Tag: Obstructive Sleep Apnea

MINNEAPOLIS – Gem Specialty Health, whose first offering, GEM SLEEP, provides an end-to-end solution for obstructive sleep apnea, has raised $5 million. The seed financing round, led by HealthTrend Capital, with participation from existing investor Base10 Partners and new investor Mairs & Power Venture Capital, will allow the company to expand payment options by offering insurance coverage through more local and national health plans, making convenient care affordable to millions. “We...

PLEASANTON, Calif. – Precision oral appliance therapy was effective among 90% of moderate and 85% of severe OSA patients during a recent study, says ProSomus, maker of the ProSomnus EVO. The company’s First Line Obstructive Sleep Apnea Treatment (FLOSAT) study looked at 136 patients to compare the effectiveness of precision OAT vs. CPAP therapy. Key findings to date include: Precision oral appliance therapy is effective, and non-inferior to CPAP, as a first-line treatment for moderate...

MINNEAPOLIS – Inspire Medical Systems has added Charisse Y. Sparks, MD, as its chief medical officer. She will be a member of the company’s executive leadership team and will lead its medical and clinical affairs functions, reporting to Tim Herbert, president and CEO. “We are excited to add Dr. Sparks, a board-certified physician with extensive business and leadership experience, to our executive team,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical...

YARMOUTH, Maine - Adults with obstructive sleep apnea were more likely to experience long-term symptoms suggestive of long COVID (75%) than those without the sleep disorder, according to a study supported by the National Institutes of Health (NIH). The findings, part of the NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, were published in the journal SLEEP. The EHR data of more than 2.2 million Americans with COVID-19 was studied and suggests close monitoring after a COVID-19...

MINNEAPOLIS – Inspire Medical Systems has received approval from the U.S. Food and Drug Administration to offer its obstructive sleep apnea therapy to pediatric patients with Down syndrome. The approval includes patients with Down syndrome who are at least 13 years old, with an apnea hypopnea index between 10 and 50, and who do not have the ability to benefit from CPAP. “Since our first FDA approval in 2014, the research team at Mass Eye and Ear, led by Dr. Christopher Hartnick,...

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...