Cough & Lung Acoustic Endpoints for Clinical Trials

The RESP® Biosensor

FDA 510(k) Class II | CE Mark | HIPAA Compliant

RESP® Biosensor Overview

The RESP® Biosensor is a next generation digital health technology developed to collect greater respiratory insights in clinical trials and research studies.

Patient-Friendly: Wireless, discreet form factor that respects patient comfort in daily life
Multi-Parameter: Comprehensive respiratory and physiological measurements
Validated Reporting: Automated or manual (human) analysis of cough and lung sounds

Measures

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

- - - - Cough Frequency (24-hour)
      - Cough Sound Intensity & Bouts
      - 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

Clients & Partners

Metrics-at-a-Glance

1.5M

Lung Sounds Captured

50M

Breaths Captured

5

Continents

34

Countries

36

Languages

245

Sites

Why Measure Cough & Lung Sounds in Your Study?

From primary, exploratory endpoints to sub-studies, RESP® can add value to your clinical program by:

Increasing evidence and insight into how patients feel and function

Reducing reliance on PROs to demonstrate treatment effectiveness with another objective lens

Differentiating your asset in an increasingly competitive market

Uncovering signals that may point to new or expanded indications

Digital Endpoints for Multiple Indications

Unlock insight across therapeutic areas to complement patient-reported outcomes and strengthen evidence

	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

Features & Specifications

- Wireless and discreet
- Passive and continuous
- Lightweight (100g)
- Data transfer to cloud
- 24+ hour battery life
- Water resistant
- Adhered to chest via 3M Tegaderm dressing
- 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