REMSleep Holdings Stock

REMSleep Holdings, Inc. engages in developing and distributing sleep apnea products.

The company offers DeltaWave CPAP interface (the DeltaWave) as an innovative new device to treat patients with sleep apnea. The patent-pending DeltaWave product is a nasal-pillows type interface. The company’s DeltaWave is designed to effectively address the stubborn issues that continue to affect a patient’s ability to comply with treatment, as follows: does not disrupt normal breathing mechanics; is not claustrophobic; causes zero work of breathing (WOB); minimizes or eliminates drying of the sinuses; uses less driving pressure; and allows users to feel safe and secure while sleeping. In 2016, the company applied for a patent for a new, innovative sleep apnea product that serves as an interface for the delivery of CPAP therapy and other respiratory needs.

Marketing

The company plans to market the DeltaWave product in the U.S., as follows:

Submit manufacture orders to its manufacturer according to market demand.

Negotiate and secure agreements with industry distributor partners.

Secure agreements with Internet retailers for online sales.

Market DeltaWave at respiratory trade shows, social media, press releases.

Market and generate online sales through the company’s website supplemented by search engine optimization.

Disseminate press releases to media outlets and publications that reach sleep medical practices and DME managers/distributors, including trade publications like Sleep Medicine, Sleep Review, Sleep, The Sleep Magazine.

Attend sleep and healthcare, respiratory industry trade shows.

The company expects that most of its revenues will be in the home care dealers and hospital target market.

Target Market

The company’s target market includes sleep product distributors that will distribute its product; home care dealers; private sleep labs; product end users; physicians, particularly sleep physicians; medical groups; hospitals; and medical associations, such as the American Academy of Sleep Medicine and the American Sleep Association.

Government Regulations

The company’s products are subject to extensive regulation particularly as to safety, efficacy and adherence to FDA Quality System Regulation, and related manufacturing standards. Medical device products are subject to rigorous FDA and other governmental agency regulations in the United States and similar regulations of foreign agencies abroad.

The company’s products marketed in the United States are marketed in reliance on 510(k) pre-marketing clearances as either Class I or Class II devices.

Any devices the company manufactures and distributes pursuant to clearance or approval by the FDA are subject to pervasive and continuing regulation by the FDA and certain state agencies. As a medical device manufacturer, the company’s manufacturing facilities are subject to inspection on a routine basis by the FDA. The company is required to adhere to applicable regulations setting forth detailed cGMP requirements, as set forth in the QSR, which require, manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process. The company’s design, manufacturing and quality control procedures are in compliance with the FDA’s regulatory requirements.

The company must also comply with post-market surveillance regulations, including medical device reporting, or MDR, requirements which require that it reviews and reports to the FDA any incident in which its products may have caused or contributed to a death or serious injury. The company must also report any incident in which its product has malfunctioned if that malfunction would likely cause or contribute to a death or serious injury if it were to recur.

Under the Federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Department of Health and Human Services, or HHS, has issued regulations to protect the privacy and security of protected health information used or disclosed by covered entities, including health care providers, such as the company.