Ann: New Health Sensor Patent Applications Covering Gaming, Computer Devices, and Other Electronic Hardware, page-129

Hey Kevpod,

Thought it worthwhile to look into a few areas of interest you raised. I wasn't fully aware of the difference between FDA Approval  and FDA Cleared, and how the process relates to CONNEQT Pulse and CONNEQT Wearable Band. 

A PMA Approval is required if a product/device is new to market or classified as a Class III device. The FDA requires extensive scientific evidence to determine that the device is ready to be marketed. This includes detailed plans for clinical trials and the resulting data - safety, efficacy etc. - from the completed clinical trials. The PMA process can take years.

FDA Clearance - the 510k - relates to a medical device that is similar to one already on the market - a predicate device.  FDA guidelines state that a 510(k) should be submitted at least 90 days before the device is marketed. Submisssions for a 510(k) include  showing how the device is different from the predicate device, that it maintains the same levels of safety and effectiveness as well as the same intended use - in our case CBPM. While documented laboratory testing data is required, human data from clinical trials is typically not required for 510(k) submissions. An FDA Cleared device cannot be marketed as FDA Approved.

All CardieX market updates for the CONNEQT suite of products clearly state FDA Cleared. I think I'm right in saying the predicate device for both the CONNEQT Pulse and CONNEQT Wearable Band is the FDA-Approved gold standard XCEL SphygmoCor device. Hence the confidence in gaining FDA Clearance.

"The key differentiating feature for the CONNEQT brand and its products, will be the ability to provide medically reliable data and information in their chosen markets by obtaining 510K clearance from US FDA."

The May 17 Corporate and Consumer Brand Launch Update confirmed these timelines, previouslyannounced in the March Quarterly, all of which suggest we're entering a period of strong material news flow:

CONNEQT PULSE:

1. Device Development/Testing Clinical Validation Study Complete Q4/FY21*
2. Hardware Testing Q4/FY21
3. App/Device Testing Q4/FY21
4. FDA regulatory submission (US) Q1/FY22
5. CE regulatory submission (EU) Q1/FY22
6. NMPA regulatory submission (China) Q1/FY22
7. CE anticipated approval (EU) Q2/FY22
8. FDA anticipated approval (US) Q2/FY22
9. NMPA anticipated approval (China) Q2/FY22

*Successfully completed. Abstract to be presented at Artery Society Conference, Paris 21 –23 Oct.

CardieX Limited on Twitter: "A step closer to FDA clearance! @ATCOR division has successfullyvalidatedPULSE clinical outputs against the gold standard non-invasiveradialtonometry device. We’ll be showcasing our abstract at the upcoming @ArterySociety conference! https://t.co/jLON6aVd2n #medtech $CDX https://t.co/VPfSYLalZA" / Twitter

CONNEQT WEARABLE BAND:

1. Hardware Development/Testing Q2/FY22
2. Clinical Validation Study Complete Q2/FY22
3. FDA regulatory submission (US) Q2/FY22
4. FDA anticipated approval (US) Q4/FY22
5. Trial production of ArtyBand units Q2/FY22
6. Pre-Launch Marketing and Pre-Orders Q2/FY22
7. Mass production of ArtyBand units Q3/FY22
8. Product Launch Q4/FY22