THE LEVL DEVICE

Personalized Weight Loss with a Simple Breath

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LEVL is an FDA cleared point-of-care device that measures acetone in exhaled breath to provide patient specific metabolic insights for customized weight loss in a clinical setting

SENSITIVITY + CALIBRATION = PRECISION TESTING

LEVL device

The LEVL device was designed specifically for weight loss and uses a proprietary sensor to measure low levels of acetone – a by-product of fat loss – and can be integrated into any weight loss program. Blood and urine ketone tests were developed to identify ketoacidosis, which occurs once ketone levels are extremely high and blood becomes acidic. These tests are therefore not sensitive to lower levels of ketones.

To ensure accuracy and precision, the LEVL device is calibrated every 14 days using known gas concentrations. Calibration gas can also be used to check accuracy at any point.

BREATH ACETONE SPECTRUM

The LEVL measurement of breath acetone can assess a wide spectrum of ketosis regardless of dietary approach.

Breath Acetone Spectrum

VALIDATION OF ACCURACY + REPEATABILITY

The accuracy and repeatability of breath acetone concentration using the LEVL device was evaluated with breath samples spaced at least 15 minutes apart. The two breath samples were analyzed by the same LEVL and mass spectrometer – the gold standard for rapid assessment of parts-per-million concentrations of acetone in exhaled breath. The accuracy of the breath acetone concentration (BrAce) as measured by LEVL was assessed by comparison to BrAce as measured by the mass spectrometer, which validated 91% of the LEVL measurements were within ± 1.0 ppm of the mass spectrometer

Using duplicate breath samples, the repeatability of the LEVL device was assessed. With the LEVL device, over ninety percent (90%) of the breath samples were within ± 0.4 ppm of their duplicate breath sample. To achieve repeatability, LEVL prescribes a defined breathing maneuver – a moderate inhalation followed by a 5 second breath hold and a comfortable exhalation. This comfortable breathing maneuver combined with a breath hold, reduces the impact of uncontrolled human factors on exhaled breath acetone.

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