Nexstim announces FDA clearance for NexSpeech® - enabling noninvasive speech mapping prior to neurosurgery

NBS System now available to US patients for both motor and speech mapping of the cortex

HELSINKI--(BUSINESS WIRE) – June 11, 2012 -- Nexstim Oy, a medical device company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the NexSpeech® module for use with the Navigated Brain Stimulation (NBS) System. In presurgical planning for patients with brain tumors, the NBS System enables accurate and reliable mapping of the vital motor areas in the brain. Now, with NexSpeech, cortical areas that do not contain essential speech function can also be localized.

Neurosurgeons have long awaited accurate and reliable noninvasive tools for pre-operative planning. Previously, the only reliable techniques were invasive and required craniotomy. NBS is a major advance for tailoring neurosurgical treatment to the needs of the individual patient with a brain tumor. Information from NBS with NexSpeech may help lower the risk of damage to eloquent cortex, as well as help shorten operating times. Importantly, using NBS with NexSpeech potentially allows more patients with brain tumors to benefit from surgery.

With NexSpeech, the NBS System uses navigated repetitive transcranial magnetic stimulation (rTMS) to temporarily disrupt cortical areas essential for speech. While the patient names everyday images, a coil is gently moved over the head and used to give synchronized bursts of stimuli. Analysis of patient´s speech behavior results in a map of cortical areas vital for speech, displayed in the patient´s MRI.

About Nexstim and Navigated Brain Stimulation

Nexstim was founded in 2000 to develop Navigated Brain Stimulation (NBS) for noninvasive brain diagnostics and neurotherapy. With NBS an operator moves a TMS coil over the patient´s head delivering harmless magnetic pulses whose electric fields gently activate neurons in the cortex. Converting a standard head MRI into a 3D-model of the patient´s brain, allows the operator to precisely navigate the coil´s electric field in the cortex. Patient responses to the magnetic stimuli reveal the locations of vital functional areas inside the brain.

With over 90 installations world-wide, the NBS System is CE-marked and FDA-cleared for cortical mapping prior to neurosurgery. In addition, the NBS System is being developed as a novel neurotherapy platform with several investigational applications. Nexstim is backed by leading European venture capital investors. See

Further information

Janne Huhtala, CEO
Mobile +358 40 861 5046