Blue Note Therapeutics Receives Breakthrough Device Designation from FDA for Prescription Digital Therapeutic to Treat Cancer-Related Anxiety and Depression

June 2020

Blue Note Therapeutics, Inc., a prescription digital therapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to BNT001, the company’s lead prescription digital therapeutic (PDT) candidate for the treatment of symptoms of anxiety and depression related to cancer in adult patients.

Breakthrough Device Designation is a process designed to expedite the development and review of certain medical devices, including PDTs, in the United States. BNT001 met the designation criteria by offering a potentially more effective treatment for cancer-related distress delivered via breakthrough technology.  As a digital therapeutic, BNT001 helps to address the limitations of current face-to-face treatment methods through improved access to psychosocial behavioral therapy.

BNT001 is based on a cancer-specific face-to-face behavioral intervention created and studied by Michael H. Antoni, PhD and Frank J. Penedo, PhD at the Sylvester Comprehensive Cancer Center at the University of Miami. Learn more about the licensing agreement.

Clinical studies and pilot programs for BNT001 will begin February 2021 at sites across the United States. The data from these trials is intended to support the product’s future FDA regulatory submission. A manufacturer that receives Breakthrough Device Designation is also eligible for prioritized review of their submission.