I endorse all that
@LeeKing has said about the AGM.
This was not the evangelical Craig show ( there was a bit of that … ) , but rather a presentation of gravitas from senior CardieX employees in Mark, Josh and Catherine. This is turn gave one confidence that Craig’s enthusiasm is backed by the calibre of employee that can deliver the projects & results which form the backbone of the prospects for this company. Niall, as always, delivered a calmness and resolute determination.
It was very, very encouraging.
Some additional points that I picked up :
1) Andon did not conduct a “User Factors Study” on the Pulse, therefore it was not submitted as part of the FDA Pulse submission. It is a prerequisite for OTC approval. CardieX is now conducting this study, and it will be submitted to the FDA on completion. The expectation is that the Pulse device will be redesignated to an OTC device by mid-2024. The Band will be submitted with a view to OTC designation ( ie. a Uses Factors Study will be submitted for the Band ), with an expectation clearance for the Band will be received at the end of 2024.
2) Working to a minimum 50% CAGR per year over next 3 years.
3) Update on new Directors early in the New Year.
4) Applying for US Blood Pressure Vaildated Service Listing for Pulse. First stage passed ( 6 months ). Not needed for launch, but accreditation, once achieved, would place Pulse with a select few devices ( mainly from Omron ) that opens Pulse to otherwise unattainable commercial contracts.
5) The Pulse App already has the API for the American Health Association built in … once lunched the AHA guidelines will instruct users on possible actions resulting from their cardiovascular market readings.
6) Craig estimated $12m required to see company thru to cash flow positive ( in addition to forecast income of course ). Clinichain will recover $6m, and other capital raising initiatives will raise $14m, $20m in total.
7) I was buoyed by a passing comment from Mark that data collected from apps etc will feed into future AI models. It is a relief that we are thinking/planning on AI applications of our IP.
8) Pre order for Pulse of USD $500k. Given first “mass production” will now be 3,000 units, followed by 7k then 10k, this is encouraging , as leasing model is making up a large part of the GTM plan. Staged production it to reduce risk. Trial production is planned for end of this week … a bug was discovered in testing and needed to be addressed before production.
9) Discussions with Bayer and needs for their DCTs was a significant precursor to decision to develop and launch Band.
10) LifeQ continue to develop all the functionality ( like sleep monitors) that will come with our vascular biomarkers on the Band. The band will have a full suite of health biometrics.
I have heaps of other notes, I’ll pick through them later to see if there is anything of value.
Very confident that 2024 will be the year of delivery that 2023 was meant to be !
