digital therapeutics

Nerve cells affected by Alzheimer's disease

(Photo by Sebastian Kaulitzki/Getty Images)

By  Dave Muoio 03:04 pm April 1, 2021
Those keeping an eye on the digital therapeutics industry over the last several years likely remember the name Dthera Sciences. The startup and its CEO Ed Cox became one of the developing space's many standard bearers around 2018. During that timeframe it landed a Breakthrough Device designation from the FDA for its Alzheimer's symptoms treatment, with Cox chairing a handful of industry...
A child using a pre-commercial version of Akili's product.

(Image courtesy of Akili Interactive)

By  Dave Muoio 03:07 pm March 29, 2021
Akili Interactive has published the full data from its STARS-ADHD Adjunctive trial. The data builds upon the company's pivotal study of AKL-T01 (now available as EndeavorRx) and suggests the videogame-like digital therapeutic delivers benefits with or without accompanying stimulant medication, and that they persist up to one month following the treatment. "These results increase the...
Happify Health's health and wellness app

Image courtesy of Happify Health

By  Dave Muoio 11:40 am March 17, 2021
Happify Health, a platform for mental health and disease management programs, has brought in $73 million in funding as part of a new Series D and other "related financing." Deerfield Management Company headed the investments, which also included funds from Omega Capital Partners, ION Crossover Partners and other prior backers. WHAT IT DOES Founded in 2012, Happify is best known for digital...
A nerve cell affected by Alzheimer's disease
By  Dave Muoio 02:25 pm March 10, 2021
Yesterday Cognito Therapeutics, a startup using visual and auditory stimulation to treat neurodegenerative disorders, announced Phase 2 trial results suggesting its gamma frequency neuromodulation therapy slowed declines in memory and cognition among mild-to-moderate Alzheimer's disease patients. The OVERTURE study, a multi-center, randomized controlled trial, enrolled 76 such patients aged 50...
By  Dave Muoio 01:12 pm March 1, 2021
Prescription digital therapeutics company Pear Therapeutics announced this morning that it has added $20 million more to an $80 million Series D funding round announced back in December. The company did not name any participants of this second closing, but highlighted "a leading national Integrated Delivery Network" as the source of the $20 million and the digital therapeutics company's newest...
By  Dave Muoio 02:06 pm February 25, 2021
The digital health ecosystem has swelled to encompass a broad range of products over the years. On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time...
Panelists from DTx West share how they successfully executed a digital therapeutic and payer relationship.
By  Mallory Hackett 12:20 pm February 25, 2021
After a year of incredible innovation across the digital health market, the task remains of how to make these products available to consumers at scale. Oftentimes, this means partnering with a payer that can offer coverage and reimbursement for the digital solution. While making those partnerships stick is easier said than done, it is possible to get stakeholders from different spaces in...
By  Dave Muoio 09:00 am February 24, 2021
Otsuka Pharmaceutical and Click Therapeutics have announced the launch of a new, fully remote clinical trial being conducted on Verily's Project Baseline platform. Called the Mirai study, it will be measuring a digital therapeutics intervention's effectiveness in reducing symptoms of depression among adults who have a major depressive disorder (MDD) diagnosis and are on antidepressant monotherapy...
By  Dave Muoio 03:50 pm February 12, 2021
Digital therapeutics have been plodding on a steady path toward acceptance within healthcare, but the modality reached new heights during a year of unprecedented adoption for digital health technologies. More and more software-based treatments are picking up regulatory approvals – including three De Novo clearances in 2020 alone – while the ongoing COVID-19 pandemic has exposed more consumers,...
The current version of PEAR-004, the company's digital therapeutic for schizophrenia
By  Jonah Comstock 01:59 pm January 13, 2021
Novartis has published results from a clinical trial of Pear Therapeutics' new digital therapeutic for schizophrenia, and the results don't paint a rosy picture. The single-blinded 112-person trial found no difference between the Pear app and a placebo app in any outcome measure, including the primary outcome measure of reducing schizophrenia symptoms. However, the trial did further establish the...