<p><strong>SAN FRANCISCO</strong> &#8212; <a href="https://cts.businesswire.com/ct/CT?id=smartlink&;url=https%3A%2F%2Fwww.bighealth.com%2F&;esheet=54423506&;newsitemid=20260212541697&;lan=en-US&;anchor=Big+Health&;index=1&;md5=69c6015452cd2784c5259a5b7ef78973" target="_blank" rel="nofollow noopener" shape="rect">Big Health</a>, a developer of digital treatments for the most pervasive mental health conditions, has secured a new round of strategic funding of $23.7 million to accelerate access to its FDA-cleared, reimbursable solutions (<a href="https://cts.businesswire.com/ct/CT?id=smartlink&;url=https%3A%2F%2Fwww.bighealth.com%2Fsleepio-rx&;esheet=54423506&;newsitemid=20260212541697&;lan=en-US&;anchor=SleepioRx&;index=2&;md5=f3ed858fb77802604642cf4a3fbe988b" target="_blank" rel="nofollow noopener" shape="rect">SleepioRx</a> for insomnia disorder and <a href="https://cts.businesswire.com/ct/CT?id=smartlink&;url=https%3A%2F%2Fwww.bighealth.com%2Fdaylight-rx&;esheet=54423506&;newsitemid=20260212541697&;lan=en-US&;anchor=DaylightRx&;index=3&;md5=716caccfe0a24cf5262fd00f0c01eb72" target="_blank" rel="nofollow noopener" shape="rect">DaylightRx</a> for generalized anxiety disorder (GAD)).</p>
<p id="pull-quote" class="font-figtree text-lg lg:text-[24px] leading-6 lg:leading-[38px]">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.</p>
<p>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.</p>
<p>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.</p>
<p>This progress comes at a critical time: anxiety disorders are the most commonly diagnosed mental health condition, affecting <a href="https://cts.businesswire.com/ct/CT?id=smartlink&;url=https%3A%2F%2Fwww.nimh.nih.gov%2Fhealth%2Fstatistics%2Fany-anxiety-disorder%23%3A%7E%3Atext%3DPrevalence%2520of%2520Any%2520Anxiety%2520Disorder%2520Among%2520Adults%2C-Based%2520on%2520diagnostic%26text%3DAn%2520estimated%252019.1%2525%2520of%2520U.S.%2Cthan%2520for%2520males%2520%252814.3%2525%2529.&;esheet=54423506&;newsitemid=20260212541697&;lan=en-US&;anchor=nearly+20%25&;index=4&;md5=d43f63945781ea71793c14df36d533e8" target="_blank" rel="nofollow noopener" shape="rect">nearly 20%</a> of US adults. Meanwhile, close to <a href="https://cts.businesswire.com/ct/CT?id=smartlink&;url=https%3A%2F%2Fpmc.ncbi.nlm.nih.gov%2Farticles%2FPMC1978319%2F%23B2&;esheet=54423506&;newsitemid=20260212541697&;lan=en-US&;anchor=one-third&;index=5&;md5=e9571b8f2cb114a3eea23060a318da16" target="_blank" rel="nofollow noopener" shape="rect">one-third</a> 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.</p>
<p>&#8220;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,&#8221; said Dr. Alexi Nazem, MD, General Partner at AlleyCorp.</p>
<p>“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.”</p>
<p>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.<sup>1,2</sup> 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.</p>
<p>Backed by a robust body of clinical evidence and recommended in leading guidelines, including the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&;url=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F27136449%2F&;esheet=54423506&;newsitemid=20260212541697&;lan=en-US&;anchor=American+College+of+Physicians&;index=6&;md5=64ebf7dc0449b070995c2fe5b121f993" target="_blank" rel="nofollow noopener" shape="rect">American College of Physicians</a> and the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&;url=https%3A%2F%2Fwww.nice.org.uk%2Fguidance%2Fmtg70&;esheet=54423506&;newsitemid=20260212541697&;lan=en-US&;anchor=National+Institute+for+Health+and+Care+Excellence&;index=7&;md5=216f2f6fcaeebfc9305394061ad46193" target="_blank" rel="nofollow noopener" shape="rect">National Institute for Health and Care Excellence</a>, these treatments expand access to safe, effective mental health care at scale.</p>
<p>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,<sup>1</sup> and 71% of DaylightRx patients experience improvement in GAD. 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.</p>
<p>“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.”</p>
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