Pear Therapeutics

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<div class="infobox-header">Pear Therapeutics</div>
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<table>
<tr><th>Headquarters</th><td>Boston, MA</td></tr>
<tr><th>Founded</th><td>2013</td></tr>
<tr><th>Status</th><td>Public (NASDAQ: PEAR)</td></tr>
<tr><th>FDA Clearances</th><td>3 products</td></tr>
<tr><th>Focus</th><td>Prescription Digital Therapeutics</td></tr>
</table>
</div>
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Overview

<div class="infobox">
<div class="infobox-header">Pear Therapeutics</div>
<div class="infobox-content">
<table>
<tr><th>Headquarters</th><td>Boston, MA</td></tr>
<tr><th>Founded</th><td>2013</td></tr>
<tr><th>Status</th><td>Public (NASDAQ: PEAR)</td></tr>
<tr><th>FDA Clearances</th><td>3 products</td></tr>
<tr><th>Focus</th><td>Prescription Digital Therapeutics</td></tr>
</table>
</div>
</div>

Overview

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["@pear"].

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.

Financial Overview

| Metric | Value |
|--------|-------|
| IPO | 2021 (NASDAQ: PEAR) |
| 2024 Revenue | ~$20M |
| Products Cleared | 3 FDA clearances |
| Active Pipeline | 10+ programs |
| Employees | ~200 |

Products and Pipeline

FDA-Cleared Products

reSET

Indication: Substance Use Disorder (SUD) FDA Clearance: 2018 (first FDA-cleared prescription digital therapeutic)[@fda2018]

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

reSET-O

Indication: Opioid Use Disorder (OUD) FDA Clearance: 2018 (first FDA-cleared digital therapeutic for OUD)[@fda2018a]

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

Somryst

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.

Parkinson's Disease Programs

Pear has developed digital therapeutic programs specifically for [Parkinson's disease](/diseases/parkinsons-disease), targeting both motor and non-motor symptoms:

Motor Symptom Management

• Digital exercise and movement programs
• Gait and balance training modules
• Home-based rehabilitation exercises
• Real-time symptom tracking

Non-Motor Symptom Management

• Cognitive behavioral therapy for depression and anxiety
• Sleep hygiene and insomnia management
• Fatigue management strategies

Medication Adherence

• Digital tools to improve compliance with dopaminergic medications
• Reminder systems and dose tracking
• Integration with medication schedules

Speech Therapy Support

• Digital programs supporting LSVT (Lee Silverman Voice Treatment) BIG therapy
• Home practice modules
• Progress monitoring

Pipeline Products

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 |

Clinical Evidence

Pear's products have been validated through multiple clinical trials:

reSET Clinical Trial[@clinical]

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

reSET-O Clinical Trial[@clinicala]

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

Real-World Evidence

• Improved healthcare utilization patterns
• Reduced emergency department visits
• Higher patient engagement rates
• Cost-effectiveness demonstrated in payer studies

Business Model

Pear operates on a prescription-based model that differs from over-the-counter wellness apps:

Revenue Streams

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

Market Access Strategy

• Evidence generation for payer coverage
• Published health economic studies
• Key opinion leader development
• Clinical champion programs

Parkinson's Disease Strategy

Pear's PD programs target several significant unmet needs in the Parkinson's community:

Motor Complications

Non-Motor Symptoms

Caregiver Support

• Digital resources for caregivers of PD patients
• Education modules on disease progression
• Care coordination tools

Rehabilitation Focus

• 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 |

Regulatory Pathway

Pear's approach to FDA clearance has established precedent for the prescription digital therapeutics industry:

De Novo Classification

• reSET received De Novo clearance (first for a digital therapeutic)
• Established new regulatory classification for software as medical device

Real-World Evidence

• Post-market studies using real-world data
• Continued evidence generation for label expansions

International Regulatory

• CE Mark obtained for European commercialization
• Regulatory discussions in Asian markets

Future Directions

Technology Development

Pipeline Expansion

Strategic Partnerships

Cross-References

• [Parkinson's Disease Treatment](/therapeutics/parkinsons-disease-treatment)](/therapeutics)
• [Digital Therapeutics Overview](/therapeutics/digital-therapeutics)](/therapeutics)
• [LSVT Global](/companies/lsvt-global)](/companies/lsvt-global)
• [Click Therapeutics](/companies/click-therapeutics)](/therapeutics)
• [Hinge Health](/companies/hinge-health)

References