Internal Tool · Strados Labs

Endpoint Suite Brochure — Website Theme

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Page 1 — Cover

Strados Labs
FDA 510(k) ClearedCE MarkISO 13485HIPAA Compliant

The full spectrum of respiratory endpoints.
One partner.

Spirometry, cough monitoring, FeNO, lung sound analysis, and eCOA — validated and integrated across the Strados Endpoint Suite. One data stream. One specialist partner.

Explore the Strados Endpoint Suite

Strados Endpoint Suite

55+ Clinical Trials46 Countries2,500+ Kit Shipments
Air Next spirometer

Spirometry

Air Next spirometer

Primary / Secondary / Exploratory
FEV₁FVCFEV₁/FVCPEFFEF25-75

ICC = 0.98 vs. in-clinic · Home & clinic · ArtiQ AI QA + RT overread · Flexible deployment

FDA 510(k) Cleared · CE Mark · ATS/ERS 2019

RESP® Biosensor + RESP® WatchRESP® Biosensor + RESP® Watch

Cough Monitoring

RESP® Biosensor + RESP® Watch

Primary / Secondary / Exploratory / Sub-study
24-hr Cough FrequencyCough BoutsNocturnal CoughCough Intensity

Continuous 24/7 · CoughCheck™: 97.4% precision · 95.7% sensitivity · Aligned with primary endpoint requirements · Retained audio

FDA 510(k) Cleared* · CE Mark* · HIPAA Compliant

*Includes RESP® Biosensor only

RESP® Biosensor

Lung Sound Analysis

RESP® Biosensor

Exploratory / Sub-study
WheezeCracklesRhonchiStridorRespiratory Rate†Heart Rate†Breathing Patterns†Orientation†Actigraphy†

†Measure not included in FDA clearance

Continuous chest-worn · AI detection + pulmonologist overread · Diurnal & nocturnal profiling

FDA 510(k) Cleared · CE Mark · HIPAA Compliant

via NObreath®

FeNO

via NObreath®

Primary / Secondary / Exploratory
FeNO (ppb)Airway Inflammation

Single-exhale maneuver · No daily QC · Peer-reviewed top-tier usability · Population breadth · Supply ready

FDA 510(k) Cleared · CE Mark · Single-Exhale

Respiratory PROs

eCOA

Respiratory PROs

Primary / Secondary / Exploratory
ACQCATSGRQmMRCLCQePRO DiariesQoL

Multi-language · Reminders · Gamified adolescent interface

Software · 40+ Validated Instruments

©2026 Strados Labs, Inc. · stradoslabs.com

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Page 2 — Endpoint Detail

Strados Labs · Endpoint Suite

Intelligence. Evidence. Partnership.

Strados Labs

The Intelligence Advantage

Human-validated.
AI-driven.
Endpoint-ready.

Patient coughing

Continuous by design.

Episodic clinic visits miss the disease burden that lives between appointments. Strados captures what matters continuously — in patients' daily lives — for every endpoint in the suite.

Retained. Reviewable. Auditable.

AI detects. Experts review. Audio is retained. The full evidence chain — from capture to annotation to audit — is preserved. This is what separates Strados from algorithm-only solutions.

Intelligence is the standard.

Every data point is traceable, defensible, and built for regulatory submission — reviewed, annotated, and audit-ready from the moment it is captured.

55+

Clinical Trials

2M+

Coughs Captured

60M+

Breaths Captured

46

Countries

243

Clinical Sites

2,500+

Kit Shipments

Why Strados

Why Partner with Strados?

Respiratory specialists.

Patient and physician founded. Every product, every hire, every decision is made in service of respiratory medicine.

Scientific rigor.

FDA cleared, peer-reviewed algorithms, retained audio, GCP-aligned — built for pivotal trials from day one.

Real-world capture.

Continuous ambulatory monitoring captures what clinic visits miss — the disease burden patients actually live with.

One partner. No gaps.

From spirometry to cough to eCOA — the Strados Endpoint Suite, one data stream, one specialist partner.

Proven global scale.

55+ trials, 46 countries, 2,500+ kit shipments — the operational infrastructure to support your global program.

Endpoint-ready.

Full audit trails, calibration logs, and data lineage — ready for regulatory review.

Ready to design your respiratory study?

Tell us about your program and we'll design the right respiratory endpoint strategy — from study design to data submission.

Strados Labs · incorporating the clinical trial capabilities of NuvoAir

Making every breath count®

Get in touch

sales@stradoslabs.com

stradoslabs.com

©2026 Strados Labs, Inc. · stradoslabs.com

stradoslabs.com

8.5 × 11 in · 816 × 1056 px

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