Internal Tool · Strados Labs
Endpoint Suite Brochure
2 pages · 8.5 × 11 in (816 × 1056 px @ 96dpi) · For internal use
Page 1 — Cover / Front
Respiratory Endpoint Intelligence
Strados
Endpoint
Suite
The only unified platform delivering the full spectrum of respiratory endpoints — from spirometry to cough to eCOA — under a single contract, single integration, and single point of accountability.
Five Integrated Endpoints
AirNext™
Digital Spirometry
FEV₁ · FVC · PEF
NObreath®
FeNO Measurement
T2 Inflammation
RESP® Biosensor
Cough & Lung Sounds
FDA Cleared
RESP® Watch
Wrist Cough Monitor
24/7 Passive
eCOA Platform
Patient-Reported Outcomes
Multi-language56+
Clinical Trials
46
Countries
2M+
Coughs Captured
2,500+
Kit Shipments
243
Clinical Sites
"Making Every Breath Count™"
stradoslabs.com
©2026 Strados Labs, Inc. · For internal use only.
sales@stradoslabs.com · Philadelphia, PA
8.5 × 11 in · 816 × 1056 px
Page 2 — Endpoint Detail / Back
Strados Labs · Endpoint Suite
Five Endpoints. One Platform.
AirNext™ Digital Spirometry
Primary / Secondary Endpoint
FEV₁ · FVC · FEV₁/FVC · PEF · FEF25-75
ATS/ERS 2019 certified · Home & clinic
ICC = 0.98 vs. in-clinic spirometry
AI-assisted QA grading + RT overread
FeNO — NObreath®
Enrichment Biomarker / Primary
FeNO (ppb) · T2 Inflammation Phenotype
Single-exhale, no daily QC required
5.5× more T2 detection vs. clinic alone
Age 7+ · adult & adolescent modes
RESP® Biosensor
Primary Endpoint — Cough Frequency
Cough · Wheeze · Crackles · RR · HR · Activity
FDA 510(k) cleared chest-worn wearable
94% avg. precision · CoughCheck™ DNN
FDA CDER · EMA · NMPA accepted
RESP® Watch
Secondary / Exploratory Endpoint
Cough Events · Sleep · SpO₂ · Activity · ECG
Samsung Galaxy Watch 8 · 24-hr passive
Nocturnal & diurnal cough profiling
Cloud AI + optional human review
eCOA Platform
Secondary / Primary Endpoint
ACQ · CAT · SGRQ · mMRC · ePRO Diaries
40+ validated COA instruments
Multi-language · Reminders · Gamification
Unified with device data in RESP® Cloud
Data Pipeline
Collect
Devices capture 24/7 real-world data
AI Classify
CoughCheck™ DNN + spirometry QA
Expert Review
RT/MD annotation & overread
Deliver
CDISC-ready · EDC push · portal
Compliance & Certs
FDA Cleared 510(k)
RESP® Biosensor & AirNext™
CE Mark · EU MDR
All active devices
ISO 13485:2016
Quality management system
21 CFR Part 11
Electronic records & audit trails
GDPR & HIPAA
US & EU patient data privacy
CDISC Ready
SDTM/ADaM submission datasets
Therapeutic Areas
Contact Us
sales@stradoslabs.com
stradoslabs.com
©2026 Strados Labs, Inc. · For internal use only. Data on file.
8.5 × 11 in · 816 × 1056 px
