Ann: Positive Results from the SOLVE-CRT Randomised Sub-Study, page-35

I think it's better to keep things in perspective, and refer to the initial ASX release of 21 Oct 2022 which stated:

"Following ongoing technical assessments, EBR has identified a potential increased rate of battery depletionaffecting a small number of WiSE® systems.
Preliminary analysis confirmed the cause as an insulation breachin the system’s transmitter, which may result in the development of a leakage pathway, leading to the batterydraining at a faster rate than normal.
The issue has been clinically confirmed in 1 patient representing a device failure rate of 0.8%, with an additional 7 devices suspected of having a similar issue which could raise the failure rate to 6.3%.
There have been no reported complications to patient health or safety as a result of this issue to date.
EBR continues to investigate the issue further, however the Company believes that this will not affect the outcomes of the pivotal SOLVE-CRT (“SOLVE”) trial and said devices will continue to function normally and deliver biventricular pacing until the battery is depleted."

Then in the latest Annual Report 27 April 2023:

"Implementing changes to rectify battery transmitter issue
During the year, EBR identified an increased rate of battery depletion caused by the transmitter in a subset of WiSE devices. The issue was picked up as part of ongoing technical assessments and subsequently, EBR issued a notification to customers in line with regulations and industry best practice. The Company is confident that the issue will not impact the headline data or timing of the SOLVE trial.
Affected devices were able to continue functioning normally and deliver biventricular pacing until the battery was depleted. The Company has actively been working toward a solution which will be completed prior to PMA submission to the FDA in the second half of 2023."

And furthermore:
"Continuing rigorous R&D and innovationDuring the period, EBR continued its research into optimising the WiSE battery performance and lifetime.
The objective of the R&D project is to substitute the existing battery with a smaller and rechargeable one that can last up to 20 years; charged through the skin for approximately one hour per week using inductive charging. Similar technology is already being used in implantable devices for heart failure and neuromodulation and EBR is collaborating with a well-established vendor that supplies similar batteries to other medical device firms."

I too believe John McCutcheon touched on the subject in recent webinars (but not in a position to check back now) where he referred to a manufacturing solution to the problem.

EBR was able to draw down the second tranche of the Growth Capital Facility in July 2023 so IMO that may have required careful consideration of any significant issues/risks at that time.

Certainly I was very surprised with the CR (having just bought shares at $1.05 prior to the announcement) but considered it a decision by a very conservative board - particularly with the general state of the markets at the time.

But I'd like to say that any anonymous posters on HC who queries the management of EBR maybe needs to look a bit closer at the backgrounds and career paths of the Chairman, the CEO, and some of the other board members. If not satisfied then maybe invest elsewhere! Any suggestion that this board isn't trustworthy IMO is way off track.