Cough & Lung Sound Endpoints for Clinical Trials

The RESP® Platform

FDA 510(k) Cleared | CE Mark (Biosensor only)

Remote Respiratory Monitoring: RESP Biosensor

Technology Overview

The Strados Labs RESP® Platform enables life sciences teams to objectively measure respiratory symptoms and physiological signals in daily life, providing greater insight into treatment response and differentiation across clinical programs.

Patient-Friendly: Wireless, discreet form factor and privacy-preserving

Multi-Parameter: Comprehensive respiratory and physiological measures that matter to patients

Validated Reporting: Automated or manual (human) overread to meet endpoint requirements

Clients & Partners

Measures

A robust combination of measures that reflect how patients feel and function

- - - - Cough Frequency (24-hour)
      - Cough Bouts
      - Cough Sound Intensity
      - Wheeze, Rhonchi, Crackles
      - Breathing Patterns*
      - Respiratory Rate*
      - Heart Rate & Heart Rate Variability*
      - Orientation (e.g. Supine or Upright)*
      - Sleep/Wake*
      - Activity Levels*

*Measurement not FDA cleared but may be collected in clinical trials

Metrics-at-a-Glance

1.5M

Lung Sounds Captured

50M

Breaths Captured

5

Continents

34

Countries

36

Languages

245

Sites

Device Selection for Varying Applications

Digital Measures for Multiple Indications

	Cough	Wheeze	Crackles	Rhonchi	Respiratory Rate*	Heart Rate*	Activity*
Chronic Cough
Pulmonary Fibrosis
Bronchiectasis
COPD
Asthma
Infectious Diseases
Lung Cancer
Congestive Heart Failure

Chronic Cough
IPF
Bronchitis
COPD
Asthma
RSV
Covid-19
Heart Failure

*Measurement not FDA cleared but may be collected in clinical trials

Why Include Cough & Lung Sounds as Endpoints?

Improve insight into how patients feel and function, strengthening evidence to regulatory agencies

Reduce reliance on questionnaires to demonstrate treatment effect on symptoms

Differentiate your asset in a competitive marketplace

Uncover signals that may point to new or expanded indications

Identify new pharmacologic insights into your treatment

Features & Specifications

- Wireless and discreet
- Patient-friendly form factor
- Continuous
- Data transfer to cloud
- 24+ hour battery life
- Water resistant
- Patient-privacy preserving (HIPAA compliant)
- Flexible reporting including automated or human analysis of cough and lung sounds
- Verifications: FDA 510(k) Class II and CE Mark (RESP Biosensor only)