Therapeutic Areas

Cardiovascular

Advancing Cardiovascular Measurement Beyond the Clinic Visit

Koneksa’s cardiovascular measurement model connects clinic-based cardiac assessment with real-world function and physiology, without compromising clinical rigor.

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A more complete way to detect cardiovascular treatment effects

Koneksa’s cardiovascular measurement strategy integrates digital cardiac physiology, functional capacity, biomarkers, and patient-reported outcomes into a single, protocol-ready endpoint framework – enabling sponsors to capture clinically meaningful signal beyond what a scheduled clinic visit can see.

Multimodal precision for concept equivalence across settings

That framework is built on equivalence modeling, linking clinic-based cardiac assessment with real-world functional capacity and activity so a single, interpretable concept can be tracked consistently from screening through database lock.

This matters most in conditions where progression unfolds between visits, like heart failure and cardiomyopathy, where episodic assessment alone can miss the window in which a treatment effect is detectable.

Measures Include

ECG & heart rate dynamics (HRV, recovery)
NT-proBNP & HS Troponin I/T
Gait speed & 6MWT-equivalence modeling

Activities of daily living (ADL) capacity
Echocardiography-derived function metrics
Patient-reported outcomes (KCCQ, MLHFQ, EQ-5D)

The model is also device-agnostic by design, so data stays harmonized across hardware generations and vendors as technology evolves over a multi-year trial.

Why Multimodal Cardiovascular Measurement?

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Expand Access

Collect functional and physiologic data from participants without frequent access to cardiology specialists or imaging centers, improving representation across rural, underserved, and mobility-limited populations.

Reduce Patient Burden

Replace repeated clinic-based functional testing with structured at-home and ambulatory capture, easing the burden on symptomatic or lower-functioning participants.

Detect Events Earlier

Continuous physiologic and activity monitoring increases the chance of capturing disease events and progression between scheduled visits, not only at them.

Capture Real-World Variability

Frequent, longitudinal measurement reflects how cardiovascular status actually fluctuates day to day, rather than relying on a single point-in-time clinic reading.

Strengthen Statistical Power

Higher-quality, higher-frequency signal can reduce the sample size needed to detect a true treatment effect — lowering cost and timeline risk.

Purpose-Built for

Scientific Rigor

Koneksa’s cardiovascular models are grounded in disease-specific mechanistic frameworks and validated equivalence modeling between clinic-based and real-world assessment.

Koneksa platform for respiratory clinical trials

Key Features

Measurement Strategy Embedded
Pre-Protocol

Aligned to cardiovascular therapeutic objectives with risk reduction, functional improvement, and event detection pre protocol design.

Concept-Equivalent Frameworks

Linking clinic-based cardiac assessment with real-world functional capacity and activity on a single interpretable scale.

Multimodal Signal Integration

Digital cardiac physiology, laboratory biomarkers, imaging, and patient-reported symptom and function measures combined into one evidence strategy.

Device-Agnostic
Data Harmonization

Consistent longitudinal analysis regardless of hardware vendor or generation.

Data Science, AI/ML, and Statistical Services

Composite & Longitudinal Modeling

Repeated-measures and composite event frameworks built to detect progression and outcomes over time.

Cardiometabolic Context

Measurement frameworks spanning heart failure, CKD, diabetes, obesity, and rare cardiomyopathies, not a single-condition model.

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 Sponsors and Sites

Koneksa’s cardiovascular measurement model is built to be usable across a wide range of functional status, with data visualizations designed to help site staff monitor compliance and quality without adding operational burden.

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