DeepWell gets FDA clearance for games and interactive media to treat mental health issues

DeepWell Digital Therapeutics said it has received a groundbreaking clearance from the FDA for games and interactive media to treat mental health problems.

Ryan Douglas, chairman of Deepwell DTx, said in an interview with GamesBeat that the company was founded to use games to help address mental health challenges that were brought to light during the pandemic, such as isolation and loneliness, depression, stress and more.

Deepwell considers games to have a kind of medical power, and today it said it has received 510(k) clearance from the Food and Drug Administration (FDA) on its biofeedback (ABS) software development kit (SDK) for use in over-the-counter treatments for the reduction of stress and as an adjunctive treatment for high blood pressure, together with other pharmacological and/or nonpharmacological interventions.

“It’s going to be pretty exciting for this period of time. We’ll see what else happens. But for a period of time, nobody else is going to be able to take media and attach something to it, allowing the media to still be wild and free and be what it needs to be and wants to be, and attach it to reimbursements through being a medical device,” Douglas said.

Getting clearance

Overall, the process of getting the approval took about 3.5 years. That’s not bad compared to the eight to ten years it takes to get approval for a drug. Deepwell’s tech was embedded in Zengeance, a mental health game that debuted in June.

“It’s a really interesting time,” he said. “This was the dream from the beginning to be able to do this. I really did think it would take a lot longer than it took. The FDA was able to find that we had met the requirements. Games are part of the treatment.”

DeepWell will make the new technology available to media companies to embed or use adjacently with their products, which allows the potential to accelerate the commercialization of video games and other immersive media as FDA-cleared digital therapeutics. Media featuring DeepWell technology can be available to consumers over the counter (without a prescription) on all mobile device platforms.

Douglas calls his initial deliverable a “kernel.” The company is updating its games to be more reflective of the key playstyle.

“We’re going to get the kernel going and drop that into a couple of partner games,” Douglas said.

The company is working with the companies that will be its best partners.

“It turns out that for a game to be really therapeutic, it has to be a very good game,” Douglas said. “We’ve got to be working with someone who is good at what they do. They have to have the ability to differentiate themselves.”

Putting patients into a state of flow, or intense concentration, is what is needed in order for a digital therapeutic to be really effective, Douglas said.

Under the FDA’s 510K rules, Deepwell pointed out that its medical solution is very similar to other approved solutions.

“We got cleared in a way that we can now bring other people along with us, so we don’t have to keep going back and going back,” Douglas said. “Players aren’t going to play the same thing forever. That was really what we spent a lot of time getting the FDA to understand. We needed the FDA and the doctors in my world to think different and start respecting the game designers as really part of the therapy design.”

Significance of clearance

Clearance for this device by the FDA clearance is significant given the recent (July 2024) proposal from theCenters for Medicaid and Medicare Services (CMS) for codes which would enable Digital Mental HealthTreatment (DMHT) devices to become reimbursable as a physician service beginning in 2025. These codeswould provide monetary incentives for companies to develop, doctors to recommend, and patients to use DTx that incorporates DeepWell technology.

“The mental health emergency has reached unprecedented levels, profoundly impacting us all. That’s whyDeepWell has been working to create accessible, affordable health care solutions at scale. With the work the Digital Therapeutics Alliance (DTA) has done to secure reimbursement pathways, the last mile was to build technology that allows engaging media to be efficiently evaluated and marketed as a medical device. That is what our team has accomplished,” said Douglas, who is cofounder and a serial med-tech entrepreneur, in a statement.

He previously founded Nextern Innovation and collaborated to commercialize nearly 30 medical devices, including neurostimulators for pain, robotic surgical devices for women’s health, and light therapy for treating depression and seasonal effective disorder.

“The DeepWell clearance, along with DTA’s work with Congress to secure reimbursement pathways, will bring mental and physical health support to millions of struggling American families,” said Andy Molnar, CEO at Digital Therapeutics Alliance and member of the FDA Digital Health Advisory Committee, in a statement.

How it works

The DeepWell software provides bio stimulation in interactive media that activates the user’s vagus nerve while greatly increasing patient engagement, reducing sympathetic nervous system activation, and releasing dopamine for coping that improves resilience to reduce stress and hypertension. Immersive biofeedback-driven media increases consistent use for immediate and long-term mental and physical health benefits.

“This is a significant neurological advancement with the potential to take medicine to the next level,” said Samuel Browd, a doctor and cofounder of DeepWell and a pediatric neurosurgeon at the University of Washington, in a statement.

Browd is an advocate for Artificial Intelligence and Computational Brain Sciences for the American Association of Neurological Surgeons and Congress of Neurological Surgeons.

Browd added, “Makers of interactive media – used by five billion people — can now leverage DeepWell’s technology toward creating new therapeutic solutions.”

Browd notes that there are more than 350,000 digital wellness products, of which 90,000 have been piloted during the FDA Covid emergency order, yet only 20 have been FDA cleared, including just five for mental health and only one SDK, from DeepWell DTx.

“DeepWell has unlocked new revenue for media producers, taking us back to the golden age of great storytelling while simultaneously doing moonshot work, paving the way in a new area of mental health”, said Lauren Selig, executive producer and investor in academy award winning films and video games, including Hacksaw Ridge, Rocketman, Wheel of Time, Build a Rocket Boy, and FOAD, in a statement.

“Working with DeepWell, companies can now significantly reduce the time and cost of bringing their mental and physical health solutions to market,” said Jeffrey Tseng, DeepWell DTx CEO and chief productdeveloper, in a statement. DeepWell has a dedicated following of individuals who have reported relief and improved mental wellbeing using the technology. The company is also piloting new engagement mechanics and therapeutics concepts.

Tseng, who has had a long career in games at places such as Crowdstar (maker of Covet Fashion and Design Home), became CEO of DeepWell a few months ago. Tseng brought some engineering discipline to the company and helped it execute on getting its core work done using internal teams rather than external developers. The team has about 12 people right now.

“Jeffrey Tseng was a super good fit. He’s also really good at making games, and is really interested in what he can do with that from a humanitarian aspect. And not everybody in that space has both the talent and the desire to go this direction,” Douglas said.

“Our technology could be used in future digital treatments for pain, PTSD, epilepsy, sleep disorders, immune disorders, Parkinsons, Alzheimer’s, and as a critical connection point for brain computer interfacing,” said Douglas.

He said those additional indications are not yet cleared but the company may pursue them.

DeepWell has been prototyping and conducting viability assessments on the use of its technology with some of the largest media and medical device companies in the world. It expects to begin announcing its first collaborations soon.

Tseng said the FDA clearance has spurred additional interest in the company from partners and investors and its technology has been reviewed and endorsed by dozens of innovators in digital therapeutics, media, medicine and mobile, including Russell Lonser, chair of the Department of Neurological Surgery at The Ohio State University.

“I expect DeepWell’s technology and treatment approach to change how we design therapeutics for a wide range of neurological conditions,” Lonser said in a statement.

Deepwell DTx, launched in 2022, has several patents and has 20 patent applications pending. The company is part of NeuFluent, a venture studio developing neuroscience innovation — novel components, systems, and processes for highly reliable interconnectivity that streams data to digitally native processing and communication platforms.

NeuFluent technology promotes accelerated adoption of new behaviors, self-discovery, and learning. NeuFluent holds multiple patents in dynamically controlled shunts, distributed sensing and control, central nervous system monitoring and interventions, spinal fluid polarization, therapeutics augmentation, AI based managed care, brain computer interfaces, and more.

Douglas said he is very excited about expanding the utility of games, or legitimizing games, when it comes to being digital therapeutics. There are big problems right now, as 40% of the population is reaching high levels of stress, anxiety and depression, Douglas said.

“We’re in this loneliness epidemic. I don’t think people are understanding how serious it is. The Surgeon General said that 65% of parents are lonely and stressed,” Douglas said.

He added, “That’s unprecedented, and there are not enough doctors to go around. Game designers are the ones with the reach and the ability to make people feel better. They start to become a very viable alternative for management of stress and anxiety. Games can treat people and they are non-invasive.”

One of the revolutionary notions is that if a game is approved as a digital therapeutic, then a patient using that game can be reimbursed for the cost of buying the game.

“We’re working on that right now,” he said. “This can bring a whole new monetization scheme for games. Nobody has the reach of the video game world. But mental health is a far bigger industry.”

But not just any game can be classified as a digital therapeutic, as Deepwell has to do a very deep analysis before it can add a game to the kernel.

“Any time we make an addition to this kernel, we’re required to do something called a risk analysis. And that’s a room full of experts,” he said. “It has to pass muster with a lot of teams and stay in compliance.”

There are plenty of conclusions that people could draw based on the notion that games can be good for people to play.

“I don’t think game designers understand the power they really have, which also comes with greater levels of responsibility. We run on story. Our brains are perception engines,” Douglas said. “They’re not ones and zeroes. It shouldn’t surprise us that stories can change you neurologically. If you buy into the right stories, you can feel better about yourself. You can check in and change and connect in different ways.”