus.com .
  • In May 2022, ProSomnus entered a definitive merger agreement with Lakeshore Acquisition I Corp. (Nasdaq: LAAA), a special purpose acquisition company.

Axsome Therapeutics Announces Publication of Post-hoc Analysis of Sunosi® Effect on Excessive Daytime Sleepiness in Narcolepsy or Obstructive Sleep Apnea Patients with a History of Depression in the Journal of Psychiatric Research

Retrieved on: 
Wednesday, September 7, 2022
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Excessive daytime sleepiness may persist in people with sleep apnea despite using CPAP.

Key Points: 
  • Excessive daytime sleepiness may persist in people with sleep apnea despite using CPAP.
  • Narcolepsy is a serious and debilitating neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep.
  • Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for CNS conditions that have limited treatment options.
  • At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians.