Ann: EBR Systems Investor Roadshow, page-8

I attended the investor meeting in Melbourne on Mon 30 Jan. The explanation for the delay was reiterated as due to testing on the battery lead needing to take longer than expected. The lead has to be shown to continue to work despite chest movement due to respiration for the life of the battery - about 4-5 years. So a large number of movement cycles need to be simulated. They underestimated the time to get access and duration of this until informed by an expert consultant late in 2023. They did not state any other difficulties and reiterated the view that FDA approval is expected in Q1 2025.
They indicated the quarterly cash spend should not continue at the present rate. Some yearly expenses were included in the last quarter's number. Most sales and manufacturing costs will not be needed until after FDA approval. Manufacturing much stock in advance of FDA approval is not planned as units have a shelf life due to the need to maintain sterility compliance. The sales team can be increased without huge investment after FDA approval as the sites targeted for early sales are highly concentrated in a relatively limited number of hospital centres in the US
One new piece of information they did mention was that the initial addressable target market estimate they have used in past of US $2.6 billion is now out of date. Medtronic has now implanted over 200,000 right-side wireless units and the market is clearly bigger than past estimates.
My impression was that management was confident in the technology, FDA approval and having sufficient funding until FDA approval. They do not see any other competitors with left-sided heart wireless heart failure treatment emerging for years.