FDA Supports De Novo Pathway for Dthera Sciences’ Breakthrough Alzheimer’s Device

SAN DIEGO, CA / ACCESSWIRE / December 13, 2018 / Dthera™ Sciences (OTCQB:DTHR), the leading digital therapeutic company focusing on the elderly, announced today that the U.S. Food and Drug Administration (FDA) has informed Dthera that it believes that a De Novo submission is the most appropriate regulatory pathway for DTHR-ALZ, as Dthera had proposed.

DTHR-ALZ is a medical device that has been granted Breakthrough Device designation by the FDA for the mitigation of the symptoms of agitation and depression associated with Alzheimer's disease. If granted clearance by the FDA, DTHR-ALZ would become the first non-pharmacological prescription treatment for the symptoms of Alzheimer's disease.

According to the FDA, the De Novo pathway is used for the review of novel, low to moderate risk devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no existing predicate to use in determination of substantial equivalence. To the Company's knowledge, there are no other FDA-cleared or approved predicates with a similar clinical indication and embodiment to DTHR-ALZ. DTHR-ALZ is indicated for the symptoms of Alzheimer's disease and its physical embodiment is a customized computer tablet.

About Dthera Sciences

Dthera Sciences (OTCQB: DTHR) is the leading digital therapeutic company focusing on the elderly. The San Diego based, publicly traded company is working to improve the lives of seniors and individuals suffering from neurodegenerative diseases, as well as those who care for them. Dthera is developing DTHR-ALZ, a medical device that has been granted Breakthrough Device designation by the FDA for the mitigation of the symptoms of agitation and depression associated with Alzheimer's disease. To the company's knowledge, DTHR-ALZ is the first product to receive Breakthrough Device designation for the treatment of Alzheimer's disease, and Dthera Sciences is only the second digital therapeutic company to receive this designation. If granted approval by the FDA, DTHR-ALZ would become the first non-pharmacological prescription treatment for the symptoms of Alzheimer's disease. Please see www.dthera.com for more information.

Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of therapeutic products and technologies, as well as the Company's efforts to increase its customer base. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release, and the Company expressly disclaims any intention or obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from the Company.

Contacts:
Geno Kostikov,
Corporate Development
[email protected]
(858) 284-0880

Investor Relations
Marek Ciszewski, J.D.
[email protected]
(949) 574-3860

SOURCE: Dthera™ Sciences