SAN FRANCISCO - Better Therapeutics, Inc. (NASDAQ: BTTX), specializing in prescription digital therapeutics for cardiometabolic diseases, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Cognitive Behavioral Therapy (CBT) platform. This designation is aimed at treating adults with metabolic dysfunction-associated steatohepatitis (MASH), a serious liver condition.
The FDA's recognition is based on the promising results of the LivVita clinical study, which showed a reduction in liver fat and improvements in liver health within 90 days, without any device-related adverse events. Frank Karbe, President and CEO of Better Therapeutics, stated that this development could accelerate marketing authorization for a potential second indication and the company is seeking partnerships to advance the therapy's development and commercialization.
MASH is a severe stage of metabolic dysfunction-associated steatotic liver disease (MASLD), which is linked to the growing obesity and diabetes epidemics. It's estimated that one in four American adults may have MASLD, with a significant number facing severe liver complications. MASH is a leading cause of liver-related mortality and poses a considerable challenge to healthcare systems worldwide.
Better Therapeutics' CBT platform is designed to modify the lifestyle behaviors that contribute to metabolic diseases. The company's approach to treatment is to effect changes in the neural pathways of the brain to enable lasting behavioral changes. The platform has already received FDA authorization for AspyreRx™, a prescription digital therapy for treating type 2 diabetes (T2D).
Naim Alkhouri, MD, Director of the Steatotic Liver Program at Arizona Liver Health and Principal Investigator of the LivVita Liver Study, emphasized the significance of this milestone, highlighting the potential of digitally delivered CBT to offer a critical option for patients with few alternatives.
AspyreRx, authorized by the FDA in July 2023, has shown a clinically meaningful and sustained reduction in A1c levels and other cardiometabolic health markers when used for up to 180 days. It provides CBT as an adjunctive treatment to standard of care for adults with T2D.
The information in this article is based on a press release statement from Better Therapeutics, Inc.
InvestingPro Insights
In light of Better Therapeutics, Inc.'s (NASDAQ: BTTX) recent FDA Breakthrough Device Designation, investors may find the following real-time data from InvestingPro and InvestingPro Tips particularly relevant. The company's market cap stands at a modest $11.91 million, reflecting the size and speculative nature of this biotech firm. Despite the positive news, it's important to note that the company's stock price has experienced a significant return over the last week of 27.33%, as per the latest metrics. This surge could be a reaction to the recent FDA announcement, indicating increased investor optimism regarding the company's future prospects.
InvestingPro Tips suggest caution, however, as Better Therapeutics has been quickly burning through cash and suffers from weak gross profit margins. This financial situation is underscored by the fact that the company is not profitable over the last twelve months as of Q1 2023, with an operating income adjusted at a negative $29.61 million. Moreover, their short-term obligations exceed liquid assets, which could pose liquidity risks. Analysts also do not anticipate the company to be profitable this year, which is a critical consideration for potential investors.
For those interested in a deeper dive into Better Therapeutics' financial health and future prospects, InvestingPro offers additional insights. There are 10 more InvestingPro Tips available that could provide valuable information for making an informed investment decision. To access these tips, visit https://www.investing.com/pro/BTTX and remember to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.