Blue Note Therapeutics Receives Revolutionary Device Designation for Digital Prescription-Only Therapy for AML

We are encouraged by our ability to help reduce symptoms of distress and improve the quality of life and care of patients newly diagnosed with AML.

– Geoffrey Eich, CEO of Blue Note Therapeutics

SAN FRANCISCO, California, United States, Jan.6, 2022 /EINPresswire.com/ – Blue Note Therapeutics, a digital prescription therapy company dedicated to reducing the burden of cancer and improving outcomes, today announced that the The United States Food and Drug Administration (FDA) has granted breakthrough device designation for BNT200. BNT200 is a unique digital prescription treatment for anxiety and depressive symptoms in adults with acute myeloid leukemia (AML) hospitalized on a regimen of high intensity induction chemotherapy.

“For the thousands of patients diagnosed with AML each year, managing and managing the symptoms of the disease can be particularly difficult,” said Areej El-Jawahri, MD, Massachusetts General Hospital. “The advancement of innovative therapeutic options for the treatment of associated distress that often follows a diagnosis holds promise for patients and addresses an unmet need. Dr. El-Jawahri is the principal investigator whose research team is leading the clinical study to assess the impact of BNT200 on the quality of life, mood and symptoms of patients diagnosed with AML.

“Patients hospitalized after a diagnosis of AML often experience a sudden disruption in their lives with substantial physical and psychological impacts,” said Geoffrey Eich, CEO of Blue Note Therapeutics. “We are delighted that the FDA has recognized the need to expedite the development and review of BNT200, as well as encouraged by our ability to help reduce symptoms of distress and improve the quality of life and care of new patients. diagnosed with AML. ”

The breakthrough designation by the FDA is granted to new 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 the Revolutionary Device designation was supported by positive preliminary results in use and efficacy.

About the BNT200
BNT200 is software as a medical device (SaMD) for treating anxiety and depressive symptoms created by unique psychological stressors specific to adult patients with AML undergoing high intensity induction chemotherapy (HIC). This digital on-demand therapy is intended for hospital use during the 4-6 weeks associated with HIC treatment. The content is synchronized with the HIC treatment regimen to alleviate the unique psychological stressors endured by this subset of AML patients and therefore is not applicable to AML patients who are on outpatient treatment.

About cancer distress
There are approximately 18 million cancer patients and cancer survivors in the United States today.1 Almost half of all cancer patients experience psychosocial distress, anxiety, or depression.2 S ‘left untreated, these feelings can reduce a cancer survivor’s quality of life and negatively affect survival.3 The National Comprehensive Cancer Network (NCCN) has established guidelines for the delivery of mental health care services in oncology, which includes screening patients for signs of distress and implementing a treatment plan to meet those needs with a mental health care specialist.4 Unfortunately, less than half of patients who experience cancer distress, which can be defined as an unpleasant feeling, emotion, or experience affecting a patient’s quality of life or their ability to cope with cancer diagnosis and treatment , are oriented towards mental health care. Specialists.5,6 Prescription digital therapies designed to treat cancer-related distress may help close this cancer treatment gap.

About acute myeloid leukemia
AML is a relatively rare type of cancer of the bone marrow and blood that accounts for only about one percent of all cancers.7 By 2021, it is estimated that there will be 20,240 new cases of AML and that ‘around 11,400 people will have died from the disease. .8 AML can progress rapidly and require immediate treatment. Treatment often takes place in two phases, induction treatment and post-remission treatment (consolidation). The first phase, induction therapy, aims to bring about remission and usually uses a combination of two or more chemotherapeutic agents. Consolidation therapy, conducted after the patient has reached remission, is often performed using either intensive chemotherapy or a stem cell transplant.9

About Blue Note Therapeutics
Blue Note Therapeutics is a digital prescription therapy company uniquely dedicated to serving cancer patients. We aim to make treatment accessible to any cancer patient, at any time, by merging in-depth scientific and clinical expertise, neuroscience and digital innovation. Working closely with cancer research and patient communities, we are developing a pipeline of clinically validated digital prescription therapies to help reduce anxiety, depression, and other forms of cancer-related distress. For more information, visit www.bluenotetherapeutics.com.

About Prescription Digital Therapeutics (PDT)
Digital Prescription Therapies (PDT) are a therapeutic class of medical devices that use software approved by the U.S. Food and Drug Administration (FDA) to treat illnesses and conditions, such as anxiety and depression related in the diagnosis and treatment of cancer. Like prescription drugs, PDTs must demonstrate their safety and effectiveness in randomized clinical trials before their approval by the FDA.

The references
1 American Cancer Society. Cancer Facts and Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer- facts- and-figures-2020.pdf.
2 Mehnert A, Hartung TJ, Friedrich M, et al. One in two cancer patients is in significant distress: prevalence and indicators of distress. Psychooncology. 2018; 27: 75-82.
3 Centers for Disease Control and Prevention. Use of drugs for anxiety and depression in cancer survivors. https://www.cdc.gov/cancer/dcpc/research/articles/anxiety_dep_med_survivors.htm.
4 Comprehensive National Cancer Control Network. Managing Distress, version 3.2019, NCCN Clinical Practice Guidelines in Oncology. https://jnccn.org/view/journals/jnccn/17/10/article-p1229.xml.
5 OncoLink. What is cancer distress? https://www.oncolink.org/support/practical-and-emotional/coping-communication-concerns/what-is-cancer-related-distress.
6 American Cancer Society. Cancer Treatment and Survival Facts and Figures 2019-2021. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-treatment-and-survivorship-facts-and-figures/cancer-treatment-and-survivorship- facts-and-figures-2019-2021.pdf.
7 American Cancer Society. Key statistics for acute myeloid leukemia. https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html#:~:text=The%20American%20Cancer%20Society%E2%80%99s%20estimates%20for%20leukemia % 20in, of% 20AML.% 20Almost% 20all% 20will% 20be% 20in% 20adults.
8National Cancer Institute. Cancer Statistics Facts: Leukemia – Acute Myeloid Leukemia (AML). https://seer.cancer.gov/statfacts/html/amyl.html.
9 Leukemia and Lymphoma Society. Chemotherapy and pharmacotherapy. https://www.lls.org/leukemia/acute-myeloid-leukemia/treatment/chemotherapy-and-drug-therapy

Kim king
Blue Note Therapeutic
+1 805-410-0180
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