Better Therapeutics Inc (BTTX)

[Frankestin]

Expected Upcoming Milestones

Apply for Breakthrough Device Designation: Following the successful completion of the LivVita Liver Study, Better Therapeutics commenced work on an application to the FDA for Breakthrough Device Designation for its investigational PDT in NAFLD and NASH and is expected to submit the application in the first half of 2023. Currently, there is no FDA approved treatment for NAFLD and NASH, which affect approximately one in four Americans. Behavioral change is foundational to addressing the root causes of the diseases and having a prescription treatment option could be of significant benefit to millions of patients.
Potential FDA Authorization and Commercial Launch of BT-001: Better Therapeutics is diligently advancing its preparations for the potential commercial launch of BT-001 in mid-2023. Upcoming milestones in market access include the submission of health economic outcomes research (HEOR) for publication and commencing pre-authorization information exchange meetings with Payers beginning in April.
First Dataset from BT-001 Real-World Evidence Program: This randomized, controlled, multi-site program is designed to generate real-world evidence to provide payers and providers with long-term data related to usage and outcomes in a real-world setting. Interim study results are expected to be reported in the fourth quarter of 2023.
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