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Blue Note Therapeutics Receives Breakthrough Device Designation for Prescription-Only Digital Therapeutic for Acute Myeloid Leukemia

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Press Release

Jan 6, 2022 16:00 EST

Blue Note Therapeutics, a prescription digital therapeutics company dedicated to easing the burden of cancer and improving outcomes, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for BNT200. BNT200 is a first-of-its-kind prescription-only digital therapeutic to treat anxiety and depressive symptoms in adults with acute myeloid leukemia (AML) who are hospitalized for a regimen of high-intensity induction chemotherapy.

“For the thousands of patients diagnosed with AML each year, managing and coping with disease symptoms can be especially difficult,” said Areej El-Jawahri, M.D., Massachusetts General Hospital. “The advancement of innovative therapeutic options for the treatment of the associated distress that often follows a…

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