To obtain FDA clearance, the company had to run clinical trials and submit to the FDA clinical data demonstrating efficacy and safety, which demonstrated a justification of need by patients and providers. The FDA requires that NightWare consistently delivers the same therapy to all patients. We created a kit with software, hardware, and instructions for the set up and use of the products that has been evaluated and approved by FDA. Upon meeting all FDA requirements, the agency cleared NightWare for use with patients in November 2020.

Breakthrough Device status is the agency’s process to expedite the development and review of devices that may provide new effective treatments of life-threatening or irreversibly debilitating diseases or conditions where there is a need and that preliminary information shows there is likelihood of clinical benefit. By granting NightWare this special designation, the FDA verified that the medical device met the requirements of the Breakthrough Device program.

In November 2020 the FDA cleared NightWare for the reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). It is intended for use by this patient population and is available only by prescription.  It is not intended to be used alone.  It should not be used in patients who have been known to act out their nightmares (i.e., sleep walking, violence).

NightWare is a Class II Medical Device, which means that a prescription is required by a physician to use this device. Class II Medical Devices may involve some risk of use to the patient and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety.

Our company is actively seeking coverage by Medicare. Once Medicare coverage is determined, we will approach private insurance companies for coverage.  NightWare has medical policy coverage with Highmark Health BCBS.  We are actively approaching additional insurers in collaboration with clinicians.  If you are a clinician or patient associated with the VA or DoD, please contact us directly about coverage for NightWare.

The prescription digital therapeutic platform uses patented artificial intelligence (AI) algorithms to analyze your sleep patterns and to improve the quality of sleep by disrupting nightmares in real time.

We are committed to providing full access to NightWare through as many providers and insurance plans as possible. We launched NightWare with the Veterans Administration (VA) and the Department of Defense (DoD) because they have a high concentration of patients in need. They also are able to provide access to those patients rapidly. We are working with VA and DoD leaders to be able to provide our device to all patients who have been prescribed NightWare.

Currently we are accepting names from those providers or patients that are interested in NightWare but are not able to access it through the VA or DoD. The best first step is to speak with your physician, who can determine if NightWare is right for you. You can also reach us on our Contact page and let us know about your interest in NightWare. When we launch into other markets we will give you an update on the system’s availability.

Before the FDA clears any device or drug for marketing to the public, the manufacturer must demonstrate to the agency’s satisfaction that the product is effective and safe. Medical devices must also prove that they are manufactured, stored, and shipped with processes that ensure they will meet the agency’s requirements and the public’s expectations. You will know if it’s working for you if you have fewer nightmares.

New versions of software will be automatically installed on your NightWare Digital Therapeutic System.