San Francisco-based company Better Therapeutics Inc. (NASDAQ: BTTX), known for its pioneering work in developing prescription digital therapeutics (PDTs) for cardiometabolic diseases, has achieved a significant milestone. The United States Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Better Therapeutics’ innovative Cognitive Behavioral Therapy (CBT) platform aimed at effectively treating adults with metabolic dysfunction-associated steatohepatitis (MASH), previously known as NASH.
Breakthrough Device Designation for Enhanced Treatment
The coveted Breakthrough Device Designation for Better Therapeutics’ CBT platform highlights its potential to revolutionize the treatment landscape for advanced liver diseases. This designation signifies that the FDA recognizes the platform as a transformational technology, capable of significantly improving patient outcomes in a field with limited therapeutic options.
Partnership to Accelerate Adoption of AspyreRx for Type 2 Diabetes
Further reinforcing its commitment to addressing cardiometabolic diseases, Better Therapeutics has announced a strategic collaboration with Glooko, Inc. a global leader in chronic condition management. This partnership aims to integrate Better Therapeutics’ AspyreRx digital behavioral treatment specifically designed for type 2 diabetes (T2D) into Glooko’s widely used diabetes management platform. By combining their expertise, the two companies aim to provide more effective and personalized care for patients with T2D in the United States.
Breakthrough Device Designation for Liver Disease Treatment
In addition to its breakthrough designation for the CBT platform in treating MASH, Better Therapeutics has also submitted a request for Breakthrough Device Designation to the FDA for its novel PDT designed to treat metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). This submission underlines the company’s commitment to developing innovative solutions for addressing liver diseases, which have become increasingly prevalent.
Conclusion:
Better Therapeutics Inc. continues to strengthen its position as a leader in the field of prescription digital therapeutics for cardiometabolic diseases. The FDA’s Breakthrough Device Designation for the CBT platform targeting advanced liver disease signifies its potential to disrupt the treatment landscape. Furthermore, the strategic collaboration with Glooko to integrate AspyreRx into their diabetes management platform showcases Better Therapeutics’ dedication to improving patient outcomes for type 2 diabetes. With its ongoing commitment to innovation and development, Better Therapeutics is poised to make a significant impact in the field of digital therapeutics.

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