Cough & Lung Sound Measures for Clinical Trials

The RESP® Platform

RESP® Platform Overview

The RESP® Platform offers clinical trial teams a new approach to understanding treatment response by capturing respiratory symptoms in daily life, enabling more robust evidence generation and clearer differentiation of clinical programs.

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

Multi-Parameter: Comprehensive respiratory and physiological measures

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

Clients & Partners

Measures

A robust combination of multi-modal data alongside patient reported outcomes (PROs)

- - - - 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?

Strengthen evidence into how patients feel and function

Reduce reliance on PROs to demonstrate treatment efficacy

Differentiate your program to patients and regulators

Uncover signals that may point to new or expanded indications

Identify new pharmacologic insights into your treatment

Features & Specifications

- Wireless and discreet
- Passive and 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)