Tal Medical, Inc., a clinical stage neuroscience company, develops non-invasive neurostimulation treatments for brain disorders. The company provides medical devices for the treatment of psychiatry and neurology disorders; and develops non-invasive sub-threshold neurostimulation platform to target brain disorders. Its Low Field Magnetic Stimulation (LFMS) technology produces a sub-threshold electric field that modulates brain circuitry involved in unipolar and bipolar depression. The company was founded in 2010 and is based in Boston, Massachusetts. Tal Medical, Inc. operates as a subsidiary of PureTech Health PLC.
501 Boylston Street
Boston, MA 02116
Founded in 2010
Tal Medical Announces Results from Two Studies of Tal Medical's LFMS Technology in Treatment-Resistant Major Depressive Disorder
Dec 20 16
Tal Medical announced results from two studies evaluating Tal's proprietary Low Field Magnetic Stimulation (LFMS) technology in treatment-resistant major depressive disorder (TR-MDD). A Tal dose optimization study did not meet statistical significance on its Hamilton Depression Rating Scale (HAMD6) primary endpoint, although it showed a rapidly-acting, trending effect across multiple measurements in a dose-dependent manner. Separately, a functional magnetic resonance imaging (fMRI) study at Weill Cornell Medical College showed a reduction in functional connectivity in brain networks associated with depression after LFMS treatment. Given these latest results and the data from the RAPID trial reported in June, company will assess the utilization of Tal resources and previously-earmarked PureTech cash and re-allocate as appropriate. Although company did not achieve statistical significance on the primary endpoint of their dosing study, the observed magnitude of the effect achieved in 2 to 4 days is on par with or higher than what antidepressant drugs typically achieve in 4 to 10 weeks and with a good safety profile. They are considering several options to potentially increase the effect size and statistical power, including working with strategic partners and trusted academic collaborators through non-dilutive sources. The data from both the dose ranging and Weill Cornell studies are encouraging and further suggest that LFMS has rapidly-acting effects on mood. Importantly, the dose-dependent effects of LFMS on self-rated as well as investigator-rated symptoms of depression seen in the dose ranging study, coupled with a highly favorable safety profile, support further work to optimize the LFMS field properties for the potential treatment of clinical depression.
Tal Medical Enrolls First Patient in Dose Optimization Study for Innovative Investigational Therapy to Treat Depression and Other Neuropsychiatric Disorders
Sep 9 15
Tal Medical announced that the first subject has been enrolled in the dose optimization study. The randomized, placebo-controlled dosing study will be conducted in 120 patients across multiple sites in the U.S. Topline data are expected in early 2017. The Company also announced that it has received positive confirmation from the U.S. Food and Drug Administration (FDA) that Tal's dosing study is a nonsignificant risk (NSR) device study. The FDA's NSR designation allows Tal to proceed with the dose optimization study in the U.S. without submitting and obtaining approval of an investigational device exemption (IDE) application because the study, as assessed by the FDA, is not considered to present a potential for serious risk to the health, safety, or welfare of a subject. NSR devices are those that are generally considered to be low risk based on their intended use in the study. Examples of NSR devices include daily wear contact lenses, dental filling materials, and jaundice monitors for infants. In 2013, Tal received initial proof-of-concept data from a randomized, double-blind, sham-controlled trial in patients with major depressive and bipolar disorders conducted by McLean Hospital, a psychiatric research hospital affiliated with Harvard Medical School. In the study, a single 20-minute treatment demonstrated rapid onset of action, substantial effect size, and a strong safety profile. Given this unique, rapid effect of LFMS treatment, the National Institute of Mental Health has selected LFMS for a multi-site clinical trial. The trial is examining the efficacy and durability of the treatment over an extended period of time in patients with major depressive disorder.