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Blue Note Therapeutics Receives Breakthrough Device Designation for Prescription-Only Digital Therapeutic for Acute Myeloid Leukemia
San Francisco, January 6, 2022
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 diagnosis is promising for patients and addresses an unmet need.” Dr. El-Jawahri is the principal investigator whose research team is leading the clinical study to evaluate the impact of BNT200 on quality of life, mood, and symptoms of patients diagnosed with AML.
“Patients hospitalized after diagnosis with AML often experience a sudden disruption of their life with substantial physical and psychological impacts”, said Geoffrey Eich, CEO of Blue Note Therapeutics. “We are pleased that the FDA has recognized the need to speed up development and review of BNT200, as well as encouraged by our ability to help reduce the symptoms of distress and improve quality of life and care in patients newly diagnosed with AML.”
The FDA Breakthrough Designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Blue Note’s application for Breakthrough Device Designation was supported by positive usability and preliminary efficacy findings.
About BNT200
BNT200 is a software as a medical device (SaMD) intended to treat the anxiety and depressive symptoms created by the unique psychological stressors specific to adult patients with AML undergoing high-intensity induction chemotherapy (HIC). This on-demand digital therapeutic is intended to be used in the inpatient setting during the 4-6 weeks associated with HIC treatment. The content is synchronized with the HIC treatment regimen to blunt the unique psychological stressors endured by this subset of patients with AML and is therefore not applicable to patients with AML undergoing outpatient treatment.
About Cancer-Related Distress
There are about 18 million cancer patients and survivors in the United States today.1 Nearly half of all cancer patients experience psychosocial distress, anxiety, or depression.2 If left untreated, these feelings can lower a cancer survivor’s quality of life and may negatively affect survival.3 The National Comprehensive Cancer Network (NCCN) has established guidelines for the delivery of mental health care services in oncology, which include screening patients for signs of distress and implementing a treatment plan to address these needs with a mental health care specialist.4 Unfortunately, fewer than half of patients who experience cancer-related distress, which can be defined as any unpleasant feeling, emotion, or experience that affects a patient’s quality of life or ability to cope with cancer diagnosis and treatment, are referred to mental health care specialists.5,6 Prescription digital therapeutics designed to treat cancer-related distress can help close this cancer treatment gap.
About Acute Myeloid Leukemia
AML is a relatively rare type of bone marrow and blood cancer accounting for only about one percent of all cancers.7 In 2021, it is estimated that there will have been 20,240 new cases of AML and an estimated 11,400 people will have died of this disease.8 AML can progress rapidly and require immediate treatment. Treatment is often conducted in two phases, induction therapy and postremission (consolidation) therapy. The first phase, induction therapy, aims to bring on remission and typically uses a combination of two or more chemotherapy drugs. Consolidation therapy, conducted after the patient has reached remission, is often conducted using either intensive chemotherapy or stem cell transplant.
About Blue Note Therapeutics
Blue Note Therapeutics is a prescription digital therapeutics company singularly dedicated to serving patients suffering from cancer. We aim to make treatment accessible to any cancer patient, at any time, by merging deep scientific and clinical expertise, neuroscience, and digital innovation. Working closely with cancer research and patient communities, we are developing a pipeline of clinically validated prescription digital therapeutics to help reduce anxiety, depression, and other forms of cancer-related distress. For more information, visit www.bluenotetherapeutics.com.
About Prescription Digital Therapeutics (PDTs)
Prescription digital therapeutics (PDTs) are a therapeutic class of medical devices that use U.S. Food and Drug Administration (FDA) approvable software to treat diseases and conditions, such as anxiety and depression related to cancer diagnosis and treatment. Similar to prescription medicines, PDTs must demonstrate safety and efficacy in randomized clinical trials prior to their approval by the FDA.
