MedTech DiveBetter Therapeutics Wins Breakthrough Status for Health App to Treat Liver Disease

The FDA awarded the designation after seeing evidence the digital cognitive behavioral therapy may help reduce liver fat.

The FDA has recently awarded breakthrough device status to Better Therapeutics’ digital cognitive behavioral therapy (CBT) app, designed to treat adults with advanced liver disease. This recognition comes on the heels of promising clinical trial results demonstrating the app’s efficacy in reducing liver fat. Amidst the digital therapeutics sector’s challenges with commercialization, this development marks a significant milestone, not only for Better Therapeutics but for the future of non-pharmacological interventions in managing complex health conditions.

Key Points:

• FDA Breakthrough Device Status: Better Therapeutics has been granted breakthrough device status for its digital therapeutic aimed at treating metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH).
• Clinical Trial Evidence: The designation was based on clinical trial results, which showed that the digital CBT application contributed to significant reductions in liver fat among participants.
• Challenges in Lifestyle Modification: Despite the known benefits of weight reduction and increased physical activity for MASH patients, maintaining these lifestyle changes has proven difficult due to lack of effective delivery mechanisms by healthcare providers.
• Digital CBT as a Solution: The app utilizes digital cognitive behavioral therapy to facilitate behavioral changes necessary for managing liver disease, addressing the gap in healthcare capacity for lifestyle intervention.
• Evidence of Efficacy: A clinical trial involving 22 subjects demonstrated a more than 16% reduction in liver fat after 90 days of using the app, designed to improve dietary quality and physical activity.
• Strategic Commercialization: In facing the digital therapeutics sector’s commercialization challenges, Better Therapeutics has adopted a focused strategy, targeting high-volume providers for early adoption of their Type 2 diabetes app, AspyreRx.
• Financial Sustainability: Despite the sector’s commercial challenges, Better Therapeutics has secured enough funding to support its operations into the first quarter of 2024, with strategies in place to achieve commercial traction for its products.
• Broader Implications for Digital Health: The breakthrough status and clinical success of Better Therapeutics’ digital CBT app underscore the potential of digital interventions in managing chronic diseases and the importance of behavioral change in improving patient outcomes.

According to the National Institute of Diabetes and Digestive and Kidney Diseases, nonalcoholic fatty liver disease (NAFLD) affects about 24% of adults worldwide, highlighting the urgent need for effective treatments like digital therapeutics.

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