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.
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. Building on this clinical and regulatory foundation, Big Health’s latest funding follows the creation of new reimbursement codes by CMS, enabling the first national Medicare coverage for FDA-cleared DHMTs 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. Now formally recognized as FDA-cleared DMHTs and reimbursable by Medicare, they offer an evidence-based option 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, and 71% of DaylightRx patients experience improvement in GAD. Delivered at the 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 Ventures, 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.
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.
About Gilde Healthcare
Gilde Healthcare is a specialized investor managing €3 billion across three impactful fund strategies: Venture&Growth in healthcare, Private Equity in healthcare and Climate Solutions. The Venture&Growth fund invests in fast growing companies active in healthtech, medtech and therapeutics, based in Europe and North America. The Private Equity fund of Gilde Healthcare participates in profitable lower mid-market healthcare companies in Europe. Climate Solutions is focused on profitable lower mid-market companies supporting energy transition, biodiversity and waste/pollution in Benelux and Germany. For more information, visit the company’s website at www.gildehealthcare.com.
