The digital therapeutics developer plans to make its biofeedback software development kit (SDK) available to video game developers and media companies to embed or use adjacently with their products, DeepWell co-founder and Chair Ryan Douglas said in an interview ahead of the company’s official announcement.
DeepWell used the core technology for the Zengence mental health action shooter game it launched earlier this year.
“We cleared the software development kit. We did not clear the game,” Douglas said. “We cleared something that you can use to either put into a piece of media or adjacent to that media. The latitude that we were given [covers] any piece of media that doesn’t change the safety or efficacy of the core biofeedback mechanism — very broad — through any mobile platform … and through any commercial means.”
DeepWell has already been collaborating with media and medical device companies and plans to announce some of those partnerships soon.
“There are 350,000 digital wellness apps in the world, 90,000 of them were produced during the health emergency order, 20,000 of them still call themselves digital therapeutics,” he said. “But to be a digital therapeutic, by definition, you must be FDA-cleared. Twenty of those have been cleared. Only five are for mental health, and only one is a software development kit that allows you to make more.”
Video games and other media using DeepWell’s SDK will be available to patients over-the-counter on any mobile device platform, the company said.
The company is working on what it called “new engagement mechanics and therapeutics concepts,” with its founders saying their technology has the potential for future indications for treating pain, PTSD, sleep disorders, immune disorders, and diseases like epilepsy, Parkinson’s and Alzheimer’s.
“This is a significant neurological advancement with the potential to take medicine to the next level,” DeepWell co-founder and pediatric neurosurgeon Dr. Samuel Browd said in a statement. “Makers of interactive media — used by 5 billion people — can now leverage DeepWell’s technology toward creating new therapeutic solutions.”
Douglas (who is also chair and co-CEO of DeepWell parent company NeuFluent and founder and former CEO of Nextern) said this is the 28th medical device he’s helped bring to market. But it’s the first time he’s won FDA clearance on a product “that can expand and continue to grow in a way that a market needs to expand and grow,” he said. “And that becomes significant because the reimbursement codes are coming in now.”
Reimbursement would be available under Digital Mental Health Treatment (DMHT) device codes proposed by the Centers for Medicaid and Medicare Services (CMS) starting in 2025, the result of efforts by the Digital Therapeutics Alliance (DTA) and members of Congress.
The DeepWell clearance and reimbursement pathways “will bring mental and physical health support to millions of struggling American families,” DTA CEO Andy Molnar — who is also a member of the FDA Digital Health Advisory Committee — said in a statement.
Read more at Medical Design & Outsourcing: DeepWell DTx thinks it’s cleared the blockages holding back digital therapeutics
