Big Health, a leading developer of digital treatments for the most pervasive mental health conditions, today announced a new round of strategic funding of $23.7M to accelerate access to its FDA-cleared, reimbursable solutions (SleepioRx for insomnia disorder and DaylightRx for generalized anxiety disorder (GAD)).
SleepioRx and DaylightRx are among just nine FDA-cleared treatments in CMS’s recently established category of Digital Mental Health Treatments (DMHTs), a new class of reimbursable medical device treatments for mental health conditions. FDA clearance provides essential guardrails around safety, efficacy, and clinical validation, setting these treatments apart from non-FDA-cleared digital tools and wellness apps. Amid growing concerns about the safety of newer digital approaches to mental health, Big Health’s evidence-based treatments give patients, clinicians, and regulators confidence that they are safe and effective.
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Building on this clinical and regulatory foundation, Big Health’s latest funding follows the CMS DMHT policy, which created new G-codes in the 2025 Physician Fee Schedule, enabling the first national Medicare coverage for FDA-cleared DMHTs such as SleepioRx and DaylightRx. After years of fragmented reimbursement, these novel codes represent a milestone in integrating evidence-based digital mental health treatments into routine care, paving the way for better outcomes for patients and economic value for health systems. These codes position leaders like Big Health to drive the scale and patient impact long envisioned by clinicians and policymakers.
This progress comes at a critical time: anxiety disorders are the most commonly diagnosed mental health condition, affecting nearly 20% of US adults. Meanwhile, close to one-third of adults report persistent insomnia or sleep difficulties. Yet despite their prevalence and impact, both conditions remain widely underdiagnosed and undertreated, often due to lack of access to quality care.
SleepioRx and DaylightRx have been helping patients for over a decade, generating a long track record of real-world use and meaningful clinical improvements across diverse populations.1,2 Now formally recognized as FDA-cleared DMHTs and reimbursable by Medicare, they offer evidence-based options for patients who often face long waitlists or limited access to care.
Backed by a robust body of clinical evidence and recommended in leading guidelines, including the American College of Physicians and the National Institute for Health and Care Excellence, these treatments expand access to safe, effective mental health care at scale.
To date, Big Health has supported more than 750,000 individuals, with clinical studies showing that up to 76% of SleepioRx patients achieve improvement in insomnia,1 and 71% of DaylightRx patients experience improvement in GAD.2,3 Delivered at the critical point of care, they enable clinicians to integrate evidence-based digital solutions into routine practice and reach more patients where they need support.
The new round of funding 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, a syndicate with deep expertise in US healthcare and strong relationships across provider and payer ecosystems. This funding will accelerate the commercialization of Big Health’s FDA-cleared digital treatments, expanding access through strategic provider partnerships, integrating seamlessly into clinical workflows, and ultimately delivering safe, effective care to millions of patients in need. Investors emphasized Big Health’s clinical rigor, reimbursement readiness, and scalable provider-led model:
This investor support is already accelerating real-world adoption. Leading health systems including Henry Ford and Northwell have partnered with Big Health to deliver Big Health products at scale, demonstrating strong early traction and momentum. These collaborations highlight a growing movement among forward-thinking clinical leaders dedicated to transforming how conditions like insomnia and anxiety are treated.
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