PEAR Therapeutics Scores $50M in Series B Funding Round

Digital therapeutics pioneer Pear Therapeutics closed a $50 million Series B financing, led by Temasek and joined by new and existing investors 5AM Ventures, Arboretum Ventures, JAZZ Venture Partners, Novartis, EDBI and the Bridge Builder’s Collaborative.

On Sept. 14, 2017, the U.S. Food and Drug Administration (FDA) approved the company’s De Novo request, which allowed Pear to market reSET for the treatment of patients with substance use disorder (SUD) under a new class of treatment. This is the first FDA approval of a Prescription Digital Therapeutic.

reSET is a 12-week Prescription Digital Therapeutic used with standard outpatient treatment for substance use disorder. It is not for treating opioid dependence. It combines patient-facing interventions and assessments by way of a mobile device, as well as doctor-facing dashboards and back-end data analytics.

"This is a defining moment for digital therapeutics and for patients with substance use disorder," said Corey McCann, Pear’s president and chief executive officer, in a statement. "As the first FDA-cleared Prescription Digital Therapeutic for disease treatment, reSET has demonstrated improved abstinence and treatment retention in a randomized controlled clinical study. We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas. Pear was impressed by the collaborative approach the FDA took in reviewing this innovative technology."

The funds raised from the Series B will be used to further commercialize reSET and its pipeline and platform. In addition to reSET and reSET-O, the company is developing software-based treatments for schizophrenia, post-traumatic stress disorder, general anxiety disorder, pain, major depressive disorder, insomnia, and other programs.

"At Pear, 2017 was a year filled with noteworthy achievements," McCann said in a statement. "Our team made significant strides in advancing our pipeline of prescription digital therapeutics. We plan to use this additional capital to substantiate the clinical efficacy of our therapeutics across a variety of indications. This latest financing recognizes the strides we’ve made in proving the clinical utility and commercial viability of prescription digital therapeutics."

The reSET approval was supported by a National Institute on Drug Abuse (NIDA)-sponsored clinical trial. It looked at 399 patients with SUD at 10 treatment centers in NIDA’s Clinical Trial Network over 12 weeks. Patients either received standard treatment made up of face-to-face counseling, or a lower amount of face-to-face counseling plus the digital therapeutic. The trial showed that the digital therapeutic more than doubled the rate of abstinence compared to standard, face-to-face counseling. A sub-group of non-abstinent patients, which is a poor prognostic indicator, showed an almost five-fold improvement in abstinence.

"In 2016, an estimated 20.1 million people aged 12 or older needed substance use disorder treatment according to the Substance Abuse and Mental Health Services Administration," said Edward Nunes, professor of Psychiatry at Columbia University Medical Center and independent Lead Investigator of the trial. "The clinical outcomes demonstrated in the reSET pivotal study are remarkable. Clinically-validated digital therapeutics may become a cornerstone of future treatment."