Major Depressive Disorder (MDD) exerts a tremendous burden on our society, annually affecting over 350 million people worldwide and incurring a direct medical cost of over $100B in the US alone. It is a truly debilitating disease, with symptoms such as inability to perceive pleasure, feelings of hopelessness, loss of energy, and suicidality. In spite of several treatments available, MDD remains the number one cause of disability and suicide worldwide.

Existing treatments fail to meet the medical needs of depression patients. Drugs, the most common form of anti-depressant therapy, take 4-10 weeks to onset of action. Furthermore, they don’t work with about one third of patients, and have many undesired side effects. Electro-convulsive therapy (ECT) can produce effects within one to two weeks in most patients, but its safety profile is controversial, with about a 50% chance of causing significant memory loss. Psychotherapy and Transcranial Magnetic Stimulation (TMS) are slow-acting, and work better with milder forms of depression.

LFMS has been tested in both MDD (also called unipolar depression) and bipolar depression (BPD). Five randomized, sham-controlled, blinded trials have studied LFMS in depression to date, exploring different dosing protocols. Four of these studies have shown rapid, clinically meaningful effects in MDD and BPD patients (in approximately 300 patients), of which two achieved statistical significance and two showed trending effect. A 20 minute treatment protocol appears to be bioactive in BPD, while a 60 minute treatment is required in MDD.

The optimal treatment duration (i.e., number of days to repeat the treatment) as well as the durability of antidepressant effect has yet to be determined. We believe that repeated treatment sessions will be required for maximum efficacy and meaningful durability, as is the case with other brain stimulation techniques such as ECT or TMS.

 

The Tal Medical LFMS Device is limited by US Federal Law to Investigational Use.