Ann: CardieX Submits FDA Application for CONNEQT Pulse, page-34

Hi All,

Still here on CDX invested & great news for FDA application for CONNEQT on 510K pathway for FDA approval. It’s really exciting this is now finally happening & our patience we soon be realised, thanks for posting the FDA timeline for 510K, it doesn’t happen overnight, but good for investors to know. Just finding the time to read & post here has been a bit scant, but congratulations to all the LTH

I was reading Fierce Biotech this morning & came across an article of interest to us. Live Metric has just had a wearable band to monitor BP approved by the FDA on 510K pathway. As you know, I’m a great believer in reading up on what’s happening in our clinical space, but I came across this quite by accident this morning.

https://www.fiercebiotech.com/medtech/fda-clears-livemetrics-smartwatch-cuffless-blood-pressure-sensor


https://www.prnewswire.com/news-releases/livemetric-receives-fda-clearance-for-its-watch-like-wearable-blood-pressure-monitoring-technology-a-long-awaited-revolution-in-cuff-free-hypertension-monitoring-301578780.html


I won’t have the time today to read all the details about Live Metrics technology, but it sounds quite similar to CDX.

George Bakris MD is a world renowned cardiologist, involved with many large pharma trials in cardio-renal disease that commented on the approval in the article.

Initially I was a little disappointed reading this, but I think this approval bodes well for CardieX FDA application with the FDA & a more confidence that they will be accepting of new technology. It will be interesting to maybe take a look at this company as a case study & how our technologies compare.

This market is huge & not just in wearables for consumers monitoring hypertension, but also in the clinical trials space which is increasingly moving towards decentralisation, brought about by COVID-19, but far more convenient for clinical trial patients as well.

We all thought things were getting better with the COVID-19 pandemic, but looking like it’s getting worse with new variants (BA.4 & BA.5) that are immune & Vaccine evasive. News out this morning is that the FDA is recommending tweaking of vaccines, which won’t be available until at least October 2022 & another wave of infections is imminent. So the need for decentralised clinical trials is increasing.

Feeling very positive about CDX, nothing has changed. It’s just been a rough ride for markets and all biotechs recently, and requires patience.

Have a good day all & will check in this afternoon.