Respiratory Innovation Summit · Strados Labs
Advancing Respiratory Endpoint Science: A Novel, Multi-Modal Approach to Clinical Trial Measures
Delmonico N, Powers R, Au YK MD, Krauss S, McCarty M, deLaubenfels T PhD, Hollatz R RRT · Strados Labs, Inc., Philadelphia PA & Atlanta GA, USA
A fully integrated respiratory endpoint suite
for decentralized and hybrid trials
Patient at Home or Site
Decentralized / Hybrid
Patient captures the full suite of respiratory endpoints at home — continuously, 24/7 — no clinic visit required between assessments
Spirometry
AirNext™ Spirometer
ICC 0.98 vs clinic
FDA 510(k) Cleared · CE Mark
Cough Monitoring
RESP® Biosensor + Watch*
*Watch not a medical device or FDA cleared
94% avg precision
FDA 510(k) Cleared · 24/7 Continuous
Lung Sound Analysis
RESP® Biosensor
†Measure not included in 510(k) clearance
Continuous acoustic
FDA 510(k) Cleared · CE Mark · Acoustic AI
FeNO
NObreath® FeNO
Airway Inflammation
FDA 510(k) Cleared · Single-Exhale
eCOA
eCOA Platform
Multi-language
40+ Instruments
Strados Endpoint Suite
One Unified Data Stream
Patient & Site Interface · All endpoints, one platform
Patient Device
→
Secure Cloud
→
AI + Overread
→
Sponsor Portal
Patient-Facing
Device setup walkthroughs & training
eDiary prompts, reminders & notifications
Real-time compliance feedback
Site-Facing
Subject dashboards & device status
Remote management, all endpoints
5.5M
Minutes of RESP. Data
55+
Clinical Studies
46
Countries
234+
Sites
65+
Publications
Why One Platform?
One data stream — no reconciliation across vendors
Single regulatory submission package
Unified patient app, one training workflow
Remote Access Points
Virtual Coaching
Onboarding, device guidance & study support delivered remotely — eliminating site visit burden
Remote Tech Support
24/7 support across 46 countries — real-time device troubleshooting without travel to site
AI + Expert Validation
CoughCheck™ Algorithm — 94% avg. precision
Certified expert overread · Retained audio · Full audit trail
Real-Time Sponsor & Site Visibility
Sponsor & Site
Sponsor
Real-time multi-arm endpoint data
Protocol deviation alerts
Clean CDISC datasets, audit-ready
Regulatory-accepted evidence package
One partner, all devices
Site
Subject-level compliance dashboards
Remote management of all devices
Automated reminders & eDiary tracking
Reduced site burden — decentralized
Real-time query management
Regulatory Ready
©2026 Strados Labs, Inc. All rights reserved. Strados Labs® and RESP® are registered trademarks. Philadelphia, PA and Atlanta, GA. · stradoslabs.com
Scan for
Publications
Draft 3 · Patient Journey Map · Print → Landscape, 16 × 9 in, no margins, 100% scale.
