REMSleep proceeds to file for Emergency Use Authorization from the FDA for its Deltawave CPAP Interface
REMSleep Holdings, Inc. (OTC PINK: RMSL) is proceeding to file for “Emergency Use Authorization” from the FDA for its Deltawave CPAP Interface. The Company is confident the safety and effectiveness of their improved Deltawave Interface is equal, or better compared to its original LaminAir CPAP Interface, which received 510K approval in 2017.
Since the LaminAir CPAP Interface received 510K approval from the FDA the Company has made significant improvements, which include an increase in the total number of air molecules delivered to the patient at a slower air velocity, increased comfort, improved exhaust ports and it will not disrupt normal breathing mechanics. With these improvements, the Company filed for a US Patent under the new product name of Deltawave receiving US Patent pending number 37/847,783 for the adult sleep apnea market.
The Company is confident its flagship product Deltawave will make a significant impact for treating sleep apnea and other comorbidities such as COPD, heart failure, and respiratory insufficiencies. The Deltawave is specifically designed with unique airflow characteristics to enable patients with sleep apnea to breathe at a normal respiratory rate. Mask interface comfort and work of breathing are overwhelming complaints of patients. RemSleep Holdings, Inc. believes it has virtually eliminated these issues with its unique design, which is a major breakthrough.
The global sleep apnea devices market size was valued at $5.9 billion in 2019 and is projected to expand at a CAGR of 7.4% through 2027. One of the key factors contributing to the market growth is the increasing prevalence of obstructive sleep apnea (OSA) among the global population. In addition, increasing awareness regarding the target condition, early disease diagnosis, increasing patient adherence for positive airway pressure devices, and increasing medical coverage for sleep apnea devices are further anticipated to drive the market growth through 2027. The Company anticipates Deltawave will become the industry standard for sleep apnea therapies.
REMSleep Holdings, Inc. was founded to design and manufacture devices and products for the treatment of sleep apnea and other respiratory conditions. With over 50 years of collective experience in CPAP therapy, the REMSleep team has extensive knowledge and understanding of CPAP and the challenges of patient compliance. REMSleep Holdings, Inc. has a new patent pending, innovative sleep apnea product that will meet multiple market needs and then be able to reach and address a large percentage of the patient population who continue to struggle with CPAP compliance.
Source: Company Press Release