EIQ requests FDA meeting for AI heart failure product.
Our AI heart disease detection Investment, Echo IQ (ASX: EIQ) released a positive announcement on Christmas Eve while we were on break - and it points to good progress towards a big blue sky opportunity in AI heart failure tech.
EIQ announced that a pre-submission meeting had been requested with the FDA for its Heart Failure technology.
The EIQ share price has been relatively stable, trading sideways in recent weeks.
But may be starting to move again, after yesterday’s trading saw it up ~8.5% to 25.5c.
EIQ is commercialising AI heart disease detection software.
In October last year, EIQ got FDA clearance last year for Aortic Stenosis (a heart valve condition) which affects ~1.5M people in the US alone.
We have previously said that we think EIQ could make revenue north of US$85M a year if its commercialisation strategy goes really well.
Meanwhile, we think there’s a big blue sky opportunity for EIQ to save lives (and hospitals money) with its heart failure product.
Heart failure is the leading cause of rehospitalisation in the US.
Over 64 million people suffer from heart failure each year across the world.
And in the US, heart failure costs the healthcare system approximately $60BN annually, largely due to patients being readmitted to hospitals within 30 days.
If EIQ is able to secure a second FDA clearance, this time for heart failure, it could be a big step change in EIQ’s revenue potential.
This pre-submission meeting is where EIQ confirms with the FDA what it needs to show to get clearance for its AI heart failure solution.
This will help EIQ design its study which is expected to commence next quarter, before final submissions to the FDA for clearance.
All going well, EIQ should have clearance in the second half of this year which we think will be a transformational catalyst for EIQ.
In the meantime, we are hoping to see EIQ get some more runs on the board commercialising its Aortic Stenosis tech, where EIQ secured FDA clearance earlier this year.
How does this affect our EIQ Investment Memo?
This news directly relates to our third objective, which is below:
Objective #3: Secure FDA approval for heart failure product
FDA approval will allow EIQ to commercialise its technology for heart disease.
Milestones
✅ Publish results of clinical study (A)
🔁 FDA Pre-Submission meeting
🔲 Clinical study (B) starts
🔲 Clinical study (B) interim results
🔲 Clinical study (B) final results
🔲 FDA 510(k) application
🔲 FDA 510(k) decision
Source: 6th September 2024 EIQ Investment Memo
What’s next for EIQ?
In the most recent investor presentation, EIQ announced a number of different short term catalysts that the company expects including:
- Commence Australian pilot program with leading device manufacturer - this will advance EIQ’s licensing revenue pathway and be a “proof of concept” study that EIQ can take into the US.
- Heart Failure validation study with US based Group - the indication from the most recent webinar is that the US based group is the Mayo Clinic, we think that the outcome of this study will be a big coup for EIQ.
- Partnership with European re-seller to broaden market exposure
- CE Mark and TGA applications (so that EIQ can sell into Europe and Australia).
🔁Further commercialisation progres
Of course, we are also looking towards any further news across the commercialisation front.
This will be the main focus for us now that EIQ has secured a reimbursement code for its Aortic Stenosis product, and already signed an integration agreement with the prestigious Beth Israel Deaconess Medical Center in the US in November of 2024.
