Dear Friend;
Attached is today's news release and here is some background on its significant for the Company.
1. A lot can happen in two weeks! We announced the Company passed the EU-MDR audit for its quality systems on Oct 8, which was a prerequisite to the EU review of our submission for clearance for the VMS+4.0 product, which we announced submitting on Oct 11th. Here its October 24 and we now have CE Mark for VMS+4.0.
2. You may remember we predicted the CE Mark would come in November so it was a surprise even to us it came so quickly and is a credit to our team for submitting such a stellar package for review.
3. This is very good news as we have several dozen hospitals in Europe who have asked to be kept informed about when the VMS+4.0 would be available. This is due to the world-first nature of having a fully-automated whole-heart analysis capability.
4. In Europe, it is the cardiologist who do the exam and collect the images as well as do the analysis and then decide upon treatment (In North America technicians - sonographers - collect the images and do the analysis which is reviewed by the cardiologist). In Europe the cardiologist often goes with the patient for the MRI exam if the echo exam is inconclusive, so they are acutely aware of the difficulties of doing MRI and are looking for alternatives.
5. The VMS+4.0 is faster, more consistent analysis results as well as number of new measurements of heart function, which need to be validated as useful, but our medical advisors are excited about the possibilities and are looking at a number of new adult patients groups who would benefit from this increased information for screening, diagnosis and monitoring.
6. All this is good but it is really the major upgrade in the integration of the VMS+ into the normal workflow within an echocardiography service that is the game changer. I have spoken to you before about the tsunami of patients just starting to show up with heart problems due the aging population (left heart problems) and the COVID pandemic (right heart problems). The predictions (from Harvard University experts) of 10-15% of people infected (and I would argue that was everyone in the world) will have long-term effects is coming true.
7. So a faster, reliable, accurate way to assess the whole heart (left and right) is only going to become essential if all these new patients are going to be properly diagnosed and treated given the shortage of echocardiography clinicians
8. I could go one for days about the nuances of the VMS+4.0 approach to cardiac care, but enough for now.
9. The Company now will begin to circle back to all those clinicians in Europe to make them aware of the VMS+4.0 which will be sold as a premium product. the VMS+3.0 is being used by our users now and some have been upgraded to VMS+3.2 which will be the base unit going forward. We anticipate VS+4.0 will be the model most desired and the added cost will not stop hospitals from acquiring this more efficient and powerful system that will address their greatest need which is workflow efficiency.
Thank for you interest and support as we continue too improve Cardiac diagnostics for everyone everywhere, and especially for children born with great defects.
Regards,
Dr. George Adams ICD.D