Big Health announced it has secured $23.7 million in new strategic funding to accelerate the adoption of its FDA-cleared digital mental health treatments, as health systems increasingly integrate reimbursable digital care into routine practice. The company develops prescription digital therapeutics targeting some of the most common mental health conditions. Its flagship products, SleepioRx for insomnia disorder and DaylightRx for generalized anxiety disorder, are among just nine treatments cleared by the U.S. Food and Drug Administration in the Centers for Medicare & Medicaid Services’ newly established Digital Mental Health Treatments category.
The financing follows a pivotal policy shift from the Centers for Medicare & Medicaid Services, which introduced new G-codes in the 2025 Physician Fee Schedule. The move enables the first national Medicare reimbursement pathway for FDA-cleared digital mental health treatments, marking a major milestone after years of fragmented coverage. The policy change is expected to accelerate integration of evidence-based digital therapeutics into mainstream clinical workflows.
SleepioRx and DaylightRx have been used in clinical settings for more than a decade and are supported by randomized controlled trials and real-world evidence. FDA clearance establishes regulatory standards around safety, efficacy, and clinical validation, distinguishing these therapies from general wellness apps and non-cleared digital tools. The treatments are also recommended in leading clinical guidelines, including those from the American College of Physicians and the National Institute for Health and Care Excellence.
The funding arrives amid growing demand for scalable mental health solutions. Anxiety disorders affect nearly 20 percent of U.S. adults, while close to one-third report persistent insomnia or sleep difficulties. Despite their prevalence, both conditions remain underdiagnosed and undertreated, often due to provider shortages and limited access to behavioral health specialists.
To date, Big Health says it has supported more than 750,000 individuals. Clinical studies show that up to 76 percent of SleepioRx patients achieve improvement in insomnia, while 71 percent of DaylightRx patients experience improvement in generalized anxiety disorder. Delivered at the point of care, the treatments allow providers to offer first-line, evidence-based interventions without long wait times.
The round was co-led by .406 Ventures and AlleyCorp, with participation from CVS Health Ventures, Blue Venture Fund, Sandbox Clinical Ventures, Gilde Healthcare, and Supermoon Capital. The capital will support commercialization efforts, deepen provider partnerships, and expand access across health systems and payer networks.
Early adoption is already underway. Major health systems, including Henry Ford Health and Northwell Health, have partnered with Big Health to deploy its digital treatments at scale, signaling growing institutional confidence in reimbursable digital mental health solutions.
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“We’re already seeing the most innovative health systems seize this opportunity, and this funding will help us scale access to these treatments faster. For the first time, providers can offer proven, safe, and effective digital treatments that deliver measurable, reproducible outcomes, and receive reimbursement just as they would for traditional treatments.”
Yael Berman, CEO of Big Health
“Big Health has developed highly effective digital therapeutics for insomnia, anxiety, and depression, backed by a deep evidence base that is proven to work at-scale. With excellent products and substantial new financing, Big Health is poised to improve the lives of so many more people—which is needed in the mental health space now more than ever.”
Dr. Alexi Nazem, MD, General Partner at AlleyCorp
“There’s a significant gap between people who need mental health care and those who can access it. SleepioRx and DaylightRx can help fill that gap—offering first-line, evidence-based treatment for insomnia and anxiety at scale, where and when patients need it most.”
Alyssa Reisner, Executive Director and Partner at CVS Health Ventures
“We are thrilled to be investing in the Big Health team as they unlock the potential created by CMS’s wise decision to reimburse for FDA-cleared digital treatments targeting conditions where such an intervention is proven to be appropriate, superior to current pharmaceutical-only approaches, and ultimately better value for the system.”
Liam Donohue, Managing Partner at .406 Ventures
“This investment reflects our belief that clinically validated, first-line digital treatments with clear reimbursement and predictable economics can meaningfully improve the lives of many, while reducing avoidable healthcare costs. We are excited to help increase access to Big Health’s digital treatments.”
Tom Hawes, Managing Director at Blue Venture Fund and Sandbox Clinical Ventures
