Apnimed Announces First Patient Dosed in SynAIRgy, the Second Phase 3 Clinical Study of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea

– SynAIRgy Compares AD109 to Placebo Over 6 Months in People with OSA who Are Intolerant of or Refuse Positive Airway Pressure (PAP) Therapy, the Current Standard of Care

– Part of a two-study registrational Phase 3 program that also includes LunAIRo which began enrollment in September 2023

CAMBRIDGE, Mass., December 21, 2023 – Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced the first patient dosed in its SynAIRgy Phase 3 study designed to examine the efficacy and safety of AD109 (aroxybutynin/atomoxetine) compared to placebo at six-months. AD109 has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.

Currently, fewer than half of the people using PAP therapy are compliant long-term, leaving many people at risk from the consequences of untreated OSA, including a higher risk for stroke and heart attack.

“Together, LunAIRo and SynAIRgy represent the largest ever prospective evaluations of a novel pharmacologic for OSA,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “These trials are a major step in developing a potential treatment that meets the needs of patients who have limited or no other options. It’s vital to discover and test alternative treatments for people with OSA to potentially help improve their quality of life both at night and during the day. Based on the results, AD109 has the potential to be a major advance in how we treat OSA. Topline results from the Phase 3 program of AD109 are expected in the first half of 2025.”... Apnimed's Press Release -

Vivos Therapeutics Receives First Ever FDA 510(k) Clearance for Oral Device Treatment of Severe Obstructive Sleep Apnea

With this unprecedented FDA clearance, Vivos redefines what it means to have a truly non-invasive treatment for all levels of OSA severity, opening new revenue opportunities for Vivos

 LITTLETON, Colo., Nov. 29, 2023 — Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance.

As a result of this FDA clearance, Vivos becomes the first company ever to have approved and bring to market a clear alternative treatment to CPAP or surgical neurostimulation implants for patients with severe OSA. This latest clearance comes just eleven months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA, and represents the first time the FDA has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

Nationally renowned medical sleep specialist, author and lecturer, Dr. David McCarty, MD, elaborated on the impact of this landmark decision, stating “Make no mistake: this is a huge development on the landscape of treatments for OSA. As the medical profession has gained a better understanding of the complex factors contributing to OSA, we now recognize that a critical component to this condition is the form and functionality of the oral vault. This is where medical collaboration with an airway-centered dentistry approach like Vivos offers is a game-changer. This decision by the FDA could be life changing for patients who suffer from severe OSA and for whom other treatments have failed.”

Kirk Huntsman, Chairman and CEO of Vivos, stated, “This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine. It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention.”... Vivos Therapeutics' Press Release -

Data Published by Cureus Journal of Medical Science Shows Successful Treatment of Obstructive Sleep Apnea with ProSomnus Precision Oral Appliance Devices

Additional clinical research indicates patients using ProSomnus devices have decreased apnea-hypopnea index events per hour, with strong treatment adherence

PLEASANTON, Calif., Dec. 19, 2023 -- ProSomnus, Inc. (NASDAQ: OSA) (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced the publication of a study by the Cureus Journal of Medical Science, in which the Company’s precision oral appliance therapy (OAT) devices successfully treated patients’ OSA.

“The study underscored what we see daily in our practice at Star Sleep & Wellness. Our team continues to favor the ProSomnus® EVO® Sleep and Snore Device, as it not only garners the fewest number of patient complaints regarding fit and comfort, but also shows to be superior in resolving chief complaints such as partner discontent, fatigue and daytime sleepiness,” said Dr. Kent Smith, D-ABDSM, ASBA, a co-author of the study.

Key findings from the study, titled “Evaluating the Clinical Performance of a Novel, Precision Oral Appliance Therapy Medical Device Made Wholly from a Medical Grade Class VI Material for the Treatment of Obstructive Sleep Apnea,” include:

89% of all patients and 98.5% of mild to moderate OSA patients were treated to an apnea-hypopnea index (AHI) of fewer than 10 events per hour.

80% of severe OSA patients were treated to an AHI of fewer than 20 events per hour with a 50% improvement.

After a minimum one-year follow-up period, 96% of patients continued using their precision OAT devices.

“Oral appliance success is traditionally evaluated with the AHI metrics. My experience with the ProSomnus® EVO® precision oral appliance is that it exceeds the American Academy of Sleep Medicine (AASM) and the American Academy of Dental Sleep Medicine (AADSM) standards for efficacy. This study shows that residual AHI using an EVO device is superior to other oral appliances, and superior to hypoglossal nerve stimulation in reducing the AHI. Clinically speaking, I have delivered over 300 EVO devices. I find EVO to have great patient compliance, minimal delivery adjustments, and overall better patient comfort than other traditional oral appliances for sleep apnea,” said John A. Carollo, DMD, D-ABDSM, D-ASBA, a co-author of the study.

“My experience with ProSomnus began in 2019 and since that time, I have come to appreciate the benefit to my patients in delivering precision oral appliances such as these. The study irrefutably demonstrates this,” said Dr. Aditi Desai, BDS, MSc, FCGDent, a co-author of the study. “The ethos of the company has certainly helped drive the field of oral appliance therapy as a most credible alternative to CPAP.”... ProSomnus' Press Release -