Mental health technology company Medibio Limited (ASX:MEB) has submitted a Designation Request for Breakthrough Device for its depressive burden software medical device MEB-001 with the US FDA.
The US Food & Drug Administration’s Breakthrough Devices Program supports accelerated development, assessment, and review of devices that promise a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and meet at least one of the following criteria: (a) Represents Breakthrough Technology; (b) No Approved or Cleared Alternatives Exist; (c) Offers Significant Advantages over Existing
Chief Medical Officer of Medibio Ltd, Dr Archie Defillo says Breakthrough Device Designation provides additional opportunities to interact with FDA experts and senior management prior to its submission for approval; and fast-tracks the FDA’s review process to reduce time-to-market for qualified devices. The FDA typically communicates its decision to grant or deny
Depression is one of the most common mental health conditions in the general population,” Dr Defillo said.
“Fifty three percent of adults in the United States have reported that their mental health has been negatively impacted by the COVID-19 pandemic. The need for an objective mental health tool has never been greater.”
Dr Defillo said depression is a known and robust risk factor for self-harm behaviour and death by suicide. The global annual mortality rate from suicide has been estimated by the World Health Organization to be 10.7 per 100,000 individuals, with variations across age groups and countries.
A major barrier to effective treatment for depression is inaccurate and/or inadequate diagnosis, which in turn contributes to its recurrence. Significantly, under-detection of depression increases the likelihood that it will result in a life-threatening disorder.
Only 50% of patients with depression who are seen in the primary care setting will be accurately diagnosed, and of these, fewer than 10% will be appropriately treated.
Currently, screening is often conducted through subjective self-report questionnaires, which introduce multiple difficulties and biases into the screening. MEB-001 provides an objective measure of depressive burden overcoming multiple difficulties and biases of self-report questionnaires.
MEB-001 is a software-only medical device that analyses physiological signals, specifically electroencephalogram (EEG) and electrocardiogram (ECG), obtained from polysomnography (PSG). It automatically scores sleep-study results, including the staging of sleep, and autonomic modulation throughout sleep stages to discriminate the presence of depressive burden.
According to Medibio, there are no other FDA-approved or cleared alternatives in the US market with this principle of operation.
