Better Therapeutics Targets FDA Breakthrough Device Designation for Liver Disease Treatment

Prescription digital therapeutics (PDTs) pioneer, Better Therapeutics (Nasdaq: BTTX), has submitted a request to the 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). The company expects to receive a response from the FDA within approximately 60 days.

Frank Karbe, President and CEO at Better Therapeutics commented on the submission, saying, “Securing Breakthrough Device Designation from the FDA has the potential to accelerate the expansion of our digital therapeutics platform beyond type 2 diabetes. The versatility of our therapeutic approach across a broad spectrum of cardiometabolic conditions is an exciting and unique aspect of our platform. Furthermore, the digital nature of our products allows for potential expansion in a fraction of the time and cost compared to traditional drug development.”

Naim Alkhouri, MD, Director of the Fatty Liver Program at Arizona Liver Health and Principal Investigator of Better Health’s clinical study said the company’s innovation has the potential to offer effective and scalable support that can make a meaningful impact on those living with 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.

About Better Therapeutics

Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioral therapy to address underlying factors that sustain or worsen cardiometabolic diseases. The Company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions. The CBT delivered by Better Therapeutics’ PDTs is designed to enable changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs. Better Therapeutics’ clinically validated mobile applications are intended to be prescribed by physicians and reimbursed like traditional medicines.