Pear
The new tool will be released for limited distribution and will provide multimodal neurobehavioral interventions.
Somryst, a prescription digital therapeutic combining cognitive behavioral therapy and personalized sleep restriction, is the first software product to put the FDA's early Precertification Program framework through its paces.
The industry is better off viewing the the floundering deals between Onduo and Sanofi, Proteus and Otsuka, and Pear and Sandoz as a learning opportunity.
The pharma's Sandoz division will be handing commercialization of reSET, reSET-O and future therapies back to Pear over the course of a transition period.
Digital therapeutic stakeholders came together at this week's DTx East conference to discuss the state of digital health investment, developing successful business models, the need for robust data and more.
CEO and President Dr. Corey McCann said that Somryst, a digital treatment for chronic insomnia and depression, is the first software as a medical device product to be submitted through the regulator's pilot pathway.
Pharma companies also continued to explore the promises of digital therapeutics.
Development of the Pear-006 digital therapeutic is a joint collaboration with Novartis.
The latest funding was led by Temasek, with participation from Novartis, 5AM Ventures, Arboretum Ventures, Jazz Partners, The Bridge Builders Collaborative and EDBI.
As the first prescription digital therapeutic approved by the FDA, the treatment will be distributed and supported by a specialist-staffed service center.