Discover Koneksa

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Clinical Pipeline

Koneksa is leading the revolution in digital biomarker development. We provide standard and customized digital biomarker and measure solutions in conjunction with a robust end-to-end data integration platform. We have a proven record of developing innovative algorithms, and delivering high-quality data from validated measures. Our science-driven approach simultaneously lowers patient burden in clinical trials and speeds clinical study conduct as well as data collection, shortening the path to mission-critical milestones.

Biomarker development follows standard steps, as shown in the digital biomarker and measure pipeline, and summarized as 1) concept creation / sensor verification, 2) analytical validation, and 3) clinical validation. These steps are based on the work of the the scientific community, such as frameworks from the FNIH Biomarker Consortium’s qualification evidentiary criteria and the verification, analytical validation, and clinical validation (V3) steps, as well as regulatory documents, including Biomarker Qualification Evidentiary Framework and Digital Health Technologies Remote Data Acquisition In Clinical Investigations by the FDA.

From oncology to neuroscience, Koneksa is advancing clinical research by developing, validating, and deploying digital biomarkers . Check out our clinical pipeline and see for yourself.

Therapeutic Area

Measure

Concept/Verification

Analytical

Clinical

Partner

Reference

Respiratory

Lung function FEV1

13, 15, 18

Therapeutic Area:

Respiratory

Measure:

Lung function FEV1

Clinical:

Complete

Partner:

Reference:

13, 15, 18

Oncology

Step count

5, 16, 25

Therapeutic Area:

Oncology

Measure:

Step count

Clinical:

Complete

Partner:

Reference:

5, 16, 25

Neuroscience

Gait measures

9, 10, 11, 12, 20, 23, 24

Therapeutic Area:

Neuroscience

Measure:

Gait measures

Clinical:

In-Progress

Partner:

Reference:

9, 10, 11, 12, 20, 23, 24

Neuroscience

Gait, tremor, pronation, supination, etc.

12, 14, 20, 21, 22, 24

Therapeutic Area:

Neuroscience

Measure:

Gait, tremor, pronation, supination, etc.

Clinical:

In-Progress

Partner:

Reference:

12, 14, 20, 21, 22, 24

Neuroscience

Enhanced gait measures

Therapeutic Area:

Neuroscience

Measure:

Enhanced gait measures

Clinical:

In-Progress

Partner:

Reference:

N/A

Neuroscience

Speech and vocal measures

Therapeutic Area:

Neuroscience

Measure:

Speech and vocal measures

Clinical:

In-Progress

Partner:

Reference:

N/A

Multiple

Motion-controlled HR/HRV

Therapeutic Area:

Multiple

Measure:

Motion-controlled HR/HRV

Analytical:

In-Progress

Partner:

N/A

Reference:

N/A

Multiple

Pediatric gait speed

Therapeutic Area:

Multiple

Measure:

Pediatric gait speed

Analytical:

In-Progress

Partner:

N/A

Reference:

N/A

Multiple

24x7 functional status

5, 16, 19, 25

Therapeutic Area:

Multiple

Measure:

24x7 functional status

Analytical:

In-Progress

Partner:

N/A

Reference:

5, 16, 19, 25

Neuroscience

Disturbed sleep

Therapeutic Area:

Neuroscience

Measure:

Disturbed sleep

Concept/Verification:

Complete

Partner:

N/A

Reference:

N/A

Multiple

Enhanced gait speed

Therapeutic Area:

Multiple

Measure:

Enhanced gait speed

Concept/Verification:

In-Progress

Partner:

N/A

Reference:

N/A

Neuroscience

Kinetic and resting tremor

Therapeutic Area:

Neuroscience

Measure:

Kinetic and resting tremor

Concept/Verification:

In-Progress

Partner:

N/A

Reference:

N/A

Multiple

Configurable digital walk test

Therapeutic Area:

Multiple

Measure:

Configurable digital walk test

Concept/Verification:

In-Progress

Partner:

N/A

Reference:

N/A

Respiratory

Enhanced lung function FEV1/FVC

Therapeutic Area:

Respiratory

Measure:

Enhanced lung function FEV1/FVC

Concept/Verification:

In-Progress

Partner:

N/A

Reference:

N/A

Neuroscience

EEG monitoring biomarker

Therapeutic Area:

Neuroscience

Measure:

EEG monitoring biomarker

Concept/Verification:

In-Progress

Partner:

N/A

Reference:

N/A