in context

The problem is with ONE version of the device - the LV4 - only. The LV3 version does not seem to have any problems.

The question is NOT whether the device is reliable, even with this type of problem the early looking-in results success rate was 78.6% exceeding the trial bench-mark!!!!.....When I read this result, I thought it was a lower than the established 83% success they had with the feasibility, now we "probably" know why!!!!!

So if the problem is fixed, they are back to having 2 working versions/models.

The questions are;
1) What impact this will have on the stats (for FDA approval for BTT), and how will they address this in the final submission (to the FDA) of the result.
2) How much will it cost to have this problem fixed in the implanted devices? Because this is now an extra cost that was not taken into account when they sought additional funds!!

There is no question regarding the efficay of the LV3 version, and, imo only, there is no reason NOT to continued implants of this version/model for (any remaining BTT patients) and if they decide to press-on with the DT trials.

IMO ONLY, I don't expect revenue or the trials to be affected since LV3 is available. What I expect is that any would be "purchaser" will have an "execuse" to drop the price, and SH being fed-up with this management may decide to accept it. IMO, I like the idea of a financier, and again, I don't see the playing field changing that much, since there is a perfect working version of the device.

Time will tell.