RemSleep Holdings Inc.'s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

TAMPA, Fla., Jan. 22, 2024 -- RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) has received a response to the company’s 510(K) submission K233415. The agency has determined that additional information is required. The agency has asked for additional information regarding Administrative Information, Device Description, Substantial Equivalence (SE), Labeling, Biocompatibility, and Performance testing. All these questions can be answered, and we are in the process of responding with the answers.

The agency has also requested additional Shelf-Life testing for DeltaWave packaging. We are in the process of initiating accelerated Shelf-Life testing for the DeltaWave packaging. This request was a surprise to us, but we will promptly comply.

Remsleep CEO, Tom Wood, commented: “Investors want a 510(K) almost as much as Remsleep. We understand the frustration. Investors can be assured we will answer the questions from the agency, perform the additional tests required, and we will make every effort to gain approval for 510(K) submission (K233415) as soon as possible”.

Judy Strzepek comments: “Remsleep submitted our 510(K) on 10/10/2023. Remsleep received feedback from FDA with a request for additional information. This is not unusual. The type of information requested varies based on the type of product. CPAP device and the mask with accessories needed for sleep apnea therapy is a class II device that requires extensive data and information. So, the agency’s request for clarification of any part of the submission is not unexpected. We are working diligently to address any of FDA’s questions. We will do this as quickly as possible, while ensuring our response is thorough and complete.”... RemSleep's Press Release - 

Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

WASHINGTON, Feb. 5, 2024 -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review. In a letter to Vanda dated July 17, 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.

Vanda has extensively studied the efficacy of HETLIOZ® in the treatment of insomnia characterized by difficulties with sleep initiation. A Phase III, multi-center, placebo-controlled, 4-week trial evaluated patients with chronic primary insomnia. Two transient insomnia studies induced by phase advance of the sleep-wake cycle were also conducted with five-hour and eight-hour phase advance, which showed a significant effect the first night in improving sleep parameters... Vanda Pharmaceuticals' Press Release [PDF] - 

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 - 

StimAire Completes First-In-Human Study of Injectable Stimulator for Obstructive Sleep Apnea (OSA)

UAVenture Capital Portfolio Company StimAire Completes First-In-Human Study of Injectable Stimulator for Obstructive Sleep Apnea (OSA)

TUCSON, Ariz., Oct. 11, 2023 -- Paradigm-shifting neuromodulation company, StimAire, has completed its first clinical trial in Australia. The first-in-human study tested a tiny injectable stimulator to treat obstructive sleep apnea (OSA). This study assessed the safety of the injection procedure, the operation of the patented device, and the feasibility of the approach. In addition, the first overnight sleep studies were conducted of an OSA patient with and without the StimAire device modulating the hypoglossal nerve throughout the night.

There were no adverse events during the study. Furthermore, no significant pain or discomfort was experienced from the injection procedures.

Efficacy results from the sleep studies of the OSA patient, as measured by obstructive events, were as expected. Furthermore, this patient slept 2.5 times longer with our device than without it and enjoyed 30 minutes of REM sleep vs. none without it.

Robert Dean PhD MD/ENT, StimAire Chief Clinical Officer, said, "After developing this injection procedure for StimAire at the University of Arizona College of Medicine, I was delighted to see these results. This technology has the potential to move treatments like this from the operating room to the doctor's office, lowering the cost of care and enabling immediate recovery." 

StimAire's device modulates peripheral nerves, like the hypoglossal, using a tiny, battery-free, injectable receiver/stimulator activated by a small wearable. StimAire's system can be built with readily available components, expediting the path to production. The tiny injectable is placed in close proximity to the nerve through a 17-gauge needle under ultrasound guidance... UAVenture Capital's Press Release -

Signifier Medical Technologies Announces Upcoming Publication of Randomized Controlled Trial Results Examining High-Intensity (Active) Vs. Low-Intensity (Sham) Neuromuscular Electrical Stimulation in Patients for 6 Weeks

Signifier Medical Technologies LLC, a Boston-based medical technology company, is pleased to announce that the publication of AEGIS clinical trial results is in press at the ERJ Open Research. The objective of the trial was to determine whether patients with mild obstructive sleep apnea (OSA) would adhere to eXciteOSA, a daytime neuromuscular electrical stimulation (NMES) therapy. Results showed high adherence, with approximately 90% of participants in each arm adherent to NMES. This trial demonstrates the potential of Signifier Medical’s innovative medical technology to significantly improve the lives of individuals suffering from obstructive sleep apnea (OSA).

“The encouraging results from our first randomized controlled trial further validate the data from our previous studies, and we’re thrilled to see how well patients accept the therapy,” says Co-founder and Director, Akhil Tripathi.

The current standard of care for treating mild OSA, positive airway pressure (PAP), has long been plagued with low adherence and low patient satisfaction. Clinical trials and observational studies indicate 25-46% of patients are not adherent to PAP.1-3 There is also evidence that those with mild OSA are 34% less likely to adhere to PAP than those with moderate/severe OSA.4 Given that adherence to positive airway pressure (PAP) therapy in OSA is suboptimal, alternative strategies are needed, particularly for patients with mild OSA.

The AEGIS clinical trial was a randomized, double-masked, sham-controlled study to assess the adherence and overall impact of Signifier Medical’s innovative medical device, eXciteOSA, in managing and treating obstructive sleep apnea. Using NMES to “exercise” the upper airway muscles, eXciteOSA improves tongue muscle endurance and reduces the occurrence of airway collapse during sleep. The trial involved 40 patients and was conducted in collaboration with a network of renowned medical institutions and healthcare professionals....Signifier Medical Technologies' Press Release -