Better Therapeutics, Inc. announced it has submitted a request to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for its novel PDT designed to treat metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NAFLD and NASH. This regulatory step for Better Therapeutics follows the completion of the Company?s LivVita Liver Study and the subsequent publication of its results in Gastro Hep Advances. 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 study?s authors concluded the totality of positive efficacy, safety and usability data indicates the potential of Better Therapeutics? digitally delivered CBT to help address the significant unmet clinical needs observed in MASLD and MASH. The FDA?s Breakthrough Device Designation is designed to expedite the development, assessment, and review of devices that demonstrate the potential to address life-threatening or irreversibly debilitating conditions where no approved or cleared alternative treatment options exist.

The expected response timeline from the FDA is 60 days after receipt of a Breakthrough Device Designation application.