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  Cardiac Safety Trials

Monebo provides technology-based products and services to the pharmaceutical, biotech, and medical device communities. These unique products and services are designed to efficiently monitor and interpret the ECG signal to properly characterize the effect a drug or device has on cardiac safety.

Kinetic™ - Intervals ECG Algorithm

Monebo has developed a unique method for automatically measuring the distance between any two fiducial points on ECG, resulting in highly accurate measurements of standard ECG-based biomarkers. Additionally, the measurement precision has enabled the identification of new biomarkers which are currently undergoing validation studies.

ECG Analysis Methods
Manual Method
Monebo Automated Method
Number of replicates around time points and the number of beats for averaging are limited Unlimited number of predefined replicates and time points, mitigating individual pharmacokinetic and pharmacodynamic profile differences
10 second replicates Unlimited time on replicates
Most common method averages three consecutive beats Calculates average values of intervals using all measurable beats, mitigating the effect of interval variability
Inter-reader and intra-reader variability No inter-reader or intra-reader variability
Human errors No human errors
More study subjects due to the limited frequency of time points and number of beats Reduced sample size
Time and associated cost Shorter time and lower cost

An automated approach makes possible the use of every beat of the data a patient generates. This will lead to better, more valid data on which to base a decision. It also opens up the ability to have one consistent, common method for evaluating the ECG records across all of a compound or devices clinical studies.

CardioBelt™ ECG Acquisition System

High quality ECG in a system that is easy for the patient to use by themselves defines the CardioBelt™ ECG Acquisition System. It was designed so the patient can easily put it on, take it off, and have total mobility.

For clinical trials, CardioBelt™ can be integrated into a variety of systems including home care appliances, cell phones, or PDA diaries.

© 2010 Monebo Marketing Team