Hyfe
Hyfe is a digital health AI company that builds privacy-preserving, on-device acoustic cough detection for pharmaceutical clinical trials, academic respiratory research, and consumer wellness, anchored by its CoughMonitor Suite endpoint product and a ResolveDTx digital therapeutic for chronic cough.
- Company typePrivate
- Founded2020
- HeadquartersWilmington, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Hyfe does
Hyfe Inc. is a Wilmington, Delaware-incorporated digital health company founded in 2020 that builds privacy-preserving, on-device acoustic AI for continuous cough detection and monitoring. Its proprietary two-model architecture runs entirely on-device, analyzing timestamps rather than recording audio, and has been trained on what the company describes as the world's largest cough dataset of more than 700 million samples. The product portfolio spans the CoughMonitor Suite (a wrist-worn wearable, companion app, and dashboard providing regulatory-grade cough frequency endpoints for clinical trials), ResolveDTx (a digital therapeutic for cough hypersensitivity using Behavioral Cough Suppression Therapy), the CoughPro consumer wellness app for iOS and Android, the CoughWatch wearable, and the in-development Hyfe Cough Diary positioned for FDA clearance.
Hyfe monetizes primarily through per-participant or per-study subscription contracts with pharmaceutical sponsors, CROs, and academic researchers using the CoughMonitor Suite in 50+ clinical trials and research studies; through milestone payments and royalties on the KYORIN-led ResolveDTx digital therapeutic for Japan; through SDK/API licensing into third-party platforms (including ActiGraph's FDA-cleared LEAP wearable and ObvioHealth's decentralized trial platform); and indirectly through the freemium CoughPro consumer app, which serves as both a brand-awareness funnel and a continuous data-collection layer for model retraining. Distribution combines enterprise field sales for pharma and research accounts, OEM/embedded integration for device partners, and consumer app stores for the wellness product.
The company's strategic positioning is to convert cough from an unmeasured, subjective symptom into a quantitative digital biomarker and regulatory-grade endpoint for drug development, targeting an RCC market the company estimates at roughly $9B today growing to $14-15B by 2035 with zero FDA-approved antitussive competitors. Recent strategic moves — including the KYORIN partnership, the 2026 pivotal-trial primary endpoint agreement, the ActiGraph LEAP integration, and the December 2023 transition to a non-founder CEO — indicate a deliberate shift from founder-led research to commercial and regulatory scaling.
Hyfe firmographics
Firmographics- Name
- Hyfe
- Legal name
- Hyfe Inc.
- Website
- https://hyfe.com
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Hyfe is a digital health AI company that builds privacy-preserving, on-device acoustic cough detection for pharmaceutical clinical trials, academic respiratory research, and consumer wellness, anchored by its CoughMonitor Suite endpoint product and a ResolveDTx digital therapeutic for chronic cough.
- Ownership category
- akta.pro rank
Hyfe industry classification
Industry- Product category
- Digital Respiratory Health / Cough Monitoring AI
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Respiratory & Sleep RPM (COPD, asthma, sleep apnea) (HLALAFAB)
- akta.pro secondary industry
- Medical Device Connectivity & Interoperability Middleware (MDI, EHR/HL7/FHIR Integration) (HLACAPAJ)
Keywords
Where Hyfe is headquartered
LocationHeadquarters
- HQ city
- Wilmington
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Hyfe business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- CoughMonitor Suite: Continuous cough monitoring endpoints for clinical trials and drug development. Priced per-participant or per-study models depending on deployment scope, duration, level of integration and support, and regulatory and validation requirements. Used by pharmaceutical sponsors, CROs, and academic researchers.
- ResolveDTx Digital Therapeutic: Prescription digital therapeutic platform for cough hypersensitivity combining cough monitoring, real-time feedback loops, and behavioral cough suppression therapy. Partnership with KYORIN Pharmaceuticals for Japanese market with milestone payments and royalties.
- CoughPro Consumer App: Leading wellness app for monitoring cough available on iPhone and Android. Free consumer application with premium features, generating user base for brand awareness and potential upsell to clinical-grade features.
- SDK/API Licensing: Flexible integration into digital health ecosystems via APIs and SDKs. Hyfe's cough detection models integrated into third-party platforms and devices such as ActiGraph's LEAP wearable.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | CoughMonitor Suite - Clinical Trials |
| Freemium | Monthly | CoughPro Consumer App |
| Other | Multi-year contract | SDK/API Integration |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels6 records
Hyfe product offering
Product offeringCore offering
Hyfe builds a privacy-preserving, on-device acoustic AI platform that detects and monitors cough sounds without recording audio. Its CoughMonitor Suite provides continuous, regulatory-grade cough frequency endpoints for clinical trials and drug development, while ResolveDTx delivers prescription digital therapeutics for chronic cough, and CoughPro offers a consumer wellness app. The company serves pharmaceutical sponsors, CROs, academic researchers, and individuals with a platform-plus-products architecture centered on transforming cough into a quantifiable digital biomarker.
Product overview
Hyfe is a digital biomarker and digital endpoint company offering a platform-plus-products architecture centered on privacy-preserving, on-device AI cough detection. The core technology transforms ambient sound into clinically meaningful, quantitative cough data without recording audio. The product portfolio includes: (1) CoughMonitor Suite — the primary research tool for clinical trials, comprising CoughWatch wearable, Companion App, and Dashboard; (2) ResolveDTx — a digital therapeutic platform for chronic cough using Behavioral Cough Suppression Therapy; (3) CoughPro — a consumer wellness app for individual cough tracking; and (4) Hyfe Cough Diary — an FDA-clearance-track medical device. Products share core AI detection technology while targeting different segments: pharma/clinical research (CoughMonitor Suite), patients/providers (ResolveDTx), and consumers (CoughPro). An SDK enables third-party platform integration.
Differentiator
Problem solved
Functional benefit
Brands
- CoughMonitor Suite: Continuous cough monitoring endpoints for clinical trials and drug development. Objective, validated, and regulatory-ready.
- ResolveDTx
- CoughPro
- CoughWatch
- Cough Diary
Products and services
- CoughMonitor Suite
Quantifiable outcome
- 41.8% reduction in cough frequency in DTx proof-of-concept study
- +5 more outcomes
Companies that use Hyfe
Customer profileNamed customers7 records
Segments4 records
Ideal customer profiles3 records
Hyfe technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration4 records
AI capability5 records
Feature8 records
Hyfe partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered flagship, core and minor.
- KYORIN Pharmaceutical Co. Ltd.flagshipStrategic partnership for development and commercialization of the world's first prescription digital therapeutic to treat chronic cough in the Japanese market. Built on proven principles of Behavioral Cough Suppression Therapy (BCST) and powered by Hyfe's advanced cough monitoring technology. Includes milestone payments and royalties. This collaboration marks a significant milestone in leveraging advanced digital therapeutics to address a debilitating condition affecting millions worldwide.
- ActiGraphcoreFormal product launch of the ActiGraph-Hyfe combined digital health solution on ActiGraph's LEAP wearable platform. Integration of Hyfe's cough detection into ActiGraph's FDA-cleared wearable for clinical research. Hyfe's cough detection models run natively in Ametris' category-leading LEAP device.
- MerckcorePartnership to integrate Hyfe's AI cough tracker into Merck's consumer disease education efforts targeting an estimated 12 million U.S. adults with chronic cough. Joint marketing and education collaboration.
- Creative Destruction LabminorHyfe joined the Creative Destruction Lab accelerator program in 2021 for business development and mentorship support.
- Plug and Play VenturesminorHyfe joined the Plug and Play accelerator program in February 2021 and participated in their Health Engine Accelerator programs. Closed ~$1M seed round with participation from Plug and Play Ventures.
- Health Engine AcceleratorminorHyfe joined the Health Engine Accelerator program in 2021 for healthcare startup development and validation support.
- University of NavarraminorYear-long respiratory research trial partnership with University of Navarra, Zizur's Health Center, and Montreal University Hospital Center using Hyfe's app.
Scale indicators16 records
Recent moves6 records
Expansion highlights6 records
Hyfe competitors and assessment
Company assessmentEmerging players
- VitalConnect: VitalConnect provides FDA-cleared biosensor patches and a remote cardiac/respiratory monitoring platform used in clinical trials and hospital RPM. Comparable as an RPM hardware + cloud platform vendor whose channels overlap with Hyfe's pharma and clinical research customers.
- Cohero Health: Cohero Health develops connected respiratory devices and RPM platforms for asthma and COPD patients. Comparable as a digital respiratory health player using connected devices and patient-reported data, though with a different sensor approach than Hyfe's acoustic AI.
- Sonavi Labs: Sonavi Labs makes a FDA-cleared AI-powered digital stethoscope (Feelix) for auscultation and respiratory/cough analysis. Comparable in combining acoustic AI with a clinical-grade hardware device for respiratory assessment.
Broad incumbents
- ResMed: ResMed is the global leader in connected respiratory care (sleep apnea, COPD, asthma) with cloud-connected devices, RPM infrastructure, and large pharma services. Comparable as a broad incumbent whose respiratory franchise could expand into cough monitoring and digital endpoints.
- Propeller Health (ResMed): Propeller Health, now part of ResMed, is a leading digital respiratory health platform for asthma and COPD using connected inhalers and RPM. Comparable as a digital respiratory health platform serving pharma and providers, though its focus is inhaler adherence rather than cough.
- Philips Respiratory Care: Philips has a large respiratory care portfolio (ventilators, CPAP, sleep & respiratory RPM). Comparable as a broad incumbent with the clinical relationships, regulatory footprint, and device installed base to enter cough monitoring and digital endpoints.
Direct peers
- Strados Labs: Strados Labs develops AI-enabled wearable respiratory monitoring (RESP® Biosensor) that captures lung sounds including cough. Directly comparable to Hyfe in using acoustic AI and wearables to objectively measure cough and other respiratory biomarkers for clinical trials and remote monitoring.
- ActiGraph: ActiGraph is a partner of Hyfe and a leading clinical-grade wearable (LEAP) and digital health platform for clinical research and trial endpoints. Comparable as a wearable + endpoint infrastructure vendor serving pharma and academic sponsors — and an integration partner whose installed base amplifies Hyfe's distribution.
- ResApp Health (Pfizer): ResApp (acquired by Pfizer) developed AI algorithms to analyze cough and respiratory sounds for disease diagnosis and monitoring. Highly comparable to Hyfe's cough-detection AI for clinical and telehealth use cases.
- Eko Health: Eko Health combines digital stethoscopes with AI to analyze heart and lung sounds, including cough and respiratory abnormalities. Directly comparable as an AI-driven acoustic cardiopulmonary analysis platform with FDA-cleared devices used in clinical settings.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Hyfe social profiles
Digital presenceHyfe compliance and trust
Trust signalCompliance3 records
Hyfe financial estimates
Financial estimateRevenue estimate
Valuation estimate
Hyfe leadership team
Management profileNumber of profiles
Profiles7 records
Hyfe funding detail
Funding detailFunding overview
Funding rounds2 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Hyfe M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Hyfe
What does Hyfe do?
Hyfe builds a privacy-preserving, on-device acoustic AI platform that detects and monitors cough sounds without recording audio. Its CoughMonitor Suite provides continuous, regulatory-grade cough frequency endpoints for clinical trials and drug development, while ResolveDTx delivers prescription digital therapeutics for chronic cough, and CoughPro offers a consumer wellness app. The company serves pharmaceutical sponsors, CROs, academic researchers, and individuals with a platform-plus-products architecture centered on transforming cough into a quantifiable digital biomarker.
Is Hyfe a public or private company?
Hyfe is a private company. It is classified as venture growth investor backed and is currently operating.
When was Hyfe founded?
Hyfe was founded in 2020. It employs 11 to 50 people.
Where is Hyfe based?
Hyfe is headquartered in Wilmington, United States, in the North America region.
How does Hyfe make money?
Four revenue lines are on record. CoughMonitor Suite is the primary driver. The others are resolveDTx Digital Therapeutic, coughPro Consumer App and SDK/API Licensing.
Who are Hyfe's main competitors?
Emerging players on record are VitalConnect, Cohero Health and Sonavi Labs. Broad incumbents are ResMed, Propeller Health (ResMed) and Philips Respiratory Care. Direct peers are Strados Labs, ActiGraph, ResApp Health (Pfizer) and Eko Health.
Does Hyfe have an API?
Yes. Hyfe provides API-based access to derived cough data for downstream analysis. Typical formats support standard statistical workflows (e.g., CSV or structured JSON outputs). The API enables integration of cough data into EDC systems, data warehouses, or analytics platforms. Hyfe also offers SDKs for flexible integration into digital health ecosystems.
What industry is Hyfe in?
Hyfe's product category is Digital Respiratory Health / Cough Monitoring AI. Its primary akta.pro industry code is HLALAFAB, Respiratory & Sleep RPM (COPD, asthma, sleep apnea), with a secondary code of HLACAPAJ, Medical Device Connectivity & Interoperability Middleware (MDI, EHR/HL7/FHIR Integration). Its SIC code is 3841.