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BrainsWay gets FDA nod for next generation stimulator

Published 07 May 2018

BrainsWay has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new stimulator to be integrated into BrainsWay’s deep transcranial magnetic stimulation (Deep TMS) system for the treatment of major depressive disorder (MDD).

BrainsWay’s next-generation stimulator enhances the complete Deep TMS system and streamlines treatment for physicians and their patients.

It is the most advanced stimulator in its class and custom-designed with the Company’s proprietary H-Coil helmet for the treatment of MDD. BrainsWay’s Deep TMS proprietary H-Coil technology reaches deeper and larger surface areas of the brain than standard TMS treatments.

The new stimulator provides enhanced features focused on increasing the ease of use for the physician, integrating enhanced energy utilization, a patient management system with the built-in depression treatment protocol and a user-friendly tool for accurate, rapid motor threshold detection. These features will decrease set up time and increase office efficiencies.

BrainsWay CEO Yaacov Michlin said: “BrainsWay’s new stimulator represents a very important product advancement that solidifies the company’s leading innovative position within the US market.

“Furthermore, it sets the foundation for BrainsWay to become a fully integrated company that develops, produces and commercializes our innovative, non-invasive medical systems for the treatment of brain disorders globally.”

Overall, there are more than 15 million people in the U.S. who suffer from depression, making MDD a remarkably common disease. Within the total population of individuals with MDD, there is a subpopulation associated with even greater individual costs related to the disease. This subgroup of MDD patients experience treatment-resistant depression (TRD), which is defined as depression that does not respond to treatment with antidepressant medications.

Roughly 29% to 46% of MDD patients fail to respond adequately to antidepressant medications, and only approximately 30% of patients achieve remission from first-line pharmacological treatment. Patients who are more resistant to treatment (fail to respond to a greater number of medications) tend to experience lower rates of remission.

MDD is often recurrent, and at least 50% of those who experience a single episode and 80% of those who experience two episodes will have another in their lifetime. MDD is considered to be the psychiatric disorder with the greatest economic burden in the U.S., with costs totaling $210 billion annually, and antidepressant expenditure totaling roughly $15 billion annually.

BrainsWay is engaged in the research, development and marketing of a medical system for non-invasive treatment of common brain disorders.

Source: Company Press Release