08 Jul, 2021, 12:02 ET
ST. LOUIS, July 8, 2021 /PRNewswire/ -- Readout Health, an early-stage breath biosensing digital therapeutic company has announced the release of the first integrated biomarker-based personalized fasting solution, PrecisionFast™, as part of its metabolic behavior modification solution.
Used in conjunction with FDA Class 1 handheld Biosense®, a medical-grade breath ketone trending device, PrecisionFast™ will provide user-specific, highly accurate levels of fat burn (ketosis) overlaying user-specific fasting durations throughout clinical or personal fasting periods. Until now, intermittent fasting protocols have been based on arbitrary periods of eating restriction based on published studies, lacking user data. With PrecisionFast™ within the Biosense® mobile app, consumers or patients under fasting protocols can tweak fasting durations based on personal physiologic requirements to reach desired states of fasting, including ketosis or autophagy (cell regeneration). Intermittent fasting has quickly become one of the most popular, easily adoptive dietary protocols in weight loss and disease prevention the past few years.
"PrecisionFast™ is a natural progression from nutritional ketosis with carb restrictive diets to food restrictive protocols and consumer nutritional plans. The real value is the combination of both, and the market has been asking for their own data and guidance to remove the guesswork," states Readout Health CEO Jim Howard.
There is growing support in breath ketones versus the other option in fasting to track elevating ketosis levels – multiple finger pricks to measure beta hydroxybutyrate (BHB), a ketone in capillary blood. According to Dom D'Agostino, PhD, a leading metabolic research expert at the USF Morsani College of Medicine, "breath ketones through Biosense® appears to be a better proxy for fat burning in the fasted state, since during prolonged fasting, BHB is quickly swept up by our cells for fuel, thus lowering the amount of BHB in the blood." Dr. D'Agostino is designing further research in breath acetone in the fasted state.
Readout also has announced a fasting research collaboration with Charite Universitatsmedizin in Berlin, one of the largest medical research centers in Europe. "We look forward to using the Biosense® device in our pending clinical trial on prolonged fasting to enhance fertility in women with hormonal dysregulation, specifically in protocol adherence," according to principal investigator Andreas Michalsen, MD.
This trial represents the first clinical trial for Biosense® outside of the United States, where several pharma and academic research trials or chronic disease treatment and reversal are underway or scheduled for later this year with Biosense®, including two trials with hometown Washington University. Howard adds, "Our research collaborators are setting the table for clinical adoption with frictionless, frequent metabolic testing in the reparative state of ketosis for metabolic disorders, neurocognitive and mental health decline, oncology, and newer disease areas like infertility and heart failure where physiologic feedback is essential."
About Readout Health:
Readout Health, founded in 2018, is a digital biomarker startup building frictionless medical devices and digital therapeutics based on a patented fractionated lung sampling platform. The Company released Biosense® in 2020 as the first medical grade, portable breath ketone monitoring solution, designed to provide the full picture of fat oxidation changes leading to behavior modification in nutritional interventions of chronic disease. Biosense® is used in clinical research, clinics using ketosis therapy, and consumers in the US, Canada, Hong Kong, and Singapore. Readout's Biosense® measurements are widely integrated into nutrition, fasting, and clinical protocol third party apps and programs. The Company is developing additional breath analyte devices in for launch in 2022 that address unmet in-home testing needs in rapidly expanding markets.
Kristin Kirkpatrick, Head of Precision Nutrition
SOURCE Readout Health
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