Better Therapeutics Receives FDA Breakthrough Device Designation for Digital Therapeutic Platform Targeting Advanced Liver Disease
Signifies the FDA’s recognition of the Company’s novel Cognitive Behavioral Therapy as a potential treatment for metabolic dysfunction-associated steatohepatitis
Opens an accelerated path towards a potential second indication
“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
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
About MASH
MASH represents an advanced stage of metabolic dysfunction-associated steatotic liver disease (MASLD), a condition tied to the escalating obesity and diabetes epidemics. One in four American adults is estimated to have MASLD1, with up to 16.5 million adults diagnosed with severe liver complications, including MASH.
MASH is a leading cause of liver related mortality and an increasing burden on healthcare systems globally. Additionally, patients with MASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality.
About
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About AspyreRx
AspyreRx (formerly BT-001) was granted marketing authorization by the FDA in
Indications for Use
AspyreRx is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. AspyreRx provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.
Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements in this press release include, but are not limited to, statements regarding Better Therapeutics’ expectations related to the efficacy and potential benefits of PDTs, including AspyreRx and CBT, and their potential treatment applications and their ability to improve clinical outcomes, expectations regarding the amendment to the Hercules debt facility and the outcome and success of cost saving initiatives, including salary reductions, and operational plans and their impact on Better Therapeutics’ financial position and cash runway, and expectations regarding the commercial traction of AspyreRx and partnering discussions, among others. These forward-looking statements are based on the current expectations of the management of
1https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts
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