Dthera Sciences, a San Diego-based developer of clinical and consumer digital therapeutics for individuals with neurodegenerative conditions, announced today that its development stage intervention, DTHR-ALZ, has been granted Breakthrough Device designation by the FDA.

As laid out in the 21st Century Cures Act, the Breakthrough Devices Program looks to streamline new medical technologies that offer improved treatment or diagnosis for serious diseases with unmet needs. While the Breakthrough Device designation itself is not a clearance, FDA works with the device’s sponsors to reduce the time and and money spent during validation and regulatory approval.

Dthera’s DTHR-ALZ now follows Pear Therapeutic’s reSET as one of the first digital therapeutic products to receive this designation from the regulatory agency.

“Obviously I’m biased, but I think this is great move by the FDA because it shows that they care for these patients and their families,” Edward Cox, CEO of Dthera Sciences, told MobiHealthNews. “To our knowledge, we’re the only non-pharmalogical, non-pharmaceutical product to ever be given this designation for the Alzheimer’s indication. That means that they’re looking to make a difference with this public health crisis, as Alzheimer’s is the only top-ten, leading cause of death that has no cures and can’t be treated.”

DTHR-ALZ is a digital intervention “intended to mitigate the symptoms of agitation and depression associated with major neurocognitive disorder of the Alzheimer’s type,” according to the current proposed indication for use.

The therapy is delivered through a custom-built tablet with a front-facing camera. Content such as photos of loved ones or memories are uploaded by a patient’s family, and are displayed on the tablet. As the patient views and reacts to their memories, an artificial intelligence incorporating biofeedback collected through the camera automatically adjusts the content on screen to guide the viewers' emotions, thereby reducing or preventing agitation.

“The underlying science behind DTHR-ALZ is something called Reminiscence Therapy, and Reminiscence Therapy has been around for many years and is very well accepted … in fact, the Alzheimer’s Association writes that it’s one of the leading ways to combat the symptoms of Alzheimer’s,” Cox said. “It’s very effective, and trial after trial has shown it to be something that makes a difference. The problem is that it’s very labor intensive. It’s not repeatable, and it’s not scalable. So we at Dthera, our goal is to bring reminiscence therapy to Alzheimer’s patients and their families using digital technology, and deliver it at scale.”

Cox said that DTHR-ALZ’s underlying technology has been in development for roughly four years and shares some many similarities with ReminX, the company’s consumer product that provides seniors with images of their past to mitigate anxiety and loneliness. By pairing insights from that product’s development with published studies of reminiscent therapy, a proof-of-concept trial with the University of California San Diego, and their own anecdotal observations and feedback from patients using the system, Cox said that Dthera was confident enough in the digital therapeutic to take it to the FDA.

“For us, we have every reason to believe that this will be successful,” he said. “What we want to do is work closely with the FDA to guide a product that can consistently, repeatedly, and importantly, proven in a clinical trial, bring these patients back from the edge.”

Cox — who earlier this year served as co-chair of February’s Digital Therapeutics and Digital Medicine Summit in San Jose — also saw the designation as a step forward for the digital therapeutics sector as a whole, both in terms of validation and reach.

“We’re opening up digital therapeutics to a brand new age bracket. There’s a very large number of people who need digital therapeutics [but] don’t have access to them,” he said. “I think we’re [helping] a lot of encouraging digital therapeutics to follow along behind us and bring new innovative therapies to the public. I’m very excited and hopefully it helps the entire digital therapeutics sector, because I really believe in what these companies are doing.”