Helsinki, 18 September 2014
Nexstim (the “Company”), a medical technology company focused on Navigated Brain Stimulation (NBS), announces the launch of a new NBS system, NBS 5, for noninvasive presurgical mapping in clinical neurosurgery. The new device will be showcased at two international neurosurgery congresses during the month of October 2014, one in Europe and the other in the USA.
The new NBS 5 system combines MRI-guided Transcranial Magnetic Stimulation (TMS) with electromyography (EMG) measurement and incorporates DICOM[1] export to surgical planning systems, surgical navigators and microscopes. Nexstim has developed and implemented several novel proprietary features in the new NBS 5 to enable NBS to be easily adopted as the routine solution for presurgical mapping of the cortex in clinical neurosurgery. Computer-aided alignment of the stimulation coil, motor threshold determination and E-field-based stimulation enable mapping of motor areas around the point of interest.
The new system also includes an improved targeting tool for the stimulating E-field, optimising the stimulation dose and shortening the mapping time for both the patient and the user; a new consumable head tracker, engineered to ensure a more comfortable experience for the patient and to allow for more freedom when positioning the device; and a new camera aiming tool to ensure optimal camera positioning.
NexSpeech™ software has been upgraded to automatically import speech data to NBS MRI view for efficient analysis and seamless integration into the surgical workflow. Nexstim’s data sharing capabilities have also been upgraded with a new SFTP data transfer solution solution that improves the data workflow at the hospitals.
Nexstim will be showcasing the new NBS 5 system at two events this month. The first event is the 6th International Symposium on Navigated Brain Stimulation in Neurosurgery, 10 – 11 October 2014, Berlin, Germany[2]. The second event is the Congress of Neurological Surgeons (CNS) 64th Annual Meeting, 18 – 22 October 2014, Boston, Massachusetts[3].
The 6th Annual International Symposium on Navigated Brain Stimulation in Neurosurgery is hosted by Charité-Universitätsmedizin Berlin and supported by Nexstim. Participants have an opportunity to share their practical experiences with colleagues on the Navigated Brain Stimulation technology. There will be a demonstration and mapping protocol discussions. Featured lectures will be on presurgical motor mapping for tumors and epilepsy; speech mapping; radiosurgical planning; brain plasticity; and stroke rehabilitation.
The theme for the Congress of Neurological Surgeons (CNS) 64th Annual Meeting is A Question of Balance, focusing on the competing challenges faced by neurosurgeons in their everyday practice.
Janne Huhtala, Chief Executive Officer of Nexstim, commented: “We are delighted to launch the new NBS 5 system today which addresses the unmet need for more precise and reliable noninvasive planning tools in clinical neurosurgery. This launch is another exciting milestone for Nexstim’s innovative product line and research into navigated TMS therapy for the treatment of brain diseases, and we are pleased to be making this progress whilst our Phase III clinical trial in therapy continues according to plan. We look forward to showcasing the NBS 5 system at conferences in Berlin and Boston later this month and to educating wider audiences about the potential of this technology.”
Dr. Thomas Picht, Department of Neurosurgery, Charité Universitätsmedizin Berlin, added: “Nexstim’s technology for both diagnostics and therapy is pioneering and the navigation aspects of it make it unique in the market. This upgrade to the system further enhances Nexstim’s significant contribution to advancing neurosurgical practices.”
About Nexstim
Nexstim is a medical technology company focusing on improving rehabilitation for stroke patients. Nexstim has pioneered the technology for brain diagnostics with the Navigated Brain Stimulation (NBS) system as the first and only FDA-cleared and CE-marked navigated Transcranial Magnetic Stimulation (nTMS) device for presurgical mapping of the motor and speech cortices. Based on the same technology platform the company has developed a device for stroke therapy, called Navigated Brain Therapy (NBT®). Nexstim has initiated a pivotal Phase III study at 12 sites in the US aiming to demonstrate the effectiveness of NBT® and gain FDA clearance for commercialisation in post-acute stroke.
About Transcranial Magnetic Stimulation (TMS) and Repetitive Transcranial Magnetic Stimulation (rTMS)
Transcranial Magnetic Stimulation (TMS) is a noninvasive technique that consists of a magnetic field emanating from a wire coil held outside of the head. The rapidly changing magnetic field induces a stimulating electrical field in targeted regions of the brain. Repetitive Transcranial Magnetic Stimulation (rTMS) sends repetitive and focused stimulation to selected regions of the brain. Short rTMS bursts are used for FDA cleared speech and language mapping (NexSpeech®) and longer rTMS sequences are used in clinical trials for therapies such as stroke and depression.
About Navigated Brain Stimulation (NBS)
Navigated Brain Stimulation NBS is a noninvasive procedure providing an accurate and detailed map of the critical functions of the cortex. Through the use of a standard MRI brain scan, transcranial magnetic stimulation, and EMG, this procedure excites and records responses of precise areas of the cortex for use in diagnostic applications.
About Navigated Brain Therapy (NBT®)
Navigated Brain Therapy (NBT®) is a noninvasive system that uses navigation to accurately target therapy directly to the cortical structures believed to be involved in brain dysfunctions. The device is CE-marked to offer patients a personalised treatment for major depression. In addition, the system is CE-marked for use with patients recovering from stroke as a supplement to conventional rehabilitation.
Please Note: Nexstim´s NBS system is cleared by the FDA for assessment of the motor and speech cortices for pre-procedural planning. The NBT® system is not cleared for commercial distribution in the United States.
[1] Digital Imaging and Communications in Medicine
[2] 6th International Symposium on Navigated Brain Stimulation in Neurosurgery
[3] Congress of Neurological Surgeons (CNS) 64th Annual Meeting