- Conference call to be held today at 3pm EEST / 1pm BST / 8am EDT
- Interim data analysis by an independent Data Safety Monitoring Board shows that safety criteria are met
- Trial now further de-risked and to continue without any modifications towards the primary endpoint of demonstrating a clinically important functional improvement with NBT®
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 there will be a conference call today for analysts and investors to discuss the positive interim analysis recommendation. The call will take place at 3pm EEST / 1pm BST / 8am EDT and will be hosted by Janne Huhtala, CEO and Mikko Karvinen, CFO. The dial in instructions are below. A copy of the presentation will be available on the Company’s website shortly before the call. The call ID is 61745818#. A playback can be accessed on +44 (0)20 3426 2807 with the reference 662425#.
Finland +358 (0)9 8171 0317
Sweden +46 (0)8 5059 6306
UK +44 (0)20 3139 4830
USA +1 718 873 9077
In a statement issued on Saturday 26th September at 12:00 noon (EEST) Nexstim Plc announced that it had 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. As previously announced, 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.
Nexstim commenced the pivotal, randomised, sham-controlled, double-blinded multi-centre Phase III study in H1 2014 to demonstrate the effects of its NBT® 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 NBT® and sham groups of patients to achieve a clinically important functional improvement from baseline to six months post treatment. The safety data was assessed on all patients 160 recruited to-date.
Commenting on the DSMB’s positive recommendation, Janne Huhtala, Chief Executive Officer of Nexstim, said: “The DSMB recommendation confirms the good safety profile of our product and de-risks the programme heading into the pivotal efficacy outcome data. With positive outcome data, Nexstim will be strongly placed to take a significant market position with NBT® for stroke therapy. We continue the unmodified trial, as planned, with excitement and with the aim of hitting the primary endpoint and bringing this important product to patients and care givers in rehabilitation centres as quickly as possible.”
Janne Huhtala, CEO
Janne Huhtala, Chief Executive Officer
+358 (0)40 8615046
UB Securities Ltd (Certified Adviser)
+358 (0)9 2538 0254
Consilium Strategic Communications
Mary-Jane Elliott / Ivar Milligan / Laura Thornton
+44 (0)20 3709 5700
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 (NBT®). In H1 2014, Nexstim initiated a two-year 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 therapy in the US. Nexstim's shares are listed on Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com.
Navigated Brain Therapy (NBT®) 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.
About NICHE (Navigated Inhibitory rTMS to Contralesional Hemisphere)
The NICHE trial is a pivotal, prospective, multi-centre, randomised, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardised task-oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for six weeks and primary outcome assessed six months later. For more information on the trial, please visit: