Nearly a decade ago, Corey McCann, a PhD-MD and McKinsey wonk turned serial entrepreneur, was intrigued by the formative concept of software-as-a-drug: a prescription program that collects data and helps modify behavior to heal patients. The thing was, no program like that existed. "What was missing," McCann says, "was a hybrid company that was able to execute with the rigors of a pharmaceutical company and the agility of a tech company."

So, in 2013, he founded Pear Therapeutics--the first such company to get to market. Its reSET-O is a prescription app that delivers a series of interactive therapy lessons including a cognitive behavioral therapy (CBT) component, fluency training exercises, and contingency management for those taking buprenorphine to recover from opiate addiction. (Pear's reSET works on other substance-abuse disorders.) Patients download Pear's app and use it to check in with clinicians, get guided through therapy sessions, report cravings or relapses, or get reinforcement for staying clean.

Software-as-a-drug may seem a little hard to swallow, so McCann frames it this way: "Think about CBT as the active ingredient." ReSET-O was approved by the FDA as any drug is: through randomized clinical trials. Those tests showed that reSET-O is more effective at helping those with addictions than medication and therapy alone. Pear's next product is for chronic insom­niacs, and the company and big-pharma partner Sandoz now face another issue: getting insurers to pay for a prescription that isn't a medication. "We are building a novel business," says McCann. "We expect to have novel problems."