Better Therapeutics announced the pre-print publication of the LivVita study’s results in Gastro Hep Advances, a peer reviewed journal produced by the American Gastroenterological Association. The study successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device related adverse events. The company anticipates submitting a request to the FDA for Breakthrough Device Designation by the end of 2023. The study’s authors conclude that the positive efficacy, safety, and usability data underscore the potential of Better Therapeutics’ digitally delivered novel form of Cognitive Behavioral Therapy to address the significant unmet clinical needs associated with metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis MASH , formerly known as NAFLD and NASH. The LivVita study evaluated Better Therapeutics’ novel CBT platform that targets individuals’ thoughts and beliefs related to improving healthy behaviors, such as diet and physical activity. Over the course of 90 days, the investigational treatment was delivered to participants without requiring additional intervention from healthcare providers.
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