Big Health Adds Former FDA Deputy Commissioner Anand Shah to Its Board of Directors

Dr. Shah joins the Big Health Board of Directors following the company’s Series C funding to expand access to safe and effective mental health care using digital therapeutics

SAN FRANCISCO, January 26, 2022 — Big Health, a digital therapeutics company dedicated to helping millions back to good mental health, today announced that it has added former Food and Drug Administration (FDA) Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah to its Board of Directors. This key addition follows Big Health’s $75 million Series C financing, led by SoftBank Vision Fund 2.

As a member of the Big Health Board of Directors, Dr. Shah will help expand access to digital therapeutics as non-drug alternatives for mental health care. Dr. Shah will take an active role in bolstering the company’s clinical and public policy strategies.

“As a result of the COVID-19 pandemic, we are now seeing a second and very different crisis emerge,” said Big Health Co-Founder and CEO Peter Hames. “While the prevalence of mental health conditions continues to rise at alarming rates, we have learned that traditional models of mental health care cannot possibly meet the scale of need. We are extremely excited to welcome Dr. Shah to the Big Health Board of Directors to champion the expanded adoption of digital therapeutics. Dr. Shah brings unique industry and federal government leadership experience, and will play a key role in providing safe and effective digital therapeutics for all Americans in need.”

Dr. Shah held multiple senior leadership roles at FDA and the Centers for Medicare & Medicaid Services (CMS) from 2016 to 2021, where he focused on bringing new technologies to market, redesigning health care delivery and payment models, and expanding consumer choice. At FDA, he developed multiple public health policies and programs including those related to digital health, clinical trials, and real-world evidence. At CMS, Dr. Shah led the clinical design of novel value-based payment and service delivery models, including those for advanced primary care, specialty care, and prescription drugs.

“The growing mental health crisis is one of the most pressing issues for the American health care system today,” said Dr. Shah. “Through the combination of evidenced-based digital therapeutics and an innovative reimbursement model, Big Health has a unique opportunity to transform our current approach to mental health care. I am honored to join Big Health’s Board of Directors to advance their mission of helping millions back to good mental health.”

Big Health is the most studied and scaled digital therapeutics company, with over 10 million covered lives globally, 13 randomized controlled trials evaluating its approach, and more than 28,000 participants across all clinical evidence studies. Sleepio and Daylight¹, Big Health’s digital therapeutics for insomnia and anxiety, offer fully automated products that deliver evidence-based mental health care, including cognitive behavioral therapy, without intervention from coaches or clinicians. Through robust clinical evaluation, Big Health’s digital therapeutics serve as non-drug alternatives for mental health care. To ease adoption for payers and patients alike, Big Health pioneered the ability to bill through the PBM, enabling employers and health plans to add Big Health to their formulary and pay for their use via a drug claim – which is the same way they pay for medications.

Following Big Health’s Series C funding and the addition of Dr. Shah, the Big Health Board of Directors now consists of:

• Arun Gupta, Big Health Executive Chairman
• Peter Hames, Big Health Chief Executive Officer
• Dr. Anand Shah, Former FDA Deputy Commissioner
• John Cassidy, SoftBank Investment Advisers, Investment Director, Life Sciences & HealthTech
• Alliott Cole, Octopus Ventures co-CEO
• Janke Dittmer, Gilde Healthcare Venture & Growth – General Partner HealthTech
• Liz Rockett, Kaiser Permanente Ventures Managing Director

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About Big Health

Big Health’s mission is to help millions back to good mental health by providing safe and effective non-drug alternatives for the most common mental health conditions including insomnia and anxiety. Designed by leading clinical experts, Big Health’s digital therapeutics expand access to gold standard care, including behavioral medicine, and are backed by industry-leading research and randomized controlled trials. By seamlessly integrating across the care pathway, from member engagement to billing via pharmacy benefit managers, Big Health simplifies adoption for both payers and patients, providing an inclusive, scalable, and affordable approach without serious side effects. For more information, please visit www.bighealth.com or follow Big Health on LinkedIn and Twitter.

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Big Health Media Contact:

Jake Mazanke

630-640-5253

press@bighealth.com

¹ In accordance with FDA’s Current Enforcement Discretion Policy for Digital Health Devices for Psychiatric Disorders, for patients aged 18 years and older, who are followed by and diagnosed with Insomnia Disorder or Generalized Anxiety Disorder by a medical provider, Sleepio and Daylight can be made available as an adjunct to their usual medical care for Insomnia Disorder or Generalized Anxiety Disorder, respectively. Sleepio and Daylight do not replace the care of a medical provider or the patient’s medication. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for these indications.

Disclaimer: In the UK, Sleepio and Daylight are CE marked medical devices available for the treatment of insomnia disorder and generalized anxiety disorder, respectively