A Leader in Navigated Transcranial Magnetic Simulation (TMS)
Nexstim is a medical technology company focusing on improving rehabilitation for stroke patients through the use of noninvasive brain stimulation. Nexstim has pioneered the technology for brain diagnostics with its Navigated Brain Stimulation (NBS System) as the first and only FDA cleared and CE marked navigated transcranial magnetic stimulation (nTMS) device for presurgical mapping (PSM) of the motor and speech cortices. Based on the same technology platform Nexstim has developed a device for stroke therapy called Navigated Brain Therapy (NBT® System).
In 2014, Nexstim initiated a pivotal Phase III clinical trial in 12 of the leading US rehabilitation centres (see above) on the therapeutic effects of Nexstim’s NBT® following highly encouraging Phase II results. Nexstim stopped the trial after 138 patients at end of March 2016 following the recommendation of the Data Safety Monitoring Board (DSMB), an independent committee of experts monitoring the trial, after significant and clinically meaningful responses from both active and sham patient groups. No safety concerns were observed with any of the 199 patients enrolled in the trial.
Nexstim is now preparing a FDA 510(k) De Novo submission based on the clinical data, and aims to obtain FDA marketing clearance for the NBT® device for post-acute stroke treatment.
With its NBT® System, Nexstim is initially focusing on the rehabilitation of hand and arm movement (upper limb motor disability) which is the most common symptom following a stroke. Nexstim has developed a navigational technology which allows for the accuracy to target the correct area of the brain repeatedly, maximising the dose control of stimulation for improvement of hand and arm control. Nexstim has been able to achieve promising levels of improvement in motor functions (twofold improvement compared to conventional rehabilitation) that last throughout a 6-month observation period due to the effectiveness of its navigation algorithms. Nexstim is preparing to seek for an FDA clearance in the US to begin the commercialization of its NBT® System for use in stroke rehabilitation.
Our History of Innovation
Nexstim was established in 2000 as the result of a spin off from research into low temperature physics at the Helsinki University of Technology (currently part of Aalto University) following various research projects that were carried out at the BioMag laboratory of the Helsinki University Central Hospital in 1994-1999.
The purpose of Nexstim was to commercialize the opportunities discovered through the addition of navigation to existing transcranial magnetic stimulation (TMS) technology. Nexstim believed navigation to be the crucial aspect for the emerging TMS technology to become a clinical tool for patient treatment.
To materialize the full potential of navigated TMS, Nexstim first set out to develop the navigation aspect of the technology by developing and launching a diagnostics tool. By proving the safety, accuracy and reliability of the NBS System through diagnostics established a regulatory base and market foundation for the use of the same device in other more commercially profitable markets, such as the stroke therapy market. Nexstim's NBS System has been successful in receiving positive research attention and utilization by key opinion leaders (KOLs) in addition to being fully CE marked and FDA cleared, paving the way for use in stroke therapy.
With safety and reliability proven through the diagnostic utilization of the NBS System, application of Nexstim's NBT® System in stroke rehabilitation now requires proof of efficacy through Phase III studies, which aims to prove the repeatability of earlier Phase II results on a larger patient base in order to receive FDA clearance.
Nexstim’s strategy is to validate the navigated transcranial magnetic stimulation (nTMS) technology's therapeutic utility in post-acute stroke motor rehab demonstrating the high value clinical impact of the navigated technology platform in noninvasive neuromodulation.
Nexstim’s strategy is also to further validate the commercial potential with the clinical utility of the same technology in presurgical mapping. For presurgical mapping, Nexstim has developed the NBS System, which is FDA cleared, CE marked and sold to approximately 120 universities and teaching hospitals. Nexstim now plans to utilize the validation of its navigation technology in the PSM market to launch its stroke rehabilitation device the NBT® System on the basis of the promising Phase II results achieved in the rehabilitation of upper extremity motor disability.
After the first interim analysis of the Phase III results, Nexstim received a recommendation from the Data Safety Monitoring Board (DSMB), an independent committee of experts monitoring the trial, to continue the Phase III stroke therapy NICHE trial, without any modifications towards the goal of achieving its primary endpoint. The first interim analysis on the NICHE (Navigated Inhibitory rTMS to Contralesional Hemisphere) trial using Nexstim’s Navigated Brain Therapy (NBT®) was performed after 81 patients reached their primary safety outcome assessment, on track, at six months post-treatment.
The second interim analysis is expected to occur in Q1 2016 and the study is scheduled to complete in Q3 2016 when full data will be disclosed.
In the future, Nexstim plans to expand to other indications within stroke and, for example, in pain and tinnitus.
Our Commitment to High Quality Technology
The Navigated Brain Stimulation and Navigated Brain Therapy Systems are manufactured using internationally-accepted standards of performance. Nexstim is ISO 13485 (medical device standard) certified. Nexstim has also achieved ISO9001 Quality Certification. Nexstim’s products are CE-marked as medical devices in the EU, Medical Device Directive 93/42/EEC. The Navigated Brain Stimulation System and NexSpeech® are cleared by the FDA for use in presurgical planning for patients undergoing brain surgery.
Nexstim’s noninvasive Navigated Brain Therapy (NBT) System is not approved for Stroke Therapy by the Food and Drug Administration in commercial distribution or use in the United States and is available to select physician for investigational use only.