Nexstim Plc receives FDA's response to the propose
Post# of 301275
Company announcement, Helsinki, 21 December 2016, at 5 pm
Nexstim Plc (NXTMH:HEX, NXTMS:STO), a medical technology company with a pioneering navigated non-invasive brain stimulation system, announces that Nexstim has, on December 21, 2016, received US Food and Drug Administration's (FDA) response and comments to its limited size trial protocol (E-FIT; Electric Field Navigated 1Hz rTMS for Post-Stroke Motor Recovery Trial). Nexstim's good relationship with FDA and the meeting held on September 14, 2016 ensured fastest possible response time, in fact several weeks ahead of expected timeline. The response was positive and provides Nexstim the possibility to start the new 60 patient trial in Q1 2017. According to FDA recommendation the data from the new trial will be combined with data from the previous phase III trial. In addition, in their response FDA stated that Nexstim's new sham coil design is appropriate for the new trial.
Nexstim expects that the E-FIT trial will be completed in Q1 2018. During the trial Nexstim will continue communication with FDA to ensure efficient review of the subsequent submission and the trial results will be immediately supplemented to the direct de novo 510(k) submission. De novo process provides a 120-day pathway to 510(k) clearance for novel Class II medical devices for which there is no legally marketed predicate device. In the pre-submission phase FDA has indicated that de novo pathway is appropriate for Nexstim NBT system towards the marketing and sales clearance in the USA.
Following positive efficacy results from the limited size trial Nexstim expects the de novo 510(k) clearance in Q4 2018 as FDA has already reviewed the technological and safety sections of the submission. De novo 510(k) clearance will allow Nexstim to start marketing and selling the NBT system for stroke rehabilitation in the USA.
Nexstim's financing plan supports the described trial approach. The current cash and cash generated from sales, the financing arrangements with Bracknor and Sitra, combined with the strategic changes in the organization, is estimated to finance the Company until early 2018.
Commenting on the announcement, Martin Jamieson, Chairman of the Board and CEO, said: "I'm delighted that our good relationship with FDA continues to pay off and supports our business plans for NBT stroke therapy not only in the USA but also in the other markets."
NEXSTIM PLC Martin Jamieson, Chairman and CEO
Further information is available on the website www.nexstim.com or by contacting:
Nexstim +447715163942 Martin Jamieson, Chairman and CEO martin.jamieson@nexstim.com UB Securities Oy (Certified Adviser) +358 (0)9 2538 0246
Consilium Strategic Communications +44 (0)20 3709 5700 Mary-Jane Elliott / Ivar Milligan nexstim@consilium-comms.com
About Nexstim Plc Nexstim is a medical technology company which 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) system for pre-surgical mapping of the motor and speech cortices. Based on the same technology platform, the Company has developed a system called Navigated Brain Therapy (NBT®) which is CE-marked for chronic neuropathic pain, major depression and stroke therapy. Nexstim's shares are listed on Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com
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