Tal Medical is a clinical stage neuroscience company developing a non-invasive, rapid-acting neuromodulation therapy for depression. The company aims to redefine the clinical practice of psychiatry by introducing the first safe, acute depression treatment as a standard of care.
Major Depressive Disorder (MDD) affects 350 million adults globally and is the leading cause of suicide and disability worldwide. The direct medical cost of individuals with MDD in the US alone has recently been estimated to be $100B per year. Despite widespread use of antidepressant drugs (e.g., 1 in 10 Americans), a vast unmet need remains for a safe, rapid-acting treatment. Antidepressants take 4-10 weeks to work, and up to 70% of patients do not adequately respond to their first-line therapy leaving many patients at risk. The current standard of therapy for acute, unstable or severely depressed patients is hospitalization. Electro-convulsive therapy (ECT) is often the last resort, despite safety risks including memory loss.
Tal Medical is developing a novel, proprietary Low Field Magnetic Stimulation (LFMS) technology that uses a unique magnetic field waveform, with a mechanism of action different from those of other brain stimulation techniques such as ECT or transcranial magnetic stimulation (TMS). Tal’s current prototype device is a table-top unit which slides over to cover the crown of the head while the patient lies flat on their back to receive treatment. LFMS has a non-significant risk designation by the US Food and Drug Administration, and no safety problems have been reported in current and past trials.
The proof of concept for LFMS was established in two randomized controlled studies in MDD and bipolar depression (including 117 patients) at McLean Hospital, a Harvard University teaching hospital. A single 20-minute LFMS treatment in these studies demonstrated an effect size greater than antidepressant drugs typically achieve in 4-10 weeks. For more on scientific publications, click here.
Further questions, such as the optimal treatment protocol (e.g., session length, number of sessions) and the durability of antidepressant effect, are being examined in two ongoing multi-center, randomized, controlled studies in MDD (N=210), including one funded by the National Institute of Mental Health. Both studies are expected to read out in 2016.
Validation of LFMS as a safe, rapid-acting therapy for depression by Tal has the potential to fundamentally redefine a vast and poorly served disease.