Nexstim's Brain Therapy System Receives CE Mark for Treatment of Depression and Stroke Rehabilitation

HELSINKI--(BUSINESS WIRE)-- Nexstim Oy, a medical device company, announced today that the Navigated Brain Therapy (NBT) System meets the requirements of the European Medical Devices Directive (MDD).The NBT System is the first non-invasive, non-systemic therapeutic device CE-marked to offer patients a personalized treatment for major depression. In addition, the NBT System is CE-marked for use in patients recovering from stroke as a supplement to conventional rehabilitation. The navigation feature of NBT allows for accurately targeting therapy directly to the cortical structures believed to be involved in brain dysfunctions.

In brain stimulation therapy for depression, pulsed magnetic fields are used to stimulate a specific region of the cerebral cortex believed to be crucial for the control of mood and associated with depression. Nexstim’s NBT System is unique because its clinically-proven MRI-based navigation allows the user to visualize the electric field inside the patient’s brain and accurately target therapy. Nexstim’s navigation feature eliminates the unscientific “hit and miss” errors inherent in other devices and uniquely enables treatment sessions to be identically replicated for each patient.

In depression, non-invasive, navigated brain therapy has been shown to be safe, well-tolerated and without the side-effects frequently associated with oral antidepressants. A course of therapy with NBT is a painless outpatient procedure and is typically performed in the physician’s office.

About Nexstim and Navigated Brain Therapy

Nexstim was founded in 2000 to develop navigated transcranial magnetic stimulation (TMS) solutions for non-invasive brain therapy and diagnostics. With NBT, MR-images of the brain are used to visualize the stimulating electric field and allow the user to precisely modulate any desired brain structure. NBT works by using a TMS coil placed over the patient’s head to gently activate neurons in the underlying cortex. MRI-based guidance allows for stimulation therapy to be personalized and quantified to the needs of the individual patient.

The NBT System is the first in a new line of therapy products based on Nexstim´s proven technology, including the world’s first and only CE-marked and FDA-cleared navigated stimulation device for neurosurgery. See www.nexstim.com.

Caution to US residents: The NBT System has not received clearance from the FDA for marketing in the USA.

Contact:

Nexstim Oy

CEO Janne Huhtala

Mobile +358 40 861 5046

janne.huhtala@nexstim.com