Respiratory Innovation Summit · Presented by 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
Background & Objective
Episodic clinic visits fail to capture the full burden of respiratory disease between appointments
No single suite has previously integrated cough, lung sounds, spirometry, FeNO, and eCOA into one unified data stream
We introduce a novel end-to-end endpoint suite combining wearable sensing, AI acoustic analysis, and expert human validation
Designed to enable continuous, decentralised measurement of lung health — from anywhere, at any time
Therapeutic Areas
Spirometry · Cough · eCOA
Spirometry · FeNO · Cough · Lung Sounds · eCOA
Cough · Spirometry · eCOA
Spirometry · eCOA
Cough · Lung Sounds · eCOA
RESP® Watch · Biosensor · eCOA
Compliance & Quality
Leadership
Nick Delmonico
President & CEO
Richard Powers
COO / CPO
Jason Kroh
CTO
Matthew McCarty
CCO
Innovations · Novel Endpoint Technologies & Analytical Performance
Spirometry
AirNext™ Spirometer · FDA Cleared · CE Mark · ATS/ERS 2019
Primary / SecondaryMeasures
FEV₁, FVC, FEV₁/FVC, PEF, FEF₂₅₋₇₅ · Flow-volume loops
Technology & Validation
Validated performance: ICC = 0.98 vs. in-clinic spirometry · Home & clinic decentralised design · ArtiQ AI QA + RT overread
Cough Monitoring
RESP® Biosensor + RESP® Watch · FDA 510(k) · Continuous 24/7
Primary / SecondaryMeasures
24-hr Cough Frequency · Cough Bouts · Nocturnal Cough · Cough Intensity
Technology & Validation
CoughCheck™ DNN validated at 94% avg. precision · Regulatory acceptance: FDA CDER, EMA & NMPA · Retained audio + full expert overread
Lung Sound Analysis
RESP® Biosensor · FDA 510(k) · CE Mark · Acoustic AI
Secondary / ExploratoryMeasures
Wheeze · Crackles · Rhonchi · Stridor · Respiratory Rate · Heart Rate
Technology & Validation
AI classification validated against expert pulmonologists · Continuous diurnal & nocturnal acoustic profiling capability
FeNO
NObreath® FeNO · FDA 510(k) · CE Mark · Single-Exhale
Primary / EnrichmentMeasures
FeNO (ppb) · T2 Inflammation Phenotype · Airway Inflammation
Technology & Validation
Serial home monitoring designed to detect T2 inflammation more frequently than single clinic visits · Beeh KM et al. Pulm Ther. 2025
eCOA
eCOA · Software · 40+ Validated Instruments
Primary / SecondaryMeasures
ACQ · CAT · SGRQ · mMRC · LCQ · ePRO Diaries · QoL
Technology & Validation
Multi-language · Unified with RESP® Cloud — one integrated data stream · Designed to improve retention and compliance vs. paper
Endpoint Suite At a Glance
55+
Clinical trials
42
Countries deployed
94%
CoughCheck™ avg. precision
0.98
Spirometry ICC vs. clinic
5.5×
FeNO T2 detection vs. clinic
2,500+
Kit shipments
Expected Insights & Potential
This end-to-end suite is positioned to generate novel respiratory insights not previously accessible in clinical trials:
Continuous 24/7 capture expected to reveal nocturnal and diurnal cough patterns invisible to clinic visits
Serial home FeNO monitoring may detect T2 inflammation phenotypes missed by single clinic measurements
Home spirometry at high frequency enables longitudinal lung function profiling between site visits
Unified cough, lung sound, spirometry, FeNO, and eCOA data streams enable multimodal disease characterisation
Decentralised design supports broader, more diverse patient populations across geographies
stradoslabs.com · sales@stradoslabs.com
Disclosures: All authors are employees of Strados Labs, Inc. · Funding: Strados Labs, Inc. · © 2025 Strados Labs, Inc. All rights reserved. Strados Labs®, RESP®, CoughCheck™, AirNext® are registered trademarks of Strados Labs, Inc.
stradoslabs.com
sales@stradoslabs.com · Philadelphia, PA & Atlanta, GA
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