XHALE SMART®  |  An Xhale, Inc. Company

Smart® – How It Works

The SMART® device is an ergonomic, easy-to-use handheld instrument. It generates an electronic reminder when it is time for a study participant to take the study medication, and then guides the user to blow into the device following ingestion of the medication.

Specific steps to confirm adherence using the SMART® Adherence System:

  • Step 1

    The SMART® device generates an audible, electronic reminder when it is time for a study participant to take the investigational drug which will include a non-invasive adherence marker.

  • Step 2

    Study subject swallows   SMART™ medication with adherence marker incorporated.

  • Step 3

    The adherence marker is released in stomach then absorbed into the stomach and small intestines.  The adherence marker metabolite is then transported via blood to the lungs and exhaled.

  • Step 4

    Study subject is prompted by the SMART® device to deliver a post-ingestion breath sample.

  • Step 5

    Upon the breath sample being received, the SMART® device will report that the sample was successfully delivered.

  • Step 6

    The SMART® Device analyzes the breath sample to generate a “breath print” that shows the increase in breath biomarker from baseline to definitively confirm that the dose of study medication was ingested.  All data is time-stamped, encrypted and automatically uploaded to a HIPAA-compliant database.

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As a result of the real-time monitoring, our SMART® Medication Adherence Monitoring System will enable immediate follow-up with patients who fail to take medication according to a specified regimen.

Unique Database System

The SMART® device both stores data and wirelessly transmits it to a database, which is used to track the real-time adherence of each individual, as well as the entire study population, within a clinical trial.

In pharmaceutical clinical trials, the study participants can be contacted directly and in a timely manner if they have not taken their study medication in accordance with the study protocol.