Tal Medical said today it launched a dose optimization trial of its low field magnetic stimulation device designed to treat depression and other neuropsychiatric disorders.
The company said it enrolled the 1st patient in the randomized, placebo-controlled 120-patient study, with data from the trial expected in early 2017.
“Initiating the dose optimization study represents a significant milestone in our strategy to bring a safe, rapidly-acting treatment to patients suffering from major depressive disorder. We look forward to advancing this study and assessing various dosing regimens with the potential to provide significant medical benefits to depression patients,” CEO Jan Skvarka said in prepared remarks.
Tal Medical said the FDA cleared the trial as a nonsignificant risk study, which allows the company to proceed with the study without submitting and obtaining investigational device exemption.
The approval is granted to studies not considered to present a potential for serious risk to the health, safety or welfare of the subject, the company said.
The device uses non-invasive neuromodulation technology that has been shown in previous trials to have a rapid-acting effect on major depressive and bipolar depressive disorders, Tal Medical said.
In July, MassDevice.com spoke with Tal Medical CEO Skvarka about the company’s hopes of being 1 of the 1st medical device companies to explore a potential new vertical for medtech: Psychiatry.