General Investor Information EBR Systems, page-301

So according to here;
the first ever implant was in early 2021, performed by Prof Pascal Defaye of CHU de Grenoble-Alpes
On April 15, 2021 https://brandonbiocatalyst.com/2021...mplant-utilizing-ebr-systems-wise-crt-system/ wrote he had performed the ..”world first Leadless LBBAP implant.

EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that Professor Pascal Defaye, Head of Rhythmology and Cardiac Stimulation Unit, CHU de Grenoble-Alpes, France, performed the world’s first successful Leadless Left Bundle Branch Area Pacing (LBBAP) implant performed utilizing the WiSE CRT System.”​

According to the AFR story above EBR was remade as a public company with a new IPO in November, seven months later?


And around three years after that first WiSE procedure, in April, 2024 Bell Potter produced a useful report (shared by @megamutts on HC here; https://hotcopper.com.au/posts/73200208/single ) , stating 108 people who had received the procedure had been in a study which reported impressive results in May 2023….
… which caused the EBR price to jump from 80c to a brief high of $1.17 in June last year ..

It wrote (amongst much more);

The company now expects to submit the final module of the PMA dossier to the FDA in 3QCY24.​

The PMA is subject to priority review, therefore, approval is anticipated 1QCY25.
Following a transition of coverage, we adopt a detailed bottom-up revenue model reflecting this revised commercialisation timetable.
Expected ramp-up in our risk adjusted model sees EBR reach EBITDA / cash flow positive in FY28.​

Investment View: Maintain Buy (Spec) Valuation at $1.43
We anticipate additional equity funding post FDA approval in 1HFY25, driving a 10% valuation adjustment to A$1.43 / sh.
Note that our un-risked valuation is at $2.18 / sh.
Catalysts include publication of the trial data in a peer review journal, submitting the 5th module for the PMA in 3QCY24 and FDA approval in 1QCY25.
​

So an interesting point we are at in this potentially life saving company’s history?


cheers