media kit · ‘tes’ from dartmouth university. receives fda-clearance for reset
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Media KitSeptember 2017
About PearPear Therapeutics is the leader in FDA-cleared Prescription Digital Therapeutics. The company’s approach is to integrate clinically-validated software applications with previously approved pharmaceuticals and treatment paradigms to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear’s lead product, reSET®, is an FDA-cleared 12-week interval prescription therapy for Substance Use Disorder (SUD) to be used as an adjunct to standard, outpatient treatment. Pear’s product development pipeline includes reSET-O™ for opioid use disorder (OUD) and additional prescription digital therapeutics in schizophrenia (Thrive™), combat post traumatic stress disorder (reCALL™), general anxiety disorder (reVIVE™), pain, major depressive disorder, and insomnia, for which Pear intends to obtain FDA clearance. www.peartherapeutics.com
• Launched in 2013
• Based in Boston and San Francisco
• First, and only, FDA-cleared prescription digital therapeutic with claims toimprove patient outcomes
Pear is committed to bettering patient outcomes through technology
Corporate Timeline
AUG 2013 OCT 2013 NOV 2013 MAR 2015 JUL 2015 FEB 2016 MAY 2016 DEC 2016 JUL 2017 SEP 2017 SEP 2017 2018
PearTherapeutics
is formed
Screens2,500digital
technologies
Seed financing
from Kennedy Family
Foundation and 5AMVentures
Raises$20M
financing
FDA submission for reSET®
17 patents issued
reSET®
launch
Receives NIDA grantLaunch
reSET® pilot studies
Forms Advisory
Board chaired by
Patrick Kennedy
In-licenses ‘TES’ from Dartmouth University
ReceivesFDA-clearance
for reSET®
Milestone
About Prescription Digital Therapeutics
Prescription Digital Therapeutics are clinically-validated, FDA-cleared software applications that demonstrate safety and efficacy in randomized clinical trials to improve patient outcomes. Prescription Digital Therapeutics are designed to enhance clinical outcomes, and where clinically relevant, may be combined with current treatment regimens including approved drug or device therapies and patient counseling. Prescription Digital Therapeutics usually include patient-facing applications, clinical assessment and outcomes tracking, clinician monitoring dashboards and HIPAA-compliant data storage.
FDA’s Digital Health Initiative
Fostering Medical Innovation: A Plan for Digital Health Devices
FDA Announces New Steps to Empower Consumers andAdvance Digital Healthcare
Digital Health Software Precertification (PreCert) Program
Links to latest FDA correspondence concerning digital health:
About reSET®
reSET® is a 12-week (90 day), FDA-cleared prescription digital therapeutic to be used as an adjuvant to standard outpatient therapy for treating Substance Use Disorder (SUD) related to stimulants, cannabis, cocaine and alcohol. The product combines patient-facing interventions and assessments via a mobile device, with clinician-facing dashboards and data analytics on the back-end.
reSET® has been proven to increase abstinence from a patient’s substances of abuse during treatment and retention in the outpatient treatment program. reSET® provides clinicians with immediate access to self-reported substance use, triggers, cravings and outcomes.
reSET® is limited to persons with a valid prescription from their licensed provider and is intended is for patients 18 years of age and older.
How reSET® Works
reSET® is a prescription digital therapeutic designed and engineered to deliver neurobehavioral therapy modeled on the Community Reinforcement Approach (CRA) for patients with Substance Use Disorder (SUD). CRA is a specific form of cognitive behavioral therapy (CBT) designed for patients with SUD. reSET® combines CRA (for therapy) and fluency learning (to reinforce concept mastery) and can be implemented in conjunction with Contingency Management to support and incentivize patients with SUD in achieving abstinence and retention in outpatient SUD treatment.
Patients are able to download the application on their mobile device. Following the download, patients can activate the product with a prescription access code provided by their physician or medical provider. Access codes correspond to the duration of the FDA-cleared label (and clinical study), in the case of reSET® stipulating 12 weeks of therapy. The patient’s physicians or medical providers can monitor the patient’s treatment and progress from a clinician dashboard as they progress through various modules and responses to questions.
About reSET®
About reSET®
About Substance Use Disorder
In 2016, approximately 20.1 million people aged 12 or older had a substance use disorder (SUD) related to their use of alcohol or illicit drugs in the past year. Abuse of and addiction to alcohol, nicotine, and illicit and prescription drugs cost Americans more than $700 billion a year in increased health care costs, crime and lost productivity, and contribute to the death of more than 90,000 Americans.
According to the Substance Abuse and Mental Health Services Administration (SAMHSA), only about 1 in 10 people who needed substance use treatment received treatment at a specialty facility in the past year (10.6 percent).
Link to SAMHSA Report
Leadership
Corey McCann, M.D., Ph.D.Founder and Chief Executive OfficerBoston, MA • San Francisco, CA
• Dr. McCann is a physician, scientist, entrepreneur, and healthcare investor.
• Previously, he was an investor with MPM Capital and with RiverVest Venture Partners, where he evaluated new investment opportunities, managed relationships with strategic partners, and oversaw board-level strategy and execution at portfolio companies. Prior to MPM, he was with McKinsey & Company, where he advised pharmaceutical, medical device, and biotechnology companies on the acquisition, development, and commercialization of life science technologies. He also led McKinsey’s Central Nervous System (CNS) expertise group, serving clients across pharma and biotech. He is a founding member of multiple start-ups including Alcyone Lifesciences, a company developing technologies to deliver therapeutics to the brain. Additionally, he is a co-founder, advisor or Board Director for multiple start-ups, including at AgNovos Healthcare, Alcyone Lifesciences, Dragonfly Sciences, Edumedics, New Frontier Bio, Resolute Bio, Selexys Pharmaceuticals and Zillion Health.
• Dr. McCann’s post-graduate training was at Harvard University, Washington University in St Louis, and at the Massachusetts General Hospital, and he graduated summa cum laude from The Pennsylvania State University where he was an Evan Pugh Scholar.
PipelinePear’s robust pipeline includes the reSET and reSET-O programs, as well as further product development programs in additional CNS disorders.
Contacts
Pear Therapeutics:[email protected]
Media:MacDougall Biomedical CommunicationsKaren Sharma or Stefanie Tuck(781) [email protected]