Breakthrough Device Designation Granted for Digital and Adaptive Reminiscence Therapy
The Food and Drug Administration (FDA) has designated a digital therapy for persons with Alzheimer’s Disease (AD) as a breakthrough device. This designation, a provision of the 21st Century Cures Act, expedites regulatory review to give patients more timely access to diagnostic and therapeutic technologies.
Developed by Dthera Sciences in San Diego, the DTHR-ALZ is a custom-built computer tablet that delivers adaptive reminiscence therapy to patients with AD and is intended to be a prescription digital therapeutic. Reminiscence therapy has been shown to mitigate the symptoms of agitation and depression in clinical trials. If proven effective, DTHR-ALZ would deliver this therapy in less labor-intensive and more scalable manner, making it more widely available to persons with AD and hopefully reducing caregiver burden by reducing the agitation patients with AD experience.
The custom tablet of DTHR-ALZ uses artificial intelligence, facial recognition, and biofeedback to deliver reminiscence therapy in an adaptive manner that is unique. With a specially placed forward-facing camera, DTHR-ALZ objectively measures 27 facial points including eye movements to assess a patient’s facial expression. When agitation is detected, the device delivers the visual input of reminiscence therapy, and can rotate through visual scenes and audio narration as facial expression changes.
Edward Cox, Chief Executive Officer of Dthera Sciences said, “Our hope is that DTHR-ALZ will create a breakthrough medical effect—decreased agitation—by delivering people the stories of their lives through artificial intelligence making decisions in real time about what to show people on the device.”
Martin Culjat, PhD, Vice President of Scientific and Regulatory Affairs at Dthera Sciences said, "This Breakthrough designation has provided us with a remarkable opportunity to expedite the development of our digital therapeutic device. We feel deeply honored that the FDA has confirmed DTHR-ALZ meets the requirements for this designation, and we are eager to work together with the FDA throughout this process."