Nexstim regulatory release03.12.2015 08:30:00 CET
Helsinki, 3 December 2015 at 9:30 am
Nexstim Plc (NXTMH:HEX, NXTMS:STO), a medical technology company aiming to improve rehabilitation for stroke patients through the use of non-invasive brain stimulation, announces that it has successfully completed enrolment of its Phase III NICHE (Navigated Inhibitory rTMS to Contralesional Hemisphere) clinical trial in stroke therapy, ahead of schedule.
Nexstim commenced the pivotal, randomised, sham-controlled, double-blinded multi-centre Phase III study in H1 2014 to demonstrate the effects of its NBTŪ system on upper limb motor rehabilitation post-stroke. The two year study is being conducted on up to 198 patients at 12 prominent rehabilitation sites in the USA. The primary objective of the study is to demonstrate a difference between the active NBTŪ and sham groups of patients to achieve a clinically important functional improvement from baseline to six months post treatment.
The announcement follows a recent recommendation from the Data Safety Monitoring Board (DSMB) which showed that safety criteria were met and that the trial should continue without any modifications. As previously announced, the study is scheduled to complete in Q3 2016 when full data will be disclosed. The company has ongoing dialogue with FDA regarding the 510(k) De Novo submission.
Nexstim's CEO, Janne Huhtala, said: "The successful and early completion of enrollment for the study's final cohort demonstrates significant interest in our ground-breaking NBTŪ technology for a more effective stroke therapy product. This confirms our view that upon successful publication of the trial data, Nexstim will have an important part to play in stroke rehabilitation and is well positioned to fundamentally transform this market. We look forward to treating the remaining patients before they progress into the six month follow up period."
Jarmo Laine, Nexstim's Vice President of Medical Affairs, added: "Nexstim's non-invasive neurostimulation with NBTŪ has significant potential for revolutionising upper limb motor rehabilitation post-stroke and we can see interest growing as the study progresses. We are committed to improving the quality of life of patients with significant unmet clinical needs."
NEXSTIM PLC
Janne Huhtala, CEO
For further information please visit www.nexstim.com or contact:
Nexstim +358 (0)40 8615046
Janne Huhtala, Chief Executive Officer janne.huhtala@nexstim.com
UB Securities Ltd (Certified Adviser) +358 (0)9 2538 0254
Consilium Strategic Communications +44 (0)20 3709 5700
Mary-Jane Elliott / Ivar Milligan / Laura Thornton nexstim@consilium-comms.com
About Nexstim Plc
Nexstim is a medical technology company aiming to improve rehabilitation for stroke patients. Nexstim has pioneered its technology in 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 pre-surgical 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 (NBTŪ). In H1 2014, Nexstim initiated a two-year pivotal Phase III study at 12 sites in the US aiming to demonstrate the effectiveness of NBTŪ and gain FDA clearance for commercialisation in post-acute stroke therapy in the US. Nexstim's shares are listed on Nasdaq First North Finland and Nasdaq First North Sweden. In H2 2015, the Company received a recommendation from the Data Safety Monitoring Board (DSMB) to continue the Phase III stroke therapy NICHE trial without any modifications. The first interim analysis on the NICHE (Navigated Inhibitory rTMS to Contralesional Hemisphere) trial using NBTŪ was performed after 81 patients reached their primary safety outcome assessment, on track, at six months post-treatment. For more information please visit www.nexstim.com.
About Transcranial Magnetic Stimulation (TMS) and Repetitive Transcranial Magnetic Stimulation (rTMS)
Transcranial Magnetic Stimulation (TMS) is a non-invasive 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 electric field in the brain. In repetitive Transcranial Magnetic Stimulation (rTMS) the coil delivers a rapidly pulsed magnetic field in order to modulate cortical function in a region of the brain.
About Navigated Brain Stimulation (NBS)
Navigated Brain Stimulation is a non-invasive technique that allows accurate and detailed mapping of the critical motor and speech functions of the cortex. Through the use of a standard MRI brain scan, transcranial magnetic stimulation, and EMG, the NBS mapping stimulates areas of the cortex and records motor responses.
About NBTŪ
Navigated Brain Therapy (NBTŪ) is a non-invasive 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 in patients recovering from stroke as a supplement to conventional rehabilitation.