VentriPoint Diagnostics Ltd (VPTDF)

[UCParadise]

Dear Stakeholder; 
 
Attached is the press release about our FDA filing and here is some background.
 
1.  We are our own predicate device which means since we are approved for RV analysis, the FDA compares our current updated device (all 4 chambers) to our existing device (RV only).  Of course the devices are identical since all we have changed is the databases, which are used to determine the volumes and ejection for each chamber of the heart.  
2.  We use the same artificial intelligence approach for all the chambers so the actual workings of the VMS+ device have not changed and so all the previous reviews by the FDA about how the device works and its safety are valid.
3.  This means the FDA has very little to do except look at the mean and the variance for all three measured parameters volume at start of the heart beat, volume at the end of the hearts beat and the ejection fraction for the additional 3 chambers (LA.RA,LV) so  2x3x3 or 18 numbers and these all show equivalency (within +/-10%) to MRI.  We still used the MRI as the reference determination for each hear analyzed.
4.  Previously the FDA has been concerned we do hearts form many different heart conditions (CHD, PAH, congestive heart failure, MI, ischemic heart failure, etc.) so we did all of these and many more so they can have confidence the VMS+ can analyze any heart.
5.  Last time we applied to go from PAH to all hearts for RV analysis it took them 42 days to approve the application, so we are hopeful this one will be equally as quick, but you never know with the FDA.
6.  We know the application is complete as it has passed administrative review and so is actively being reviewed for content.
 
As usual, if you have questions send me an email or call.
 
Thanks for your continue support.

Regards,

George Adams, PhD, ICD.D
CEO
Ventripoint Diagnostics Ltd..
Cell: 519-803-6937
TSXV: VPT

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