FREQUENTLY ASKED QUESTIONS FOR PROFESSIONALS

Based on its review of all data submitted by the company, 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 not intended to be used alone and should not be used by patients who have acted out their nightmares (i.e., sleep walking, violence).

The prescription digital therapeutic platform uses patented artificial intelligence (AI) algorithms to improve the quality of sleep by disrupting nightmares in real time. NightWare develops a customized treatment plan for each patient using high-fidelity data monitored and analyzed continuously. It applies AI to calculate a patient’s unique “stress index,” enabling the system to interrupt nightmares as they happen without waking the patient, reducing sleep disturbance.

NightWare demonstrated efficacy over placebo during clinical trials. It exhibited a 3.2-point improvement on the Pittsburgh Sleep Quality Improvement Scale in an ongoing randomized controlled trial. This exceeds the minimal clinically important difference. The PSQI-A improvement was more than double that of the sham device. PSQI-A measures important differences in sleep quality directly related to PTSD. These data are interim and were not statistically significant. Clinical trials are ongoing. These data points and more are contained in our Prescriber Instructions for Use, which is available for review and download on this Resources web page.

We would be happy to review all of our available data with any clinician who would like to know more about our prescription digital therapeutic system. This can be done through a video call with our Chief Medical Officer or clinical staff.

In 2020, the FDA designated NightWare a Breakthrough Device. It's the agency's way to acknowledge new treatments are needed for a condition that is life threatening or irreversibly debilitating where there is an unmet medical need and preliminary clinical evidence demonstrating the treatment may result in substantial improvement on a clinically significant endpoint. It also allows the FDA to expedite the development and review of these devices. NightWare is currently continuing the pivotal trial at our second site, the Tampa VA facility.

We launched NightWare with the Veterans Administration (VA) and the Department of Defense (DoD) because they have a high concentration of patients in need and an ability to provide access to those patients rapidly. Our success in the VA and DoD will ensure that our expansion into private health systems and insurers goes as smoothly as possible.

We recognize that many people need and deserve access to the NightWare therapeutic platform. We are committed to providing full access to NightWare through as many providers and insurance plans as possible.

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. Please 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.

IMPORTANT SAFETY INFORMATION

Please review NightWare’s ISI.

Resources/ISI

PROVIDER INSTRUCTIONS

Read NightWare’s Instructions for Use, written specifically for health care professionals.

PROVIDER IFU

REQUEST A MEETING

We would appreciate the opportunity to speak with you in greater detail about NightWare and how it might fit into your treatment algorithm. Please visit our Contact page, provide us with your information, and we will respond within three business days to schedule a meeting.

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