So, watched the replay of today's webinar, and took a few notes for all. I’ve only noted what John McCutcheon spoke about that is not clear from the slides alone, or that I have not seen in previous presentations:
JM reiterated that EBR is now past the binary risk phase of the device due to successful pivotal trial data. He explained that unlike in medicines, in medical devices there is no Phase 1, 2 and 3 trials. There is a pilot study and a pivotal study. The recent SOLVE-CRT study (EBR’s pivotal study) serves as the safety measure that Phase 3 trials would do in medicines. EBR now has that data that proves safety and efficacy. Regarding FDA approval JM stated: “It’s not a 100% guarantee, but it’s very high probability [JM's emphasis] that when you get to this stage, then you’re going to get FDA approval. It’s time, not if. Aiming to finalise PMA submission to FDA in Q1 2024, and receive FDA approval in H2 2024.
FDA Breakthrough Device Designation means that EBR goes to the front of the queue if there is any FDA backlog. EBR can and does have informal meetings with the FDA. EBR has a very positive working relationship with the FDA. John highlighted numerous examples of this positve relationship in action over the last few years.
Breakthrough Device Designation also means EBR is eligible for New Technology Add-on Payment. Meaning that whatever the standard that is paid for a device, EBR gets add-on payment. I'm not clear on specific numbers here, exact numbers were not mentioned in webinar or on slides.
Within 4 years, EBR aims to be able to do Totally Leadless CRT (TLC) as a frontline therapy, i.e. not reliant on any existing CRT system which will address an extra 2bn market. Long-term addressable market with next-gen systems (such as TLC) is estimated at 9.6bn.
Company is continuing to work on the rechargeable battery for the WiSE device. More details to come as clarity around timelines is known.
This has been said before, but love hearing it: “There’s no competition [for what EBR does], we’re in this big space, that has some major incumbent players; Abbot, Medtronic, Boston Scientific, but we’re not going head-to-head with them. We’re filling a gap in their lines with a unique clinical benefit. We don’t have to displace anyone.”
At the end of Q2 EBR had approx. $128million AUD in funds. Recent Capital Raise funds will be used for; establishing a sales force as FDA approval approaches to take device to market, investment in a manufacturing facility, and funding new technology, “..such as the rechargeable battery .. and some other things that we haven’t announced yet, but we, we are excited to do that .. in the near future when we talk about other innovations that will help expand the market and provide even better things for our patients.”
EBR has more than 90 patents with very broad coverage of EBR’s technology. Company is continuing to add to patents. There is no risk of patents expiring that would give EBR exposure to competition replicating the WiSE device technology. “You’d have to violate numerous patents to try and copy us” and “We will have very good [patent] coverage for a very long time when we get to market” were the words JM used.
Expanded indications: There’s another type of pacing called Conduction Systems Pacing. EBR plans to do a pilot study next year for CSP. Very significant upside potential here. Not mentioned in slides, but very exciting. Good to know they're not resting on their laurels.
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