# CoughMonitor Suite — Hyfe Inc.
# Full content version for AI retrieval systems (llms-full.txt)

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## Homepage — coughmonitor.com

### What is CoughMonitor Suite?

Hyfe is the global leader in continuous cough monitoring in clinical trials. The CoughMonitor Suite — Hyfe's flagship platform designed specifically for clinical research — delivers validated, objective cough frequency data. It has been deployed across the clinical development pipeline from Phase 1 to Phase 3, with multiple top ten global pharma companies, Nocion Therapeutics, KYORIN Pharmaceuticals, and many leading academic institutions.

The platform enables passive, continuous cough monitoring as a clinical endpoint. It requires no active patient participation — acoustic AI technology monitors and counts coughs automatically in the background.

### Who is CoughMonitor Suite for?

- **Pharmaceutical sponsors** designing clinical trials where cough is a primary or secondary endpoint
- **Contract Research Organizations (CROs)** managing multi-site respiratory studies
- **Academic and clinical researchers** conducting studies on cough as a clinical measure
- **Biotech companies** developing treatments where cough frequency is a relevant outcome

### Key Features

- Passive acoustic cough detection — AI identifies cough sounds automatically without patient effort
- Continuous real-world monitoring — captures cough frequency throughout daily life, not only in clinic
- Validated against manual cough counting — clinically validated accuracy
- eClinRO integration — compatible with electronic clinical outcome assessment platforms
- EDC export — data exports in formats compatible with major Electronic Data Capture systems
- Cloud infrastructure — secure, scalable data storage and analysis
- HIPAA and GDPR compliant data handling
- Multi-site clinical trial support

### Clinical Evidence

CoughMonitor Suite has been validated in peer-reviewed clinical studies. Validation studies assess the system's sensitivity and specificity for cough detection compared to manual gold-standard cough counting methods. Clinical validation data is available upon request via validation.hyfe.com.

### Partners and Academic Collaborators

Hyfe Inc. works with leading pharmaceutical companies and academic medical centers globally, including:

- **KYORIN Pharmaceuticals** — pharmaceutical partner
- **Nocion Therapeutics** — pharmaceutical partner
- Multiple additional top 10 global pharma companies

Academic collaborators include researchers at:
- Johns Hopkins University
- Imperial College London
- McGill University
- University of California San Francisco (UCSF)

### Regulatory and Compliance

- **Data privacy**: HIPAA compliant (United States), GDPR compliant (European Union)

### How CoughMonitor Works

1. **Device or app**: Patients use a designated device or smartphone application that passively records acoustic data
2. **AI detection**: Hyfe's acoustic AI algorithm identifies and counts cough events in real time
3. **Cloud upload**: Data is securely transmitted to Hyfe's cloud infrastructure
4. **Dashboard and export**: Investigators access cough frequency data through a clinical dashboard; data is exportable to EDC systems in standard formats
5. **Study reporting**: Aggregated and individual-level cough data feeds into clinical trial statistical analysis

### About Hyfe Inc.

Hyfe Inc. is a digital health company that develops AI-powered acoustic monitoring technology for respiratory health. The company is focused on establishing cough as an objective, validated clinical endpoint for use in pharmaceutical drug development and clinical research.

- Website: hyfe.com
- LinkedIn: https://www.linkedin.com/company/hyfe/
- YouTube: https://www.youtube.com/@hyfe

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## Privacy Policy — coughmonitor.com/privacy-policy

The privacy policy covers how Hyfe Inc. collects, stores, processes, and protects data gathered through the CoughMonitor Suite platform. It addresses GDPR compliance for European users and HIPAA compliance for U.S. clinical data. Full details are available at coughmonitor.com/privacy-policy.

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Last updated: March 2026