Tal Medical was founded in 2010, after in-licensing exclusive rights to a novel Low Field Magnetic Stimulation (LFMS) platform technology from McLean Hospital, a teaching hospital of Harvard University. LFMS is a non-invasive form of neuromodulation that applies an imperceptible electromagnetic field to brain via a magnetic coil placed around a patient’s head.
LFMS was serendipitously discovered at McLean Hospital when bipolar depression patients undergoing a specific form of magnetic resonance spectroscopy unexpectedly reported rapid mood elevating effect. As subsequently demonstrated in imaging studies, LFMS suppresses brain activity, incl. in neural circuits that have been shown to be hyperactive in depression (e.g., Default Mode Network).
Five randomized, sham-controlled studies with a total of 389 subjects have investigated LFMS in Bipolar Depression and Major Depressive Disorder (MDD) to date. Combined with PET-FDG and fMRI imaging evidence, these studies provide a “proof of concept” for LFMS’ rapid anti-depressant effect and support a planned pivotal study in MDD that will lead to FDA approval if successful.
More specifically, our most recent dose optimization study in treatment resistant MDD (N=122) showed an antidepressant effect after 60-min daily treatments over four days (2.7-point delta on MADRS, p=0.09), a dose ranging effect, and no major side effects. The effect size observed was in the range seen after 4-10 weeks of drug or 6 weeks of TMS therapy (no head-to-head data).
Our clinical studies utilize an investigational table-top prototype device placed in a physician’s office. However, our commercial strategy is based on a next-generation portable helmet device self-administered by a patient at home. We believe that the convenience and economics of home use will be critical contributing drivers for the adoption of LFMS by patients, providers and payors.
In 2016, we started a new non-invasive neuromodulation effort in sleep. Our sleep therapy, targeting chronic insomnia patients, is being rationally designed based on the knowledge of sleep biology. The approach utilizes certain aspects of the LFMS technology, but uses parameters optimized for modulating sleep, and a custom-designed wearable capcoil. The sleep program is in its early clinical stages, before technical proof of concept.