Tag: CPAP Alternative
Apnimed backs OSA pill with two new peer-reviewed articles
May 19, 2026HME News Staff
CAMBRIDGE, Mass. – Apnimed has published two peer-reviewed articles on AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg), an investigational, once-daily oral pill taken at bedtime designed to improve oxygenation and target the neuromuscular root cause of obstructive sleep apnea (OSA). The Phase 3 SynAIRgy trial results are published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), alongside a companion mechanistic review article in the American Journal of Respiratory...
ProSomnus: ‘We are enabling smart sleep medicine’
April 14, 2026HME News Staff
SAN FRANCISCO – ProSomnus Sleep Technologies has announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The company says the RPMO2 OSA Device is the first theranostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device. With this new clearance, it says the device is positioned as...
Apnimed secures $150M in debt financing ahead of planned launch of pill to treat OSA
April 7, 2026HME News Staff
CAMBRIDGE, Mass. – Apnimed, a pharmaceutical company developing oral therapies for obstructive sleep apnea (OSA), has entered into a senior secured credit facility for up to $150 million with funds managed by HealthCare Royalty Partners (HCRx). The company plans to use the capital to support commercial readiness activities and the planned U.S. launch of its lead product candidate, AD109, if approved by the U.S. Food and Drug Administration (FDA). "HCR is a highly respected health care...
LivaNova receives FDA premarket approval for CPAP alternative
March 23, 2026HME News Staff
LONDON – LivaNova has announced that the U.S. Food & Drug Administration (FDA) has granted premarket approval (PMA) for the aura6000 System for the treatment of adult patients with moderate to severe obstructive sleep apnea (OSA). The system uses proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with an apnea-hypopnea index (AHI) between 15 and 65 and who have failed, do not tolerate or are ineligible for first-line therapies,...
ProSomnus receives $38M investment to grow in alternative sleep market
February 18, 2026HME News Staff
SAN FRANCISCO – ProSomnus has raised $38 million through a strategic investment from Catalio Capital Management to accelerate the expansion of its sleep health platform, according to a report from MassDevice.com.
ProSomnus develops non-CPAP obstructive sleep apnea (OSA) therapy offerings. With the investment, it plans to advance the development of next-generation remote patient monitoring and proprietary sleep diagnostic devices. It hopes to...
New study backs virtual treatment pathway for CPAP alternative
January 12, 2026HME News Staff
LOS ANGELES – A new Cedars Sinai Physician Associated Study used the processes and care of Daybreak to evaluate a dentist-led, telehealth-guided treatment pathway that includes remote sleep testing, guided at-home capture of dental impressions, ongoing virtual titration, and follow-up. Researchers found the clinical outcomes were comparable to, or better than, traditional in-clinic mandibular advancement device studies, demonstrating effective...
Robert Miller leads Daybreak’s push for CPAP alternatives
January 2, 2026Theresa Flaherty, Managing Editor
YARMOUTH, Maine – There’s a new landscape of available sleep apnea treatments, something that Robert Miller, an RSPGT, has seen evolve over his long career, which has included leading roles at major sleep players, including MedBridge Healthcare and, most recently, Apria Healthcare.
Miller is now senior vice president of commercial strategy for Daybreak, a provider of at-home sleep testing and care,...
Apnimed announces positive results for sleep apnea pill, plans FDA filing
July 28, 2025HME News Staff
CAMBRIDGE, Mass. – Apnimed, a pharmaceutical company developing oral therapies for obstructive sleep apnea (OSA) and related conditions, announced positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin 2.5mg/atomoxetine 75mg). The 12-month LunAIRo study assessed the efficacy and safety of AD109 in adults with mild to severe OSA across various weight classes. The primary endpoint, measured at 26 weeks, was met with a 46.8% mean reduction in AHI compared to 6.8%...
Apnimed shares positive results for sleep apnea pill
May 19, 2025HME News Staff
CAMBRIDGE, Mass. - Apnimed has announced positive topline results from its pivotal Phase 3 SynAIRgy clinical trial evaluating the efficacy and safety of AD109 in adults living with mid, moderate and severe OSA and across all weight classes. The SynAIRgy trial met its primary endpoint: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo (p=0.001). “Today is a landmark moment for Apnimed and for millions living with OSA who have long struggled with limited...
apZme secures more VA business for CPAP alternative
April 29, 2025HME News Staff
HOLLYWOOD, Fla. – Dental sleep medicine company apZme has announced that additional clinics have been credentialed through the U.S. Department of Veterans Affairs, bringing its total number of clinics to nearly 100 across the United States. Each clinic is approved to provide oral appliance therapy to veterans seeking alternatives to CPAP therapy. "It's an honor to serve the ones who served," said Rani Ben-David, chairman and founder of apZme. "This expansion shows our...