Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Thursday, December 22, 2016

Nexstim Plc receives FDA's response to the proposed limited size stroke trial plan

I guess you have to be an insider to have any clue what this is.

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
Further information is available on the website www.nexstim.com or by contacting:
Nexstim                                                                  +447715163942
Martin Jamieson, Chairman and CEO  martin.jamieson@nexstim.com

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