The entire report is now available on Anteris' website:
https://anteristech.com/us/en/home/investor-center.htmlThis is new and sounds good. Wayne mentioned a European trial at the annual meeting but investor relations didn't know anything about it when I talked to them in August:
"...the company is also embarking on its European clinical trials in an equivalent patient population towards a potential CE Mark filing in 2023. To gain European approval, a trial involving around 100 patients will be required, with European approval most likely to be received before the US approval."This timeline regarding the FDA pivotal trial doesn't make sense to me though:
The company will then conduct a pivotal IDE study in the US and Australia, this is expected to take around one year to recruit. Anteris will be eligible for reimbursement for these procedures (US$25,000 per device). Patients will be followed for one year. This study is expected to start in Q1 2024 and may include around 400 patients. We also estimate the device could be approved by the FDA in late 2024, with first commercial sales commencing in 2025.How can the pivotal trial start in 2024, take a year to fully enroll (each patient undergoes the TAVR procedure upon enrollment) and follow patients for a year but lead to an approval in 2024? That doesn't add up. If this timeline is correct it will take 2 years to get full data on the final patient. Then that data will have to be processed and the Premarket Approval application will need to be filed with the FDA. After that, the FDA has 180 days to make a decision (shorter if we get a Breakthrough Device designation). According to this timeline, the earliest we could see US approval would be later in 2026, not in 2024.
I guess the question is whether this report is setting us up for another raise as Evolution Capital has underwritten offerings in the past. We'll likely need money at some point before Q2 of next year. I've figured that the next raise will accompany the Nasdaq uplisting and will be more US money but this report could portend another Aussie raise.
(20min delay)