Oftentimes individuals suffering from post-traumatic stress disorder experience severe nightmares where they relive horrible experiences from their past over and over again.

These kinds of nightmare disorders have been linked to increased rates of suicide, as well as physical and mental health risks for conditions like heart disease, diabetes, anxiety and depression.

Minneapolis, Minnesota-based NightWare is trying to help this patient population get better sleep and manage their nightmares through their digital therapeutic, which uses vibration to jog a person out of a nightmare without waking them.

The startup’s Apple Watch application has received “breakthrough therapy” status from the Food and Drug Administration, expediting its clinical validation and review process with the aim of getting the product to market faster.

NightWare‘s product learns the biometric pattern of a person’s sleep and uses the wearable to intervene when a nightmare is detected, eventually adapting to a person’s individual rhythms and sensitivities.

“The PTSD population is a high visibility and high risk population and care providers and payers have prioritized PTSD as an area of focus since there’s not a lot of available solutions,” said NightWare CEO Grady Hannah.

NightWare was co-founded by Hannah and Tyler Skluzacek in 2017 and was initially developed as a way to help Skluzacek’s Iraq War veteran father with his PTSD symptoms.

The company is currently in the midst of enrollment for two RCTs to prove out the application’s safety and efficacy. One study is being conducted at VA hospitals in Minneapolis and St. Cloud, Minnesota, the other is a 400-person virtual study, intended to have a wider scope of research participants.

Because of the high prevalence of PTSD among veterans, Hannah said the company’s initial focus for commercialization is the VA. One potential go-to market strategy with VA medical centers being explored by NightWare is to offer its product through the prosthetics sales channel, which distributes products which aren’t pharmaceuticals or implantable devices.

Hannah added that the company is also working with health economists to develop evidence of healthcare cost savings to get NightWare covered by commercial and government payer organizations.

The healthcare costs for someone with PTSD or nightmare disorder is up five times more than an average pateint. Our idea is if people are getting better sleep, they’ll have better overall wellbeing and health,” Hannah said.

Daniel Karlin, the company’s chief medical officer said that while pharmaceutical therapies for traumatic nightmares exist, their scope and potential patient pool is limited. He pointed to the FDA designation as helping to endorse NightWare’s idea of traumatic nightmares as a cause of mortality that needs to be addressed.

“When you work on a product, you often spend a lot of time thinking about the potential impact,” Karlin said. “It’s really validating for us to get this decision from an independent body that reiterates to us the urgency of our work.”

Hannah said the company has raised around $750,000 in equity funding so far and is the midst of raising another $2 million this year to support its clinical and regulatory activities, of which $700,000 is committed.

Last year, the company won a $100,000 grant from the Minnesota Department of Veterans Affairs Support our Troops program to help defray the cost of its VA clinical trial.

Still, while PTSD is generally associated with the military, veterans make up only around 20 percent of diagnoses for the condition. Hannah said he wants the product to eventually be made available to others suffering from PTSD including first responders and victims of sexual trauma.

Ultimately, Karlin said the company’s current focus is ensuring that their product is supported by solid evidence that it can help improve the lives of patients.

We’re looking to provide new treatments to market backed by really good research in order to build comfort that we’re doing something that’s safe and effective because that’s the only way to ethically drive physician behavior,” Karlin said.

Picture: yanyong, Getty Images

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