General Investor Information EBR Systems, page-282

Welcome Lumpymash, and great to hear from a fellow shareholder.

As you've followed the Company for quite a while you've probably listened to most, if not all, of the presentations and webcasts provided by various members of the Company and especially John McCutcheon.
Whilst you can never rule out the possibility of failure with anything, you'd be aware that the WISE device has already achieved the criteria necessary for safety and efficacy through the SOLVE-CRT trial, in order ultimately for submission to the FDA. Thus John's view is that there is no binary decision, it is just a matter of timing before the device is approved.

I take comfort that the senior management team from the Chairman down, including corporate, financial, medical, and sales focussed individuals, have had ennumerable years experience and involvement with this particular sector of the health space, many of whom have been involved with the major manufacturers that supply 90%+ of the huge US pacemaker market. And that WISE is complementary, not competitor, to that pacemaker market.
Whilst the Chairman and CEO have both indicated previously their interest to develop and market the WISE product separately within EBR Systems, I feel as though everything has a price, and with the financial wherewithal that manufacturers (eg Medtronic, Boston Scientific, Abbott bring it is possible that EBR will only last as long as WISE remains an FDA submission. Once approved it may be immediately targeted for takeover - obviously the longer it is able to build its market separately the more value EBR will be able to command.