CLEARWATER, FL, March 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire - REMSleep Holdings, Inc. (OTC PINK: RMSL) gives an update on FDA process and REMSleep status. We have had numerous inquiries asking for REMSleep regulatory status update. REMSleep was asked to answer questions and perform added shelf-life testing. We have initiated the shelf-life testing and are waiting on results. We hope to get test results in the next six weeks. Then we have to resubmit the results. We believe we submitted the perfect 510(K) application and were stunned the agency requests more information. We were fortunate to find the top expert for 510(K) submissions and he is now on-board with REMSleep going forward, which will make a huge difference in guiding us to the finish line.
We are hardly unaware of the frustration. However, REMSleep is in chains until we receive our 510(K). Once we receive our 510(K) everything changes overnight. REMSleep consultants are confident we will receive our 510(K) and we will never give up until we are successful. Once we receive our 510(K) we will begin to realize our specific aims.
Specific Aims
Obstructive sleep apnea (OSA) affects approximately 39 million people annually in the United States. It can be caused by a range of factors including BMI, anatomical factors, familial history, smoking and the use of alcohol or sedatives. Its incidence increases with age, and it is almost twice as likely to affect men than women. OSA is strongly associated with poor cardiovascular health, metabolic diseases such as Type 2 diabetes and obesity and cognitive decline including an increased risk of dementia. OSA is most commonly treated with continuous positive airway pressure (CPAP), and the National Council on Aging estimates that 33 million adults in the US use a CPAP machine.
There is a bi-directional relationship between OSA and congestive heart failure (CHF) in which each exacerbates the other. OSA worsens CHF symptoms by causing low oxygen levels, increased blood pressure and cardiac arrhythmia. Conversely CHF can cause accumulation of fluid in the lungs and can alter rates and patterns of respiration. As its name implies, CPAP delivers continuous airway pressure which enhances inhalation but makes exhalation more difficult. This difficulty is a significant cause of discontinuation and non-compliance with current usage recommendations of 4 hours per night and 4 nights per week. An alternative is Bilevel Positive Airway Pressure (BiPAP) which delivers higher pressure during inhalation and reduced pressure during exhalation, which makes exhaling easier thereby improving comfort and compliance. BiPAPs have been shown to be more effective for severe OSA and OSA that is complicated by CHF, however their cost and complexity limit widespread use relative to the CPAP. REMSleep has addressed this problem by developing a novel CPAP nasal pillow interface that has been engineered to reduce pressure and enable better airflow. Adaption of this interface to conventional CPAP machines delivers the performance features of a BiPAP which will directly affect individuals with severe OSA or OSA that is complicated by CHF. REMSleep has completed development of 1st and 2nd generation nasal pillow interfaces and is advancing completion of a third generation that contains design improvements that improve airflow and comfort. The objective is the ability of this interface to improve comfort, physiologic parameters associated with sleep, sleep quality and compliance to 8 hours per night and 7 nights per week. This objective will be met through three specific tasks:
Task 1.Engineering and design improvements: Our goal is to improve delivery of air through the nostrils in a manner that is comfortable enough to be worn 8 hours per day, 7 days per week and does not compress the nostril in any way.
Task 2.Biocompatibility testing in accordance with International Organization for Standardization (ISO) standard 10993 1:2018.
Task 3.This new design will have measurable physiologic parameters of sleep quality, comfort, and compliance to 8 hours per day and 7 days per week.
Successful completion of these tasks will result in the production of a nasal pillow interface that will improve the utility of CPAP machines for the general population by increasing comfort, relieving pressure during exhalation. For people with severe OSA or OSA complicated by CHF, these improvements may improve the performance of the CPAP to approach the benefits of the more complex and costly BiPAP. These improvements will have overall positive effects on sleep quality which impacts cardiovascular, metabolic, and cognitive health.
About REMSleep Holdings, Inc.
REMSleep Holdings, Inc. is a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive sleep apnea patients. Our focus is primarily designing and manufacturing devices and products for the treatment of sleep apnea and other respiratory conditions. With over 30 years of collective experience in CPAP therapy, the REMSleep team has extensive knowledge and understanding of CPAP and the challenges of patient compliance. We diligently strive for our products to make a difference and improve the condition of those suffering from sleep apnea.
REMSleep Holdings, Inc. has a new patent pending, innovative sleep apnea product that will meet multiple market demands and be able to reach and address a large percentage of the patient population who continue to struggle with CPAP compliance.
Forward-looking Statements.
This press release may contain forward-looking statements regarding the Company. All statements, other than statements of historical fact included herein, are "forward-looking statements" including statements regarding the Company's future prospects and risks in investing in Company's common stock. These statements are based upon the Company's current expectations and speak only as of the date hereof. Financial performance in one period does not necessarily mean continued or better performance in the future. The Company's actual results in any endeavor may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, which factors or uncertainties may be beyond our ability to foresee or control. Other risk factors include the status of the Company's common stock as a "penny stock" and those risk factors stated in reports filed with the U.S. Securities and Exchange Commission or "SEC" on its EDGAR website (URL: www.sec.gov)
Contact:
REMSleep Holdings, Inc.
14175 ICOT Blvd
Suite 300
Clearwater, FL 33760
Email: twood@remsleep.com
Phone: 912-590-2001
Fax: 813-639-7501
