New investment fuels expansion as leading health systems adopt evidence-based digital care, driven by new billing codes and strong demand for proven mental health solutions.

SAN FRANCISCO–(BUSINESS WIRE)–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)).

“We’re already seeing the most innovative health systems seize this opportunity, and this funding will help us scale access to these treatments faster.”Share

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.

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.

“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,” said 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,” said Alyssa Reisner, Executive Director and Partner at CVS Health Ventures. “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.”

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.

“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,” said Yael Berman, CEO of Big Health. “We’re already seeing the most innovative health systems seize this opportunity, and this funding will help us scale access to these treatments faster.”

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:

“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,” said 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,” said Tom Hawes, Managing Director at Blue Venture Fund and Sandbox Clinical Ventures.

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.

Learn more about how Big Health is transforming mental health care at: https://www.bighealth.com/

About Big Health

Big Health’s mission is to help millions improve their mental health by providing safe and effective digital treatments for the most common mental health conditions, including insomnia and anxiety. Designed by leading clinical experts, Big Health’s digital mental health treatments expand access to gold‑standard care, including behavioral medicine, and are backed by industry‑leading research and randomized controlled trials. By making treatments available both directly to patients and through providers, and by simplifying adoption for providers, payers, and employers, Big Health is increasing access to affordable evidence-based care. For more information, please visit www.bighealth.com.

1. Changes up to these levels have been demonstrated across studies, including: Espie et al. (2012). Sleep 35(6), 769-781; Tarnai et al. (2025). Aging and Mental Health, 1-7; Prather et al. (2025). JMIR Mental Health,12, e84323.
2. Carl et al. (2020). Depression & Anxiety 37(12), 1168-1178.
3. Parsons et al. (2025). JAMA Network Open, 8(12):e2548884.

SleepioRx and DaylightRx are prescription digital therapeutics, available by order of a licensed healthcare provider, for use alongside usual care. SleepioRx treats chronic insomnia in adults 18+, and DaylightRx treats generalized anxiety disorder (GAD) in adults 22+. Patients should read the instructions for use for full information.

Contacts

Media Contact:
press@bighealth.com

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