Dthera Sciences’ device intended for Alzheimer’s patients has received a breakthrough designation that will speed regulatory review.
The company’s device, DTHR-ALZ, delivers reminiscence therapy, which includes calling attention to past activities, events and experiences. Its technology uses an AI chatbot and proprietary emotional recognition software.
San Diego-based Dthera stated limited caregiver time and resources has limited the adoption of reminiscence therapy, which the company promises to provide with greater frequency and personalization, with less time involved.
The company said DTHR-ALZ, if approved, would be the first “non-pharmacological prescription treatment” for the symptoms of Alzheimer's disease.
Dthera, at least to the company’s knowledge, is only the second digital therapeutics company to obtain a breakthrough device designation from the U.S. Food and Drug Administration.
The designation goes to products that could be a significant improvement over the status quo for life-threatening diseases.
“We commend the FDA for recognizing this significant unmet medical need as well as the critical importance of providing innovative new treatments to patients with Alzheimer's and their caregivers,” CEO Edward Cox, who recently landed on the San Diego Business Journal’s list of Next Top Business Leaders Under 40, said in a news release.