Big Health, a leader in digital treatments for common mental health conditions, announced it has secured $23.7 million in strategic funding to accelerate the adoption of its FDA-cleared, reimbursable digital therapeutics. The funding supports the company’s solutions, SleepioRx for insomnia and DaylightRx for generalized anxiety disorder, enabling more patients to access evidence-based care at scale. Big Health’s approach emphasizes clinical validation, regulatory clearance, and integration into provider workflows to ensure safe, effective, and accessible treatment options.
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SleepioRx and DaylightRx are among the few FDA-cleared digital mental health treatments recognized under the Centers for Medicare & Medicaid Services new category of Digital Mental Health Treatments. This designation allows for national Medicare reimbursement, creating a pathway for broader access. FDA clearance ensures that these treatments meet rigorous standards for safety, efficacy, and clinical effectiveness, distinguishing them from unregulated wellness apps and non-validated digital tools. The new CMS reimbursement codes, introduced in the 2025 Physician Fee Schedule, mark a significant step toward embedding digital therapeutics into standard clinical practice.
Mental health conditions such as anxiety and insomnia are highly prevalent in the United States. Nearly one in five adults experience an anxiety disorder, while roughly a third report persistent sleep difficulties. Despite their frequency and impact, both conditions remain underdiagnosed and undertreated, often due to limited access to care. Big Health’s digital therapeutics address this gap, offering scalable, first-line interventions that can be delivered where and when patients need them most.
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Dr. Alexi Nazem, General Partner at AlleyCorp, noted that Big Health’s products are backed by strong evidence demonstrating effectiveness at scale. He said that with new funding and innovative solutions, the company is well-positioned to expand access to high-quality mental health care and improve outcomes for millions. Alyssa Reisner, Executive Director and Partner at CVS Health Ventures, emphasized the gap between demand for mental health care and availability, explaining that SleepioRx and DaylightRx provide reliable, evidence-based treatment to reach patients efficiently.
Big Health’s treatments have demonstrated long-term real-world benefits. Clinical studies indicate that up to 76 percent of patients using SleepioRx see improvements in insomnia, while 71 percent of DaylightRx users experience improvement in generalized anxiety disorder. These solutions integrate into routine clinical care, enabling clinicians to provide measurable, reproducible outcomes and expand access to care for patients who might otherwise face long wait times or limited treatment options.
Yael Berman, CEO of Big Health, said the new funding will help scale the company’s treatments faster, noting that innovative health systems are already adopting these solutions to improve patient outcomes. The funding round was co-led by .406 Ventures and AlleyCorp, with additional support from CVS Health Ventures, Blue Venture Fund, Sandbox Clinical Ventures, Gilde Healthcare, and Supermoon Capital. Investors highlighted Big Health’s rigorous clinical evidence, reimbursement readiness, and scalable model as key factors in their support.
Liam Donohue, Managing Partner at .406 Ventures, stated that the investment reflects confidence in Big Health’s ability to deliver clinically validated digital treatments with clear economic and clinical benefits. Tom Hawes, Managing Director at Blue Venture Fund and Sandbox Clinical Ventures, emphasized that these interventions can improve lives while reducing unnecessary healthcare costs.
Early adoption is already gaining momentum, with major health systems such as Henry Ford and Northwell partnering with Big Health to integrate SleepioRx and DaylightRx into patient care. These collaborations demonstrate the growing recognition of digital mental health therapeutics as safe, effective, and essential tools for addressing widespread mental health challenges in the United States.
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