Apnea–hypopnea index

American Journal of Respiratory and Critical Care Medicine Publishes Full, Positive Results of Apnimed’s MARIPOSA Study on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea

Retrieved on: 
Tuesday, October 10, 2023
BMI, Nursing care plan, Xerostomia, Food, Female, AJRCCM, Desaturation, American Journal, American Journal of Respiratory and Critical Care Medicine, Confusional arousals, ST, AHI, Safety, Nausea, Insomnia, CPAP, Hypopnea, Fatigue, Research, Obstructive sleep apnea, Sleep, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Critical Care Medicine (journal), IQR, Sleep apnea, Șaeș, Patient, Apnea–hypopnea index, Pharmaceutical industry, Medical imaging

AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.

Key Points: 
  • AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.
  • The study met its primary endpoint, reduction in Apnea-Hypopnea Index (AHI4, 4% desaturation definition for hypopneas).
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.

Inspire Medical Systems, Inc. Announces FDA Approval for Apnea Hypopnea Index Indication Expansion and Increased Body Mass Index Labeling

Retrieved on: 
Friday, June 9, 2023
AHI, Food and Drug Administration Amendments Act of 2007, BMI, FDA, Obstructive sleep apnea, Patient, Body mass index, NYSE, OSA, Food, Apnea–hypopnea index, Pharmaceutical industry, Inspiration

The update includes an increase on the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index (BMI) warning in the labeling to 40 from 32.

Key Points: 
  • The update includes an increase on the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index (BMI) warning in the labeling to 40 from 32.
  • “We are excited that the FDA has approved Inspire’s application to expand our indication to include patients with AHI up to 100 events per hour,” said Tim Herbert, President and Chief Executive Officer of Inspire.
  • “These patients experience severe OSA and have historically had limited treatment options available.
  • Furthermore, we are very pleased that the FDA raised the BMI warning in the labeling to 40 from 32,” concluded Mr. Herbert.

Apnimed Presented Positive Phase 2b Results on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea, for the First Time at ATS 2023

Retrieved on: 
Sunday, May 21, 2023
Breaking news, Apnea–hypopnea index, ATS, DC, Confusional arousals, Hypopnea, OSA, Desaturation, International Conference on Population and Development, Obstructive sleep apnea, Conference, News, Safety, Pharmaceutical industry

CAMBRIDGE, Mass., May 21, 2023 (GLOBE NEWSWIRE) -- Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, presented positive results from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study of AD109 over a one-month duration, for the first time in the Breaking News in OSA Mini Symposium today at the ATS 2023 International Conference in Washington, DC.

Key Points: 
  • Dosing with AD109 led to clinically important reductions in AHI in most patients with mild, moderate and severe OSA.
  • MARIPOSA also incorporated other standard clinical endpoints designed to characterize improvement of oxygenation, sleep, and daytime function of patients with OSA.
  • Apnimed plans to advance AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) into Phase 3 following productive discussions with FDA that occurred in February 2023.
  • Apnimed continues to develop and optimize the dosing of this drug for the OSA population.

Apnimed to Present Positive Phase 2b Results on AD109, an Investigational Oral Treatment for Obstructive Sleep Apnea, at ATS 2023

Retrieved on: 
Monday, May 15, 2023
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, FOR, CPAP, Obstructive sleep apnea, Apnea–hypopnea index, Sleep, DC, SDB, International Conference on Emerging Infectious Diseases, Patient, Annals of the American Thoracic Society, Randomness, AHI, NEWS, Research, ST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Trial of the century, Conference, Food, Safety, Pharmaceutical industry, Medical imaging

A total of 294 participants with a wide range of OSA severity, from mild to severe (AHI4 of 10-45), were enrolled at 25 sites across the United States.

Key Points: 
  • A total of 294 participants with a wide range of OSA severity, from mild to severe (AHI4 of 10-45), were enrolled at 25 sites across the United States.
  • Participants were randomized to parallel arms comparing two doses of AD109, two doses of AD504 (a second candidate in an earlier phase of development), atomoxetine alone, and placebo.
  • MARIPOSA also incorporated other standard clinical endpoints designed to characterize improvement of oxygenation, sleep, and daytime function in OSA.
  • It is one of the largest clinical trials ever conducted of potential drug treatments designed to target the underlying cause of OSA.

Nyxoah Announces Achievement of Key Clinical and Regulatory Milestones

Retrieved on: 
Monday, March 6, 2023
DREAM, Euronext, Oxygen, Diagnosis, OSA, Observational study, Mont-Saint-Guibert, CET, AHI, Obstructive sleep apnea, IDE, Patient, PMA, Apnea–hypopnea index, ODI, Notre Dame of Genio Edcor Inc., CCC, Medical device, Pharmaceutical industry

The DREAM study is a pivotal, investigational device exemption (IDE) trial designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States.

Key Points: 
  • The DREAM study is a pivotal, investigational device exemption (IDE) trial designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States.
  • In the ACCCESS trial, Nyxoah will implant 106 complete concentric collapse (CCC) patients with co-primary efficacy endpoints of Apnea-Hypopnea Index (AHI) responder rate, per the Sher criteria, and Oxygen Desaturation Index (ODI) responder rate, both assessed at 12 months post-implant.
  • “The achievement of these key clinical and regulatory milestones brings us closer to offering our patient centric Genio solution to all OSA patients in the U.S.
  • The DREAM and ACCCESS studies demonstrate Nyxoah’s mission of providing Genio to patients regardless of CCC status and without the requirement for a CCC diagnosis,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer.

Vivos Therapeutics Schedules Release of Second and Third Quarter 2022 Financial Results and Conference Call

Retrieved on: 
Friday, December 16, 2022
VIP, Nature, Dentist, Security (finance), Webcast, Obstructive sleep apnea, Risk, Palate, Consultant, Eastern Time Zone, Apnea–hypopnea index, ASC, Therapy, Snoring, CARE, OSA, Tissue, Patient, File, Pharmaceutical industry

A replay will be available shortly after the call and can be accessed by dialing (844) 512-2921, or for international callers, (412) 317-6671.

Key Points: 
  • A replay will be available shortly after the call and can be accessed by dialing (844) 512-2921, or for international callers, (412) 317-6671.
  • A live webcast of the conference call can be accessed on Vivos’ website at https://vivos.com/investor-relations .
  • Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children.
  • The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.

Vivos Therapeutics Announces New Revenue Stream Through Strategic Medical Billing Relationship with Nexus Dental Systems

Retrieved on: 
Thursday, December 15, 2022
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LITTLETON, Colo., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), today announced the creation of a new strategic collaboration with Nexus Dental Systems (“Nexus”), which Vivos expects to generate new revenues starting immediately.

Key Points: 
  • LITTLETON, Colo., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), today announced the creation of a new strategic collaboration with Nexus Dental Systems (“Nexus”), which Vivos expects to generate new revenues starting immediately.
  • The agreement between Vivos and Nexus effectively combines Vivos’ proprietary out-of-network Billing Intelligence Service with the Nexus’ in-network medical billing platform to create what is expected to be one of the most comprehensive medical billing services in the dental industry.
  • “This relationship will allow Nexus additional opportunities to significantly grow our revenue by partnering with such an established, highly successful medical billing platform.
  • Nexus Dental Systems is the only company in the market with a true end-to-end billing solution for dental practices.

Incannex Expands Intellectual Property Position over IHL-42X

Retrieved on: 
Tuesday, December 6, 2022
Government budget balance, Accident, Associate, Depression, Sleep, Muscle, Clinical trial, Patent Cooperation Treaty, Incidence, Irritability, ASX, Cardiovascular disease, Obstructive sleep apnea, Hypertension, Continuous positive airway pressure, Fatigue, Sleep-related breathing disorder, THC, US, Dronabinol, Physiology, University, Polysomnography, AHI, Acetazolamide, Loop gain, Metabolic acidosis, CPAP, Research, Apnea–hypopnea index, Patent, Risk, Blood, Finswimming at the 2017 World Games – Men's 50 m apnoea, Patient, Monash University, Anxiety, Pharmaceutical industry, Medical device

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.

Vivos Therapeutics Announces Receipt of Notice from Nasdaq Regarding Late Filing of Third Quarter 2022 Quarterly Report on Form 10-Q

Retrieved on: 
Monday, November 28, 2022
Nature, Palate, Tissue, Therapy, Patient, ASC, OSA, Snoring, File, Security (finance), VIP, Risk, Apnea–hypopnea index, Dentist, CARE, Consultant, Pharmaceutical industry

Such a notice is typical and normal procedure, and it has no immediate effect on the listing or trading of the Companys common stock on the NASDAQ.

Key Points: 
  • Such a notice is typical and normal procedure, and it has no immediate effect on the listing or trading of the Companys common stock on the NASDAQ.
  • As reported by the Company in its press release dated November 22, 2022, the Company has resolved any open matters on this topic, and accordingly restated its Form 10-Q for the period ended March 31, 2022 on November 25, 2022.
  • Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children.
  • The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.

Vivos Therapeutics Provides Update on Revenue Recognition Review

Retrieved on: 
Tuesday, November 22, 2022
Nature, Palate, Tissue, Therapy, Obstructive sleep apnea, Patient, ASC, Net, OSA, Snoring, File, Classification, Security (finance), VIP, Risk, Prior, Apnea–hypopnea index, Dentist, CARE, Consultant, Audit committee, Risk management, Pharmaceutical industry, Renewable energy, Vivos

HIGHLANDS RANCH, Colo., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company'') (NASDAQ: VVOS), a medical technology company focused on developing innovative treatments for patients suffering from dentofacial abnormalities and/or mild to moderate obstructive sleep apnea (OSA) and snoring in adults, today provided an update on its review of the Company’s revenue recognition policies and the expected timing for the release of its second and third quarter 2022 financial results.

Key Points: 
  • The Company expects it will restate its first quarter 2022 revenue to reflect an increase of approximately $200,000.
  • Also, managements analysis has concluded no previously reported revenue will be lost; rather the timing for recognizing revenue and the classification of revenue between product and service revenue requires modification in order to be compliant with ASC 606.
  • Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children.
  • The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.