Tag: Obstructive Sleep Apnea

MINNEAPOLIS – Inspire Medical, the maker of an FDA-approved neurostimulation device to treat obstructive sleep apnea, expects revenue of $137.5 million to $137.9 million for the fourth quarter of 2022, about a 76% increase year over year. It expects revenue for the full year to be $407.5 million to $407.9 million, about a 75% increase compared to 2021. “We are very pleased with our strong preliminary revenue performance in the fourth quarter primarily driven by higher utilization at existing...

LITTLETON, Colo. - Vivos Therapeutics, a medtech company focused on developing innovative treatments for patients suffering from obstructive sleep apnea, has received clearance from the U.S. Food and Drug Administration for its proprietary daytime-nighttime (DNA) appliance. With FDA clearance, the DNA appliance offers a new treatment regimen that opens the airway by expanding the palate and training the tongue to rest in the proper position, converting patients to nasal as opposed to oral breathing. ...

CAMBRIDGE, Mass. – Apnimed has secured $79.75 million in an oversubscribed financing round that extends its Series C financing to a total of $142.25 million. The company will use proceeds to fund the planned Phase 3 trials for its lead candidate, AD 109 (aroxybutynin + atomoxetine), which has the potential to be the first oral treatment for obstructive sleep apnea. “This substantial additional investment is a significant vote of confidence by our investors,” said Larry Miller, M.D.,...

CAMBRIDGE, Mass. – Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies to treat obstructive sleep apnea (OSA) and related disorders, has announced positive topline results from the MARIPOSA Phase 2b trial – an efficacy, safety and dose-finding study of one-month duration. The results were positive for the company’s lead candidate for OSA, AD109 (atomoxetine + aroxybutynin). The primary endpoint showed a statistically significant...

SAN FRANCISCO – ProSomnus Sleep Technologies, a manufacturer of oral appliance therapy devices, has announced definitive agreements with institutional investors led by funds affiliated with or managed by Cohanzick Management and CrossingBridge Advisors. The financing - $30 million of debt comprised of two tranches: $15 million of senior secured convertible notes and $15 million of junior secured convertible notes with maturities of 36 months and 40 months, respectively – will support...

BOSTON – Signifier Medical Technologies, a Boston-based medical technology company, has announced that Waha Capital PJSC, Angelus Sano Fund L.P., Segulah Medical Acceleration AB and certain other individual investors have collectively invested approximately $49 million in the purchase of existing shares in the company from shareholders unrelated to the board and management. Signifier's eXciteOSA medical device for the treatment of sleep disordered breathing has been launched in...

SAN DIEGO – About 52% of Americans reported snoring or being told they snore, but only 33% are concerned about the associated health implications, according to ResMed’s 2022 Global Sleep Surveys.  “Sleep quality can be impacted by lifestyle changes and poor habits, but many people are struggling with undiagnosed conditions that may be the root cause,” said Carlos M. Nunez, M.D., ResMed’s chief medical officer. “Sleep apnea is a serious health concern, but...

DEERFIELD, Fla. – AirAvant Medical and First Nation Group have partnered to provide the FDA-cleared Bongo Rx Expiratory Positive Airway Pressure device to veterans and active-duty military members suffering from obstructive sleep apnea. First Nation Group is a medical-surgical supplier for all federal government agencies. “The opportunity to proudly serve veterans attracted AirAvant Medical to the partnership,” said Bruce Sher, co-president and co-founder. “It’s an honor...

SAN DIEGO – ResMed has bought Ectosense, which makes the NightOwl home sleep test.  The NightOwl, approved by the U.S. Food and Drug Administration, is currently sold in the United States, Australia, New Zealand, India and parts of Europe. ResMed has distributed the NightOwl, under the brand ResMed onesleeptest, in Australia, New Zealand and India since 2020, and has been a minority investor in Ectosense since July 2020.  "Sleep labs and home tests each have critical roles to...

DARIEN, Ill. – The Centers for Disease Control and Prevention has awarded a grant to the American Academy of Sleep Medicine for a new awareness program focused on improving recognition of obstructive sleep apnea.  Nearly 30 million American adults have OSA and 80% are undiagnosed, costing the U.S. more than $149 billion annually in increased health care and mental health care costs, lost work productivity and increased accidents, according to a press release.  “Millions...