http://sports.yahoo.com/news/nexstim-plc-receives-fdas-response-150101654.html
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
Martin Jamieson, Chairman and CEO
Further information is available on the website www.nexstim.com or by contacting:
Nexstim +447715163942Martin Jamieson, Chairman and CEO martin.jamieson@nexstim.com
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