OSA

Vivos Therapeutics’ Flagship CARE Oral Medical Devices Receive Full Approval for Medicare Reimbursement

Retrieved on: 
Tuesday, April 9, 2024
Research, CARE, OSA, Health, Sleep apnea, Conditional sentence, Obstructive sleep apnea, Risk, Diabetes, DDS, Patient, Stroke, Sleep, Chronic pain, Quality of life, Heart failure, Therapy, FDA, CMS, Dementia, Pharmaceutical industry

Effective immediately, this milestone achievement allows millions of Medicare beneficiaries coverage and reimbursement for allowable charges billable to Medicare.

Key Points: 
  • Effective immediately, this milestone achievement allows millions of Medicare beneficiaries coverage and reimbursement for allowable charges billable to Medicare.
  • “Prior to these latest developments, moderate to severe OSA patients on Medicare were relegated almost entirely to a lifetime of some form of CPAP—something most patients find undesirable.
  • Our CARE oral medical devices, on the other hand, can significantly improve and even resolve OSA in about 12 months, with no further intervention required in most cases,” said Kirk Huntsman, Vivos Chairman and Chief Executive Officer.
  • “We are very pleased the Centers for Medicare and Medicaid Services (CMS) recognizes and validates the benefits our FDA cleared devices can have on the lives of patients diagnosed with OSA.

Apnimed to Participate in the 23rd Annual Needham Virtual Healthcare Conference

Retrieved on: 
Wednesday, April 3, 2024
OSA, Obstructive sleep apnea

CAMBRIDGE, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, including its lead oral treatment candidate AD109, today announced the company will participate in the 23rd Annual Needham Virtual Healthcare Conference taking place virtually on April 8-11, 2024.

Key Points: 
  • CAMBRIDGE, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, including its lead oral treatment candidate AD109, today announced the company will participate in the 23rd Annual Needham Virtual Healthcare Conference taking place virtually on April 8-11, 2024.
  • Apnimed’s management will participate in a fireside chat on April 10 from 12:45 pm to 1:25 pm ET and will be available for one-on-one virtual meetings during the conference.
  • Investors can view the webcast of the presentation using this link .
  • A replay will be available after the conference on the Apnimed website events page.

Vivos Therapeutics Schedules Release of Fourth Quarter and Full Year 2023 Financial Results and Conference Call

Retrieved on: 
Thursday, March 28, 2024
OSA, Webcast, Sleep, Eastern Time Zone, Therapy, Obstructive sleep apnea

The Company will conduct a conference call today at 5:00 p.m. (Eastern Time) to review the results and provide an overview of the Company’s recent milestones and developments.

Key Points: 
  • The Company will conduct a conference call today at 5:00 p.m. (Eastern Time) to review the results and provide an overview of the Company’s recent milestones and developments.
  • To access Vivos’ investor conference call, please dial (888) 886-7786, or for international callers, (416) 764-8658.
  • A live webcast of the conference call can be accessed on Vivos’ website at https://vivos.com/investor-relations .
  • An online archive of the webcast will be available on the Company’s website for 30 days following the call.

ProSomnus Reports Record Fourth Quarter and Fiscal Year 2023 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Research, OSA, Interest, Growth, Food and Drug Administration, Insurance, Trial of the century, News, Investment, Oxygen saturation (medicine), Depreciation, Obstructive sleep apnea, FDA, Marketing, RPM, Food, Pharmaceutical industry

Generated record revenues of $7.8 million for the fourth quarter and $27.7 million for the fiscal year 2023, a 35% increase compared to $5.8 million for the fourth quarter 2022 and 43% increase compared to $19.4 million for fiscal year 2022.

Key Points: 
  • Generated record revenues of $7.8 million for the fourth quarter and $27.7 million for the fiscal year 2023, a 35% increase compared to $5.8 million for the fourth quarter 2022 and 43% increase compared to $19.4 million for fiscal year 2022.
  • I am proud of the 2023 results, and I look forward to building upon this momentum during 2024.”
    Financial Results for the Fourth Quarter and Year Ended December 31, 2023
    Revenues increased to $7.8 million for the fourth quarter ended December 31, 2023.
  • Fourth quarter 2023 sales and marketing expense reflects a modest increase compared to the quarter ended September 2023, and an increase of $1.0 million, or 40%, compared to the quarter ended December 2022.
  • Fourth quarter 2023 general and administrative expenses reflect an increase of $0.5 million, or 16%, compared to the quarter ended September 2023, and a decrease of $1.7 million, or 30%, compared to the quarter ended December 2022.

Nyxoah Advances Patient Access Strategy through Partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation

Retrieved on: 
Monday, March 25, 2024
OSA, Growth, Otorhinolaryngology, Partnership, Patient, Mont-Saint-Guibert, Insurance, Euronext, AAO, Obstructive sleep apnea, CMS, Corporation, Pharmaceutical industry

Nyxoah is the first medical device company to partner with the AAO-HNSF at this level.

Key Points: 
  • Nyxoah is the first medical device company to partner with the AAO-HNSF at this level.
  • The AAO-HNSF is committed to identifying and combating harmful coverage policies that threaten access to quality otolaryngology-head and neck services.
  • The Academy’s Advocacy team, in collaboration with its dedicated members and strategic industry partners like Nyxoah, actively engage with payers to achieve this goal.
  • “Nyxoah and the AAO-HNSF share the common goal of putting patients first and making sure they have access to HGNS therapy.

Investigation Alert: Cummins, Apellis Pharmaceuticals, Inspire Medical, and Applied Digital - Johnson Fistel, LLP Encourages Long-Term Investors to Submit Their Information Below

Retrieved on: 
Tuesday, March 19, 2024
Cloud, OSA, APLS, ASRS, Environment, Patient, Public, Inflammation, News, LLP, Retinal scan, DOJ, Complaint, CMI, Retinal vasculitis, EPA, Justice, Society, Retina, Safety, Paratriathlon, Physician, Pharmaceutical industry

Johnson Fistel, LLP is investigating potential claims on behalf of Cummins, Inc. against certain of its officers and directors.

Key Points: 
  • Johnson Fistel, LLP is investigating potential claims on behalf of Cummins, Inc. against certain of its officers and directors.
  • Johnson Fistel LLP is investigating potential claims on behalf of Apellis Pharmaceuticals against certain of its officers and directors.
  • Johnson Fistel, LLP is investigating potential claims on behalf of Inspire Medical Systems, Inc. against certain of its officers and directors.
  • Johnson Fistel, LLP is investigating potential claims on behalf of Applied Digital Corporation against certain of its officers and directors.

Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints

Retrieved on: 
Tuesday, March 19, 2024
DREAM, OSA, Annual report, ODI, Patient, PSG, Mont-Saint-Guibert, IDE, AHI, Euronext, ITT, Oxygen, Obstructive sleep apnea, Pharmaceutical industry

The DREAM study is a pivotal trial, being conducted under an investigational device exemption (IDE) and is 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 trial, being conducted under an investigational device exemption (IDE) and is designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States.
  • Study participants entered the DREAM study with a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5.
  • “DREAM is a pivotal, multicenter, international study of Genio, a next generation HGNS technology offering patients bi-lateral stimulation with a non-implanted battery solution powered and controlled by a wearable.
  • A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: DREAM Results Webcast .

ProSomnus Reschedules Fourth Quarter and Fiscal Year 2023 Investor and Business Update Call

Retrieved on: 
Saturday, March 16, 2024
OSA, Conference

PLEASANTON, Calif., March 15, 2024 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (NASDAQ: OSA ) (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced today it has postponed the release of its 2023 fourth quarter and full year financial results and the related investor conference call.

Key Points: 
  • PLEASANTON, Calif., March 15, 2024 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (NASDAQ: OSA ) (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced today it has postponed the release of its 2023 fourth quarter and full year financial results and the related investor conference call.
  • The rescheduled call will be held after market close on Tuesday, March 26, 2024 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.
  • Registration and dial-in information can be found on the investor relations website.
  • Additionally, the Company will not be attending the Roth Conference.

Optomind and MaxLinear Demonstrate 800G LRO Optical Modules and AOCs at OFC2024

Retrieved on: 
Thursday, March 21, 2024
Data Management, Consumer Electronics, Technology, Semiconductor, Security, Satellite, Telecommunications, Artificial Intelligence, Networks, Mobile, Wireless, Hardware, OSA, Optics, Conference, DSP, Partnership, LRO, Mechanics, Architecture, High Speed, Nvidia BR02, AOCS, Multimedia

View the full release here: https://www.businesswire.com/news/home/20240321013791/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240321013791/en/
    Optomind and MaxLinear demonstrate 800G LRO optical modules and AOCs at OFC2024 (Graphic: Business Wire)
    800G half re-timed LRO optical modules and AOCs play a crucial role in enabling ultra-high-speed data transmission over optical fiber networks, meeting the growing demand for bandwidth in modern communication and computing systems.
  • In active optical cables, this eliminates the need for separate transceivers and optical connectors, providing a cost-effective and robust solution for short-reach optical connections.
  • The demonstration at OFC2024 will showcase an LRO optical module/AOC solution with significantly reduced latency and best-in-class power consumption for an 800G transceiver.
  • “Leveraging our existing partnership with MaxLinear to build LRO optical modules and AOCs allows us to, once again, provide best-in-class solutions for our customers.”
    Optomind (booth 5822) and MaxLinear (booth 4501) will both be exhibiting at the Optical Fiber Communication (OFC) Conference in San Diego from March 26-28, 2024.

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

Retrieved on: 
Wednesday, March 20, 2024
Research, Mental Health, Medical Devices, FDA, Clinical Trials, Cardiology, Biotechnology, Pharmaceutical, Health, Science, Principal, OSA, LivaNova, Obstructive sleep apnea, Somnolence, PLC, Patient, AHI, University, Trial of the century, LIVN, University of California, Randomized controlled trial, Safety, Probability, Food, Medical imaging

LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced its OSPREY clinical study, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation , has achieved a positive predictive outcome and will conclude enrollment earlier than anticipated.

Key Points: 
  • LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced its OSPREY clinical study, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation , has achieved a positive predictive outcome and will conclude enrollment earlier than anticipated.
  • This means there is a greater than 97.5% probability that the OSPREY trial will successfully meet its primary endpoint.
  • LivaNova notified the U.S. Food and Drug Administration (FDA) and its partner trial sites of this significant milestone for the OSPREY study.
  • “We are pleased to have achieved this positive milestone for the OSPREY study,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova.