Better Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH. Breakthrough status is reserved for technologies that demonstrate the potential to be more effective than current standard of care in patients with serious or life-threatening conditions. Better Therapeutics earned breakthrough status based on the outcomes of its LivVita clinical study, which 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.

Results of the study were published in Gastro Hep Advances. Better Therapeutics' novel form of CBT works by targeting the lifestyle behaviors that are known to cause and/or contribute to the progression of metabolic diseases. The platform was developed to address the current gap in broadly accessible and standardized intensive behavioral therapies that effectively enable the implementation of existing treatment guidelines that call for behavior change as the foundation of treatment.

The Company's CBT platform has already demonstrated clinically meaningful outcomes in type 2 diabetes (T2D), leading to the FDA authorization of AspyreRx tm in 2023 as the first prescription digital therapy to deliver CBT as a treatment for T2D.