Clearance will almost certainly be RX, this was the main focus. It allows for everything discussed so far which is at-home patient monitoring and decentralised trials.
This FDA clearance put the Pulse as the ONLY Blood pressure device that allows physician reimbursement for Full arterial health measurements. The global remote patient monitoring market is set to be $117 Billion by 2025 digital health market $500 billion. Granted not all of this will be cardiovascular however, it's already one of the most important metrics to measure someone's general health (with a blood test). Cardiovascular health is only becoming more important, especially considering scientists are finding more links between it and illnesses/diseases (depression, diabetes, liver disease, dementia, Parkinson's) previously not attributable to the heart.
Cardiovascular disease is the leading cause of death worldwide, accounting for about a third of all deaths. Having the only FDA-cleared and doctor-reimbursement-cleared device in the market transfers into a completely untapped market. Doctors don't have to see patients to help assess their heart health, and they will be able to get better metrics than a visit would get anyway. But the kicker is doctors will be able to charge for monitoring these at-home at-risk patients and getting paid directly from the government as a result. Win for patients and doctors.
Then we have the decentralised clinical trial market. 8 out of the top 10 big pharma already use CDXs SphygmoCor tech in their current trials. However, with the focus on decentralised trials increasing trial participation, more than 10-fold means potentially even more devices than consumer-focused are required to offer trial participants.
Now the obvious risks are associated with the current cash balance and Nasdaq listing but all in all the announcement due tomorrow is a company maker. Sales can and will be able to start almost immediately, and relationships and networks are there and will only grow now CDX actually has an FDA-cleared device.
This is finally where the rubber hits the road for CDX. While there have been delays, anyone watching LinkedIn movements knows that they are building and making some big moves. This is where Craig as the marketing man will really start to impress.
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