| Headquarters | Boston, MA |
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| Founded | 2013 |
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| Status | Public (NASDAQ: PEAR) |
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| FDA Clearances | 3 products |
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| Focus | Prescription Digital Therapeutics |
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Pear Therapeutics (NASDAQ: PEAR) is a leading prescription digital therapeutics (PDT) company developing and commercializing software-based therapeutic products to treat serious diseases. The company's platform combines clinically validated behavioral interventions with sophisticated software to deliver FDA-cleared prescription digital therapeutics that require a prescription from a healthcare provider.
Founded in 2013 based on technology from McLean Hospital and Harvard Medical School, Pear Therapeutics went public in 2021 and has established partnerships with major healthcare systems, payers, and pharmacy benefit managers. The company focuses on areas where digital therapeutics can provide meaningful clinical benefit over standard of care.
| Metric |
Value |
| IPO |
2021 (NASDAQ: PEAR) |
| 2024 Revenue |
~$20M |
| Products Cleared |
3 FDA clearances |
| Active Pipeline |
10+ programs |
| Employees |
~200 |
¶ Products and Pipeline
Indication: Substance Use Disorder (SUD)
FDA Clearance: 2018 (first FDA-cleared prescription digital therapeutic)
reSET is an FDA-cleared prescription digital therapeutic for treating Substance Use Disorder. It provides cognitive behavioral therapy (CBT) as a monotherapy for patients with SUD. The software delivers interactive therapy sessions, symptom tracking, and relapse prevention training.
Key Features:
- Interactive CBT modules
- Substance use tracking
- Craving and trigger management
- Progress visualization
- Provider dashboard for clinical monitoring
Indication: Opioid Use Disorder (OUD)
FDA Clearance: 2018 (first FDA-cleared digital therapeutic for OUD)
reSET-O is an FDA-cleared prescription digital therapeutic used as an adjunct to buprenorphine-based medication-assisted treatment (MAT) for patients with Opioid Use Disorder. It complements the pharmacological treatment with digital behavioral support.
Key Features:
- Adjunct to buprenorphine treatment
- Interactive therapy modules
- Medication adherence support
- Urge management tools
- Integration with MAT programs
Indication: Chronic pain
FDA Clearance: 2020
Somryst (formerly known as reSET) received FDA clearance for chronic pain management. It represents Pear's expansion beyond substance use disorders into the broader chronic disease space.
Pear has developed digital therapeutic programs specifically for Parkinson's disease, targeting both motor and non-motor symptoms:
- Digital exercise and movement programs
- Gait and balance training modules
- Home-based rehabilitation exercises
- Real-time symptom tracking
- Cognitive behavioral therapy for depression and anxiety
- Sleep hygiene and insomnia management
- Fatigue management strategies
- Digital tools to improve compliance with dopaminergic medications
- Reminder systems and dose tracking
- Integration with medication schedules
- Digital programs supporting LSVT (Lee Silverman Voice Treatment) BIG therapy
- Home practice modules
- Progress monitoring
Pear's development pipeline includes additional digital therapeutics for:
| Product |
Indication |
Development Stage |
| Pear-012 |
Insomnia |
Phase III |
| Pear-013 |
Chronic pain (expanded) |
Phase II |
| Pear-020 |
Schizophrenia cognitive remediation |
Phase II |
| Pear-030 |
Oncology supportive care |
Phase I |
| Pear-040 |
PTSD |
Preclinical |
Pear's products have been validated through multiple clinical trials:
A pivotal randomized controlled trial demonstrated:
- Study: 412 patients with Substance Use Disorder
- Result: 40.3% abstinence rate vs 17.6% in control (p<0.001)
- Endpoint: Drug use abstinence verified by urine testing
- Conclusion: Significantly higher efficacy than standard treatment alone
A pivotal randomized controlled trial demonstrated:
- Study: 507 patients with Opioid Use Disorder
- Result: Improved treatment retention (82% vs 68% at 12 weeks)
- Endpoint: Reduced opioid use verified by urine screening
- Conclusion: Effective adjunct to buprenorphine-based MAT
- Improved healthcare utilization patterns
- Reduced emergency department visits
- Higher patient engagement rates
- Cost-effectiveness demonstrated in payer studies
Pear operates on a prescription-based model that differs from over-the-counter wellness apps:
- Product Sales: Direct sales to healthcare systems and payers
- Prescription Revenue: Pharmacy fulfillment fees
- Licensing: Technology licensing to pharmaceutical partners
¶ Pricing and Reimbursement
- Products prescribed by healthcare providers
- Reimbursed through commercial and government insurance
- Active coverage agreements with major payers
- Integrated with electronic health record systems
- Evidence generation for payer coverage
- Published health economic studies
- Key opinion leader development
- Clinical champion programs
Pear's PD programs target several significant unmet needs in the Parkinson's community:
- Motor Fluctuations: Digital tools for continuous monitoring and exercise-based intervention to reduce "off" time
- Dyskinesias: Movement training programs to improve motor control
- Gait and Balance: Home-based exercise programs for fall prevention
- Depression and Anxiety: CBT modules specifically adapted for PD patients
- Sleep Disorders: Insomnia management and sleep hygiene programs
- Cognitive Impairment: Memory and attention training exercises
- Digital resources for caregivers of PD patients
- Education modules on disease progression
- Care coordination tools
- Home-based exercise programs for gait and balance training
- LSVT BIG therapy support
- Physical therapy integration
¶ Competitive Landscape
The prescription digital therapeutics market is evolving rapidly:
| Company |
Products |
Focus Areas |
Status |
| Pear Therapeutics |
reSET, reSET-O, Somryst |
SUD, OUD, Chronic Pain |
Market leader |
| Akili Interactive |
EndeavorRx |
ADHD |
FDA cleared |
| Happify Health |
n/a |
Depression, anxiety |
Commercial |
| Sword Health |
n/a |
Musculoskeletal |
Commercial |
| Kaia Health |
n/a |
Back pain, COPD |
Commercial |
Pear's approach to FDA clearance has established precedent for the prescription digital therapeutics industry:
- reSET received De Novo clearance (first for a digital therapeutic)
- Established new regulatory classification for software as medical device
- Post-market studies using real-world data
- Continued evidence generation for label expansions
- CE Mark obtained for European commercialization
- Regulatory discussions in Asian markets
- AI-Enhanced Personalization: Machine learning to adapt therapy content based on user behavior
- Biomarker Integration: Incorporation of wearable device data for personalized interventions
- Remote Patient Monitoring: Enhanced integration with connected devices
- Neurological Conditions: Expansion into multiple sclerosis, Alzheimer's cognitive symptoms
- Psychiatric Disorders: Depression, anxiety, PTSD
- Metabolic Diseases: Diabetes management, weight management
- Pharmaceutical Collaborations: Co-promotion with medication manufacturers
- Healthcare System Integration: Deep EHR integration
- Payer Partnerships: Value-based care arrangements