letter pertaining to lastest nr Jun 5 at 8:47 AM
Dear Friend;
Attached is a News Release announcing we have filed in Canada, Europe and USA for approval of the VMS+3.0. Here is some background:
1. These applications document the VMS+3.0, with the new tracking system and updated software, is equivalent to the VMS+. We are not asking for a change in label so from a regulatory standpoint these are relatively minor changes. From a user standpoint the changes, which allow for patient movement, easier placement of the VMS+3.0 within the echo suite and guided exams and analysis, are major advancements.
2. The last time we submitted to these agencies for approval for the VMS+, we received Heath Canada approval in a week, CE mark in 2 weeks and FDA in 6 weeks. That application was a change in labelling (from RV-only to whole heart analysis and some hardware changes). While it is not always possible to predict the behaviour of these agencies, we are hopeful a similar timeline will be achieved.
3. We have also completed a human factors study wherein sonographers were trained on the VMS+3.0 for 3 hours and then tested the next day to to see if they could operate the system correctly. All 13 passed with 100% and commented how intuitively obvious it was the operate the VMS+3.0. More on this in a later news release.
4. Our sales people have been chomping at the bit to get out and sell the VMS+3.0 and have lined up a number of demonstrations, as the the new system is portable and can be set up in a few minutes. On-site evaluations are now possible anywhere in the world. We have major sites waiting for the VMS+3.0 to be approved so they can immediately evaluate it and conduct clinical studies to show its value in patient care and cost reductions
5. With the MAJOR conference of the year the American Society of Echocardiography (ASE) coming up on 3 weeks, this is excellent timing to launch the VMS+3.0, which we demonstrated the prototype at Euroecho and a few regional conferences events already. This will be its first exhibition at an international event specific to ultrasound analysis of the heart.
6. At the ASE, the Edmonton Heart Centre will be presenting the results of their study of the ability of the VMS+ to analyze “unreadable” echo exams of the left ventricle (LV) and avoid the need for injection of contrast media to obtain a result. This will spotlight the VMS+ and its cost reduction potential at the conference. More on this in a later news release.
Please share this news release and this background piece with everyone you think would be interested.
Thanks for your continued encouragement and support.
Regards,
George Adams, PhD, ICD.D
CEO
Ventripoint Diagnostics Ltd..
Cell: 519-803-6937
TSXV: VPT
www.ventripoint.com The world's first •dot imaging• company