Therapeutic Areas

Respiratory

Advancing Pulmonary Function Testing Beyond the Clinic

Koneksa’s mobile respiratory toolkit brings high-quality spirometry into participants’ homes without compromising clinical rigor.

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A smarter, more inclusive way
to run respiratory trials

With the use of FDA-cleared and CE-marked Bluetooth-enabled ultrasonic spirometer works seamlessly with our guided mobile app, enabling sponsors to capture key endpoints like FEV₁ and FVC remotely.

Ultrasonic precision for in-clinic quality

Koneksa’s high-quality respiratory data are obtained through technology with capabilities that far exceed traditional turbine-based spirometers.

The greater sensitivity of an ultrasonic spirometer provides precise readings even for patients with low lung function, so you can be confident in the accuracy of your respiratory data.
Ultrasonic technology is even more powerful when FVC is a required measure, a common focus when researching interstitial lung disease (e.g., idiopathic pulmonary fibrosis).

Measures Include: FEV1, FVC, PEF, FEV1/FVC, BEV, FIVC

With our solution, you can collect and compare inhalation and exhalation data, ensuring ATS compliance for each successful maneuver and providing consistent, quality data for your trial’s endpoints.

Our Bluetooth ultrasonic spirometer is also drastically superior to turbine devices because there are no moving parts. While turbines depend on spinning plastic pieces, require frequent calibration, and can develop obstructions that impact turbine movement, ultrasonic units avoid these limitations. They are also easier to clean and much less likely to become contaminated.

Why Mobile Spirometry?

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Expand Access

Collect data from participants without regular access to clinics or respiratory therapists, improving representation across rural, underserved, and mobility-limited populations.

Protect Participants

Allow safe participation for immunocompromised or high-risk individuals.

Accelerate Enrollment

Reach broader participant populations and shorten recruitment timelines.

Capture Diurnal Variability

Enable frequent measurements throughout the day to better track disease trends.

Reduce Sample Size and Cost

Higher measurement frequency increases statistical power, reducing the number of participants needed and lowering overall trial costs.

Purpose-Built for

Scientific Rigor

Koneksa’s platform follows 2019 ATS/ERS guidelines and incorporates both expert and user feedback to ensure data quality and ease of use.

Koneksa platform for respiratory clinical trials

Key Features

Ultrasonic Spirometry

More sensitive to small airflows and less prone to calibration drift compared to turbine-based devices.

Mobile App with Guided Instructions

Supports participant engagement and protocol adherence.

Essential Measures Captured

FEV₁, FVC, and other critical endpoints.

GLI Lung Function Calculator Integration

Provides predicted values based on participant demographics.

Data Science, AI/ML, and Statistical Services

AI-Based Analysis with ArtiQ.QC

Automates spirometry quality grading, reducing need for manual overreaders.

Metadata and Quality Indicators

Reports on usability, acceptability, and measurement quality per ATS standards.

Proven Impact in Clinical Settings

Asthma Pilot Study

70% compliance with twice-daily measurements
Over 85% of participants completed at least one measurement daily
High correlation between mobile and in-clinic spirometry

Phase 2b IPF Study

Over 297 pulmonary function tests completed remotely
85% of FVC and 91% of FEV₁ measures graded A or B via automated quality review

Validation for Trial Design

Detecting a 0.1 L/min treatment effect in FEV₁ typically requires 100 participants per arm
With mobile spirometry, that requirement drops to just 18 patients—driving significant cost and time savings

Designed for Participants and Coordinators

Participants report that the app is intuitive and easy to use after a brief introduction. Site staff find the data visualizations to be accurate and helpful for monitoring compliance and data quality.

Future-Ready Platform

Koneksa is actively expanding and refining its respiratory offering with:

Telehealth Integration:
Real-time coaching and enhanced measurement confidence
Improved App Flow:
Enhanced user experience based on participant and coordinator feedback
Targeted Indications:
Asthma, COPD, idiopathic pulmonary fibrosis, interstitial lung disease, cystic fibrosis, ALS, lung transplantation, and COVID-related studies

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