Better Therapeutics Announces Publication of the Rationale, Design and Baseline Characteristics Manuscript for Type 2 Diabetes Pivotal Trial of BT-001, a Novel Prescription Digital Therapy, in Clinical Cardiology

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Jul 11, 2022

Better+Therapeutics%2C+Inc. (NASDAQ: BTTX), a prescription digital therapeutics company developing nutritional cognitive behavioral therapy (nCBT) to address the root causes of cardiometabolic diseases, today announced the publication of a manuscript detailing the study design and methodology for its pivotal clinical trial of BT-001 in adult patients with type 2 diabetes (T2D) in the medical journal, Clinical+Cardiology. The study represents a first-in-class randomized, controlled clinical trial of a prescription digital therapeutic (PDT) for the treatment of T2D and is expected to support the filing of a de novo classification request with the U.S. Food and Drug Administration (FDA) in the third quarter of 2022. The company announced positive primary endpoint data for this trial in March of this year and expects to release secondary data in the third quarter of this year.