# Hyfe — Full Site Description ## What is Hyfe? Hyfe makes cough measurable as an objective, continuous signal and endpoint, moving respiratory research beyond subjective reports and short cough recording windows. Using validated, privacy-preserving, on-device detection, Hyfe quantifies cough frequency and patterns in real-world conditions with high participant adherence, enabling more sensitive endpoints and clearer characterization of cough variability over time. Hyfe is built to deliver regulator-grade objective cough endpoints and trend insights — including cough bouts, cough-free time, and cough variability — without adding burden for patients, sites, or study teams. Hyfe is headquartered in the United States and operates globally. ## Why Continuous Cough Monitoring Cough is highly variable. Spot checks and short recording windows miss signal. Continuous monitoring captures real-world data and the actual nature of coughing — whether someone is producing isolated coughs or long coughing bouts — which matters both for patient experience and for endpoint sensitivity. Continuous objective cough endpoints have direct implications for clinical trial design: - Smaller studies with better signal - Higher endpoint sensitivity and statistical power - More informed asset development decisions - Early detection of antitussive signal in new programs Hyfe turns cough from a subjective, episodic symptom into a continuous, objective, high-resolution digital biomarker, enabling more reliable endpoints, better-designed trials, and clearer characterization of drug effect. ### As a primary or major efficacy endpoint Design shorter, smaller, more precise trials with continuous cough monitoring as your primary endpoint. ### As a secondary endpoint Expand your label with antitussive or cough-dynamics related quality of life claims. ### As an exploratory endpoint Investigate potential antitussive signal early in asset development. ## Privacy-Preserving and Patient-First by Design Hyfe delivers clinically reliable data with exceptional adherence because it is passive, privacy-preserving, and patient-first by design: - **On-device processing** — no raw audio is stored or transmitted; no conversations can be listened to at any point - **Passive monitoring** — no behavior change required from participants - **Proven adherence** in long-duration studies - **Smooth IRB and ethics approvals** due to privacy architecture - **Sleek, lightweight smartwatch form factor** — no adhesives, pendants, or belt-worn devices This approach makes sites, investigators, and IRBs more comfortable, improving trial execution and data completeness. ## Regulatory Context Objective cough frequency is being used as a primary and major efficacy endpoint in FDA-reviewed chronic cough programs. Regulatory expectations are increasingly explicit about measurement validity, traceability, and interpretability. Hyfe is built to meet these expectations with validated, privacy-safe continuous cough monitoring. ## Products ### CoughMonitor Suite Hyfe's flagship cough monitoring platform for pharmaceutical clinical trials and respiratory research. Provides continuous, automated cough counting with AI validated against human expert annotators. Designed for decentralized and hybrid clinical trials. HIPAA and GDPR compliant. More information: https://www.coughmonitor.com ### ResolveDTx A configurable digital therapeutic pairing continuous cough monitoring with behavioral cough suppression therapy (BCST). Available as a standalone therapeutic, adjunctive therapy, or flexible hybrid model. Customizable for different indications and commercial partners. More information: https://www.resolvedtx.com ## Solutions - **Research** — Cough monitoring for pharma/biotech clinical trials. https://www.hyfe.com/solutions/research - **Life Sciences** — Real-world evidence and endpoint development. https://www.hyfe.com/solutions/life-sciences - **Virtual Care** — Remote patient monitoring integrations. https://www.hyfe.com/solutions/virtual-care ## Partners and Collaborators Hyfe partners with KYORIN Pharmaceutical. Academic research collaborators include Johns Hopkins University, Imperial College London, McGill University, and the University of California San Francisco (UCSF). ## Compliance HIPAA and GDPR compliant. On-device audio processing ensures no raw audio is stored or transmitted. ## Company - Website: https://www.hyfe.com - About: https://www.hyfe.com/about - Team: https://www.hyfe.com/team - Advisors: https://www.hyfe.com/advisors - Careers: https://www.hyfe.com/careers - FAQ: https://www.hyfe.com/faq - LinkedIn: https://www.linkedin.com/company/hyfe/ - YouTube: https://www.youtube.com/@hyfe ## Resources - Publications: https://www.hyfe.com/publications - Insights: https://www.hyfe.com/insights - White Papers: https://www.hyfe.com/white-papers - News: https://www.hyfe.com/news - Science Resources: https://www.hyfe.com/science-resources - Company Resources: https://www.hyfe.com/company-resources