The FDA has awarded the digital therapy of dthera sciences as a breakthrough device for patients with Alzheimer’s disease. Dthra’s device, dthr-alz, provides memory therapy to treat agitation and depression in some patients with Alzheimer’s disease. Upon receipt of the status information, dthera will benefit from FDA input and will give priority to review after approval.
The breakthrough plan was set up in late 2016 as part of the 21st century cure act, although the FDA began to track certain devices quickly through innovative ways, and a few years ago it began to track certain devices quickly through the EAP. Breakthrough programs replace EAP and priority review programs, but retain some of the features pioneered in these programs.
The FDA’s February update shows that the agency is accepting about 50% of applicants. According to Jeff Shuren, head of the FDA equipment center, in December 2017, the first named device was approved by FDA. By July 2018, the agency had included 83 devices in the program.
Dhera believes that only one of these devices is a digital therapeutic instrument, making its dthr-alz the second asset in the emerging field to get the name. The lack of a publicly available list of names made it impossible to verify the statement, but it was based on what the company voluntarily disclosed. Reset-o, a pear drug for the treatment of opioid use disorder, won the title of EAP in October.
The lack of breakthrough digital therapy to some extent reflects the fact that the industry and status have a long history. Dthera believes that dthr-alz is in the short list of devices, and its status also indicates its candidates and the unsatisfied requirements it is trying to solve.
Dthr-alz provides nostalgic therapy to combat agitation and depression in patients with Alzheimer’s disease. Reminiscence therapy is a method of using life history to improve mental health. This method has been used for many years and has achieved some success. Cochrane’s review of clinical trials of the method found that, in some cases, the benefits to quality of life, cognition, communication and emotion were not significant.
Given the lack of effective treatment for Alzheimer’s disease, even small improvements may be valuable. Dhera hopes to bring these benefits to more patients. The company believes that the difficulty in expanding this approach has hampered efforts to adopt recall therapy, which requires therapists to meet patients at least once a week, once or at least once a week, with each group discussion lasting about an hour.
Dhera believes that technology can reduce the time and resources required to provide treatment, while providing more frequent, consistent and personalized support for patients. There are few details on how dthr-alz will deliver on this promise, but Reminx, the existing consumer centric product of dhera, gives instructions.
Reminx consists of a tablet and the accompanying applications. Photos, videos and recordings are uploaded via the mobile app. When the patient picks up the tablet, it will automatically start playing the uploaded content. One study found that 14 patients with mild to moderate dementia reported feeling anxious and depressed immediately after using Reminx.
Dhera’s shares rose 35% after the break. However, dhera is still a small company with a market capitalization of just over $20 million. Even after considering this week’s recovery, the stock fell in 2018.