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reSET® & reSET-O®
reSET® & reSET-O®
Overview
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About
DESCRIPTION
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reSET, the first Prescription Digital Therapeutic (PDT) to receive authorization from FDA to improve disease outcomes, is a 90-day PDT for Substance Use Disorder (SUD) intended to provide cognitive behavioral therapy (CBT), as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician.
PRODUCT ATTRIBUTES
COVID-19
Pediatric
CLIENTS OVERVIEW
Key Clients
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EHR integration
Integrations: | None provided |
EMR Integration & Relevant Hardware: | None provided |
EMRs Supported: | None provided |
Hardware Compatibility: | None provided |
Description
reSET-O, the first PDT to receive Breakthrough Designation and authorized by FDA in December 2018, is an 84-day Prescription Digital Therapeutic (PDT) for Opioid Use Disorder (OUD) intended to increase retention of patients in outpatient treatment by providing cognitive behavioral therapy (CBT), as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician.
Use cases
Description
We are developing PDTs to treat patients suffering from a range of serious diseases. Pear has the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst® for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program.
Users:
Patients with multiple serious diseases.
Differentiators
Differentiators vs EHR Functionality:
None provided
Differentiators vs Competitors:
For individuals with substance use disorder (SUD), reSET® is the first FDA-authorized prescription digital therapeutic that’s proven to increase abstinence and treatment retention. Patients download the reSET app to their smartphone for secure, discreet, convenient access to therapy, interactive learning, and support.