Deals
XRHealth Acquires PursueCare to Pair FDA-Cleared Digital Therapeutics With Avatar-Based VR Group Therapy
The deal folds RESET and RESET-O, the original FDA-cleared prescription software therapies, into a spatial care platform that runs across VR headsets, smartphones, and wearables.
Mainstay Communications Team · · 3 min read
In brief
XRHealth acquired PursueCare on November 9, 2026, bringing two FDA-cleared prescription digital therapeutics for substance use disorder and opioid use disorder into its avatar-based VR therapy platform for the first time. Both were originally developed by Pear Therapeutics. RESET received FDA De Novo clearance in 2017, which trade publications widely described at the time as the first prescription digital therapeutic authorization in FDA history, and RESET-O followed via the 510(k) pathway in 2018. PursueCare acquired both products from Pear's bankruptcy estate in December 2023 and relaunched them in October 2024; the combined entity now covers regulated app-based cognitive behavioral therapy and avatar-led group sessions in one care network.
The Deal
XRHealth, a therapeutic technology company whose platform spans AR/VR headsets, smartwatches, smartphones, and connected home devices, acquired PursueCare, a virtual addiction and behavioral health provider based in Middletown, Connecticut. Financial terms weren't disclosed. The announcement came November 9, 2026.
PursueCare's clinical team and its full caseload will move into XRHealth's platform. The acquisition brings in both PursueCare's licensed clinicians and its 2 FDA-cleared prescription digital therapeutics, RESET and RESET-O.
CEO Eran Orr said the goal is to give patients care "at the exact moment of need to prevent a further relapse," making personalized treatment more accessible across everyday devices.
What RESET and RESET-O Are
Pear Therapeutics developed the original reSET and received FDA De Novo clearance for it in September 2017. The De Novo pathway establishes a new device classification; Psychiatric News and trade coverage described the reSET clearance as the first prescription digital therapeutic authorization the FDA had ever granted. Trial data reviewed by the agency included a NIDA-sponsored study of 399 patients in which reSET more than doubled abstinence rates compared to standard face-to-face counseling alone.
Pear filed for Chapter 11 bankruptcy in April 2023. PursueCare acquired the RESET assets from Pear's estate in December 2023, then relaunched both products in October 2024 under their current all-caps branding.
RESET is a 12-week (90-day) FDA-cleared cognitive behavioral therapy course indicated for adult outpatient substance use disorder. RESET-O is an 84-day adjunct CBT regimen, also FDA-cleared, that pairs with buprenorphine to support outpatient treatment for opioid use disorder. Both run as software-based contingency management programs prescribed by a clinician, with patient access delivered via app.
The VR Layer
PursueCare's clinical caseload moves into XRHealth's platform, which offers avatar-based group therapy rooms where patients can join peer recovery circles and group counseling sessions anonymously. XRHealth says the avatar format may reduce the privacy concerns and stigma that keep patients out of traditional in-person support groups.
XRHealth's platform carries FDA registration for its VR therapeutic programs and operates across physical, cognitive, and behavioral health conditions. Pairing a cleared prescription software therapy with a spatial delivery layer puts both modalities in the same care network for a single patient, something neither company could do independently.
The Treatment Gap
SAMHSA's 2025 data show 44.6 million Americans aged 12 and older had a substance use disorder. 89% of them received no treatment. Clinician shortages, rural provider gaps, stigma, and cost are the most cited barriers.
PursueCare was licensed in 6 states at the time of the deal: Connecticut, Kentucky, Maine, New Hampshire, Ohio, and West Virginia. XRHealth operates across 22 states and is expanding.
The Regulatory Precedent
RESET's De Novo clearance carries structural significance beyond the product. Under FDA device regulations, a De Novo grant establishes a new device classification that can then serve as a predicate for future 510(k) submissions covering substantially equivalent software-based therapeutics. The 2017 reSET clearance opened that channel for prescription digital therapeutics across the industry.
The XRHealth-PursueCare deal puts a cleared product in that class inside a spatially delivered, avatar-based care platform for the first time. For MedTech companies evaluating spatial delivery models for their own FDA-registered or cleared software tools, the structure of this acquisition offers a concrete precedent: a cleared prescription app, an XR delivery platform, and a licensed clinical network operating under one roof.
Sources
- XRHealth Acquires PursueCare to Bridge VR Therapy with FDA-Authorized Prescription Digital Therapeutics, HIT Consultant
- XRHealth Expands Behavioral Health Footprint with PursueCare Deal, LevinPro Healthcare M&A
- PursueCare Introduces RESET and RESET-O, FDA-Authorized Digital Therapeutics for Addiction Treatment, BusinessWire
- RESET and RESET-O: New Era for Digital Addiction Treatments at PursueCare, HLTH
- Pear Therapeutics Gets De Novo FDA Clearance for reSET, MobiHealthNews
- FDA Clears First Prescription-Based Digital Therapeutic, Psychiatric News
- XRHealth Makes Another Acquisition, Aiming to Be a Leading Virtual Provider Using VR, STAT News via Benzinga
Companies mentioned
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