Better Therapeutics Receives FDA Breakthrough Device Designation for Digital Therapeutic Platform Targeting Advanced Liver Disease

Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, today 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.

“With breakthrough device designation in hand, we now have a pathway to accelerate the attainment of marketing authorization for a potential second indication and we are actively seeking strategic partnerships to expedite the development and commercialization of this therapy for the millions of patients with advanced liver disease,” said Frank Karbe, President and Chief Executive Officer at Better Therapeutics. “This also reinforces the potential for our therapeutics platform to broadly address metabolic disorders."

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 in 2023 as the first prescription digital therapy to deliver CBT as a treatment for T2D.

"Earning breakthrough status is a significant milestone and underscores the potential for digitally delivered CBT to offer a vital option for patients with MASH, where very few alternatives exist,” said Naim Alkhouri, MD, Director of the Steatotic Liver Program at Arizona Liver Health and Principal Investigator of the LivVita Liver Study. "We are committed to advancing this innovative therapy and look forward to its potential to transform the lives of those affected by MASH."